Earnings Call: Q4 2020

Feb 25, 2021

Okay. Thank you very much for that introduction. Welcome to Sreedhar Medical 4th Quarter and Year End Report. And together with me, I also have our CMO, Peter Saki and our CFO, Susanne Andersson and also our Commercial Director, Jens Kleinenbai. So we are loaded we are ready to have a lot of questions later today. So but anyway, I will start the session and And the ambition for today's meeting, we will go through the commercial and the regulatory development of the company, and we will go into the more of the clinical development space as well, which will be presented by Peter, and then we will end with the financial summary and highlight of the quarter, but also over the year. But I suppose I should start with another topic, and that's the topic you all have heard about. And I, as the CEO, will leave the company this summer, later this summer. And then I just wanted to comment on that shortly. And if you have further questions later on, you also ask me questions in the end of this meeting. And I just wanted to first mention that Ceramic Medical is really a fantastic company and I really believe in it. And I also want to say that there are no conflicts or anything else like that, that is behind my decision of leaving. So and the reason why Behind my decision is that I'm coming now closer to 5 years of the United Work 20 fourseven responsibility of this company. And of course, it's never right timing of taking this kind of decision. But in my mind, we have seen now that we have established inhalation with Anaconda in many markets all around the world. We have increased the sales dramatically. And we have a launch of the full therapy just around the corner, which will be handled fantastic by the team. We also have a U. S. Clinical development being initiated, and it looks promising indeed. And I think it's, as I said, never a perfect time, but it's a good timing anyway for a new CEO taking the taking the new responsibility to take the company to new level. I mean, everything has had an end, and I will now start all over again in a smaller company and starting from the beginning and to build up with the company again. And that's what I am good at, and I like the small company and entrepreneurship. And I feel now it's the time for starting down that new a challenge or a possibility for me. So with that words, I will leave that topic and go in then to Slide 3. And this is the summary of the calendar year of this year 2020. As we all are aware of, we are strongly influenced by COVID-nineteen, and especially we as a company, I would say though from a positive way, if you can say so. But nevertheless, it has opened a lot of new users for our treatment All over the world. Going to the Slide 4, You know our purpose in the company. We are here to improve life during and beyond sedation. That's what we are working for, and that's the reason why we are in the epicenter of COVID treatment. The vision is actually to make inhaled today some global and apparently for critical care patients treated in diabetes mainly. And We go into the Slide 5, you know that there are benefits that actually thanks to these advantages. This treatment has been used widely, both during COVID-nineteen treatment, but also continue with other product with other indication of patients. But you know, I mean, we have a reliable effect, on off effect. We have short wake up times, we have seen that we can reduce the ICU stay. We can also see that we have reduced the operating usage in the ICU and the possibility to reduce the different kind of cognitive side effects like hallucination and delirium. Potentially, we also have seen in interesting studies, organ protected properties with improved gas exchange for human health today in general. And going to the next slide, Slide 6, you have seen it before, the market potential is still there, even though during 2020, I would say that the number of patients have been dramatically higher in the ITUs, but the long term potential will stay the same when we have those COVID situation. EUR 2,000,000,000 to EUR 3,000,000,000 is the potential of the market divided into 3 regions as you can see on the slide. We have estimated an average price globally of EUR 100 and that's the background of the potential. Going down to Slide 7, I just want also to remind you of our financial targets and objectives for long term and also our strategic priorities. I mean, we are in a situation where we are now commercializing our therapy in Europe this year. We have a full launch later in the second half year expected. If we get to Cerro Conda registration approved by the European authorities in the different countries. We are also planning for the development and the clinical development in U. S, headed by our medical director. And it's also we are preparing, but of course, we have seen I mean, there are some challenges due to COVID, mainly due to FDA are fully crowded with other responsibilities as well during this time. But now we have the data initiatives promising that we could have we're working and still towards the same ambition of having an approval in the U. S. By 2024. And then of course, the rest of the world is not I mean, it's very interesting market as well. So we are looking to facilitate to register based on the European dossier, but also standalone dossier in an interesting margin. The ambition of our target is getting 3 years after that the registration in Europe, that we should reach SEK 500,000,000 in revenue that should be in 2024 then with a very healthy EBITDA margin, thanks to the gross margin. And also, I mean, we have reached certain level now this year where we think that should be enough with approximately 100 people in Europe to sell this product in Europe. So we will have the margin we're looking into is 40% on obviously. The initial target for growth before attrition was 20% annually, which you know that we have over performed significantly during the last year. Next slide is the strategic ambition. It's actually, as I said, we would like to make this treatment to become a new standard in isolation should be standard in the critical care patients treatment in the ICUs. And we're doing that through these levels where we are initiating anaconda in establishing anaconda treatment in estimated cancers responsible. And together with the parallel registration of the drugs, we have the full label going from off label to label. And then, I mean, the core here is actually to also show superiority. I mean, from a marketing point of view, we need to show the endpoint that is showing superiority versus intravenous drugs. And that we are doing to Phase 4 studies, investigating the invasive tires and other supports actually. So we have this evidence because they will be very important, both for pricing, but as well for expansion from a commercial point of view. And the next phase is, of course, when you have the guidance and the evidence improves, you have the possibility to get into the guideline. So you actually have fully recommended and as a standard treatment within the ICU for this. So that is the last step to reach the new mission here. And how do we succeed? Slide 9. We are now in the phase of actually painting the map blue. We are having more and more countries to choose Anaconda and actually, I would say, more and more all of the main market, I would say. Still, we are lacking the U. S. Market, which is, of course, essential for us to succeed in the future. But we are working that and we'll come back on that in the presentation. So in next slide, Slide 10, what are we doing that? I mean, despite the automated situation, you know that we are selling in many countries anaconda as an off label treatment. And during 2020, we increased the sales by almost 100%. And it's not only in Germany anymore. We can see that we are also increasing sales. But of course, Germany is still the, I mean, a giant in our sales. And they are growing also very significantly during this quarter year. So the other markets actually have a hard time to follow, but still you can see that they are growing a little bit more than the in other markets and Germany. But also you can see that also distributor markets with led by the South American market mainly, the growth is also starting to become significant in the sales. And there you know that there we also in units, in volumes, it should be a little bit higher because the selling price is distributed lower compared to the direct sales volume. Okay. Going to the next slide, we are yes, it's showing again, we have 129% increase in Q4 and 98% in over 12 months of full year, and actually it's even higher in local currencies. 12 Slide 12, what's regarding approvals and regulatory registration process. You know, I mean, we submitted application in November 13th November last year to 15 countries in Europe, including Norway. We are expecting a law approval and laws in the second half year in this year. And after the end of quarter, we also have submitted the application based on the European dossier, both in Switzerland and UK. UK also are requiring national process these days after Brexit. And we expect an approval the first half year of next year. And then, of course, we are looking into the second way. When we have first approval in Europe, we can initiate the next wave of registration countries in Europe. That's we are expecting to take approximately 6 to 8 months to have it approved and launched in that time frame. And then, of course, We are now ongoing to investigating the possibility to use the European dostion also in other markets in the world. So we will come back on that where that would be. But also from a commercial and business point of view evaluation as well as the regulatory evaluation where it's possible. So that's ongoing on the going from off label to label. When you look at Slide 13, I talked about the guidelines, which should be the 4th level in our strategic ambition. But of course, we already now are in guidelines. In Germany, we have been there many years, but only as an alternative to IV drug. And this is the latest recommendation review by NICE in UK, saying that Anaconda could it's a good alternative intravenous drug for today's and in the ICUs. So this is an example of where we are focusing quite a lot these days. And we are not mean, we are not satisfied only being an alternative. We would like to be on a higher level, and that will never be achieved before we have a good registration and when we have the evidence, which is so much needed. And going to the 14 slide, next slide, there you see definitely where We are putting our efforts and then where we are actually lot of resources are spent in supporting both our own studies, but also sponsoring an investigator in the safety trial to read both registration as well to reach the evidence that's needed to get reach the full potential out of this treatment. And I think I stay there and hand over to you, Peter, to report the clinical development and progress. And we can go to Slide 3. Thank you. So in terms of top line results from SEDD is the 1, the ICHONDA study, which was the study that was performed in order for us to register Cellicon as a therapy in Europe. It was a 300 patient randomized controlled trial and it was completed in February this year and included the marketing authorization application. Go to the next slide please, Slide 16. The primary endpoint was demonstrate non inferiority versus proper fall and this will demonstrate it clearly in this study. So the mean time, mean proportion of time at target station level was similar in both groups and Next slide please, Slide 17. Looking at the safety of ice cream plus ice desolation, there were very few adverse events in both groups despite a critically ill population. And we have no safety tolerability confirmed in the data, no adverse events that were renewed for this drug and generally as has been reported, we are not related to the station or to the device. Next slide please. Besides the primary endpoint, Slide 18, besides the primary endpoint, we have a number of other interesting endpoints that were aimed at demonstrating superiority for ice strain versus propofol. And we found that opioid Requirements were lower during sedation with eye strain, which is in line with previous smaller academic studies. We also found that patients had more spontaneous bleeding during hypsurangization. Also this has been demonstrated in other smaller trials And this is obviously beneficial for the mechanical ventilated IQ patients. And finally, we found that wake up times As the study continued into day 2, we found that the patients woken up from ICTrain had a short time to wake up, reaching an alert and awake state compared to Popafol, which also was something demonstrated in previous studies. But this is the largest randomized controlled trial We have been held in situations to date. So we're very happy about these results and they are part of the clinical study report. We go to next slide, clinical development in the U. S. And please take next slide after that, Slide 20. In the U. S, we are planning for a combined registration of SETA CODA and ANACONZA. And after meeting with the FDA in 2019, A number of steps will determine that would be taken towards best goal. One of them was non clinical studies in Solutions exposure similar to the clinical setting and these studies have been performed. We are now moving into planning of Two clinical trials that the FDA required. These will be assessor blinded studies that will include approximately hybrid patients in total. And we have great interest in the U. S. Among clinical researchers through this study. So we're in full operation with this. And as Kristin said before, we anticipate to if all goes as planned, we will have an approval in 2024. So we move over to the next slide please, 2021. Here is a timeline looking at activities in Europe And in the U. S. So last year, we had the end of the SINACONDA study. We had high level data presented and also The 2nd year endpoint, 5% were presented at the Congress in late 2020. We opened the 1st ICUs for our pediatric study, the isoconfant study, And we sent them marketing authorization application as well. And in this year, we are expecting an approval in the second half year of 0.61. And we have also started to have our first patients included in isocompatible. So in 2022, we expect the Cdianex study to be completed, and We hope that this study will be useful also for our U. S. Registration to have a full registration in 2034. And that should be to an approval of the pediatric indication in Europe by 2023. So for the U. S, we have completed the impact of for this study and then the preclinical studies. And this year, we have an end of Phase II meeting late spring, and we hope to have an IND approval in the middle of the year and to be able to start a clinical trial before the end of 2021. And as Chris said, we will decide how to commercialize this in 2022, complete the clinical studies in 2023 and submit our NDA application with an approval anticipated in 2023. Next slide please, 22. Okay. Thank you, Peter. And then some Final slide about financial. We can go to Slide 23. And as you have seen in the report, We have real demand high sales of SEK 6,000,000, an increase of 129 percent and the full year sales of $142,000,000 And the gross profit, We are a little bit disappointed of that, and that's mainly due to increased freight costs during this last year. And the costs are increasing from Asia overall. It's the answer, I would say. I assume that we hear that from many companies these days. And we are working on that And we are working looking into other opportunities to improve the gross margin in the future. So our aim is still the same as we have mentioned before. The EBITDA margin, We have a negative EBITDA, as you see, minus €10,000,000 over this year. And What you can say is that, that is very much due to that we are building up and prepared organization for the full launch in Europe, But also to be a pharmaceutical company with everything that require both from regulatory quality and So I mean, I think that's something that we are looking into now and then made Cost increases among the staff including the consultants that you see now. We are more than 80 people by the end of December. And as I said initially, I mean, we are looking to that number of people. And I have said before that roughly around 100 business to do this, only including the headquarter in Europe after launch it and prepare for the clinical registration also in other markets. Okay. Let's go to the next slide, 24. Some cash and balances. As you see, Even though we have a negative EBITDA, we have positive cash flow from operations, which is fine. And that's fine. That shows that we are going in the right direction at least. And but of course, we have still high investment in and they are increasing as you see. We have $31,000,000 in investments there the last quarter and in total, at the end of the year. And that, of course, means the clinical development and clinical status is extensive. Registration is extensive, pharmaceutical registration. So that's what it takes, as you're aware of. And overall, the burn rate It's, as we said, approximately SEK 30,000,000 during the last quarter. We burned a little bit less than SEK 90,000,000 during the full year and we have we'll say SEK 376,000,000 in cash. So it looks good and we are well prepared for in the clinic started in U. S. And also, I would like to mention, I don't think we have mentioned it before, but we have seen it obviously, but we have no Yes, that's a free company. We're no long term advisor there, which is also important. Next slide, 25. We also normally have the update of the which you can find also in the the shareholder relief, where we still have the major Swedish institutions combined with founders and also some international institutions as well as on the coffee can include here. And no dramatic changes. Okay. I think that is the next slide. So 76 is the question slide. So please, If there are any questions, we are happy to answer them. Thank you. We have a question from the line of Peter Asling from Pareto Securities. Please go ahead. Yes. Thank you. Can you hear me? Yes. Yes. Great. I have a couple of ones. I'd Take 2 or 3 and then jump back to the queue to let other ask also. Could you just talk a little bit about Within the distributor markets and the other direct sales markets, if you could highlight any Specific countries that performed really well within those categories in the quarter? In the beauty markets, I would say the biggest surprise was Central and South America, which went from almost 0 to the biggest market outside our direct market. I noticed that Colombia Issued specific guidelines for inhaled sedation During Q4, did that help or it obviously helped? Yes, yes, Absolutely, it sounds. But maybe Cees could comment on that. Well, so I mean, there is general interest in South America from There is many key opinion needed to return to us and we still have more registrations to come. And also before the Colombian guidelines, the Pan American guidelines, there was included mention of inhaled sedation. So I think it's a combination of guidelines and the COVID situation that led to this interest. And I'm every year the growth we have more modifications. So I mean, it's amazing actually what the interest is there. But anyway, we can also when it comes to the direct sales market, I think, Our commercial direct is best to answer that. Yes. I think that the first and fair statement is that we're seeing sort of quite Strong interest and good performance across all markets outside of sort of direct sales market outside of Germany. So There are new hospitals coming on board throughout the year. So it's a general statement. But I think we've seen if you want to highlight a few, we've seen France grow quite nicely in the year with 3 in the year with the double the number of hospitals that have come on board. And Spain has had a very strong year, specifically in the 2nd wave and so was the Benelux market. So I think that we're seeing quite strong uptick and with hospitals coming on. Okay. In the Q2 report, you mentioned that about 40% of the growth came from new customers. What's your best Guesstimate, if you look at H2 or Q4 or during the second wave, Those customers that came on board during the 1st wave, I guess they remained customers. And what did you see during the 2nd wave when it comes to new customers? If I divide that answer up in a couple of chunks, Have we we continue to see new customers coming on board. So that trend is and it's the same across markets. Encouraging to see is that a majority of the customers are also now repeat regular customers. We did see a few customers in the first way that came on board, maybe a bit sort of urgent due to propofol shortage that have not On repeat, but the majority are now repeat and regular customers and that's been quite a big focus for us. In terms of what Percentage of the growth comes from new customers in second half. We haven't done that analysis into the same depth, but it's fair to say that That number is likely to be a bit lower than the first half of the year, partly driven because of that we've seen And the COVID volumes have been much greater in the second half of the year, meaning that the existing customers have taken a larger chunk of the growth. But it's still a significant part of the growth is coming from new In the second half as well. Also, but the only company mentioned, Peter, is that it's I mean, during the first wave, there were quite a lot of chaotic orders due to the IV shortage. In the 2nd wave of COVID, we have not seen the same shortages of IV in Europe. So I would say that is a good interesting trend. And Despite that, we are having, I mean, such an increase. Okay. And those Have you made any general analysis of the new customers? You mentioned Shortage of existing drugs. And are there any other reasons that They use or start to use enhanced sedation? I mean, I think the main reason is that for the COVID patient, it's I mean, that they believe that this is a better treatment. And that patient doesn't have doesn't need to have ARDS? I mean, most of the patients within the ICUs suffering from COVID do suffer from ARDS. I'm looking at Peter, but that's correct. With your question whether they use it in other patients? Yes. So we don't actually have we don't have data on individuals, let's say ICUs and the patients. We certainly do believe that they do. COVID does cause ARDS among the other patients develop ARDS. And what I think what made this very attractive in the COVID pandemic is that these patients see very much sedation And they get multiple drugs. And when you have cancellation, you just can manage with that alone. And so there will be, of course, influence how people Behave when COVID is no longer here. But we do believe that this will be something that brings their attention to a unit therapy that has benefits. And certainly, I think our approval is spent on that, at least. Yes. That was my follow-up on Lars that I so I've seen some estimates that about Around 40% of patients on mechanical ventilation are in some stage of ARDS. And If it could be a risk that when you get the full approval, it will be Yes. For those patients and not as broadly used as you may hope. Yes. About 40% of all IV patients are quite good. Yes, okay. I agree. I agree. But you still have to penetrate all those 40%. Yes. I will answer this question. And I mean, I can speak to this. There are many other reasons in ARDS. I would say that ARDS is not There are many other medical conditions and patients that we have good reason, I think, to clinicians as well to see that this Treatment probably is the best choice compared to the peptide treatment. And this is hard for us to convey as we I mean, we don't have multi authorization. So And not label therapy. We are much more silent than we will after approval. Because Yes. Just kind of leading back to sort of, okay, why did they come on board, etcetera, sort of an interesting analysis that we have made Our analysis, what we've seen is that, sort of, we sort of when we're speaking with the UK team, for example, and we've seen similar pattern in the other All the customers that came on board that started up in first half and second half, pretty much 100% of those customers were customers that we had interacted with before that I showed interest before, so we've had our anacondes locally and engaging with customers. So So basically, all of them that are coming on board have already shown interest from before. So we're feeling quite comfortable that sort of They didn't come just because they were afraid of propanol shortage. They came on board because they saw the benefits and they are here to stay for recently on COVID. Sorry, but finally on this on a little bit of the same topic. The 2 largest ongoing investigator study, CSR and the Canadian study are focusing mainly on ARDS patients. Will you be able to use those data as a crossover or read through to other indication as maybe Peter alluded to? Well, I think the clinician at the bedside It's not really looking at the oxidation when we are deciding for sedation. They're looking at the patient's needs. And I'd say that, certainly, These studies will be generalized to patients who need sedation regardless if they have a good or poor oxidation. The oxidation part, I mean, the CISA study is focusing actually the primary endpoint is not oxygenation, essentially, to 3 days. That's driven not only by Oxygenation, but also how rapidly can you reverse sedation, how rapidly can you get the patient out of bed. Those things will also determine that endpoint. I think certainly that those that it will be useful not only for us to discuss inhaled patients and also for other patients. Okay. The pharmacology of inhaled anesthetics and Isopren specifically Speak very clearly to their advantage, particularly patients with organ dysfunction. So I think we have a lot to talk about besides ARDS. Okay, great. Thank you. I jump back to the queue in the queue. Okay. Okay. Are there any other questions? There are no further questions. So Peter, if you want to ask again. Okay. Can you give a Brief update on where you are at establishing manufacturing outside Malaysia? That's ongoing. We foresee to secure that during this year in Europe. And But we also I also would like to mention that we have ramped up the manufacturing capacity by almost 30% in the existing site actually concluded during the last quarter. So I'm not that worried about, but of course, from a risk mitigation, it's good to have a second pause here Europe as well. And as I also mentioned, I think it's good for the freight cost and we can reduce that kind of cost significantly. But on the headwind, the net cost is significantly higher here. But we prepare for a very lean set up and effective manufacturing of our products. So during this year, we will have it, the sooner the better. We have it under control. Okay. On the U. S. Side, the human factors study and the tox Studies that you need to do in order to file an IND. In the report, you said Say that they are ongoing, but in the presentation, you said or you have previously said that they were finalized during Q4. Can you talk about a little bit of the about the interactions that you have had with the FDA on those matters? Yes, certainly. So we've had a meeting in 2019 when it was when the statutory and substantial studies were discussed. And we have performed the studies that we believe are necessary to go move on to Several trials, these have been submitted to the FDA for a so called Type At SeaMeeting and they will determine whether they compare that the model we've done and the Study design answers the questions that they feel need to be answered, obviously, right, with some trial. So I'd say it's ongoing news that we haven't yet had the green light to go ahead with clinical trials and we hope To come back to that. Yes. So we'll certainly have a need on that. We'll come back. Okay. The U. S. Studies, will they also be non inferiority studies? Which studies? The U. S. Studies, the 21 studies? Yes, yes, Yes. They will be they are trying to be non inferiority. But once again, the FDA will have to give feedback on the 3 protocols. And then Non inferiority design is I mean, we will be able to do a placebo study, that's HABLIS, so comparing with another drug. And actually, As you could see from the SED-one study, Opiphol works pretty well in oxidation, but we believe more in other benefits. I mean, I'd say that this treatment for some patients who need very much sedation, the benefit is it works for everyone. Everyone goes You can just give one single drop and that's a fantastic feature. Hopfidence always suffice, but there are many other things that we believe among others that And the other endpoints I mentioned since the year 1 that we think makes the difference. So our primary endpoints is more to satisfy regulatory needs, That's the second element what makes Accrington stand out. Okay. That will be used also for the pricing and then for the commercial and for marketing as well. I mean, that's before the second or anything. Because they said The European study was very much statistically tilted towards the primary endpoint. And I know that you have talked about looking at the design in order to get the more Is it get the statistical chart more evenly so that you can Have it on the secondary endpoints as well? Yes. So there is an approach to secondary endpoints for U. S. Labeling that we are employing in order to deal to make more changes So we've been working a lot with that and we'll be having that discussion with the FDA later this spring. And I mean, of course, we have learned a lot also from the European strategy. Of course, we have learned where we should fine tune so to date. In Europe, do you estimate to have Reimbursement in place at the time of approval or just shortly after that? Jens is in charge of that. He will respond to that. The answer is the quick answer is depends on country. Each country has its own set of rules and processes. So there will be countries and most encouraging a country like Germany. And we look at the Nordics, Netherlands, etcetera, where we will be able to start selling Ceraconda, So basically as soon as we have product on Shell. Yes. It's the same as for drugs. Yes. Yes. So there will be a quick process. Then there are other countries like France and Spain and have slightly longer sort of standardized reimbursement processes that we need to go through and there might be a 3 plus Month delay before we can start selling to that. So it will vary across. But there are a number of countries we can move with speed as long as as soon as we have the product on shop. Okay. Can you give a Quick update on where you stand on China? Yes. We when we communicated China submission, we communicated 2 year estimated 2 years still to approval. And that should be summer 2021. And that's where we're still aiming for. And that should be possible. Okay. Well, I jump back to the queue if anybody else has any questions. Well, we can comment on the you asked about price. But just for your information, I mean, when we have when we get the registration in Europe, we will have first the national first, we will have will go into the national basis. And there you will have there they decide the label and the artwork and the initial data in local language. And I mean, you need to get that approval nationally before you can start to produce. So there is a little bit delay of some month from approval to we have product on Shell. But I suppose everyone is aware of that. But we are trying to take that time as much as possible of course. Have you been working with the German Authorities or medical board in order to change or widen the guidelines? Do you need more evidence I mean, of course, the more the evidence we get there, it will be. And the guideline committees are very independent. So it's not possible to I mean, it's quite challenging to make, what you say, yes, influence that. I mean, and I think that's important to mention. So that's the reason why Fluids and evidence from clinical studies are so essential and important. So that's the reason why they are. Maybe Piso may very well. No, I just wanted to say that we do understand that they do have a process, guide bank process, where they ask for inputs from industry. And so we are keeping an eye on that since we do not yet have a publication out there besides the post. So anytime we will be asked for any inputs, we will share generously. And while talking about publication, have you an updated timing for publication of the or one results? That will obviously depend on the review, but we We anticipate that it will be published in the second half year this year. That's about how that can become at this time point. Okay. I will jump on. We have said ambition is to get in a well reputated journal as possible. And that's the reason why aiming and hiring. Yes. Then it's a little bit of a delay because I think you said first half of 2021 originally. It might be. It depends on the review timeline. But the ambition is difficult even before launch. Have you thought of I mean, your Financial target of €500,000,000 in sales in Europe 3 years after approval. I think it's been the same since IPO. And Having the COVID experience and all the It's a good target, Peter. No, we have not I mean, of course, we will look into U. S. Later on. But for Europe, I think it's still the target of $500,000,000 And I think that the 3 years of the launch, it's still a realistic ambition. But that's Europe. And of course, we have other markets now coming closer. We need to look into that, but we will come back on that. U. S. Is, of course, interesting. I mean, I know it's longer. Yes. But I didn't finish my question. The 500 for Europe has been around and was set before the COVID Experience. And now you have had all these customers and supposedly you will start with From a higher base than originally thought when you set this SEK 500,000,000, but you still think that $500,000,000 is a good estimate. Yes. I mean, you're right in that, but still it's I think it's still challenging and still realistic. I mean, it's tough to estimate it, Paul. I don't know if you can answer that. Yes. I just wanted to comment on that. While COVID has been, from a Zodala perspective, an opportunity to demonstrate this therapy, The majority of vaccines are not using this tariff today in Europe. And it's only after launch really that we'll be able to Fully flesh out all the benefits. I think that one shouldn't overestimate the effect of COVID on our long term goals when it comes to studying good about the therapy. And how many percent of the ICUs in Europe are using Anaconda Yes. I don't want to say a figure, but it's far less average. It's less than 25%. Yes. But Hopefully, the customers that you have will stick and have had a good experience. Absolutely. COVID or not? Absolutely. What I mean is we're rolling this out in a completely different fashion once we have a launch. Okay. I think we should stop there or I think we are done. Or yes, are there other questions from any other one in the audience? There are no further questions on the phones. Okay. Then we stop there. And we thank you all for your attention and your interest in Sildana Medical and We welcome you back in 3 months. Thank you. Bye bye.