Yeah. Thank you so much. Welcome to Sobi's Q1 conference. We are in an exciting period for the company. Before going into the presentation, a quick reminder of the forward-looking statement. As per usual, I'm joined today by Henrik Stenqvist, CFO of the company, and Ravi Rao, the Head of R&D. Q1 is a quarter that deserves a second look, and I come back to this in a moment. However, first I want to draw your attention to what we have achieved during the first three months. Substantial growth in our launch business, particular with Doptelet, we more than tripled in Q1 versus last year. We stayed competitive in our hemophilia business and showed significant patient growth versus Q1 last year. We had strong earnings in the quarter, and we delivered against our objectives in R&D. Now we will address why Q1 results deserve a second look. The stats are known to you. Top line growth was -21% at actual rate and -13% at constant currency. This effect has flown throughout the P&L, and EBITDA growth was negative, -32%. However, allow me to familiarize you with the underlying drivers of our business, not to justify, but to clarify why our confidence to grow this business by end of year at constant currency has been increasing despite those results. First, let's go to the next slide. When you look at the currency effect in Swedish krona, we have a - 9%. Given the distribution of our revenues, primarily euro and U.S. dollar-dominated regions, this is more related to, it's an[Ark effect] as opposed to signifying our underlying business performance. When you look at the so-called one-time effects, we had significant stocking effects last year at the same time due to COVID and beginning of the COVID crisis. We had also a retroactive price adjustment for Elocta in Germany. This led to one-time effects that are not affecting our business moving forward. Thirdly, we are facing transitory COVID-related effects that can be attributed to our hemophilia products, primarily consumption per capita and synergies due to the low virology. Regarding both product areas, we have now obtained signals suggesting, let's say, a pathway of towards normalization. Before providing you further explanations, a quick perspective on hematology by quarter. Essentially, the growth of Doptelet was not enough to propel the entire franchise for growth. Let us go straight into the Elocta numbers. Let's say, as many questions will probably arise towards this item. When you look at Elocta at the area of one-time items, these are, as mentioned earlier, related to retroactive price reductions for the last quarter of 2020. These de-stocking effects, as mentioned in the earlier part of the presentation related to, let's say, stockings that we had at the same time of last year. Let's say some de-stockings that we are facing this year. We believe that these are transitory effects. Sorry, these are one-time effects that will not affect our business moving forward. When we can maybe go to the transitory effects. This is the consumption per capita. When you think about the consumption per capita, we believe that this is an area that we can improve over time. We have positive signals from the comparison of Q1 2021 versus Q4 where we improved our consumption per capita over 2%, even though in this chart on comparing Q1 versus Q1 last year, we have a -12% effect. Regarding ALPROLIX, let's say we continue growing the business if you take away the one-time effect for stocking in Q1. Similarly to Elocta, we will continue focusing on reclaiming the lost consumption per capita. Now let's move to Doptelet. You need to evaluate the average of Q4 results and Q1 to measure the progress in view of some of the stocking effects. We are reassured by the accelerated penetration in the U.S., early launch KPIs from Germany, and demand signals from China. Overall, this is a very positive evolution and we look forward to the Q2 results. Next slide. In immunology, you need to look at our business more on a four-quarter rolling basis. In order to balance the seasonality of synergies. In Q1, we were materially affected by the low virology to the tune of SEK 300 million, covered under these transitory COVID-related items. However, as we said, RSV is not gone, and epidemic levels were recorded by CDC in three states in April, supporting our expectations for H2. Next slide. Gamifant quarterly performance is still affected by weighted difference of patients. Let's say 47% growth at constant currency versus last year is a very positive outcome for us, and I'm very optimistic with regard to the future evolution of Gamifant. Next slide. KINERET is still going strong, as you can see, and I'm gratified by the strategic progress that we are making. + 20% at constant currency growth is a very strong outcome. Even more important is the improvement that we have made. We got the approval in Russia, foremost are the impressive results of SAVE-MORE to mention here as a significant step forward. An improvement of overall clinical outcomes by 64% in hospitalized patients with COVID-19 pneumonia is a very meaningful improvement. This notion is underscored by the fact that in April, approximately 6,000 patients per day were hospitalized in Europe, this includes the U.K. Approximately half of them would qualify for the treatment with KINERET, according to the stratification of SAVE-MORE. This gives you a sense what difference KINERET could make for patients. Ravi will share with you now on how he looks at the data from a clinician's perspective, and he will provide a general update on R&D as well. Ravi. Thank you, Guido. Before I get into the study, I just want to highlight the progress we've made in R&D in Q1, supporting our strategic goals of growing our business, delivering the pipeline, and geographic expansion. I'll talk in a little bit more detail about the SAVE-MORE results, which we announced yesterday. A reminder that KINERET was also approved in Russia for the treatment of CAPS, and Doptelet was recently approved in Europe for ITP. On the BIVV program in hemophilia, the pediatric study is well underway, with a great deal of excitement amongst investigators. That comes on the back of completed enrollment in the adult study. Finally last week, you will have seen the announcements about nirsevimab and the MELODY phase III trial, which met its primary endpoint of the reduction of RSV infections in young children. Next slide, please. Let me spend a bit of time now talking about the SAVE-MORE study, and the positive results from this investigator-sponsored study that was led by Professor Giamarellos-Bourboulis from the Hellenic Institute of Sepsis in Athens, which demonstrated that early targeted treatment of anakinra improved the outcome in COVID patients, as Guido just mentioned. This trial was of anakinra versus placebo, but on a background of standard of care. That includes remdesivir, dexamethasone, and anticoagulants. This was in hospitalized patients with COVID-19 pneumonia, but in patients not on assisted ventilation. They may have been having oxygen, but they weren't on mechanical or assisted ventilation. These patients were defined to have poor prognosis, as demonstrated by an elevation in plasma suPAR, which is a biomarker that's been associated with immune and inflammatory activation and poor prognosis, not just in COVID, but in other diseases. This patient population very much represents the type of patient going into hospital in Europe or North America or in Japan. Despite recent advances in treatment, such as the ones I'd mentioned earlier, as well as vaccination, it's clear there's still a very high unmet need in COVID-19. I should point out that we've been in ongoing dialogue in collaboration with Professor Giamarellos, with the Emergency Task Force of the European Medicines Agency, and we'll be continuing that dialogue on the back of these results. On to the next slide, please. Let me give you some key highlights from the study. 606 patients who were randomized across 40 sites in Greece and Italy, and I'd like to thank those patients and the physicians and healthcare professionals looking after them. 60% of the patients we screened were positive for suPAR. We screened just over 1,000 patients. 60% being positive is similar to real-world data that we're getting from other parts of Europe. Let me explain the endpoint in this study, which was at day 28. It was a WHO-validated clinical progression score, which actually has 11 domains. For simplicity, they can be narrowed down to five domains, which I've shown in the table on the left-hand side. The outcomes range from uninfected and discharged from hospital, through to mild disease, moderate disease, severe disease, and death. In the middle are the numbers or the percentage of patients in each group who fell into these categories at day 28. I should point out that this was a randomization in a 2:1 fashion, so there are 200 patients approximately in the standard of care plus placebo group, and 400 patients in the standard of care plus anakinra group. There are several things to observe in this schematic. The first is that the new standard of care works well. Patients did progress to ambulatory disease, but there were still significant numbers of patients with moderate disease, severe disease, and death. The effect of anakinra on top of standard of care shows fewer number of patients with severe respiratory disease, fewer numbers of patients who die, and a much higher number of patients who are able to go home virus-free by day 28. Now, overall, the odds ratio was 0.36 and was highly significant. Put more simply, a patient receiving anakinra on top of standard of care was nearly 3x more likely to improve their clinical outcome by day 28. As mentioned, let's put those data into some sort of clinical context. We're using European CDC data on the right, which shows that 175,000 patients were hospitalized in Europe during the month of April. We know from other data sets that similar numbers are still being hospitalized in the United States. Recall about half of these will have a positive or elevated suPAR. The data would support that these patients would be spending less time in hospital and leaving virus-free, thus easing the burden on the healthcare system for other patients. At the other end of the spectrum, there are still many patients being admitted to intensive care, and 25,000 patients were admitted in Europe during the month of April, to the best of our data. Obviously, intensive care admissions and mechanical ventilation represent a huge burden on the healthcare system, and we've seen even recently the pressure on intensive care beds and even on the supply of oxygen. What you can see is that with anakinra, far fewer patients are going to require mechanical ventilation or will progress to severe respiratory disease than if they just received standard of care. I think in total, these data demonstrate that anakinra represents a potential major impact on the treatment of this disease. Next slide, please. I'll finish just by showing the extent of our late-stage portfolio. We continue to execute on the medicines shown here, as I mentioned earlier. The next big event for us, other than hopefully registration of anakinra for COVID, is the U.S. approval of pegcetacoplan in PNH, followed by European approval later on this year. I'll stop there and hand over to Henrik. Thank you, Ravi, and good afternoon, everyone. Let's go to the financial summary for Q1. Revenues in the quarter, as we heard, were impacted by the pandemic and subject to tough comparisons with Q1 2020, when COVID-19 resulted in stopping, particularly of our haemophilia products. The revenue number for the quarter was SEK 3,661 million, corresponding to the decline of 13% at CER, and this was driven mainly by Elocta and Synagis. Moving on to gross margin of 80% in Q1 compared to 78% the previous year. We have, on the one hand, the negative impact on our gross margin from the mandatory price reductions in Germany for Elocta, and more so in Q1 because of part of the reduction, just about SEK 90 million, was applied retroactively from 2020. On the other hand, we also have other positive effects that improve our gross margin. These include various product mix and country mix effects and improvements in the cost of goods and also ceased royalty obligation and reduced distribution costs. We continue to trend positively, but remember that in the next two quarters, Q2 and Q3, we have seasonally weaker quarters because of the very limited sales of Synagis. This will normally bring gross margin down from the levels in Q1. EBITDA reached close to SEK 1.5 billion for the quarter, corresponding to a margin of 41%, lower than last year's 47%, but still a very profitable quarter. Operating expenses were just slightly above those of last year, despite the increased scope of our business in terms of geographic reach and R&D pipeline. I will come back to OpEx on the next slide. Operating cash flow in Q1 amounted to SEK 1.7 billion, benefiting from a reduction in working capital as planned, given the seasonal strength of cash flow in Q1. As a result, net debt at the end of the quarter amounted to SEK 12.7 billion, about SEK 1 billion below the number in the quarter before, and corresponding to the net debt to EBITDA of about 2.2x, which is similar to the level in Q4. Next slide, please. Add some flavor to the OpEx evolution, starting with SG&A. As you can see, SG&A spend in Q1 was relatively similar to previous quarters. Of course, somewhat held back by the COVID restrictions that we've seen in several of our markets during this quarter. Although cost control is high on our agenda, we foresee SG&A to gradually increase during the rest of the year as we come into the launch phase of Doptelet in Europe, which started with Germany already in Q2. Furthermore, we come closer to the potential approval of pegcetacoplan in PNH in Europe and will ramp up pre-launch and launch activities. We will continue to invest in our international expansion, not at least the commercial infrastructure. For example, in Russia, where Elocta recently got reimbursement. Finally, we do plan for less COVID restrictions during the rest of the year, which will facilitate a good activity level in our markets. Next slide, please. Let's now look at the OpEx from an R&D perspective as well. We can see that the Q1 R&D spend is in line with what we've guided for, 13%-15% of revenue. As we can see, it's mainly the programs related to the new additions to our pipeline, pegcetacoplan and SEL-212, which are driving the higher spend in R&D compared to the previous quarters. We expect this to continue to be the case as these programs progress and that our R&D spend remains in the range of 13%-15% of revenue. With that, I say thank you, and back to you, Guido. Thank you, Henrik. When we go to the financial outlook, basically, it's too early for us now to change this. We have obviously shared this with you at the last earning call, SEK 14 billion- SEK 15 billion and 30%-35%. If you're thinking about it on the next slide, what is our sense already after the first quarter, if anything, we think that there is an increasing confidence with our team and myself to grow the company at constant currency. First of all, we believe that we have significant traction with our launch of growth products. We have also, when you discern the one-time effects and the transitory effects, and granted, we have to still work on mitigating those transitory effects over the period of the year. There's a significant opportunity, again, to mitigate some of the effects that we have seen in Q1, notwithstanding the fact that the one-time effects will not affect us moving forward. Secondly, and this is what I alluded to earlier, there are positive signals that we can overcome these transitory effects. We see that we have improved the consumption per capita of Elocta Q1 versus Q4 by 2.4%. We have seen that now virology in the month of April, according to CDC, is improving or is increasing as such in the various states in the United States. That makes us optimistic with regard to the outlook of the next season. Certainly as well, we, I think, impressively have demonstrated we're delivering in R&D, whether it is in terms of regulatory affairs, getting products registered, but also in terms of delivery in our trials. Frankly, we think that there's a material opportunity to do well for patients with regard to KINERET. On the back of this, we should do well also for the company. If anything, we are more optimistic as we go into the next phase of the company, but we stay cautiously optimistic. I think on this note, we would like to, let's say, open the floor for questions. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. Please keep to a strict two questions per person, then re-enter the queue to ask your remaining questions. Our first question comes from the line of Eun Yang from Jefferies. Please go ahead. Your line is open. Thank you. I have a couple of questions. For KINERET and COVID-19, you used this soluble urokinase plasminogen activator receptor test. How widely is this test being utilized currently? What percent of COVID-infected patients would be positive for this test? Yeah. Before Ravi explains this in more detail, we have done an assessment that obviously this test can be run on the predominantly available diagnostic machines. You would have, in the case of Europe, this is high-level estimates from the team, around 70% coverage of the clinics. The question is also here, how convincing will be the data for physicians when they are confronted to make a decision when the trade-off is actually relatively marginal? Maybe, Ravi, you want to comment on this. I think we look at suPAR as a poor prognostic marker. There are other poor prognostic markers as well, which have been well-documented. I think the treatment decision for the physician is if I've got a patient who has poor prognosis based on a number of factors, including potentially a suPAR test, what's my treatment choice that I would make? As well as being available on existing machines, the suPAR test can be done in a near patient device. The company that manufactures that have obviously been working on different ways of testing suPAR. We think that what this does is change the paradigm. It's earlier treatment and you're targeting poor prognosis patients. I think that's the critical thing. We're not talking about patients on intensive care, and we're not talking about treating everyone who comes through the door. We're talking about making a medical decision, and this really is a sort of proof of concept of that idea that poor prognosis treatment with KINERET is the right thing to do. That is helpful. With this positive data, do you expect KINERET use to increase prior to any kind of emergency use authorization? How soon do you think you could get this approved for emergency use? Thank you. Yeah. Basically, I'll start with the first part of your question. Then Ravi will talk about the approval process. As you know, we have reported, KINERET is already used in COVID-related indications as we speak today. Clearly, for those who are willing to spend a bit of time, we can reach this and disseminate the information, they will have to make individual decisions. When we spoke to some physicians who are extremely excited about this data, and as a consequence, it will definitely not do any harm to the product's evolution. That we can safely say. To what degree it will instill growth prior to any regulatory approval is difficult to assess. I think we will see some uptake. This is very important news for patients who are in need and who have a poor prognosis or at least want to improve their prognosis. Ravi, you want to maybe comment on the regulatory pathway? Well, Professor Giamarellos and ourselves have had a productive dialogue so far with the Emergency Task Force at the EMA, and that will continue. We've had inquiries from a couple of other agencies for the data. We will obviously continue those dialogues. We have had not a commitment yet for a timeline from any of those agencies. We would hope to start submitting this data really within the next several weeks once we've pulled it all together. We're showing you top-line results. We now have the full set of tables, listings, and figures that we need for a full dossier. Our intent is to submit this really within a few weeks' time, and depending on the agency, the review process will depend on which agency and what data requirements they have. We know that this process can go fast. I think we believe, Professor Giamarellos believes, and other people who we've spoken to believe this data is pretty compelling. Thank you. Thank you. Thank you. Our next question comes from the line of Erik Hultgård from Carnegie. Please go ahead. Your line is open. Hi. Thanks a lot- Hi. for taking my questions. Hi there. Just on consumption and the Elocta sales, how should we think about this for coming quarters? Could you talk a little bit about some of the, I guess, early trends that you might have spotted in sort of markets such as the U.K. that have opened up earlier than other European markets due to lower incidents of COVID? Any sort of comments on that then, and should we expect sort of normal pre-COVID levels of consumption in the second half of the year? That's my first question, then I have a follow-up. Sure. When you look at the data that we have reported in the slide deck, -12% Q1 versus Q1 last year, basically when you take into consideration that we had a, granted, an early signal, but still an important signal of 2.4% improvement versus Q4, you can see that some of the work we are doing with the association is bearing some fruits. Now we are not commenting on the different countries, but what we can see is that in the moment, things are relaxing. And people are more prone to have an active life. That definitely stimulates the discussion and with physicians and also patient associations to work then on a more normalized administration of the drug. This is what we can see. I think it would be not correct for me now to comment on the individual countries, but as a trend that is true. What we will see is, and that's obviously, what is the speed now of this recovery? Frankly, that's everybody's guess. We think based on the data point we have obtained, that we will at least improve, let's say, take back a significant portion of this decline now over the next, I would think, that in the next half a year, we would see a significant improvement versus where we are today. Yeah. Is this normal levels? I think normal is in today's world, a big word. Yeah. I think I would not go so far, but at least we will see a substantial improvement. We should see a substantial improvement where we are in terms of consumption based on the work that we are performing in conjunction with the respective associations and physicians. Thank you. My second question relates to BIVV001. I know it's a bit early, I guess, to talk about pricing, but just wanted to get the sense on your confidence level in getting payer support in Europe for premium pricing on a unit basis in Europe versus Elocta. Do you see a risk that BIVV001 will be an opportunity for payers to save costs on less frequent use? Yeah. Thank you. I think based on the payer research that we have conducted and let's say in our insights, we think that BIVV001 will be welcomed to the market. Whether it will, on a net price basis, improve our pricing on a cost per therapy, I am not totally sure. Many also new entries into this market that have not on a net basis, even if they had on a nominal basis an increase, maybe not necessarily have improved it. I think this will be an important addition. This is our base assumption. If there is an opportunity for a price increase versus on a cost per therapy basis, we will have a look at this. Our base assumption is that we will have the cost of per treatment in line with existing therapy. Okay. Thank you. Yeah. Thank you. Our next question comes from the line of Christopher Uhde from SEB. Please go ahead. Your line is open. Yeah. Hi there. Thanks very much for clarifying on the products. Very helpful. I do have a few questions, but I'll start with one because it's got a few parts, I'm afraid. Looking at consensus for Sobi, I'm always struck by the enormous spreads. In my view, while that really means that we on the sell side as a group are failing to understand the equity story, and I guess it stands to reason that if we are, the market is too, and the upshot of that is that when everything's been going well for a while, of course, the market tends to factor in the upper end of the ranges. On the other hand, once there've been a string of misses, the market starts to assume the bottom end. I think the other thing here is that when consensus deviates too far above actuals across too many areas of the business, we get into an undesirable equity narrative of death by 1,000 cuts. If you'll humor me by diving into the latest consensus with me, there are a few products where I see sort of wide major spreads and a risk of big estimate cuts for 2022- 2023. The aim of my question is to ask for your help to narrow the chasm a little by providing some clarity at this point on some of the basic assumptions underlying forecasts. There are four major parts here. The first is around pricing in hemophilia. The pricing pressure, if I understand, it's so far that the price cut was in Germany. Since Germany is usually the highest, we usually see then other countries following suit. Should we expect that going forward that other countries will also cut? The second one is on Doptelet, where I'm way above consensus for 2022 because I assumed you'd offered a discount for the first two years to get on formularies. That these discounts would then expire after a couple of years, bringing your net sales per patient more in line with competitors. Now it seems Novartis are saying that it has no plans to extend its IP on eltrombopag, so meaning it would expire, I guess, in 2023. What do you expect to happen to Doptelet net sales per patient in the U.S. over the next couple of years as this event sort of materializes? In the third instance, I see consensus has Gamifant increasing steadily through 2023. I fail to see an inflection point until the RH/LH launch in 2024. You've said you're fully penetrated in the U.S. in primary. You had left behind the European market for primary, and it seems that you may get an approval in China, but the odds of a national reimbursement coming in within a year or two are probably well below 50%. Given that Gamifant is the third most expensive drug in the world or so. It seems unlikely that it'll be affordable without national reimbursement. Is there something I'm missing on Gamifant? The very final element is the margin for 2021, where consensus had relatively high OpEx for Q1. It seems to me that with all the trials and commercial buildup not starting simultaneously at the start of the year, that this should ramp up gradually over the year. Do those assumptions hold water? Thank you, and I apologize for the length of the question. Yeah. Indeed. Normally, we ask everybody for two questions and you have given me a few more. This is where maybe what we do is we set up a separate call with you to shed more light on this. Let me come back to some of the things that you said. Basically, with regard to Doptelet, I think what we can see, let's say, is that we have got on an important formulary recently, and that is benefiting us. You will see that we are on a actually very nice trajectory and that we are broadening all the product quite substantially. It's first quarter. Give us a little bit more time and I think you will share our optimism with regard to the product because we see some very strong signals also actually from our partner with Fosun. We will have an impact in the European market and starting with Germany, obviously. I hear you that 2023, Novartis doesn't want to prolong its patent, but then they have a new formulation. I cannot speak for Novartis, to be honest. I'm worried about Doptelet, but we will focus in claiming our turf with what we believe is a superior product. We want to take a fair share. Yeah. With regard to the price of Elocta, the good news is that the German price, as you rightfully suggested, was at the higher end. What we can do, what we can affirmatively say is that there is not the need for a reference price adjustment now across countries. Yeah. That basically will not now trigger necessarily other price reductions anywhere. To what degree now people are enthusiastic to do price cuts elsewhere, you never know. We don't see it right now. I can only report and I don't want to speculate what else could be there around the corner. Prices in other countries on a net basis were already, let's say, clearly in the range. I would see this as a correction. It's obviously a sharp correction. Yeah. Maybe regarding your other questions, we defer this to either the next round, if we have not next round or the other, I'd have another meeting. No. Thank you very Thank you very much. It's not that I want to avoid them. No problem. Maybe the next question, operator, and w e come back to you, Christopher. Thank you. Our next question comes from the line of Peter Sehested from Handelsbanken. Please go ahead. Your line is open. Hi, it's Peter from Handelsbanken. Thank you for taking my question. First of all, to Christopher at SEB, if you can't understand consensus we are welcome. We'll be glad to take him over at Handelsbanken for a couple of hours and learn how to use Excel and then do some modeling. Apart from that, my cockiness might come to a complete end now because I also have some stuff that I really don't understand. I'd like to ask you to that, please. Firstly, on respect to the one-off stocking effect in Q1 2020, I have in my notes noted that it was to the tune of SEK 140 million-SEK 150 million. I can see that combined for Elocta and ALPROLIX, it now amounts to SEK 260 million. Are my notes wrong? I believe that was sort of the figure you gave last year. Just to get a grip on that one, and then I have a couple of questions later. Peter, your notes are okay, but what we factored in also is the reduction in inventory that we have this year. It's not only the increase in 2020, it is also the reduction in this year. That's why it's more than SEK 200. Yeah. Yeah. We got a little bit the worst of both sides as a one-timer this year. All right. Just to get that straight. Then I would like to jump to something as boring as costs. I note that your SG&A costs are lower incrementally by roughly SEK 100 million. Clearly some of the dynamics is likely savings due to COVID-19. What I would like to understand here is sort of the exact dynamics behind this increase and how we should look at this going into the rest of the remaining quarters for 2021, please. Thank you. Henrik, do you want to take that? Now, Peter, we are not going to guide any further on exact amounts per quarter. What I said was that we obviously in Q1 are a bit held back due to COVID, but it's also the activity level that will increase in the remaining quarters. We mentioned, for example, Doptelet in Europe, where the launch starts now in early Q2. There isn't that much impact in Q1. Further markets will come along gradually as normally is the case in Europe. We have pegcetacoplan. Exact numbers per quarter, we aren't giving. You can expect higher levels than you saw in Q1. All right. Just one final then. The one-off retrospective royalty adjustment that was included in COGS, could you please quantify that? Thank you. Yeah. $3 million. Okay. Not that much. Okay, perfect. Thank you very much. Thank you. Thank you, Peter. Our next question comes from the line of Viktor Sundberg from ABG Sundal Collier. Please go ahead. Your line is open. Yeah. Hi, and thank you for taking my questions. The first one on Elocta. If you look at prescription data, it seems like Elocta is going down in France, but HEMLIBRA is accelerating in that market. Is there any insight you can share if patients are switching from Elocta to HEMLIBRA? Maybe in general also, where are you seeing most of these patient gains that you showed in the graphics before, given that some peripheral markets have a price point that's a bit less than, say, in France or Germany, et cetera? I guess I'm looking at some more details on the patient loss and gains from last year and what impact competition had on this since it was not broken out in that graphic. Thank you. Thank you. Let's say the market share evolution, when you look at the French IMS data or IQVIA data, there's an amplified effect in this because they also typically include, I'm not sure exactly which data you're currently looking at, but they include also, obviously, the inhibitor patients where they have made significant progress. When you look at our own situation, it's correct that we have a couple of patients that we are losing in a quarter to HEMLIBRA, and we are gaining less in France than we are losing, whilst we are significantly growing patients in markets like Germany, in Italy, in Central Eastern Europe. That basically is offsetting and overcompensating actually some of the losses. We take a bit of pride in having a. Because you understand that IQVIA data in Europe are not very detailed when it comes to certain markets. They are more accurate in France than in others. We take into account, to be honest, of our market share situation by account. By hospital or clinic. We have a very detailed perspective on this because it is so important and essential to our business. Okay. Thank you. Another question on Synagis also. I'm not sure how to think about it and if good nirsevimab update is necessarily a good thing for you with a price point. Let's say that is $500-$600 because Sanofi has guided for a very low price point there, and you having a smaller piece of the U.S. market compared to what you have now with Synagis. On my numbers, you need to expand the number of patients by many, many times in order to offset that impact. Could you just comment on how you view the market impact of potential nirsevimab approval? I think you need to look at two scenarios because it's a multiple effect. First of all, you have Synagis that obviously is higher priced. The question on the data regarding the head-to-head comparison, Synagis have not been published yet. I recommend you to have a look at the phase II data of nirsevimab, and you look at some of the signals that you may see there, and whether you believe that some of those signals are the right signals for 29-week pre-gestation babies. The trust is, do you want to take a chance for that basically 1% of the baby population who is very fragile and you have on the other hand, yes, it's less convenient, but you have a safety database with over 1 million patients. Real-world evidence. That's one. We don't believe that Synagis is just disappearing. This is our baseline scenario. Secondly, if my understanding is correct, and this is anyway how the trials are set up of nirsevimab, the target is here not just our 1% of the babies, but RSV is not a privilege only of the preterm babies, but is actually available in all babies. When you do the math, and there are 4 million of those in the U.S. You do multiply 4 million times SEK 600, that's a lot of money, yeah? That you can calculate. We are basically having access to 50% of the earnings out of this profit pool. To be honest, I'm supremely confident and comfortable that if, and I'm obviously thumbs up, and I'm very hopeful, let's say, for positive outcome data of nirsevimab because I hope, let's say, and I think this is going to be good for us. Yeah. That's really, I'm over simplifying the math just to make it simple. Then you can make an assumption of market share. This is a very significant product, hence deserves to be one of Sanofi's global priorities. Yeah. I think everybody can understand. We are very happy to be a partner in this regard. Okay. Thank you very much. Thank you. Thank you. Our next question comes from the line of Rosie Turner from Barclays. Please go ahead. Your line is open. Hi. Good afternoon. Thank you very much for taking my questions. I will try and stick to the two. Firstly, just going back to KINERET. I just wondered if you could give any more detail on where existing sales are and in which kind of patient population. Is it predominantly going in that moderate to severe population at the moment, or is it a kind of broader array of COVID-19 patients? Secondly, on pegcetacoplan, how do you actually see that playing out in terms of the label? Are you expecting that to come after kind of Soliris? Are you expecting it after kind of broader C5 failures? Do you expect the same label to come through from the U.S. and EU? Thank you very much. Thank you. Maybe I start and then towards, with regard to pegcetacoplan, later Ravi should comment also. When you think about KINERET, right now we have very limited data on, we know roughly what the COVID impact is, but we cannot tell you exactly where it's used. Based on previous publications, you would assume it's less used in the ICU setting than it is used in the pre-ICU setting. To be honest, I don't want to speculate here, let's say, because we have an audit in this regard. With regard to pegcetacoplan, we have submitted towards EMA based on the PEGASUS data. Hence, we are expecting second line, let's say, treatment and approval. That basically is absolutely fine with us because we think that the patient population is large enough for us to make a significant difference. Ravi, you want to comment on this? Yeah. Just on that last point, the precise wording in the label we're negotiating with the EMA right now. It probably would be difficult to comment until we've got final labeling. As Guido says, our view of the unmet need is very much in patients who will have failed Soliris, for different reasons. We know there's mechanistic and clinical differentiation of pegcetacoplan in that group of patients based on the PEGASUS study. Yeah, very clear. I guess there's still some possibility that it could get first line on the label, or is that kind of not one of the topics of discussion, or are you not able to say? What I will say is, I think whilst we're so far into the review, I'm always a bit anxious about commenting on the label language because we've got to negotiate it. I'm sort of ducking your question. Hopefully you understand why. Yeah, completely. Okay. Thank you very much. Thank you. Thank you. Our next question comes from the line of Christopher Uhde from SEB. Please go ahead. Your line is open. Hi. Yeah. Hi. Back again. Christopher. Sorry about that. Yeah. I guess coming back to my question would be on Gamifant. At what point can we start to expect that the addressable market becomes bigger than it is now, basically? Yeah. First of all, the first inflection point is hopefully the approval in China, let's say that we expect end of this year. Then obviously you have to get reimbursement. We understand that in order to be on the national list, we will have to find, let's say, a price point that is acceptable for the Chinese authorities. We will wait for the discussions that we will have in this regard. The second, obviously, inflection point is going to be the approval on the strengths of the rheumatoid HLH trial, let's say, that is on the way. We hope that we can recruit patients fast to then get an approval during the course of next year, and then obviously make an impact. That's really where our mind is. Till then, this is more of an incremental improvement where basically on the strengths of being more efficient in primary patients and obviously finding patients that have a genetic precondition as such should fall under the wider parameter of primary HLH. Okay, terrific. Thank you very much for that. Appreciate it. Thank you. Thank you. Our next question comes from the line of Peter Sehested from Handelsbanken. Please go ahead. Yeah, thanks for taking my follow-up question. Just have two very briefly. With respect to the development and royalty income from the U.S. up by 1% in CER, could you cast some flavor on whether you’ve received any sort of income from Sanofi/projections about whether they see flat sales or flat development or whether the decline has bottomed out in the U.S., just some flavor on that. Secondly, just a brief update on KINERET IP as it stands right now. Thank you. Peter, before Henrik comments, just very briefly, we obviously cannot comment on Sanofi's development. That basically is a privilege of Sanofi. What I think you need to recognize is that there are two effects in the revenue development. One effect is how the business performs in the U.S., but the other significant effect, given that from my understanding, Sanofi is probably one of the most diversified company geographically. It's obviously the effect that they have China on stream and that they are a formidable force in other countries. There will be some balancing effects. We typically don't comment on Sanofi's performance. Henrik, you have any? No, I think Henrik also agrees that we should not go there. Okay. Thank you. There are no further questions at this time. Please go ahead, speakers. Yeah. Thank you so much for your interest. These are obviously exciting times in many regards. Apologies that we had this time a little bit more explanations than we typically would have, but we felt it was important given the performance and the results. As you can see, we feel quite good about our business and really look forward to sharing our results with you in the forthcoming future, and also then some of the progress that we have made to them. Thank you so much for your interest. Wish everybody a great week.
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