Ladies and gentlemen, welcome to the Q3 2024 report conference call and live webcast. I am Alice, the call operator. I would like to remind today all participants will be listening only mode, any conference is being recorded. The presentation will be followed by question and answer session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir. Yeah, thank you so much, and welcome, everybody. This is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the third quarter twenty twenty-four conference call for investors and analysts. We posted this presentation earlier today on the sobi.com. Please turn to page number two, and as per usual, forward-looking statement, please take note of it. Unless stated otherwise, we are making comments that mostly relate to the third quarter at constant exchange rate in SEK millions. Today, we plan to cover the key aspects of the Q3 report. I'm joined by Henrik Stenqvist, our CFO, Lydia Abad-Franch, Head of R&D, and Chief Medical Officer, and during the Q&A session by Armin Reining, our Senior Scientific Advisor. We plan to review during the presentation first, and then cover Q&A thereafter, and this session will take up to 3 P.M. For those on the phone, as usual, please join the queue for questions by pressing star one, and we would really recommend to only ask one or maximum two questions at a time. So let's go straight to slide number four. And we are pleased with the performance in the third quarter and the overall strong first nine months of the year. This quarter is about top line growth, strong earnings, progress of recent launches, and important milestones of our pipeline. We saw very significant top line growth. Growth in Q3 was 39%. EBITDA margin adjusted was 43% for the quarter. This reflects a strong performance across the portfolio and significant seasonal royalty from Beyfortus in the US. Excluding this seasonal RSV franchise, the portfolio grew 16% in the quarter, reflecting a strong base of our business. When you look at the first nine months, we grew 24% year to date, and excluding the RSV effect, 22%, demonstrating the progress of the company. Hematology growth was primarily driven by Doptelet, Aspaveli, and the launch of Altuviiio. We have materially improved our market share in hemophilia A prophylaxis within the first two and a half months of launch. This is even more impressive, as Q3 is typically a more difficult period for switching patients in view of the holiday season. We will talk more about this important launch later. We continue to systematically build the launch of Vonjo, and we saw consistent quarter on quarter progress, and we are continuing to build awareness around the product and the unmet medical need in myelofibrosis. Immunology reflected a very substantial Beyfortus royalty income, as mentioned before, and strong growth of Kineret. In terms of the pipeline, our progress continues after the approval of Altuviiio in the EU for hemophilia A and the filing of SEL-212 in the first half of the year, with very encouraging readout of Aspaveli in nephrology, demonstrating a highly significant reduction of 68% in proteinuria in these rare, hard to treat diseases. We look forward to sharing the full data set this weekend at ASN. We have a very strong momentum in the Sobi business, both commercially and in development, and we are pleased to update our guidance for twenty twenty-four. We expect mid-teen growth, previously was low double digit, and mid-thirties for adjusted EBITDA. Let's move to the next slide and look at our overall performance in more detail. Our growth of 39% in the quarter was driven by both hematology and immunology sales. We saw very strong performance in hematology with 18%, and due to the contribution of Beyfortus, immunology grew 96%. The US and European business are growing strongly, with 40%- 50% in the quarter. We look forward to continuing to deliver on this progress through the remainder of the year. Please turn to slide number 6. This growth strategy has led to strong results, primarily driven by our strategic growth portfolio. 56% of our total business has been driven by this portfolio in Q3. The strategic growth portfolio has been growing by 113%. Altuviiio, now on the market, is starting to deliver and on the way to become a very important medicine for Sobi going forward. Please turn to slide number 7. This slide depicts our power station generating the energy for Sobi's growth. It depicts a healthy portfolio of today's and tomorrow's breadwinners. As outlined, the strategic portfolio has generated impressive growth rates so far this year. On the left, we have the pipeline and the major achievement it has delivered this year. We have received fast track designation for Gamifant and secondary HLH in Q2, and are preparing to complete this filing by end of year. For SEL-212, we are continuing with the submission to the U.S. FDA. In Q3, we had a positive readout for Aspaveli in nephrology, as mentioned. At the same time, we continue building our geographic footprint with the launches of Aspaveli, Doptelet, Vonjo, Zynlonta and Gamifant in new markets. This puts Sobi into a position to create strong midterm growth, driven by new products, execution on our development commitments. Aspaveli in nephrology and SEL-212 in chronic refractory gout are of substantial relevance for Sobi and will be prepared for the remainder of twenty twenty-four and twenty twenty-five. We are extremely excited to build relevant launch platforms to bring them to patients who are in need of new treatments in these diseases. While Gamifant in secondary HLH will significantly enlarge the accessible patient pool for the product, we will rely on our existing go-to-market organization. Please turn to slide eight. Altuviiio. We are very pleased with the first few months of the market with Altuviiio. As communicated at previous events, Altuviiio has a unique profile, allowing it to normalize patients for the majority of the week, with a once a week administration. Its molecular structure is creating the foundation for unprecedented levels of protection. Two recent articles in the New England Journal of Medicine confirmed the relevance of this important medicine. Our ongoing hypothesis was that this treatment would create or transform patients' life and their expectation about life. When reviewing the response two and a half months after the launch in Germany, in terms of market share gain and positive feedback from prescribers and patients, our belief to change hemophilia A therapy of tomorrow has further grown. Our market share combined, Elocta and Altuviiio, in hemophilia increased by six points in Germany within two and a half months of launch, and please bear in mind that obviously, we also took share of our Elocta, that basically is not considered in this number. We look forward to bring this important medicine to more markets across Europe and Sobi territories as the launch progresses. Please turn to slide 9. Aspaveli. The launch of Aspaveli in PNH continued well, with quarterly sales of 270 million SEK and 66% growth, continuing a solid launch trajectory and strong momentum across all regions. We also announced a partnership with Enable Injections to bring more, a much more convenient self-administration experience for patients with the enFuse injector, which we aim to bring to the market for both PNH and nephrology. As previously emphasized, Aspaveli's future growth will be primarily driven by the new nephrology indications. The highlight of the quarter, from a development perspective, was undoubtedly the very strong data we have seen in nephrology in two rare kidney diseases, C3G and IC-MPGN, showing a very significant 68% reduction in proteinuria in the primary endpoint of the phase III VALIANT study. We are excited to be sharing the full data set this weekend at the ASN Congress in San Diego. Please turn to slide number 10. As we discussed internally, to understand the epidemiology of this product, it's not, it's quite challenging. We thought it's important that you get our view on these two indications. We are very excited on the opportunity in nephrology, and I wanted to take some time to outline our view. We believe this could represent a blockbuster opportunity for Sobi, considering there are an estimated eight thousand diagnosed patients in Europe with C3G and IC-MPGN. Both diseases are significantly underdiagnosed. With an approved treatment, there's an opportunity to increase the number of diagnosed and treated patients. There's a significant work to be done in the coming months, is to understand the full patient journey with different stages and severity of the disease. This will be key to unlock the, this important market opportunity. We are in a great position, as the drug has been studied in both indications, adults and adolescents, C3G patients, as well as in pre- and post-transplant. Our endpoint reduction of proteinuria 60 or 68%, has impressed quite a few experts in the field, particularly in view of the conclusion of a Spanish group, GLOSEN. 50%, they concluded that 50% reduction in proteinuria is a threshold for clinically meaningfulness in this setting. Please turn to slide number eleven. Doptelet. Doptelet had another strong quarter with 65% growth. We did book the milestone payment from our partner in China on approval of the ITP indication in China during this quarter. Sales growth was driven by increased uptake in the U.S. and ongoing launches in the regions Europe and international. In the U.S., there's a continued positive inflection of new patients, new prescribers, higher market share. There's also accelerated growth in Europe and international, driven by our ongoing launches and continued increased market share in the earlier launched countries. Please turn to slide number twelve. Vonjo. I'm very pleased to provide you with a positive view on Vonjo after some really difficult times. As we discussed, a combination of internal challenges and a new competitive launch eroded part of our new patient base. The economic consequences you can see on the slide in Q4 2023 and Q1 2024. However, it is gratifying to see that we have been making material progress over the last two quarters, and in particular in Q3. Vonjo sales were SEK 379 million in the quarter, with 12% quarter-on-quarter growth, showing continued momentum with the product, reflecting a high level of field activity we have now in the market. This has been seen in September event impact data showing Vonjo to have more than 70% awareness now with HCPs. Our thesis to create value by broadening the product in myelofibrosis in the U.S., internationalize Vonjo, and expand the product by indication expansion, has remained unchanged. Julia will later cover two exciting diseases as a potential new indications for Vonjo. VEXAS is a disease with no approved therapy currently on the market and a highly unmet medical need. CMML, a rare hematological malignancy, also with a high unmet medical need. We are continuing in the momentum we have now with the product to further expand in myelofibrosis and further tap the potential with global launches and the new indication as mentioned previously. Let's turn to Elocta and Alprolix. We are continuing to expand the leading presence of Elocta and Alprolix to more patients in new territories. As discussed earlier, Elocta saw some switches, as expected, to Altuviiio in Germany, however, remains a key medicine in many countries. I think it's worth noting that if you take away the replacement or the substitution by Altuviiio, Elocta actually has been growing. What you see as a sales effect is more related to phasing of international tenders. Main impact this quarter were, as mentioned, the launch, but also the order phasing. For Alprolix, we continue seeing growth in the number of patients and the geographic expansion, which is partially offset by continued price pressure in many regions and some ordering phasing in the Middle East. Please turn to slide number 14, Gamifant and Kineret. We see continued growth of new patients for Gamifant as we passed an important milestone with 1,000 patients treated during the Q3. The quarter was impacted by the end of treatment as well as some destocking. Competitively, the product is in a very good shape, and we look forward to expand later. We are looking forward to submit secondary HLH indication by end of year. Regarding Kineret, we see fantastic growth of 21% in Q3, further reinforced by elevated interest in the IL-1 mechanism, and the demand comes across all regions. Please turn to slide number 15, and at this point of time, I'd like to hand over to Henrik for the financials. Thank you, Guido. Hello, everyone. We will now review some key financials for Q3. We move to slide 16. Referring to the table on the right, the revenue of SEK 6.9 billion corresponds to 39% growth at constant currencies. Main drivers were Beyfortus royalties, Doptelet, Altuviiio, and Aspaveli. The improved adjusted gross margin of 81% in the quarter, compared to 78% in Q3 2023, is mainly due to the impact of the Beyfortus royalties. The adjusted EBITDA margin reached 43%, up from 30% last year, also influenced by the higher sales and high gross margin just mentioned. Looking at operating expenses for the quarter, we observed 12% growth at constant currencies compared to the same period last year. SG&A, excluding non-recurring items and amortization, increased by 11% at CER in the quarter, driven by launch and pre-launch costs for Altuviiio, Vonjo, and SEL-212. We've managed to partly offset the impact of these activities on the SG&A line through savings in the synergies organization, as reported already in Q1. R&D expenses increased by 16% at CER, mainly due to post-approval costs for Altuviiio and Vonjo activities. With operating cash flow for the quarter at SEK 1.2 billion, net debt at the end of the quarter was SEK 16.9 billion. This included milestones to Sanofi of SEK 1.8 billion following EMA approval of Altuviiio, as well as a milestone of about SEK 300 million to Cartesian Therapeutics, following the rolling submission to the FDA for SEL-212. This corresponded to a net debt to EBITDA ratio of approximately 1.8 times, down from 2.0 times, the quarter before. Please turn to next slide, and we will discuss the financial outlook for the full year 2024. As usual, this outlook is based on revenue growth at constant rates and adjusted EBITDA margin. As you will have seen, we are upgrading our revenue guidance for the full year, anticipating mid-teens revenue growth at CER, and we are reiterating an adjusted EBITDA margin in the mid-thirties% of revenue. Regarding upgrading our revenue guidance and considering the year-to-date performance, the new guidance translates into a slowdown of growth in the fourth quarter compared to so far this year. This is expected to result from challenging comps from Q4 2023 in general, but in particular in RSV, not least through Synagis, which had very material sales in Q4 last year, and hemophilia, with positive pricing effects in Q4 last year, as well as the fact that we no longer have manufacturing revenue. The margin guidance remains unchanged at mid-30s% of revenue, given the year-to-date margin of 37% and our expectations for upcoming Q4. To reiterate what I said last quarter, we will have continued elevated spend in R&D, related mainly to multiple filings in SEL-212, Gamifant secondary HLH, and Aspaveli C3G and IC-MPGN, as well as accelerated Altuviiio phase IV studies, and in SG&A, launch and pre-launch costs for Vonjo, Altuviiio, and SEL-212. With the outlook covered, I hand over to Lydia. Thank you. Thank you, Henrik, and hello, everyone. So let's start with the pipeline milestone on the next slide, please. We continue our solid pipeline progress in the third quarter. In hematology, the New England Journal of Medicine published the XTEND-Kids study results on Altuviiio in hemophilia A, confirming that the path to normalization is also possible in the pediatric and adolescent population. We also announced the very encouraging Valiant phase III topline data for pegcetacoplan in C3G and IC-MPGN, and a partnership for a pegcetacoplan injection device, and I will get back to this in a minute. In August, we filed the Japanese application for Doptelet in ITP, and in September, we submitted the pediatric ITP application for the United States. In immunology, we initiated the rolling BLA submission for SEL-212 in chronic refractory gout at the end of June, and it's on track. Let's have a look at some of these, as well as some new perspectives for emapalumab and pacritinib. Next slide, please. In August, we announced very positive data from the VALIANT phase III study of pegcetacoplan in C3G and IC-MPGN. It met the primary endpoint with highly statistically and clinically significant proteinuria reduction of 68% compared to placebo in a broad patient population of 124 patients, age 12 and above. The positive effects were consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys. Pegcetacoplan also demonstrated a statistically significant on the key secondary endpoints, such as proteinuria reduction and eGFR. The study also demonstrated a favorable safety profile, consistent with established profile for pegcetacoplan. As Guido mentioned, the full data has been accepted as an oral late breaker at the American Society of Nephrology Congress this week in the high impact clinical trial session, and we will invite for a call on Tuesday, October twenty-ninth. Next slide, please. We also enter a partnership with Enable Injections to use the enFuse injector for subcutaneous delivery of pegcetacoplan, enhancing the patient experience and thus supporting adherence. This device is already approved for use in the U.S. by our partner, Apellis, and we plan to have it in all Sobi territories for patients with PNH and C3G and IC-MPGN. Next slide, please. Moving on to emapalumab, we want to share that the first patient has been dosed in a proof of concept study for prevention of CAR-T side effects. CAR-T is a growing blood cancer treatment, and while it's highly effective, it comes with important toxicities. Most common is hyperinflammation in the form of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, and both conditions require intensive monitoring and multidisciplinary management to mitigate their potential life-threatening effects. Interferon gamma plays a key role in these toxicities, and it has been shown that blocking interferon gamma could prevent side effects without hindering the efficacy of the CAR-T constructs. Since emapalumab targets interferon gamma, there has been interest in studying it. The Massachusetts General Hospital and Sobi are working together in a research collaboration, which is expected to see its results next year. Next slide, please. For pacritinib, on the top of other areas we have previously communicated, we also see new emerging areas of interest, namely VEXAS and CMML. VEXAS is caused by a somatic gene mutation and manifests as a wide range of inflammatory and hematological symptoms. It was first described in 2020, and therefore has a potentially high number of underdiagnosed patients. Prevalence may be as high as one in 4,000 males over age 50 in the United States. There is no standard treatment available for VEXAS, though almost all patients require corticosteroids. JAK inhibitors offer some efficacy, but they might not target root inflammatory pathways or address cytopenias. We believe that pacritinib could be beneficial because it may target additional pathways beyond JAK. Sobi is supporting an investigator-initiated sponsored trial at the Washington University School of Medicine. CMML is a blood cancer with features of both myelodysplastic syndrome and myeloproliferative neoplasm. Cytopenias and organomegaly are common, and the median survival is 20-40 months, and its prevalence is 1 in 100,000 patients. The only curative treatment is hematopoietic stem cell transplantation. Preclinical and clinical data show a potential benefit of JAK inhibitors. Sobi supports an investigator-sponsored study at the Icahn School of Medicine. Both indications show the potential of pacritinib beyond myelofibrosis, and we are looking forward to more clinical data substantiating the benefit of pacritinib in these disease areas. Next slide, please. As said, Altuviiio is rapidly being adopted in the hemophilia community. The results from the phase 3 Kids XTEND-Kids study, excuse me, have been also published in the New England Journal of Medicine. This is the first assessment of once-weekly Altuviiio prophylaxis. Oops, I'm really sorry. Just give me a second. Sorry, I've been having a cold. As I was saying, this is the first assessment of once-weekly Altuviiio prophylaxis in previously treated children. And the results indicate highly effective bleed protection in kids under 12 years of age with severe hemophilia A. Since hemophilia is a congenital bleeding disorder, early prophylaxis is crucial. However, the clearance of administered coagulation factor concentrates is known to be greater in children than in adults, and this usually leads to burdensome treatment regimens involving multiple injections per week. But the extended data shows that Altuviiio is highly effective, with once-weekly dosing in patients preventing bleeds, with 64% of patients having no bleeding episodes in this 52-week study, 82% of patients having zero joint bleeds, and 88% zero spontaneous bleeds. Going forward, joint health and physical activity will be a focus of our data generation activities. Just one bleed can lead to a vicious cycle of bleeding synovitis and damage of the cartilage, ultimately leading to arthropathy. Continuous prevention of joint bleeds is therefore paramount for hemophilia patients. Freedom is an example of this, as we are monitoring joint health and tracking which activities are enabled by the high sustained factor VIII levels. The effect of overall, on overall health outcomes is also part of this phase III study. It will help to define the future of joint health in hemophilia, and we will be releasing more information on our phase IV program soon. Next slide, please. Summing up the year so far, we have delivered on all our major milestones. Still standing on the submission of Gamifant in secondary HLH. The submission of Gamifant in secondary HLH for macrophage activation syndrome in Still's disease and the Doptelet pediatric filing in the EU. Our momentum will continue in 2025. Next slide, please. We will continue to generate data for Altuviiio, and next year we expect the initial data from the Freedom phase III study. For Aspaveli, we aim to submit our nephrology application in Europe and Japan. ... Gamifant will see U.S. regulatory decision on secondary HLH MAS, as well as submission in Japan. FDA will decide on SEL-212 for chronic refractory gout, and we also expect Kineret to be ready for the submission in CAPS disease in Japan. With that, I would like to hand back to Guido. Thank you. Thank you, Lydia. As you can see, we, at Sobi, we are very much dedicated to the mission, even in difficult situations. We are very pleased with Sobi's development, as you can see, for the first nine months of the year and with our performance in Q3. As you, as outlined, we have experienced very strong top line growth, primarily driven by Beyfortus, but also the rest of the portfolio saw significant growth with 16% for the quarter and 22% for year to date. This reflects a very strong performance in our strategic portfolio, continued strong growth of our key products around the world. This has led to upgrade the revenue guidance from low double digit growth to mid-teens for the full year, and we maintain the guidance of mid-thirties adjusted EBITDA margin. Our R&D pipeline so far this year has showed tremendous progress with approval of Altuviiio in Europe, the filing initiation of SEL-212 for chronic refractory gout in the U.S., the positive phase three topline data in nephrology for Aspaveli, and receiving two fast track designations for Gamifant and SEL-212. We have strong momentum and the business pipeline development, and we look forward to continuing this journey with our colleagues and stakeholders around the globe. Let's go straight into Q&A. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their touch tone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to use only hand lifts and eventually turn off the volume from the webcast. In the interest of time, please limit yourself to one question only. Anyone who has a question may press star and one at this time. Our first question comes from the line of Brian Balchin, Jefferies. Please go ahead. Thank you. Two, if I may. It's just on Beyfortus and competition. So just first, your view on the extent to which that big 3Q Beyfortus beat was pulled forward. Anything you can share on the 3Q, 4Q dynamic, particularly as it relates to the impact of 4Q consensus, which I believe is around SEK 1.4 billion? Just how we should be thinking about that. And then secondly, on clesrovimab, just your thoughts on the competitiveness of those data, particularly on hospitalization reduction, differences on endpoints, impact and comparability, and your view on potential full path market share that you think that could take into the 2025, 2026 RSV season. Thank you. Yeah, thank you. I mean, with regard to Beyfortus, I mean, you know, we have to say that, you know, there will be obviously a Q&A tomorrow with Sanofi, who will, who I know will update you directly. And, you know, they're not, for obvious reasons and for competitive reasons, can share all the information with us. But, you know, we, you know, let's put it this way, we are quite optimistic for Beyfortus, because I think it's a very mature. You know, we think, you know, in a trial context, you should look at the primary endpoint, and there, you know, Beyfortus has a very strong advantage as opposed to post hoc analysis. Maybe, you know, Armin, you want to comment on this, you know, how you view the data? Because, you know, but granted, this is our view, and let's say, you know, that Sanofi will update you a little bit more. Armin? Yes, of course. Thank you, Guido. Thanks for the question. I do believe that if you just look at what we can see here from the interim analysis and the published data so far, the primary endpoint is not as good as the one that you have seen for Beyfortus. And if you look at the post hoc analysis, and with all due respect, that we need to see the full data package, that one seems, at least on the slide that they showed, seems not to have the statistical significance. Yes, the number has, but if you look at the stringent and strict methodology that Beyfortus has, and it was also a New England Journal of Medicine publication, just to remind you, and as well, we do have 90% hospitalization reduction in the real world, shown by the CDC report. I think that is a very strong standard and benchmark that needs to be met first. Particularly, I think the real world data from Sanofi that have been published, I think speak for themselves. But, you know, Brian, I'm, I know that you want to know this, but I think, you know, we would refrain from speculating what this means for market share. I think you will have to directly ask Sanofi, as we don't promote the product. But, you know, let's put it this way, I mean, we are still at least still optimistic about the opportunities of Beyfortus, because we have not got any indication that we have to think of a superior product coming our way. And, you know, and obviously, you know, don't forget, I mean, Sanofi, you know, before COVID, you know, it used to be the largest vaccine company in the world. I'm sure they have. They're quite clued on what to do here. Yeah. Maybe let me go to the next slide to the next questions. The next question comes from the line of Mattias Häggblom, Handelsbanken. Please go ahead. Yeah, thanks so much taking my questions. I have two, please. The first on hemophilia in Germany, the six percentage point share you gained in one quarter. So help me think about what that means for peak market share potential in Germany going forward, since patients don't see a physician more than perhaps once or twice a year. And linked to that, what that does it imply for other European markets? I believe Germany's always been one of the strongest. So should we temper our expectations since it's accomplished in Germany, or opposite, should we see the initial uptake as encouraging also for other European markets? And then second, on systemic pegcetacoplan and kidney disease, curious to hear if there's any feedback from European regulators in terms of timelines, when you can submit. Does initial feedback suggest you will have to wait for twelve months data, or is there possibly a path to submit earlier, given the magnitude of the effect on the primary endpoint? Yeah. Thank you, Matthias. You know, with regard to the, you know, peak market share, I think what one needs to in order to bring the 6%, I think, which was probably not picked up by everybody. I mean, 6% is a net gain consolidated that we have done, that we have achieved in two and a half months as switches from competition. And obviously, the product is much larger now in Germany because the majority of patients came in addition from Elocta. Now, and this is all done within a within a relatively short period of time. And, you know, and magnitudinally, I mean, you know, there are close to two and a half thousand patients in prophylaxis in Germany. And so that gives you a kind of taste for the magnitude. Now, is this so to be honest, we are very excited actually about this very accelerated launch. Yeah. But we didn't want to lay out now the detailed numbers because, you know, then it just creates an entire industry for us. So we wanted to give you at least an indication the product is on track and it has a faster uptake, you know, than we could probably have hoped for. Which speaks to the product, because even during this vacation period, you know, we have a lot of interest, you know, asks from patients and now also from physicians to provide the product. Is this now indicative for the other launches? You know, we will get relatively soon out of the blocks in Switzerland, in Spain, in the U.K., and, you know, we were happy to update you once we have finalized the agreements with the reimbursement authorities. But, you know, this is imminent and, you know, the product and the patient needs will be the same. You know, we are quite competitive, as you said, in Germany. So is this a transferable, you know, achievement? We'll see. We will try everything, but, you know, we cannot promise this. This is traditionally more for, obviously, as you know, a conservative group. But, you know, we have switched patients, which is good from all, you know, from all products, factor and also non-factor. Primarily non-factor, but still also quite a few already from the non-factor side. I think we are on a very good track, and we are very confident that, you know, regarding the guidance that we have given the market, where we said, you know, that this is a product that will be a leader in prophylaxis and leaders in our world is between 30%- 40%. And if anything, this short period has confirmed our view, if not made us a little bit more optimistic, because it's really a very overwhelming positive feedback that we have obtained in this last couple of weeks. And with regard to the timelines on nephrology, I would like to refer to Lydia, and maybe you can shed some light. Yeah, sure. And basically, based on the magnitude of the fact that you were referring in your question, we expect to file in Europe early in 2025 and in Japan thereafter. So these are our plans, and we're in discussions with EMA to fulfill these plans. Can I squeeze in a follow-up, please, on hemophilia? Thanks so much for the clarifications, but I think there is some investor concern around the impact Altuviiio has on Elocta. So, if you gain net six percentage point share in Germany, I guess the Factor VIII franchise overall in that market must have grown by 20% year over year or so in the quarter. It has very substantially grown, yeah. We don't guide typically on market, but it has very substantially grown, and I think that this was a little bit missed in the announcement, because obviously there were some other effects, the phasing, as we said, of these international business in primarily that basically insinuated, you know, a much bigger decline of Elocta than actually has taken place. That's helpful. Thanks so much. Thank you. Our next question comes from a line of Erik Hultgård, Carnegie. Please go ahead. Yes. Hi, thanks for taking my questions. I have two, if I may. First, continue a bit on Altuviiio in Germany and the uptake. Could you specify a bit the proportion of patients ... on Altuviiio in the quarter that came from Elocta, and competing products respectively. I think, Guido, you mentioned that the majority was from other products than the Elocta, but if you can be a little bit more specific on the proportion there. And also, whether any stocking including in sales in the quarter for Altuviiio. And then I have a follow-up on Vonjo. Thank you. Hi, Erik. Yes, thank you for your question. So I should specify, the majority of our Altovoc patients is from Elocta. The delta of six points market share is what we switched from other products, not Elocta. Yeah. So that gives you, you know, let's say, a feel for this, and we don't want to go there now, how much is a majority, but it is clearly more than, significantly more than 50%. So that gives you a feel for this, and there has been no stocking. Okay. Great, loud and clear. So then on Vonjo, I think you've previously said that you expect to reach an inflection point in the uptake in the second half, and I was wondering if this still is the case. It looks like you have some slight acceleration in the third quarter, but do you have any leading indicator data points, such as prescription, new prescription data, supporting that you're actually converting the brand awareness data that you highlighted, that this is actually converting to an acceleration in also prescriptions? Yeah. What we, I mean, first of all, I mean, we felt, you know, after, you know, 6% quarter-on-quarter growth in Q2, now 12% quarter-on-quarter growth in Q3, that this is at least, you know, in our books, was an acceleration. This is now an inflection, I mean, for a product that is life cycle, probably not to the full extent. But what we see is that this, our, I would say, consistent work should bear fruits, and we should see further progress, let's say, at a significant rate in the quarters to come. We have some indications, you know, I mean, our input factors are significantly up, much more than these percentages would suggest. We have obviously improved the quality of the organization, and we see indicators. The indicators are tougher indicators because, you know, the product is, you know, in Europe, we have two channels, SD and SP channel. In the FD-SD channel, it's more difficult to get detailed information on new patients and new prescribers. But, you know, we see that the product is on a good way. Yeah. So we have, I mean, it takes us more longer, but honestly, after I would say two, you know, more depressing quarters, you know, in Q4 and Q1, we feel now that we are coming out of this and, you know, we see significant growth. You have seen the indications that we are highlighting for the product with from Lydia's presentation, and we are looking forward to, you know, more material international launches next year. The pace is accelerating. The combination actually makes us quite confident about the product that we are on a good path, but bottom line is it takes us longer. Yeah. You know, but you can expect strong growth also in Q4. That's clear. Sounds good. Just if I can sneak in a final short one on Vonjo. So, could you say something about the proportion of patients starting on Vonjo that are above or below 15 in platelet counts? Yeah. Historically, that rate was, you know, and this is, this is what, you know, this is what we explained at one of the earnings conference. Before we had, before the competitive launch, we used to have a fifty/fifty. Now, this is probably more a, a seventy, seventy-five to thirty or to twenty-five ratio favoring below fifty, where we are mining and where we have strong preference shares, obviously. Our job, that is cut out for us with the help of the clinical work, is to appeal to a broader audience, and we make respective, and to be in line with the NCCN guidelines. That's basically the journey, and that's the reason why it took us a bit of time, even though we put a lot of effort behind it, to dig ourselves out of this and now showing the quarter on quarter growth. Perfect. Thank you so much. Thank you, Erik. Yeah, very much appreciate your question. Next question? As a reminder, in the interest of time, I kindly ask you to limit yourself to one question only per person. And the next question is from Gonzalo Artiach, Danske Bank. Please go ahead. Hi, good afternoon. Gonzalo Artiach from Danske Bank. One on Beyfortus and Nirsevimab, the potential competitor from Merck. In case of this competitor receiving approval for next season, do you have any color you could share on any potential pricing pressure that this could imply for Beyfortus? If you could give us some color here, would be great. And also on Vonjo, another question. I mean, you mentioned that the slower integration of CTI in Sobi has been one of the reasons for sales taking yeah so yeah being slower than what initially expected. But also the Ojjaara, it was mentioned previously, has had like a good launch here. So I was thinking, how are you actually planning to convert this 70% market awareness that you just mentioned into sales, especially off-label, given the fact that the Jakafi is doing quite well or they're establishing itself in the market? And also, if I heard correctly in the presentation, you mentioned that your long-term goals for Vonjo are untouched. Is it including new indications that you are starting now or excluding these? Thank you very much. Yeah, thank you for your question. I mean, you know, with regard to, you know, Merck Sharp and Dohme, I think you need to really ask them how they are thinking about pricing. For, you know, historically at least, MSD was not a price fighter for innovative medicines, you know, even though, you know, the degree of innovation, I leave it up to the audience and KOs to judge. But, you know, that is, you know, it's very difficult to judge, but, you know, I would, you know. We'll figure it out. Yeah, but, you know, they're coming with a new medicine. I mean, do they want to shrink the profit pool of this medicine? I'm not sure. But, you know, that is something you have to really ask MSD. With regard to Vonjo, I mean, obviously, first comes awareness, then comes adoption. We have, you know, quite a few people now in the field. We have stepped up, as we previously reported, our digital interaction. And the reason why we left the goals that we had is to, you know, that we insinuated historically unchanged, is indeed because we see not everything has to work out, yeah. But the combination and using a probability adjustment makes us believe that we do not have to change our guidance or our, or let's say, or the magnitudes that people have associated and, you know, and we have confirmed on Vonjo. So, you know, we think that this is a fantastic medicine for Sobi. Yes, it took us a bit more time, but you know, we will continue making progress in the U.S. We are going to make progress with new data generating and also with this, broadening the product in myelofibrosis, broadening the product in new indication, and broadening the footprint of the product by launching in other countries. The combination of this is more than what we need to achieve our expectations for the product. You know, not everything is gonna become true. You know, probability adjusted, we stick to what we have set out. Great. Thank you very much. You're welcome. Maybe more questions? The next question comes from the line of Christopher Uhde at SEB. Please go ahead. Hi there. Thanks for taking my questions. So obviously, really impressive start for Altuviiio, and coming off such a high share base, it must feel rewarding after years of analysts telling you Roche's Hemlibra is gonna eat your lunch. But I do want to get a little clarity around how to think about Elocta through the conversion process component of the launch, given that, you know, you started talking about positive phasing impacts on Elocta already back in Q1 2023, that only started to unwind this quarter. Obviously, we know payers wanted to ensure market stability, but the unwind does not seem to be factored into consensus. Can you help us understand what proportion of Altuviiio sales so far were switches from Elocta, and how much stocking unwind is left? Are we talking SEK 500 million left, or could it be more or less? Second, you know, you had what truly looks like a phenomenal clinical result with Aspaveli. So kudos, of course. The share rose 15%-20% on the back of the first blockbuster sell-side forecast following the announcement, which you today are clearly backing. I know you hate when I ask long questions, so I'm sorry about that, but with up to 20% of market cap in play from this, the potential is pretty important to understand the number of, you know, and the number of addressable patients, especially because you used to say that there were up to 8,000 ex-U.S. Your partner still says 8,000 ex-U.S., while you now say 8,000 in Europe alone. Your share is up since then. Your partners is down. Your presentations say the estimate is based on the literature. When I emailed Sobi to ask how it arrived at 8,000, the reply cited a review from Nature Reviews Nephrology, summarizing data from Europe, and the reply specifically stated that the French data set may be a good anchor. We have anchored on the 14 per million in the bottom range, so that's the estimate is based on that large French study, and extrapolating that takes us to 7,000 diagnosed patients in Europe, which is pretty close to that 8,000, but reading how the review publication calculated the 14 per million, they state: point prevalence values were calculated as new cases per year, divided by the size of the referral population, in other words, the population of France, times the population average life expectancy. They explicitly state, "We assume there were no deaths. ... from C3G. They also do not remove patients who went into kidney failure, but we have that kidney failure rate data for that study from, you know, from the publication. And if you redo their calculation and it subtracts patients going into kidney failure each year, you're left with only two thousand patients. So, you know, and of course, more recent large registry-based data sets from U.K., Spain, Italy, all give similar results. Are you simply expecting to be able to treat all the patients after they've already gone into kidney failure? Or how much of your estimate relies on anecdotal evidence from KOLs and market research? Does Aspaveli need a total addressable market of at least eight thousand patients in Europe to become a blockbuster? Thank you very much for your patience and for the questions. I mean, you're so maybe what we do, because, you know, this was a lot, you know, to take in, and probably more than we can cover now as part of this conference call. You know, the question was also, do you want to have an answer or do you want to make a point, yeah? Let's say, I think what you should, you know, what you should just, you know, life is sometimes, you know, in pharmaceuticals. I'm now in this thing more than 30 years, yeah? I can tell you one thing, yeah. Just when you think you know something, there's always somebody who knows a little bit more. We have spent now, with two major consulting firms, very significant resources over the last half a year with super experts and key KOLs to understand this market. Our head of market analytics is, said this is one of the most difficult case of epi data to understand. I, you know, we will not share all our market insight, as you may appreciate, with, you know, with the world. But one thing we can guarantee you is, you know, when you think about this market, there are sixteen to twenty thousand patients. There are eight thousand diagnosed in Europe, and obviously, today's treatment is not representative of what tomorrow's treatment is, because it's gonna change. There is no effective treatment. So let's leave it there. We also can reassure you that there are many more patients outside of Europe and, you know, the data vary here more, and we don't want to, but you know, when you think about the value per patient, the way this treatment is gonna change, the way diagnosis is gonna change, if there is a hope for treating patients successfully, then we are very confident and we believe in the blockbuster potential, and we do not need to treat all patients. I can reassure, yeah. But I understand that this is a lot and, you know, that's the reason, you know, to be honest, why we have spent on this subject matter more than half a year with probably a total number of people involved, 15- 20 people. So I appreciate that this is difficult, and we are happy to share with you within reason, but we will not, you know, we are a public company, we will not stipulate something that we cannot stand behind. Life is too short for that, yeah. Let me be very clear, yeah? So, so with regard to Elocta, I just wanted to say, Elocta's growth year to date, 6%, yeah? So this doesn't look like a product that is in dire straits, yeah? And, and therefore, what I said also here with regard to, impact, quarterly impact, has to be taken into consideration, because otherwise you get the impression that the product is worse off than it is. But yes, the majority of patients, that means more than 50%, have been switched in Germany, let's say, for a lot, for Altuviiio. But still, we have gained consolidated market share of more than six%. So I think that we, we leave it like this, and then we have probably time for one more question from somebody else. Thank you. And we will come back to you, because I have a vested interest to explain this to you properly, and we have obviously not yet been able to do this. Any other questions? Yes, we do have a question coming from the line of Harry Gillis, Berenberg. Please go ahead, sir. Hi, thanks for taking the questions. Just a couple short ones from me. Just back onto Aspaveli, just wondering what your latest base case is for your relative market share versus Novartis, that you're including in this guidance for blockbuster opportunity? Yeah. And then, just thinking about... Yeah ... the patient pool that is there today, are you seeing a bonus of sort of well-identified patients that are sitting there waiting for new targeted therapies, just so we can think about how quickly the sales might ramp? And then a very quick one on the financials: do you also expect a significant step up in OpEx in Q4, like last year, or was that sort of unique to last year? Thank you. Yeah. I think, you know, the, let's start with the easy. There are quite a number of... I mean, we did quite extensive market research. There's quite a number of patients that are waiting. There's also a number of patients, you know, that are currently quite desperate and not getting adequate treatment. And then so there will be a faster uptake, and we are currently for a certain group of patients, and then there will be, you know, then we will have obviously to do also some market preparations and making sure that people understand the opportunities to treat it adequately, based on the data in proteinuria reductions. Our assumption is that we would have a larger share than Novartis with all due respect, you know, given the absolute amplitude of the effect. That's our belief. Obviously not underestimating, but they are formidable competitor. And we look forward to the discussions at ASN. And we are quite. With regard to the financing, I'd like to refer to Henrik. Yes, you are right, that, you know, mathematically, we do expect a step up in OpEx in Q4 compared to Q3, just as we saw last year. Yeah. So I think, you know, what we do is, you know, so apologies if we were a little bit extensive. And let's say, we can, if you have further questions, please do refer to Gerard. Either we make meetings available, you know, separately or otherwise, we can answer this. So, you know, as you can see, you know, we are quite excited about this data. And because it's not just step-by-step story, it's carried by our broader Sobi portfolio. And, you know, we look forward to update you. The next update, big update, is on Tuesday, when we have a call on C3G, IC-MPGN, and provide an update on the data from ASN, to make sure that we democratize basically the information to these important data points. Thank you so much. I wish you a great week, and apologies if not everybody was able to ask a question. Gerard or Jennifer, and we will make sure that you get connected with the experts, or they can probably address most of the questions in any case. Thank you.