Ladies and gentlemen, welcome to the Swedish Orphan Biovitrum Q3 Report 2025 conference call and live webcast. My name is Sandra, and I will be the operator for your call today. I would like to remind you that all participants are in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A 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, and hello everyone. I'm really delighted, and we are all overall delighted to welcome you to the third quarter 2025 conference for investors and analysts. As you know, as usual, we posted the presentation beforehand. As far as the next slide is concerned, the disclaimer, we would like to remind you of the usual provisions on statements about expectations and projections of future events. Unless stated otherwise, we will be making comments that must relate to the third quarter at constant currency rate in Swedish krona. Today, we plan to cover the following key aspects of our Q3 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Abad-Franch, Head of R&D and Chief Medical Officer. We plan to review the presentations first and then open up for Q&A at around or until around 2:00 P.M. For those on the phone, please join the queue for questions by pressing star one. We propose you ask one or two questions at a time. With this said, let's go straight to the presentation. As we want to cover quite a few topics today on the quarter, I would like to provide you with an overview before diving into the specifics. First, we delivered an outstanding Q3 performance with 21% growth at constant currency. This was driven by a remarkable 39% growth of our strategic growth portfolio and a clear validation of our innovation-led strategy and commercial execution. Adjusted EBITDA with 47% on sales shows strong, obviously, business momentum, but also cost discipline. We took an impairment on Bonjour, reflecting the deferred uptake. We'll explain later on how we drive growth moving forward. Material progress in our pipeline, foremost, the scheduled PDUFA date of NASP in June 26th and the approval of Tryngolza in familial chylomicronemia syndrome, as well as the readout of two phase III studies in severe levels of triglycerides, evidence the progress. The momentum in so many different areas of our business has prompted us to increase guidance in terms of top and bottom line. Please turn to slide number five. Let's have a closer look at our Q3 performance. We delivered net sales of over SEK 7.7 billion in the third quarter, representing a 21% increase at constant currency rate compared to last year. This growth is driven by continued success of our strategic growth products, as earlier mentioned, which account now for 64% of total sales. While nearly all products performed well, the fantastic performance of DOPTELET, GAMIFANT, and Altuvoct should be noted. Regions have performed well. Growth rates of 37% in the U.S., 21% in Europe, and 43% in international demonstrate that the engine of our company is very productive. Let us go through the specifics by product. Turning to DOPTELET, our largest product and key contributor to our growth story. In Q3, DOPTELET delivered 46% growth at constant currency, continuing its strong trajectory. As can be seen in the chart on the left, reflecting consistent demand and market expansion. This growth is underpinned by DOPTELET 's differentiated profile in ITP. Excellent efficacy and fewer dietary restrictions make it a compelling option for both physicians and patients. DOPTELET has performed well in the U.S., but the growth has been carried by all regions, including international markets. Japan launched one month ago and already showing very promising signals. Please turn to slide number seven. In Q3, BEYFORTUS delivered just over SEK 1.16 billion in the early part of the season. RSV immunization rate for the 2024/2025 season stood at 57%, indicating significant headroom for further growth. In view of the debate regarding the use of prevention medicine, we commissioned an independent survey with over 100 physicians. The summary of the findings are as follows: BEYFORTUS has been recognized as a competitive product with a high preference share of over 90% amongst HCPs. HCPs did not see restrictions or limitations in terms of access for patients and physicians. Certainly, from the survey, we also saw that physicians expect no decline in RSV cases for the season, although the season does seem to be starting later, according to the latest CDC data. In summary, BEYFORTUS appears to be well positioned as the season begins, supported by strong clinical fundamentals and high prescriber confidence. Our take is that there is a typical uncertainty around the start of the RSV season and stocking levels. This was something we also saw with SYNAGIS. Sanofi, as a product owner, may provide additional color to the status during their report. Let's turn to page number eight. Altuvoct delivered SEK 769 million in sales, resulting in haemophilia A sales of SEK 1.6 billion in the quarter, representing 31% year-on-year growth. On an annualized basis, we may exceed SEK 6 billion of haemophilia A sales this year. The market dynamics, as we talked about throughout the year, are continuing with continuous switches from Elocta and other competitors, including non-factor products, which reinforce Altuvoct 's competitive edge. Our launch strategy is progressing in three ways. We wanted to give some orientation that our current growth is primarily coming from early launch countries and obviously more to expect during this year and the years to come. We expect to launch in Italy and France during this year. When you look to the left of the slide, you can see, let's say, an increase in Q1 on Elocta. This was primarily driven by tenders at the time, and this will normalize throughout the year. In summary, a very encouraging story with Altuvoct and the overall haemophilia A franchise. Let's turn to slide number nine, GAMIFANT, which continues to deliver exceptional growth and strategic progress. In Q3, GAMIFANT generated SEK 733 million in sales, up 98% year- over- year. A key milestone this quarter was the U.S. launch of GAMIFANT for macrophage activation syndrome in Still’s disease. This marks the first ever approved treatment in both adult and pediatric patients with MAS, and gives us confidence to grow in HLH overall. Looking ahead, we are advancing our GAMIFANT IDS program, targeting immune dysregulation in sepsis. The Embrace Phase II-A trial is actively recruiting, with a primary endpoint expected by the end of 2025. We will provide a market update in our Q4 earnings. While still early, this product has obviously very material space and potential in this indication. In the U.S. alone, there are approximately around 2 million sepsis patients hospitalized annually, while nearly 1 million require ICU care. IDS represents around 20% of these patients, and these patients have a mortality of 40%, highlighting the significant unmet medical need and the potential impact that GAMIFANT could make in this space. Looking forward to updating you latest by the Q4 reporting. Please turn to slide number 10, Bonjour. Bonjour has demonstrated solid demand growth of 9% for the quarter versus previous year, but was down 11% due to growth of gross net adjustments primarily related to 340B and Medicare redesign. The disadvantage with regard to a narrower label versus competition, despite the overall strong body of evidence, has not allowed us to achieve our own ambitions yet. As a result, we have recorded an impairment charge of SEK 6.6 billion. Consequently, we focus on broadening our label NMF and internationalizing the product. Pacifica has been accelerated and will become the key cornerstone in this regard. Lydia will give you an overview later in this regard. In addition, the development of the VEXAS syndrome is making significant progress. The chart should illustrate and outline that we still expect Bonjour to become an important growth driver for Sobi, but later. Please turn to slide number 11. We have seen the positive margin in evolution in our press release, and Henrik will cover it in the financials in more detail. This was driven by a relative OpEx reduction of around 30% from 38% - 33% over sales, driving margin improvement to 47%. I just want to make a point that the efficiency program reported in Q2 helped us with the earnings this quarter, but more importantly, will give us headroom to support an important portfolio of launches and development projects in the years to come. Hence, this initiative was an important strategic move for the company's evolution. Please turn to slide number 12. We have shared quite a few insights on our portfolio at previous events. Just to emphasize, five key and planned launches and four priority clinical projects evidence a strong ambition and commitment for the group. Before closing my section, I want to shed light on the opportunity with regard to Tryngolza or OLEZARSEN. Please turn to slide number 13. Just to give a quick perspective on the disease area, we have got an approval for Tryngolza in Europe in familial chylomicronemia syndrome, an area that we are very familiar with via the preceding product called WAYLIVRA. In September, the data from the core one and core two studies, both phase III studies were announced, which included over 1,000 patients with severe hypertriglyceridemia, including MAS patients, and showed a 72% placebo-adjusted reduction in fasting triglycerides. Equally important, we observed an 85% reduction in acute pancreatitis events compared to placebo. These data suggest a major breakthrough for patients with MAS and severe hypertriglyceridemia, while the occurrence of acute pancreatitis is a major medical issue. The full data will be presented at the podium on November 8th at the American Heart Association conference. These results position Tryngolza as a potential game changer in MAS treatment. Please turn to slide number 14. Let's now look at the commercial opportunity for Tryngolza, which we believe is highly significant in the treatment of familial chylomicronemia syndrome, meaning with more than 880 mg /dL triglycerides. We have performed two deep dives on the disease over the last couple of weeks. In Europe, the cut-off point for the treatment of these patients will be at higher triglycerides level, as mentioned before, for familial chylomicronemia syndrome, or FCS, with a cutoff of 880 mg /dL. In this indication, the number of patients in EU5, in the leading five countries, is around 700,000 patients. The product will become very important for those poorly controlled with a high risk of acute pancreatitis, meaning for a subgroup of those patients, round about 1/3. Considering all these factors, the product will have a peak sales potential of over SEK 5 billion in EU5 alone. Please keep in mind that our territory extends to all Europe and most of the international markets, so a total patient population of 4 million, which obviously need to be then adjusted for the ability to purchase or the ability to get reimbursement. We will submit an EMA in 2026 for the FCS indication. In totality, you can get, I think, a sense that this is a major opportunity for Sobi. I want to close my presentation by emphasizing that we had a very strong business performance in Q3, as you can see on the left, 21% growth, 47% adjusted EBITDA. We had significant pipeline progress. Given our momentum, we increased also our guidance for sales and EBITDA. On this note, I would like to hand over to Henrik, who will lead you through the financials. Thank you. Thank you, Guido, and hello everyone. Please turn to slide 17. We will now take a look at some key financial metrics for the quarter. In Q3, our revenues of SEK 7.8 billion correspond to a revenue growth of 21% at constant currencies and 30% excluding seasonal BEYFORTUS royalties. We saw double-digit growth across all three segments and in each region. From a product perspective, growth was driven by Altuvoct, DOPTELET, GAMIFANT, and Kineret. If we look at the table on the right and the adjusted gross margin of 80% in the quarter compared to 81% last year, we saw an improvement in margin from positive mix effects and the new Aspaveli royalty agreement, but this was offset by lower BEYFORTUS royalties. Operating expenses for the quarter were flat to last year at CER. SG&A, excluding non-recurring items and amortization, increased by 3% in CER, driven by launch and pre-launch costs for Altuvoct, Aspaveli in nephrology, and NASP. This was partially offset by lower costs across Bonjour, DOPTELET, SYNAGIS, and Elocta, including the cost savings initiative we outlined earlier this year. R&D expenses declined by 6% at CER, excluding non-recurring items, mainly due to NASP programs that are now complete, as well as the cost savings initiative announced in Q2. This was partially offset by development programs in Bonjour and GAMIFANT. As a result, the adjusted EBITDA for the quarter amounted to SEK 3.7 billion, equal to a margin of 47% compared to 43% for the same period last year. The Q3 net earnings number is a reported loss of SEK 2.9 billion, and this is due to the impairment charge for Bonjour of SEK 6.6 billion. We remain confident that Bonjour will be a long-term growth driver, but also acknowledge that all expectations from our original case have not materialized. The future growth opportunity comes from potential broader label and international expansion. We also continue the development of Bonjour in potential new indications in CMML and VEXAS. Excluding the impairment and other one-off items, the adjusted EPS grew by 40% in Q3. Operating cash flow for the quarter was SEK 1.8 billion compared to SEK 1.2 billion last year, driven by improved operations. That gave a net debt at the end of the quarter of SEK 12.2 billion, maintaining the net debt to EBITDA ratio from Q2 of 1.1 times. Please now turn to slide 18, and we will discuss the financial outlook for the full year 2025. As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2025, we have upgraded the revenue guidance from high single-digit percentage to low double-digit percentage growth at CER. We've also upgraded our adjusted EBITDA margin guidance from in the mid-30s percentage of revenue to mid to high 30s percentage of revenue. Through the first three quarters, we saw strong momentum across our portfolio with 15% growth at CER. We expect continued growth into Q4 across our commercial portfolio, primarily in Altuvoct, DOPTELET, and GAMIFANT. This guidance also reflects adjusted expectations for Bonjour, reflecting the year-to-date performance. Our year-to-date adjusted EBITDA margin of 40% gives us confidence that we will be able to deliver a full-year margin in the mid to high 30s. We will benefit in Q4 from expected continued revenue growth. In addition, we see lower operating expenses than previously planned, mainly due to the realignment of SG&A and medical activities for NASP following the June 2026 PDUFA date, as well as an accelerated impact from the restructuring activities that we announced in Q2. This is together with disciplined cost control. Despite this OpEx development, OpEx are expected to increase in Q4, quarter- over- quarter. In SG&A, costs will ramp up in Q4 for our two key launches: NASP in uncontrolled gout in the U.S. and in Europe for Aspaveli in nephrology. In R&D, we will continue to invest in our priority development projects at a slightly higher pace than in Q3. In addition, we'll be preparing for regulatory submission of Tryngolza in familial chylomicronemia syndrome. With this, I now hand over to Lydia. Thank you. Thank you, Henrik, and hello everyone. We start with the pipeline milestones on the next slide, please. In the third quarter of this year, we have continued the progress across our portfolio, and I would like to highlight several key achievements. NASP for uncontrolled gout has reached an important regulatory milestone with the FDA's acceptance of our biologics license application. For DOPTELET, we received FDA approval for an extension of the indication and launched a new sprinkle formulation designed specifically for pediatric patients with immune thrombocytopenia. Additionally, DOPTELET 's indication for ITP was approved by PMDA in Japan, further expanding its reach in international markets. Continuing in Japan, we have submitted our application to PMDA for Kineret, seeking authorization to treat Still's disease. We're also pleased about the EMA approval of Tryngolza for familial chylomicronemia syndrome. We will soon transfer the marketing authorization from our partner, Ionis, to Sobi. Finally, as Guido already discussed, Ionis reported positive top-line data for Tryngolza in severe hypertriglyceridemia, which paves the way for expanding its indication. In addition to these milestones, we also see progress in other areas. Our studies for Bonjour in myelofibrosis and VEXAS are accelerating. We will present new data from several assets at ACR this week, and our reputation with patient groups has received good marks. In this slide, we will talk about Bonjour and the clinical program that is gaining speed. For the Pacifica study, our expansion efforts have accelerated recruitment even further, with the new countries and sites being successfully onboarded. Enrollment rate in the third quarter was 50% faster than in previous quarters. We remain on track to complete enrollment in 2026 and aim to get there earlier. With respect to the PAXIS proof of concept study, recruitment is already ahead of schedule, thanks to strong interest from the VEXAS community. The full interim analysis group of 30 patients have been recruited in the first four months, and we anticipate the interim analysis for futility and safety in the first half of 2026. The research collaboration on CMML is also progressing, with a planned first patient in this year. This means we will soon have new evidence on myelofibrosis, VEXAS, and CMML, and this will help us to further improve Bonjour's positioning in clinical practice and engage with regulatory authorities. Next slide, please. Bonjour and VEXAS, together with GAMIFANT in HLH MAS, will also be a topic at the ACR Congress this week, where we will have several oral and poster presentations. For our NASP program, we will have two oral presentations at ACR, demonstrating the robust efficacy of NASP on key parameters and clinical manifestations, such as serum uric acid levels, gout flares, and patient-reported outcomes. Today, I would like to highlight the long-term data for NASP, which will be one of our poster presentations. This is data from the 48-week extension to Dissolve One, our pivotal trial to assess long-term efficacy and safety of NASP in uncontrolled gout. As discussed at our investor call in September, NASP demonstrated a rapid and sustained serum uric acid reduction through 24 weeks of treatment. Similarly, there was a reduction in gout flares, and about a third of patients had complete resolution of their tophi. Participants of the Dissolve One trial continue onto the blinded extension portion of the study for another 24 weeks of treatment. On the left side, you see the long-term durability of NASP, consistently maintaining low serum uric acid levels. During the 48-week study period, serum uric acid levels consistently stayed at or below 2.4 mg /dL for NASP, whereas the placebo group maintained levels comparable to their baseline value. In addition, there was also a reduction in gout flares. All patients in the NASP high-dose arm were flare-free at the end of the study, while 23% of patients on placebo experienced flares. NASP was generally well tolerated, with low discontinuation rates during the extension phase, and no new safety signals were observed. Overall, these results confirm the durability of efficacy of NASP in uncontrolled gout. Alongside the oral presentation, poster sessions will also be featured, focusing on NASP and uncontrolled gout, including a new measure of caregiver burden. This focus on patients and caregivers brings me to the next slide, please. If you can move to the next slide, please. Thank you. I'm proud to share that the rare disease patient groups have rated Sobi the most reputable rare disease company out of 31. This was the first time we appeared in the patient view survey. This survey shares the perspective of 518 rare disease patient groups from 58 countries. Together, they represent the voice of 2.4 million patients. The groups rated Sobi highly on having a patient-centered approach and collaboration on quality and safety, as well as access, information, and integrity. This is very encouraging. It reflects our long-standing commitment to patients and our systemic approach on working with them. Our Unite for Rare program bundles our activities in this area. It was co-created with patient organization representatives and has four pillars. We aim to deeply connect with patient communities worldwide, including those that are typically underserved. We also nurture our partnership with patient organizations in a sustainable and ethical way that helps them thrive. We collaborate with and involve patients in the development of our medicines, for example, in the design of our Sobi -sponsored clinical trials. We innovate in the way we work, creating an environment that enables engagement with patients. We are honored by this feedback and inspired to become even better. Next slide, please. Looking ahead, we anticipate progress with the major regulatory submissions in the U.S., Europe, and Japan. We plan to end this year with the Aspaveli CHMP opinion for C3G and IC-MPGN, the Japanese submission of Aspaveli in these nephrology indications, the submission of GAMIFANT in HLH/ MAS also in Japan, and the IDS top-line data. As Guido said, we aim to give you an update with the Q4 figures. Next year, we will be ready to launch NASP in the U.S., Aspaveli in C3G and IC-MPGN, both in Europe and Japan, as well as GAMIFANT in Japan. Finally, we plan to submit GAMIFANT in HLH/ MAS and Tryngolza in familial chylomicronemia syndrome to EMA. With that, I would like to hand back to Guido. Thank you. Yeah, thank you, Lydia. Just summarizing maybe on the next slide. As you know, you have seen, we believe that we had a pretty spectacular performance in Q3 with 21% growth, reaching an EBITDA margin of 47% and oversales. As explained, this is driven by operating leverage, but also discipline in terms of cost and position as well for the future to support what is important to us. We had to rebase, obviously, Bonjour, but I hope we clarified that we believe that Bonjour remains a growth product. Obviously, we have to wait for the readout of Pacifica and then for a broader label and internationalization to come to a material inflection point. Overall, we believe that this is an important product for us, and then we'll see what will come out of the new indications. We're progressing right now very well. We have made significant progress with regard to our pipeline, as Lydia pointed out eloquently. Here foremost, we would like to draw your attention to NASP. With business at Sobi, we have strong momentum. We have pipeline development. As a consequence, we also were able to increase our guidance. We look forward to your questions, as you may have some. Thank you so much. Maybe we'll now do the Q&A session. Thank you, sir. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the telephone. You will hear a tone to confirm that you have entered a queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume of the webcast while asking a question. Anyone with a question may press star and one at this time. Our first question comes from Ben Jackson from Jefferies. Please go ahead. Brilliant. Thank you for the question. Just two quick ones, if I may. Firstly, could you just talk about your assumption of BEYFORTUS that is in the current guidance and the upgraded guidance that you gave for the year? Obviously, you're talking about physicians saying that they're still expecting to see the same number of RSV cases. Does that mean you're expecting this largely to be a phasing thing, with regards to this quarter? Secondly, could you also just talk about the relative contribution of the realignment, the accelerated impact of the restructuring, and also the cost control that you implemented with regards to the EBITDA margin, how it came out this year? Just trying to get a sense of in 4Q, is that a reasonable exit rate to go into next year when thinking about costs and costs ramping up? Is that a fair assumption? If I could just squeeze a third one in, sorry, just to clarify. You said that you were going to update either on the market or update the market on the GAMIFANT study at 4Q. Could you just clarify whether you were going to update the market on the results or whether you were going to update what your thoughts are around how big the market could be at 4Q? Thank you. Yeah, maybe I'll start with the easy one, and then Henrik will talk about, let's say, the financial part, and then Lydia maybe on what you can expect from us in Q4. On BEYFORTUS, we obviously don't control the product. What we try to allude to is, from what we can see based on this interview, nothing wrong with the product. The product has a high preference share. There's no limitation of access. All the worries that, for some time, people had, for patients as well as for physicians. Physicians feel that there's going to be more patients, even though it has been a slow start of the season. It's a question of how much inventory is in the trade, which we cannot tell you. Then there's a question of how quickly the season is going to pick up. What we hear from the physicians is that they are confident that the season will pick up. That does not necessarily mean that the calendar year is showing the equally good results like last year. That is a question really for Sanofi. What we can say is, and we felt that was the reason why we have also the performance survey, because we are not in charge of the business, but we wanted to get a feel, is there something we should take note of that should change our view on the product? That doesn't help with judging a calendar year, but what we found at least is that there's nothing wrong with the product. The question is, will that compensatory effect happen in Q4 or next year? This is really something you have to ask Sanofi. At least what we can say is that the product is in a good shape. Maybe now to Henrik, with regard to the financial question. If I understood you well, you wanted an understanding on the relative importance of the realignment of NASP spend to the standard review time by the FDA and our restructuring activities. Is that right? Yeah, that's right. Thank you. The answer is that the realignment of NASP spend was the larger of the two. Got it. Thank you. The next question comes from Kirsty Ross-Stewart from BNP Paribas. I'm sorry. There was what? There was time for one question related to IDS. Okay. I will open up the line of the first questioner. Okay. Thank you. Yeah. Basically, what we will have to share by Q4 is the top-line data that we will be seeing. The study is finalizing the recruitment. We will have the top-line data by the end of this year. That's what we will be able to share, what is the data that we've seen, and that will serve us to inform the next steps in terms of the development of GAMIFANT in the IDS program. Just to be clear, that's at 4Q results or within 4Q, you expect that top line? That would be at Q4 when we communicate. Thank you. The results. Thank you. You're welcome. Good. Maybe we go to the next question. The next question comes from Kirsty Ross-Stewart from BNP Paribas. Please go ahead. Hello, and thanks for taking my questions. Maybe a first one just on kind of capital allocation. In light of the launches that you've got coming next year and now kind of pursuing the OLEZARSEN indication in MAS, can you just provide an update on your kind of appetite to do further M&A? I know that that was on the cards. I'm just wondering if your perspective on this is the same or has changed in light of the evidence you're making in the investments you're making next year, or whether you still kind of got the capacity to continue to build out the portfolio further. A second one on Bonjour. Can you just confirm whether the Pacifica trial itself you believe will give you the potential to gain the broader label authorization? I noticed that the chart in slide 10 indicates that you're kind of expecting it's still an inflection in Bonjour next year. I just want to understand and have to reconcile that with the trial inclusion criteria, which I think has the same platelet count as the current label. A very, very quick one on BEYFORTUS. Can you just remind us on how the tiered royalty is set? Is the lower sales that we may have seen this quarter, could that result in a lot lower royalty rates for the year or are the step-ups from last year's 25% royalty set regardless of the revenue? Thank you very much. Yeah. Let's start with, you know, basically maybe with Bonjour. What we see is that the inflection, you know, Pacifica in conjunction with the other evidence may be enough to give us a label expansion, not on itself. It's a confirmatory trial, but as we are right now, we got a conditional approval. Even with the additional evidence that we have generated, we are a little bit stuck to get a label extension. Lydia, you want to comment on this? Yeah. As you said, Pacifica is a confirmatory trial with the platelet count that we already have in the label. We have already started some discussions with the FDA in terms of what could be the totality of the data that we could present, including existing data that we have already gathered from previous studies on patients with platelets above 50,000, plus real-world evidence and additional sources of data. We are working on that, and that's what we would like to use as a basis for an expanded label. Obviously, the first step for everything is to complete the recruitment of Pacifica to get the confirmatory data, and then we can add the additional sources of data. Okay. With regard to BD, I think we see this more like this. We have obviously now a lot to do with OLEZARSEN, with the C3G IC-MPGN launch, which we will start early next first quarter next year. We then have NASP in, BLA expected in June next year. Then OLEZARSEN submitted in Q1 and probably becoming a launch then early 2027. You can, and you have the ongoing launches for Altuvoct and GAMIFANT. Quite a bundle. What we are looking for is architecturing, obviously, the company for long-term goals. We can see that we will, with these initiatives, soon have again bandwidth, definitely in the R&D organization for additional projects in terms of pipeline. We like to architecture growth that stretches then into the, beyond the mid-2030s. This is what we are currently looking at when we look at opportunities. Obviously, we have a broader ambition, which is to become a leader in rare disease. There's still some room. It's not size for the sake of size. We need to be sure that we can manage this. Yes, as you have seen sometimes, in most of the cases, we have got it right. One guy, we had to be, we have a deferred uptake and we need to take this. Mostly, I think it was 21% growth. It's not so bad. We probably get more right than we get wrong. With regard to the BEYFORTUS royalties, the first two years was 25%. Regarding the market, there are two elements to this. One is time, and the other one is size. There's a mechanism that potentially goes up to 35%, but in the blended, it's probably the lower 30s. The royalty is going to increase for BEYFORTUS. All right. Let's move on to the next question. The next question comes from Viktor Sundberg from Nordea. Please go ahead. Yes. Hi. Thanks for taking my questions. First one on GAMIFANT. It's quite a pickup in sales here in Q3, and you referred to some impact from your extended approval into macrophage activation in Still’s disease. I was just wondering, was this a major driver here, or was it other factors? In general, also how the initial uptake is for this indication. I also have a second one on GAMIFANT, but I can start here. Yeah. Basically, the uptake, as you have seen, the previous quarters were all very strong. It is not just the launch. It is the value system, the way the organization is currently set up with very strong medical access. Obviously, the commercial team is paying here dividends. The new indication helped. The company was, the team was on a fantastic trajectory beforehand. This 19% quarter-on-quarter growth clearly has benefited from the launch and the broadening of the indication. As we are on track, as we always said, with the new indication, we think that we can double the opportunity. We stand by this, and all indications point in the right direction. Okay. Great. Also, another one here on GAMIFANT. As you mentioned, we have the Embrace trial coming up. I guess sepsis is still quite a heterogeneous patient population, even if you account for your biomarker selection with comorbidities, etc. I just wanted to understand your thinking if results show trends, but not statistically significant benefits on the SOFA score, would you still jump into a phase III? Do you see this trial as more of a chance of getting important data points for moving the program further? Maybe on the other hand, if the results are very, very robust, what's your thinking here of using accelerated approval in that case? I was trying to understand what outcomes are on the table for this readout. Thank you. Yeah. I mean, we debated it, and then Lydia will comment on this in a minute. I mean, we'll see. The bar for other treatments is not incredibly high in terms of mortality reduction, because it's a devastating disease. Many companies have, for many products, it has been a bit of a graveyard. We are more confident, and otherwise, we would have not endeavored this if there wasn't this pre-trial, where we screened with Professor Giamarellos's 5,500 patients, understood then the xenotype, and as a consequence, you narrowed down the funnel quite considerably and believe that there's a mechanistic evidence of interferon gamma involved. From my perspective, we'll really have to see what is the mix of SOFA score improvement and whether we see any signals on mortality, and then make sure that we do a sound decision. Professor Giamarellos is the President of the Sepsis Association in Europe. He's a very well-known KOL who has a lot of experience, and we will discuss this with him and obviously other KOLs, what the appropriate step is. I'm not sure that we have already the metrics in place. Lydia, you want to comment? Sure. Thanks. Basically, sepsis is a very complex disease, as you mentioned in your question. With this biomarker, we are really following this in vitro study and really targeting those patients where there is an increase in CXCL9. The study, as you mentioned, is based on the primary endpoint, which is the SOFA score. We will see some data on mortality. Obviously, these are very complex patient populations. Knowing how complex the disease is and the treatment landscape, what we need to do is really not jump ahead. We will really look at the data step by step. In the meantime, there is an independent data safety monitoring board that has reviewed the data and has agreed that the study can continue with enrollment to finalize, as we expected, very soon. I think it will be premature to say, "Oh, we have cleared the path or if this is the target SOFA score improvement, this is how we are going to proceed." We will be really discussing, A, with KOLs, as Guido Oelkers mentioned, but also with regulators. Based on that, we will make the decision on the next steps. I'm sorry to be a little bit vague, but due to the complexity of this disease, I think it would be premature to really adventure some more specific endpoints here. Great. Thank you very much. Thank you. Maybe next question. The next question comes from Henrietta Boeg from Deutsche Bank. Please go ahead. Hi. Thank you for taking my questions. Just one on what extent can we extrapolate the 2025 margin performance exceeding expectations? If you could talk about the margin outlook over the coming years, given the need to invest behind the gout and the C3G launches, that'd be helpful. I guess just a follow-up on the sepsis data in Q4. We'd have to wait till a follow-up, maybe 2026, for the phase III details. Thank you. Yeah. Let's start with margin expectations. What we have done is that we said mid to high 30s, and there is nothing more to say. Right now, we come obviously year-to-date performance. You have seen the margins are ahead. On the other hand, we have two launches that we are now preparing, one in NASP in the new therapy area and one in nephrology in Europe. This will require some investments. We haven't decided yet what to do and what to put in now. We know that we will definitely support the nephrology launch already this quarter now because it's basically under Porter's. I don't think, Henrik, you want to comment on the margin? No, that's right. We also have, obviously, the preparations for macrophage activation syndrome in MAS. Going into 2026, we expect a continued strong momentum on the top line. Yeah, I mean, that's the reason it came a bit short. Obviously, the savings have made a significant difference. For that quarter, the expense line had a higher impact. That doesn't mean that the savings we have ring-fenced are not significant enough. They will help us. Business is increasing. We expect a good strong momentum that will give us some room to grow. We have some ring-fenced savings. We will give you margin guidance in conjunction with Q4. With regard to the data now, that's Q4 earning report. We will come latest with the GAMIFANT data. If we can report something earlier, let's say we will report earlier. I mean, Lydia, you want to comment? I think, again, it's back to the data. Obviously, if there is outstanding data, maybe regulators want us even to move faster. Without data, I think we need to be cautious and just wait so that then we will be happy to report as soon as we can. Yep. Great. Thank you. Thank you. Another question? As a reminder, if you wish to register for a question, please press star followed by one. The next question comes from Georg Tigalonov- Bjerke from ABG. Please go ahead. Yeah. Hi. This is Georg from ABG. Thank you for taking my questions. I have two. Firstly, have you or Sanofi seen any price pressure for BEYFORTUS? Secondly, regarding the submission of GAMIFANT in HLH in the EU, to what degree, if any, are you awaiting a final decision here until you have more visibility on the path forward for interferon gamma-driven sepsis? That's a strong readout. Potentially, it could make sense then to await the submission in HLH in order to maximize the exclusivity period in interferon gamma-driven sepsis. Thank you. Thank you. I mean, with the price pressure, you know, Sanofi can and will not discuss these things with us. We have not heard via our informal channels of this, but that doesn't mean that I would not exclude that there is, you really have to ask them, let's say. We are not aware of it. With regard to HLH in Europe, I mean, we have supported now over 100 patients with primary and secondary HLH in Europe. We feel that we owe it to the patients. Let's say that we get the product registered based on the data that we have generated that led to the approval in Europe. You will hear from us. Lydia, you want to comment on this effort? Yeah, sure. Basically, the approval of GAMIFANT in the U.S. is based on the study 6 and the study 14, where many of the patients, I would say most of the patients on the study 14 were coming from Europe. There is a strong interest in Europe of having access to this treatment because obviously, these patients are having a condition that is life-threatening. This is our commitment to patients. We have now data that has led to an approval by the FDA, and that's why we want to bring it to patients in Europe. We do have a managed access program, compassionate use program in Europe, and we have provided access to treatment because of our intention to bring it to the different markets in Europe. I think it's really our responsibility as a company to bring the product as soon as we can. Obviously, we are in conversations with EMA, with strong support from the community. That's our commitment to the HLH community, and that's what we want to do as a first step. With regard to IDS, let's look at the results. If the product works well, for sure, we will be in very close dialogue with regulators, given the high unmet medical need in this area. We will update you, obviously. Next question. Following up with a question, back over to you for any closing remarks. Thank you so much for your interest. We had quite a lot of items today and very much appreciate that you stay tuned. We are excited about this company. As you can see, not only from today's perspective, but also from tomorrow and the day after tomorrow's perspective, looking at our pipeline. We are here to build this business and we feel that we have momentum. It's pointing in the right direction. We obviously have a bolus of new assets, but I think this is a happy problem to have. We will figure out how to manage financial expectations that a lot of people have for us. On this note, I wish you a great week and thanks for being so flexible and joining our earnings call. Thank you so much. Wish you a great day. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.