Swedish Orphan Biovitrum AB (publ) ($SOBI)

Ladies and gentlemen, welcome to the Sobi Q1 2026 Report Conference Call and Live Webcast. I'm Valentina, the Chorus Call operator. [Operator Instructions] And the conference is being recorded. The presentation will be followed by a Q&A session. [Operator Instructions] 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.

Thank you. Hello, everyone. This is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the first quarter 2026 conference call for investors and analysts. Our presentation was posted on sobi.com earlier today. Please turn to the next slide. We would like to remind you of the usual provisions on statements about expectations and projections or future events. Unless stated otherwise, we are making comments that mostly relate to the first quarter at constant exchange rates in million Swedish krona. Please turn to the next slide. Today, we plan to cover the key aspects of our Q1 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 presentation first and then have a Q&A until around 1:30 p.m. Central Eastern European time. [Operator Instructions] We propose that you ask only one, maximum two questions at a time. Please turn to the next slide. We have delivered a very strong start in Q1 2026 operationally and financially with 24% revenue growth at constant exchange rate and an adjusted EBITA at 38%, reflecting strong commercial execution across the portfolio. Disciplined cost management continued strategic investment for long-term growth. These numbers speak for the resilience of our portfolio in turbulent times. I think important to note is the progress we have made with our 6 launches. And the strategic portfolio grew by 55%, contributing 63% of our total business. This dynamic rose was driven by key launches, including Altuvoct, Gamifant and now the European and international launch of Aspaveli in C3G IC-MPGN. In addition, we have been able to achieve our milestones for Tryngolza in sHTG and submitted and launched FCS as well as completed the transaction of Arthrosi, which is obviously an important milestone for us. It enhances both the breadth of our pipeline but also our long-term growth trajectory. Overall, Q1 demonstrates strong execution across the business, and I would like to reiterate the resilience of our business even in ambiguous times, and we continue progressing our momentum for the years to come. Please turn to the next slide. Let's take a closer look at the Q1 performance. Growth was well diversified across regions and segments. Each region contributed and our key products continued to scale effectively. Our strategic portfolio is now the central engine of Sobi's performance, representing our shift towards high-value, high-innovation assets and, I mentioned, representing 63% of our revenues in Q1. All regions delivered solid growth and continued to build momentum quarter after quarter. Let me take you now through some of the key products, but before doing this, let's reiterate, let's turn to the next slide and review what our program is ahead and that we have shared with you during the recent Capital Markets Day. Looking ahead of our priority programs and launch cadence, we continue progressing a broad set of opportunities, creating material opportunities for growth and diversifying our portfolio. We had a very good start with Aspaveli in Q1 and are in the process to roll out the indications, C3G and IC-MPGN across our territory. With regard to NASP, we wait for FDA's decision before end of Q2 and discuss the first data readout for pozdeutinurad in latest by the end of Q2. For Tryngolza, we have had a good start to the FCS launch in Europe and continue building relationships with key lipid centers. The launch of FCS is an important foundational step for the planned launch of sHTG. In the quarter, we also filed Tryngolza in also in Europe in the indication sHTG. Overall, this pipeline represents a strong and diversified set of launches throughout 2028, supporting our ambition to reach approximately SEK 55 billion of revenues by 2030. Please turn to Page 7, on the next slide. Altuvoct continues to be a true standard sell-out in our portfolio. In Q1, Altuvoct continued to show exuberant growth with 186% and is consistently gaining market share as the launch progresses. We have also launched across the major EU5 markets, although it's worth mentioning or noting that some of these launches are still at the very early stage of rollout. During the quarter, our combined hemophilia A business grew by 25% at CER. This performance reflects the strong clinical profile of Altuvoct and the disciplined launch execution. We have now launched in 27 countries with key markets such as U.K., Italy and France being at an early stage. We can expect to demonstrate exuberant growth in Wave 3 and Wave 2 countries for some time. Overall, strong momentum and clear path for sustained growth. Let me now move to Gamifant. In the first quarter, Gamifant delivered SEK 734 million in sales, up 47% at constant exchange rate. Growth is driven by the U.S. launch where Gamifant is now the first approved treatment for both adults and children with MAS and Still's disease. With an uptake continuing to build, awareness will increase. From a regulatory perspective, we have completed filings in both the U.S. and -- sorry, in both in Europe and Japan in agent MAS, supporting further geographic expansion. We are now also progressing in interferon-gamma-driven sepsis, where the Phase IIa EMBRACE study has shown proof of concept, and we are now engaging with regulators on next steps, and we will provide an update latest by Q2 reporting. Overall, Gamifant is delivering strong commercial momentum today with multiple longer-term growth opportunities ahead. Please turn to the next slide. Let me turn now to Aspaveli. In Q1, we are encouraged by the strong uptake of Aspaveli in C3G. The product delivered SEK 371 million in revenues, representing 21% growth versus last quarter. This performance reflects the new momentum from our European and international launch in C3G and IC-MPGN whilst PNH remained stable, in line with our expectations. As a reminder, C3G and IC-MPGN are areas of high unmet medical need. Today's standard of care does not adequately hold long-term progression and disease progression, and it's something that both physicians and patients are acutely aware of. Aspaveli directly addresses a key driver of the disease biology, supported by what is believed to be best in class. During the quarter, we began our nephrology launch in Europe with Germany as an initial focus. I'm pleased to say that the launch is tracking ahead of our internal expectations. We see very positive feedback from the market, including some engagement from nephrologists and a clear preference share for us Aspaveli among HCPs from recent research findings. These initial segments improve our belief in the long-term potential of Aspaveli in nephrology. For orientation, our 2026 target is to have 400 to 500 patients on Aspaveli therapy. Please turn to the next slide. Doptelet continues to deliver very strong growth momentum. In the first quarter, sales reached SEK 1.4 billion, up 44% at constant exchange rates. This performance is driven by strong clinical profile with high efficacy and fewer dietary restrictions, making it an important option in ITP. Doptelet has become a truly global franchise with growth across all 3 regions but, in particular, strong growth in the international region. While demand in the U.S. is consistently expanding, we continue to increase penetration in Europe and experienced exponential growth in international markets, particularly in Asia, meaning Japan, and strong growth across other subregions, reinforcing the long-term potential opportunity. Consequently, we expect a material increase of the international's contribution in 2026. Overall, Doptelet in 2026 remains a key growth driver, supported by both established and newly launched markets. Please turn to the next slide. Arthrosi Therapeutics is an important step in building our leadership in gout and broaden our immunology therapy areas. We completed the acquisition during the quarter, added a high-quality late-stage portfolio targeting significant unmet medical need. The portfolio is anchored by 2 complementary programs, firstly, in NASP. We have PDUFA date on June 26 and expect feedback from the FDA during the forthcoming weeks. We are ready to launch in chronic refractory gout during Q3. Second, pozdeutinurad, a next-generation, once-daily URAT1 inhibitor for progressive gout with a planned launch in 2028. Pozdeutinurad represents the primary economic opportunity for Sobi in our gout franchise. For pozdeutinurad, the key Phase III readouts are coming this year, including REDUCE-2 data in Q2 and REDUCE-1 in the second half. We are eagerly looking forward to sharing the data when available with you. Overall, this acquisition will strengthen our pipeline, expand our presence in gout and adds multiple value-creating milestones in the years to come. Please turn to the next slide. And I'd now like to hand over to Lydia.

Thank you, Guido. Hi, everyone. As per usual, I will start with the pipeline milestone on the next slide, please. We started the year on a very strong foot. Aspaveli in the nephrology indication, C3G and primary IC-MPGN, was approved in the European Union in January, 1 month ahead of the scheduled timeline. We got positive top line data for Gamifant in interferon-gamma-driven sepsis that enable us to move forward with the clinical development program. And we also got some new data from the EMBRACE study, which I will talk about shortly. We submitted Tryngolza for severe hypertriglyceridemia to European Medicines Agency, and we also fully enrolled all patients in the PACIFICA trial of Vonjo in chronic myelofibrosis. PACIFICA is our confirmatory Phase III trial, key to get full FDA approval, and our attention is now on preparing for database log and subsequent submission next year. Next slide, please. Turning to Gamifant in interferon-gamma-driven sepsis. The initial data from the EMBRACE proof-of-concept study was presented last month in Brussels at ISICEM in the International Symposium on Intensive Care and Emergency Medicine. During our Capital Markets Day, we already shared the key study results of EMBRACE that show an improvement in organ dysfunction, as measured with the SOFA score, and patient survival with emapalumab at the end of treatment on day 28. 60% of patients in the high-dose emapalumab arm achieved the primary endpoint of decrease in SOFA score compared to 40% in the standard treatment plus placebo. This is shown in the left chart, which was presented at ISICEM. These results translate into 5 patients needed to treat improve organ function of 1 patient, which is very encouraging in sepsis. Last week, the long-term mortality follow-up was presented at the World Sepsis Congress. It confirmed a survival benefit with emapalumab high dose, as you can see on the right chart. At the end of the study treatment day 28, we saw a 12% point benefit of the high-dose treatment, and very similar results were seen in the follow-up period, showing survival benefit at day 60 and 90. This further supports the proof of concept and our belief in advancing the clinical development of Gamifant for interferon-gamma-driven sepsis. Next slide, please. Looking ahead, we anticipate continued momentum with major regulatory milestones across U.S., Europe and Japan as well as key readout data. In the first half of 2026, we plan for the NASP FDA decision in June, the first pozdeutinurad readout from the REDUCE-2 pivotal trial in progressive gout and the LOTIS-5 data readout in relapsed/refractory diffuse large B-cell lymphoma. Later in the year, we expect the Japanese regulatory decisions for both asp in the nephrology indications and for Gamifant in HLH/MAS. We will see the second pozdeutinurad readout in this case from the REDUCE-1 trial. And finally, the Tryngolza CHMP opinion in severe hypertriglyceridemia is also expected before end of the year. And with that, I would like to hand over to Henrik. Next slide, please

Thank you, Lydia, and hello, everyone. Please turn to next slide. I will take a look at some key financial metrics for the quarter. So in Q1, our revenues of SEK 7.2 billion corresponds to revenue growth of 24% at CER. Haematology increased by 24%, and our combined hemophilia A portfolio increased by 25% as Altuvoct continued its strong launch momentum and is now launched in all major EU markets. Doptelet increased by 44% at CER, driven by strong growth in all 3 regions. And Aspaveli in nephrology as we saw is now launched in its first market with positive feedback. In Immunology we saw strong double-digit growth in both Gamifant and Kineret, offset by lower RSV royalties. Specialty Care also increased by 24% at CER, driven by new patients in Tryngolza on FCS and patient growth in some other Specialty Care medicines. If we look at the table on the right, then the adjusted gross margin of 77% in the quarter is in line with last year. Gross margin was positively impacted by product mix and country mix effects, offset by lower Beyfortus royalties. Operating expenses, excluding nonrecurring items and amortization, for the quarter increased by 15% at CER compared to Q1 '25, reflecting the increased activity level in the company. SG&A, also excluding nonrecurring items and amortization, increased by 12% at CER, driven by launch and prelaunch costs for Altuvoct, Aspaveli in nephrology, NASP and Tryngolza. And R&D expenses increased by 22% at CER, excluding nonrecurring items, mainly due to the addition of Arthrosi development programs as well as increases related to Tryngolza and Vonjo. And as a result, the adjusted EBITA for the quarter amounted to SEK 2.8 billion, equal to a margin of 38% compared to 36% for the same period last year. Operating cash flow for the quarter was SEK 1.1 billion. Higher operating profit was offset by higher working capital buildup due to three main items: Arthrosi transaction-related payments, inventory prepayments and lower Beyfortus royalty payment following lower sales last year. And as a result, net debt at the end of the quarter was just below SEK 18 billion, net debt-to-EBITDA ratio of 1.5x. Please turn to next slide and the financial outlook for the full year 2026 million. As usual, this outlook is based on revenue growth at constant exchange rate and adjusted EBITDA margin. For the full year 2026, the outlook remains unchanged. We anticipate revenue to grow at low double-digit percentage at CER and adjusted EBITA margin in the mid-30s percentage of revenue. The key drivers for the 2026 outlook that we discussed in connection with the Q4 report in February are still relevant. On the revenue guidance, we expect continued progress with our existing commercial portfolio with Altuvoct being a continued key growth driver. Beyfortus, not to be too repetitive, remain difficult for us to forecast, but we don't believe that the fundamentals have changed with regards to recommendations and reimbursement. Regarding our EBITA margin guidance, I want to reiterate some key costs that we will have in 2026 that are new or accelerated compared to 2025. First, we have the prelaunch and launch costs for Aspaveli in NASP. While we had some of those costs in Q1, they will continue to accelerate as we get approval in additional countries for Aspaveli and as we get fully staffed for NASP closer to launch. Second, filing and prelaunch costs related to Tryngolza in sHTG. In March, we submitted to EMA for the indication expansion for sHTG. So we will also continue to see the additional costs moving forward as we near launch. Third, the acquisition of Arthrosi and the R&D cost of 2 ongoing Phase III studies and preparation for regulatory submission. Finally, we're also planning the continued development of Gamifant in IDS, and this is something we will come back to after our interactions with regulators. And all these costs will partly be offset with reallocation of resources and cost containment in the rest of the business, including the full year impact of the cost savings initiatives from 2025. With this, I now hand back to Guido. Thank you.

Thank you, Henrik, and let me close by summarizing the key messages from today and a brief recap from our recent CMD. First, Q1 2026 reflects a very strong execution across our entire portfolio in regions with robust financial performance, broad-based growth, as mentioned, across the portfolio, coupled with disciplined execution. The robustness of our commercial portfolio especially in uncertain geopolitical times is a testament of our diversified portfolio and the people who are working at Sobi. As outlined in our Capital Markets Day, we see 6 major launches as key drivers towards our 2030 ambition, and in the quarter, we continue to make strong progress in this direction with the new launch for Aspaveli in nephrology, the filing for Tryngolza in sHTG and the launch of FCS. We continue to see strong momentum in Altuvoct and Gamifant. We have strengthened our position in gout through the acquisition and continue to progress the pipeline with multiple value-creating opportunities. Overall, we remain confident in our strategy and our execution and in our ability to deliver sustainable long-term value for both patients and our shareholders. With that, I'd like to hand over for Q&A.

[Operator Instructions] The first question comes from Sheila Chen from Barclays.

May I ask about Aspaveli in nephrology launch? Could you please share with us a bit more initial market and initial feedback on this new indication? And also just wondering how do you find the competition dynamics so far in your launch countries?

Yes. Thank you. We have just recently performed a survey across the various countries. We're in the market in in Germany, obviously, we're always being the first and then also in the other two German-speaking countries. So we can see some feedback and in various international markets. And the feedback actually across surveys, but also from the conferences that we have is that there is a very strong preference for Aspaveli versus other new launches or a new launch in this indication. And it's referring to the profile -- you may remember the triangle that we pointed out with the efficacy in proteinuria, the stabilization of eGFR already after 6 months and also the important data on staining. And this seems to resonate, and we get a very strong preference share actually in high priority centers and priority centers. So we think that we still have some room to cover when it comes also to community-based with nephrologists, but our approach was more top down. We're very happy with where we stand right now. And when you think about the overall magnitude, this is really early days. We didn't launch in Germany until the late second half of January. And already what we have achieved is moving our performance. When we outlined this, we were probably more stable at PNH. This early launch is already moving the product by 21%. And that gives you, let's say, a take that the launch is quite meaningful, Granted, it's early days and we don't want to get ahead of ourselves. But we are very pleased. And so performance, number of patients, feedback from physicians are very consistent, and very excited to take the product forward.

The next question comes from Christopher Uhde from SEB.

Chris Uhde from SEB. My first question, I guess, they'll both be on the pipeline, so probably for Lydia, I guess. Pozdeutinurad, would you please tell us how you view the bar for success there? And also in terms of the timing of REDUCE-1, is it more likely to be sort of in Q3 or Q4? And then my second question is on the sepsis longer-term follow-up. Just I hadn't planned to ask on it, but since you showed the data there, 120 days, I believe, was the actual endpoint. And obviously, you have that data in-house. I'm just curious how that looks compared to the 90-day cutoff that you show. Obviously, it's benefited the patients longer than Kineret did in its trial. But curious to hear what the 120 day looks like.

Thank you. So if you want, I can start with the IDS. And as you probably know, the end of treatment was day 28, and that is where we were measuring the efficacy. And then all the sepsis trials look at mortality until day 90. That's the standard in sepsis. And the only reason why we follow up until day 120 to reassure the safety profile of emapalumab because of the long half-life of emapalumab. If emapalumab has had a shorter half life, we would have just follow-up patients until day 90. So that's where you look at mortality. If you look at all the sepsis trials that are published, they follow either 30 days, 60 or 90. 90 is the standard. So that's why we are collecting the safety data to reassure that the use of Gamifant in IDS has not increased any safety [indiscernible]. When it comes to pozdeutinurad, as you know, the primary endpoint is the reduction in serum uric acid. And what we've seen so far is the Phase II data, which is very reassuring. So I think that we are expecting very good results, but we need to be careful. And then that's what we will see top line data, as Guido has mentioned in his presentation. And later, we will see the top line reduction -- the resolution and the firm reduction. So we are expecting very strong data. When it comes to the timing, I can reassure you that we are very excited and working very closely with our gout franchise team, together with the Arthrosi people, and we are trying to push the data as fast as possible. But I think we need to be careful. Our plan is to have it before the end of Q2. If we can bring it earlier, of course, we will let all you know. But for the time being, we are planning for the end of Q2.

Okay. Could you just clarify, though, in terms of the bar. I mean, is there a particular level of SUA you need? Or is it just that sig?

Yes. So what we expect is it's what we have from the previous trials. And again, this is a large pivotal trial and 2 sister clinical trials in this indication. So I think it's maybe premature to say, okay, this will be fine or not. So we expect a very important reduction in serum uric acid because of the mode of action and because of, obviously, the data that we've seen. So more to come probably in very short few months.

The next question comes from Kirsty Ross-Stewart from BNP Paribas.

Kirsty Ross-Stewart from BNP Paribas. So with respect to Aspaveli, the step-up in Q1 sales was impressive in the expectations for relatively moderate ramp in the nephrology indication. So is it fair to assume you're tracking ahead or at least the top end of your 400 to 500 nephrology patient target that you set for the year? And then on Altuvoct, you're highlighting kind of material headroom for future growth from the second wave of launches and comfortably on track to reach double-digit growth this year in the hemo portfolio. So just wondering how long anticipate you can sustain that double-digit growth in the hemo franchise.

Yes. Thank you. Maybe let's start with the easy bit. But we obviously don't want to reset expectations 3 months into the year for us for Aspaveli. But if anything, you get a sense, you do the math, that we clearly have no reasons to believe that we don't meet this rate, yes. If anything, our confidence to make Aspaveli a very important product for Sobi in nephrology has significantly increased based on the data points we have collected in the first quarter. But we will update you in Q2. We are on a very, very important slope. And we also outlined that we are ahead of our internal expectations. With regard to Altuvoct, even though we have not reached, I think we can look forward to significant growth in the years to come. As you know, there's still quite a bit of headroom. We have seen early signs of really spectacular growth in international markets. And we have the growth opportunities in Europe, particularly in the second wave countries or in the later stage opportunities like France. We still have significant room for growth in Spain and in the U.K. and, let's say, in Italy. So this strong growth momentum that you see is clearly going to be with us. And for me, it's gratifying, when you look at the quarterly business size of the hemophilia A business and the momentum of Altuvoct, that we are clearly on track for our ambition that we set out, that we believe that our hemophilia A franchise is going to be blockbuster franchise. And so very strong momentum and very optimistic for the franchise. I hope I could give you some sense because typically we don't reforecast during the first quarter on a product level.

The next question comes from Matthias Haggblom from Handelsbanken.

Mattias Haggblom, Handelsbanken. Two questions, please. First, on Altuvoct. So Roche had their earnings call last week that strength in Hemlibra for the quarter had been driven by switches back from Altuviiio or Altuvoct and mentioned the fact that Hemlibra doesn't cause inhibitors as one of the drivers. So could you comment on what switching dynamics you see in your region? Plus also, remind me what real world evidence suggests for inhibitor incidents among patients. And then secondly again on Aspaveli, During 2025, product was largely flat until Q4 when there was a sequential decline quarter-over-quarter. But in Q1, sales up sequentially significantly rather more than the year-over-year 20% growth that you referenced. So was all of the sequential increase linked to the C3G launch? As you claim PNH was stable. And was C3G all the [ margin? ] Or was there any stocking to call out?

Yes. Let's start with the easy bit. With Altuvoct, when you grow 86%, we may have the one or the other patient. But when you gain -- this is less than 1%. So I take the 99% any day. So we don't have a problem with switching and whatsoever. And obviously, we don't see a problem of inhibitors. Inhibitors is a known risk, obviously, that you have with Factor VIII. But what we see though is a lot of very positive feedback from patients who are on the product and actually have switched from Hemlibra and telling us that they now have a much broader set of opportunities to live their lives to the fullest and don't have to for bleeding particularly during exercise. So I think maybe, Lydia, you want to comment on the risk of inhibitor?

Sure. Yes. So obviously, Hemlibra does not [ cause ] inhibitors because it's not Factor VIII replacement therapy. And as Guido mentioned, the development of inhibitors is a known risk. It's in our SMPC. And what we've seen, it's really on the patients that we have in the market. And as you remember probably in the clinical development program, which was extremely large, there were no patients who developed inhibitors in the real world we've seen. But obviously, those were patients that you get a mix of product of patients with different medical history, meaning that we know that some of those patients that have developed an inhibitor with Altuvoct, they already had previous inhibitors with other factors. There are others that develop an inhibitor while being on Altuvoct, but receiving different Factor VIII products because an emergency situation that did not have at hand the product. So there are multiple confounding factors that reassure us on the benefit risk profile of Altuvoct that remains unchanged when it comes to inhibitor development.

Yes. And then with regard to Aspaveli, indeed, what you can see as an evolution is that, yes, it's clearly an incremental benefit of the C3G launch and IC-MPGN. That's the reason why we are quite positive and excited.

The next question comes from Harry Gillis from Berenberg.

I actually have one question on Doptelet, if I may. You called out the very strong growth in international markets. And by the end of this year, that's becoming a much more significant share of the product's overall sales. Could you maybe provide us some sort of information on the split regarding the U.S. and ex U.S. just as we approach '27 and that U.S. LOE so we can try and model that with a little bit more accuracy? And then just a second question, if I may, on the full year '26 guidance. So Q1, super strong start, 24% constant currency growth, Aspaveli, ahead of internal expectations, Altuvoct going extremely well. I suppose what would you need to see and by what point in the year to lift your expectation for low double-digit top line just given the strength that we've seen so far plus with additional NASP launch as well potentially benefiting the end of the year?

Thank you. With regard to Doptelet, at this stage, what we can say the majority is still coming from our U.S. business. And what we will do is in order to -- as part of the guidance and next year, we'll probably break out the split more clearly. But what you can expect because the growth of Doptelet in international markets has not been dissimilar to our [indiscernible] growth. And if anything better, then that tells you that, that ratio is going to favor obviously the outside of U.S. markets. And so that's basically when we think about next year, that impact may not be as large as to be feared. Anyway, it comes in the second half. But we will do everything we can. We'll probably provide a good view, let's say, for when we talk about guidance for next year. But at this stage, I think we won't do this. And with regard to guidance improvement, we obviously take this quarter-by-quarter. And let's hope we have a good quarter next quarter. And then I think we make a good informed decision. You know our patents from the past. We are historically a bit of a slow start when it comes to guidance upgrade.

Got it. Can I just ask one follow-up. Could you just say the Doptelet LOE is second half of next year? And can you provide any more like specifics on the exact timing?

Henrik, what is our messaging there? Maybe you can...

Yes, it's mid next year in the second half. We haven't been specific on the month, but it's the summer next year.

Yes.

The next question comes from Georg Tigalonov-Bjerke from ABG.

This is George from ABG. Congrats on a strong quarter. I have two questions, please. So first, the Gamifant year-over-year growth was still very strong, however, somewhat short of expectations after 2 quarters with very strong sequential growth too. So do we already start to see some signs of plateauing in secondary in the U.S.? Or were there some other temporary slowing drivers this quarter? And then secondly, regarding Aspaveli in C3G and IC-MPGN, When do you expect to secure reimbursement in the major markets outside of Germany on a country-by-country basis?

Yes. I think with regard to Gamifant, I wouldn't see the growth as an indicator -- see, 7% is probably not so bad, but I don't feel too shy about it. But it's fair to say that this is not a quarter which is indicative. I think there is a very strong underlying demand. Gamifant has a bit of still like historical lumpiness due to the dependency on heavier patients. And well, I think it will be a very important opportunity for us this year. This one you can see. And obviously, there will be a base effect at one stage. But we look forward to a very important year for Gamifant. As far as Aspaveli is concerned the -- sorry, your main angle regarding Aspaveli, can you just quickly remind me? Just give me...

Yes, just regarding reimbursement in the major market .

The reimbursement. Yes, sorry. So what we expect that basically during the next couple of months, we expect positive decisions in Spain and [ Italy ], also major markets, We are not yet announcing here the list of all markets. But of the EU5 markets, they will be the next in line during this year.

[Operator Instructions] We now have a follow-up question from Christopher Uhde from SEB.

On Tryngolza, it's obviously super early days, super rare population. But can you tell us a little bit about what you're seeing there in terms of the centers, the doctors and so on, the types of patients as it relates to the ability to predict what happens in the MCS launch?

Yes. We have a very good uptake in the launch countries, granted this is now Germany, Poland, Austria and basically building up this franchise. The benefits of the product versus the existing one, Hemlibra, are intuitive, and we have expanded in any of those market share. I think the importance for us of the launch is more the connectivity to the lipid centers, which will be at the core of value creation also for sHTG next year. And I think that the connectivity works out very well. And the feedback we got from the product is very positive, particularly on the [ turnover ]. But it's a small indication. Hence, sales were not yet to too large. But think for us, the key is we have also quite a number of patients on manage access and early access programs. That number will increase. So we use the time wisely now to prepare ourselves for the large indication next year.

Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to Guido Oelkers for any closing remarks.

Yes. Thank you so much for your attention. I know that this is a very popular day and there are some other smaller or larger companies waiting for you. And I hope the view were worthwhile. Thanks for your attention, and look forward to be in dialogue with you very soon. Thank you. .

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