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 of future events. Unless stated otherwise, we are making comments that most 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 European Time.
For those on the phone, please join the queue for questions by pressing star one. 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 EBITDA 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 six launches. You know, the strategic portfolio grew by 55%, contributing 63% of our total business.
This dynamic growth was driven by key launches, including ALTUVOCT, Gamifant, and now the European and international launch of Aspaveli and C3G, IC-MPGN. In addition, we have been able to achieve our milestones for Tryngolza and sHTG and submitted and launched FCS, as well as completed the transaction of Arthrosi, which is obviously an important milestone for us that 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 as mentioned, representing 63% of our revenues in Q1. All regions delivered solid growth and continue to build momentum quarter after quarter. Let me take you now through some of the key products. Before doing this, let's reiterate. Let's turn to the next slide and review, you know, 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 indication 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, 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 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 seven or the next slide. ALTUVOCT, you know, continues to be a true standard sendout 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 a 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 equivalent 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 in MAS, 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 Europe and Japan in age-related MAS, supporting further geographic expansion. We are now also progressing in interferon gamma driven sepsis, where the phase II-A 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 remains 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 this is something that both physicians and patients are acutely aware of. Aspaveli directly addresses the key driver of 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 Aspaveli among HCPs from recent research findings. These initial segments improve our belief in the long-term potential of Aspaveli nephrology. For orientation, our 2026 target is to have 400-500 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 three regions, but in particular strong growth in the international region. While some demand, while demand in the U.S. is consistently expanding, we continue to increase penetration in Europe and experience exponential growth in international markets, particularly in Asia, meaning Japan, and strong growth across other sub-regions, reinforcing the long-term potential opportunity. We expect a material increase of the international's contribution in 2026. Doptelet in 2026 remains a key growth driver supported by both established and newly launched markets. Please turn to the next slide. Our Sobi Therapeutics is an important step in building our leadership in gout and broaden our immunology therapy area. We completed the acquisition during the quarter, added a high-quality late-stage portfolio targeting significant unmet medical need. The portfolio is anchored by two complementary programs. Firstly, 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, 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 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 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 indications, C3G in primary IgA Nephropathy, was approved in the European Union in January, one 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. We also got some new data from the EMBRACE study, which I will talk about shortly. We submitted Tryngolza for severe hypertriglyceridemia to the 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 lock 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 ECCMID, 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 ECCMID. These results translate into five patients needed to treat to improve organ function of one 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 maintained 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 percentage point benefit of the high-dose treatment. Very similar results were seen in the follow-up period, showing maintained survival benefit at days 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 clinical data. In the first half of 2026, we plan for the NASP FDA decision in June.
The first for the 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 Aspaveli in the nephrology indications and for Gamifant in HLH MAS. We will see the second for the pozdeutinurad readout, in this case from the REDUCE-1 pivotal trial. Finally, the Tryngolza CHMP opinion in severe hypertriglyceridemia is also expected before end of the year. With that, I would like to hand over to Henrik. Next slide, please.
Thank you, Lydia. Hello, everyone. Please turn to next slide. We take a look at some key financial metrics for the quarter. In Q1, our revenues of SEK 7 billion-SEK 7.2 billion correspond to revenue growth of 24% at CER, hematology increased by 24%. Our combined hemophilia A portfolio increased by 25% as ALTUVOCT did continue 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 three regions. Aspaveli 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 pozdeutinurad, 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, 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 base royalties. Operating expenses, excluding non-recurring items and amortization for the quarter, increased by 15% at CER compared to Q1 2025, reflecting the increased activity level in the company. SG&A, also excluding non-recurring items and amortization, increased by 12% at CER, driven by launch and pre-launch costs for ALTUVOCT, Aspaveli nephrology, NASP, and Tryngolza. R&D expenses increased by 22% at CER, excluding non-recurring items, mainly due to the additional development programs . Increases related to Tryngolza and Monjuvi.
The adjusted EBITDA 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 high working capital build-up due to three main items: Arthrosi transaction-related payments, inventory prepayments, and lower Beyfortus royalty payments following lower sales last year. The net debt at the end of the quarter was just below SEK 18 billion, net debt to EBITDA ratio of 1.5 x. Please turn to next slide. The financial outlook for the full year 2026. As usual, this outlook is based on revenue growth at constant exchange rates 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 an adjusted EBITDA 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, remains difficult for us to forecast, but we don't believe that the fundamentals have changed with regards to recommendations and reimbursement. Regarding our EBITDA 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 pre-launch and launch cost for Aspaveli and Asp.
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 Asp closer to launch. Second, filing and pre-launch 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 adds the R&D cost of two 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. 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 and 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 six 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 Arthrosi acquisition and continue to progress the pipeline with multiple value-creating opportunities. Overall, we remain confident in our strategy, in 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.
Thank you. We will now begin the question and answer session. The first question comes from Shirley Chen from Barclays. Please go ahead.
Hi. Thank you so much for taking my question. May I ask about Aspaveli C3G launch? Could you please share with us a bit more initial market and clinician feedbacks on the new indications? Just wondering how do you find the competition dynamics so far in your launched countries? Thank you so much.
Yeah. Thank you. I mean, we have, you know, we have just recently performed a survey across the various countries. We're on the market in Germany, obviously, always being the first and then also in the other two German-speaking countries. You know we can see some feedback and in various international markets. The feedback actually across, you know, the survey, but also from the conferences and ad boards that we have is that there is a very strong preference for Aspaveli versus other new launches or a new launch in this indication. It's, it's referring, you know, to the profile.
This, you know, you may remember the triangle that we pointed out, with the efficacy in proteinuria, the stabilization of eGFR already after six months and also the important data on staining and this seems to resonate. We get a very strong preference here actually in high priority centers and priority centers. We think that we still have some room to cover, you know, when it comes also to community-based with nephrologists. Our approach was more top-down. We're very happy with where we stand right now. When you think about, you know, about the overall magnitude, I mean, this is really early days. I mean, we didn't, you know, launch in Germany till, you know, the late second half of January.
Already, what we have achieved is moving our performance. We outlined this, we were probably more stable at PNH. This early launch is already moving the product by 21%. That gives you, let's say, a take that the launch is quite meaningful, granted it's early days. We don't want to get ahead of ourselves. We are very pleased. Performance, number of patients, feedback from physicians are very consistent and very excited to take the product forward. Next question, maybe.
The next question comes from Christopher Uhde from SEB. Please go ahead.
Hi there. Thank you very much for taking my questions. Christopher 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? Also in terms of the timing of REDUCE-1, is it more likely to be sort of in Q3 or Q4? My second question is on the sepsis longer term follow-up. Just 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. Curious to hear what the 120-day looks like. Thank you.
Mm-hmm.
Hi. Hello. Thank you. If you want, I can start with the IDS. As you probably know, the end of treatment was day 28, and there is where we were measuring the efficacy. Then all the sepsis trials look at mortality until day 90. That's the standard in sepsis. The only reason why we follow up until day 120 for safety to reassure the safety profile of emapalumab is because of the long half-life of emapalumab. If emapalumab had a shorter half-life, we would have just follow-up patients until day 90. 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.
That's why we are collecting the safety data to reassure that the use of Gamifant in IDS has not increased any safety concerns. When it comes to pozdeutinurad, as you know, the primary endpoint is the reduction in serum uric acid. What we've seen so far is the phase II data, which is very reassuring. I think that we are expecting very good results, but we need to be careful. That's what we will see top-line data, as Guido has mentioned in his presentation. Later we will see the tophi reduction, the tophi resolution and the flare reduction. We're expecting very strong data.
When it comes to the timing, I can reassure you that we are very excited and working very closely with the team and our gout franchise team together with the enthusiastic people. We are trying to push the data as fast as possible. 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 of you know. For the time being, we are planning for the end of Q2.
Okay. Could you just clarify, though, on the, in terms of the bar, I mean, is there a particular level of SUA you need, or is it just stat sig?
Yeah. What we expect is it's what we have from the previous trials. Again, this is a large pivotal trial and two sister clinical trials in this indication. I think it's maybe premature to say, okay, this will be fine or not. We expect a very important reduction in serum uric acid and because of the mode of action and because of obviously the data that we've seen. More to come probably in, yeah, very short few months.
Thank you so much.
The next question comes from Kirsty Ross-Stewart from BNP Paribas. Please go ahead.
Hi there. Thanks for taking my questions. Kirsty Ross-Stewart from BNP Paribas. With respect to Aspaveli, the step up in Q1 sales is, you know, impressive given the expectations for relatively moderate ramp in the nephrology indication. Is it fair to assume you're tracking ahead or at least the top end of your 400-500 nephrology patient target that you set for the year? 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 haema portfolio. Just wondering how long you anticipate you can sustain that double-digit growth in the haema franchise. Thanks very much.
Thank you. I mean, let's start with the easy bit. You know, I mean, let's, you know, we obviously, you know, don't want to reset expectations three months into the year for Aspaveli. If anything, you know, you get a sense, I mean, you do the math, that we clearly have no reasons to believe that we don't reach this range. I mean, this is, I mean, if anything, our confidence to make Aspaveli an important product for Sobi in nephrology has significantly increased based on the data points we have collected in the first quarter. You know, we will update you in Q2, but we are on a very important slope that.
You know, we also outlined that we are ahead of our internal expectations. Yeah. With regard to ALTUVOCT, I mean, this will take, you know, we have not reached. I think, you know, we can look forward to significant growth in the years to come. As you know, there's still some quite a bit of headroom. I mean, we have seen early signs of really spectacular growth in international markets. You know, we have the growth opportunities in Europe, particularly in the second wave countries or in the later stage opportunities like, you know, France. We still have significant room for growth in Spain and in the U.K. and let's say so, you know, in Italy.
You know, there's this strong growth momentum that you see is clearly going to be with us. You know, for me gratifying is, you know, when you look at the, you know, at the quarterly business size of the hemophilia A business and the momentum of ALTUVOCT, you know, we are clearly on track for our ambitions that we set out, that we believe, you know, that our hemophilia A franchise is gonna be a blockbuster franchise. You know, very strong momentum and very optimistic for this franchise. I hope I could give you some sense because, you know, typically we don't reforecast during the first quarter on a product level.
Sure. Thanks very much.
Thank you. Next question maybe.
The next question comes from Mattias Häggblom from Handelsbanken. Please go ahead.
Thanks so much. Mattias Häggblom, Handelsbanken. Two questions, please. Firstly on ALTUVOCT, so Roche shared on their earnings call last week that strengths in Hemlibra for the quarter had been driven by switches back from ALTUVOCT, and mentioned the fact that Hemlibra doesn't cause inhibitors as one of the drivers. Could you comment on what switching dynamic you see in your region? Plus also, remind me what real-world evidence suggests for in-inhibitor incidence among ALTUVOCT patients. Secondly, again on Aspaveli, during 2025, product was largely flat until Q4 when there was a sequential decline quarter-over-quarter. In Q1, sales up sequentially significantly, well more than the year-over-year 20% growth that you referenced. Was all of the sequential increase linked to the C3G launch, as you claim PNH was stable?
Was C3G all demand driven or was there any stocking to call out?
Yeah. Let's, let's start with the, with the easy bit. You know, with ALTUVOCT, you know, when you grow 86%, I mean, you know, we may have the one or the other patient, but, you know, when you gain. I mean, this is, you know, less than 1%. I mean, you know, I take the 99 any day. You know, we don't have a problem with switching and whatsoever. Obviously we don't see a problem of inhibitors. I mean, anyway, this is a known risk, obviously, that you have as factor base.
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 life at the fullest and don't have to worry about bleeding, particularly during exercise. You know, I think, you know, maybe, Lydia, you want to comment on the risk of inhibitor?
Sure. Obviously, Hemlibra does not get risk of inhibitors because it's not factor VIII replacement therapy. As Guido mentioned, the development of inhibitors is a known risk. It's in our SmPC. What we've seen, it's really on the patients that we have in the market. 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. 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. There are multiple confounding factors that reassure us on the benefit risk profile of ALTUVOCT that remains unchanged when it comes to inhibitor development.
Yeah. With regard to Aspaveli, indeed, you know, what you can see as an evolution is that, yes, it's clearly an incremental benefit of the C3G launch and IC-MPGN launch. That's the reason why we are quite positive and excited, Mattias, yes. Very good.
Thanks so much.
Thank you. Maybe go to the next question.
The next question comes from Harry Gillis from Berenberg. Please go ahead.
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 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 2027, and that U.S. LOE, so we can try and model that with a little bit more accuracy? Just a second question, if I may, on the full year 2026 guidance. 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 we've seen so far, plus with additional nirsevimab launch, as well, potentially benefiting the end of the year? Thank you.
Thank you. You know, I mean, with regard to Doptelet, I mean, at this stage, you know, what we can say, the majority is still coming from our U.S. business. What we will do is in order to, you know, as part of the guidance and next year, we'll probably break out the split more clearly. You know, what you can expect because, you know, the growth of Doptelet in international markets has not been dissimilar to our ALTUVOCT. If anything better, then that tells you that, you know, that ratio is gonna favor, obviously, the outside of U.S. markets. That's basically when you will think about next year, that impact may not be as large as to be feared.
It comes in the second half, you know, we will do everything we can. I mean, you know, we'll probably provide a good view when let's say fall, when we talk about guidance for next year. At this stage, I think it's, we will do this. With regard to, you know, guidance improvement, obviously takes us quarter by quarter, let's hope we have a good quarter next quarter. I think, you know, we may be, you know, we may be in a good informed decision. I mean, you know, you know our patterns from the past, you know, we are historically a bit of a slow starter when it comes to guidance upgrades.
Got it. Can I just ask one follow-up? Did you just say the Doptelet LOE is second half of next year? Can you provide any more, like, specifics on the exact timing?
I mean, Gerard, what is our messaging there? Maybe you can.
Yeah. It's mid-next year. In the second half, we haven't been specific on the month, but it's the summer next year that it goes LOE.
Yeah.
Thank you. Thanks very much.
Yeah.
The next question comes from Georg Tigalanov-Bjerke from ABG. Please go ahead.
Hi, this is Georg Tigalanov-Bjerke from ABG. Congrats on a strong quarter. I have two questions, please. First.
The Gamifant year-over-year growth was still very strong, however, somewhat short of expectations after two quarters with very strong sequential growth too. Do we already start to see some signs of plateauing in secondary HLH in the U.S. or were there some other temporary slowing drivers this quarter? Secondly, regarding Aspaveli in C3G and IC-MPGN, when do you expect to secure reimbursement in the major markets outside Germany on a country by country basis?
Yeah. I think, you know, we, with regard to Gamifant, you know, I wouldn't see the growth as an indicator. I mean, 47% is probably not so bad, but, you know, I mean, I don't feel too shy about it. You know, it's fair to say that, you know, this is not a quarter where we, you know, which is indicative. I think there's a very strong underlying demand. You know, Gamifant has a bit of still its like historical lumpiness due to the dependency on the on heavier patients. Well, you know, this, I think it will be a very important opportunity for us this year.
I mean, this one you can see. Obviously there will be a base effect at one stage. We can still, you know, we look forward to a very important year for Gamifant. As far as Aspaveli is concerned, Sorry, your main angle regarding Aspaveli, can you just quickly remind me? Just excuse me.
Yeah, that was regarding reimbursement, in the major markets.
Oh, the reimbursement. Yeah, sorry.
I think on a country basis if you have the time.
Yeah. You know, what we expect, I mean, you will not, you know, that basically during the next couple of months, we expect positive decisions in Spain and the U.K. and of the major markets. I will not, you know. We are not yet announcing here the list of all markets. You know that of the EU5 markets, they will be the next in line during this year.
Great. Thank you.
Thank you.
As a reminder, if you wish to register for a question, please press star and one on your telephone. We now have a follow-up question from Christopher Uhde from SEB. Please go ahead.
Yeah, thanks for taking my follow-up. On Tryngolza, you know, it's obviously super early days, super rare population, but can you tell us a little bit about, you know, what you're seeing there in terms of the centers, the doctors and so on, the types of patients, you know, as it relates to, you know, the ability to predict what happens in the MCS launch? Thank you.
Yeah, I mean, you know, we have a very good uptake in the launches, in the launch countries. I mean, granted this is now Germany, Holland, Austria. Basically, you know, building up this franchise. I mean, the benefits of the product versus the existing one, Waylivra, are intuitive, and we have expanded in any of those markets 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. I think that the connectivity works out very well and, you know, the feedback we got from the product is very positive, yeah, particularly on the tolerability.
You know, it's a small indication, you know, hence, you know, sales were not yet too large. You know, I think for us the key here is we have also quite a number of patients on managed access and early access programs. That number will increase. You know, we use the time wisely now to prepare ourselves for the large indication next year.
Thanks so much.
Thank you.
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.
Yeah. 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. I hope we've been worth your while. Thanks for your attention, and look forward to be in dialogue with you very soon. Thank you.
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.