speaker
Guido Oerker
CEO

Hello, everyone. This is Guido Oerker, CEO of Sobe. We are delighted to welcome you to the first quarter 2026 conference call for investors and analysts. Our presentation was posted on Sobe.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 Bart-Franzsch, 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. 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. The thing important to note is the progress we have made with our six launches, And, you know, the strategic portfolio grew by 55%, contributing 63% of our total business. This dynamic growth was driven by key launches, including AlteWacht, Gamifund, and now the European and international launch of Asper Valley and C3G ICMPGN. In addition, we have been able to achieve our milestones for Ringgold and SHDG and submitted and launched FCS, as well as completed the transaction of our Throsy, 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 continue to scale effectively. Our strategic portfolio is now the central engine of SOBE'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, 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 market 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 Aspavelli in Q1 and are in the process to roll out the indication C3G and ICMPGN across our territory. With regard to NASP, we wait for FDA's decision before end of Q2 and discuss the first data readout for prostitinerate in the latest by the end of Q2. For Tringolsa, 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 SHGG. In the quarter, we also filed Tringolsa in Europe in the indication SHGG. Overall, this pipeline represents a strong and diversified set of launches throughout 2028, supporting our ambition to reach approximately 55 billion of revenues by 2030. Please turn to page 7 for the next slide. AltaVox, you know, continues to be a true standard in our portfolio. In Q1, AltaVox 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 Haemophilia A business grew by 25% at CER. This performance reflects a strong clinical profile of AlteWorks and the disciplined launch execution. We have now launched in 27 countries with key markets such as UK, 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 paths for sustained growth. Let me now move to Gummy Fund. In the first quarter, Gummy Fund delivered 734 million SEC in sales, up 47% at constant exchange rate. Growth is driven by the U.S. launch in MAS, where Gummy Fund is now the first approved treatment for both adults and children with MAS and Stills disease with an uptake continuing to build awareness will increase. From a regulatory perspective, we have completed filings in both the US and, sorry, in both in Europe and Japan in Agile 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 will provide an update latest by Q2 reporting. Overall, Gamma Fund is delivering strong commercial momentum today with multiple longer-term growth opportunities ahead. Please turn to the next slide. Let me turn now to Asper Valley. In Q1, we are encouraged by the strong uptake of Asper Valley in C3G. The product delivered 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 ICMPGN, whilst P and H remain stable in line with our expectations. As a reminder, C3G and ICMPGN 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. ASPA Valley 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 Aspervalli among HCPs from recent research findings. These initial segments improve our belief in the long-term potential of Aspervalli nephrology. For orientation, our 2026 target is to have 400 to 500 patients on Aspervalli therapy. Please turn to the next slide. Dr. Lett continues to deliver very strong growth momentum. In the first quarter, sales reached 1.4 billion SEC, 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 IT fields. Dr. Lett has become a truly global franchise with growth across all three regions, but in particular strong growth in the international region. While demand in the US 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 potential opportunity. Consequently, we expect a material increase of the International's contribution in 2026. Overall, Dr. Lett in 2026 remains a key growth server supported by both established and newly launched markets. Please turn to the next slide. Our Thoroughly 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 a CUDUFA date on June 26th and expect feedback from the FDA during the forthcoming weeks. We are ready to launch in chronic refractory gout during Q3. Second, podstertinerate. next-generation once-daily URAD1 inhibitor for progressive gout with a planned launch in 2028. Postdoitinerate represents the primary economic opportunity for SOBI in our gout franchise. For postdoitinerate, the key phase 3 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 strengthens our pipeline, expands our presence in Goud, 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.

speaker
Lydia Bart-Franzsch
Head of R&D and Chief Medical Officer

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. As Pavelli in the nephrology indications, C3G in primary ICMPGN was approved in the European Union in January, one month ahead of this schedule timeline. We got positive top-line data for interferon gamma trigamycin and 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 Tringolza for severe hypertriglyceridemia to the European Medicine Agency. And we also fully enrolled all patients in the PACIFICA trial of Bonjo in chronic myelofibrosis. PACIFICA is our confirmatory phase three 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 gamifan and interferon gamma-driven sepsis, the initial data from the EMBRACE proof-of-concept study was presented last month in Brussels at ECCAM in the International Symposium on Intensive Care and Emergency Medicine. During our Capital Markets Day, we already share the key study results of EMBRACE that show an improvement in organ dysfunction, as measured with the SOFA score, and patient survival with emupadumab at the end of treatment on day 28. 60% of patients in the high-dose emupadumab 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 ECCAM. 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 a Mopalumab 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 maintained survival benefit at days 60 and 90. This further supports the proof of concept and our belief in advancing the clinical development of gamifan 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 poditinerate readout from the reduced to pivotal trial in progressive gout, and the LODIS 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 gamifan in HLH mass. We will see the second poditineral readout, in this case from the reduced one pivotal trial. And finally, the Tringolsa 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.

speaker
Henrik Stenqvist
CFO

Thank you, Lydia. And hello, everyone. Please turn to the next slide. And we take a look at some key financial metrics for the quarter. So in Q1, our revenues of 7.2 billion correspond to revenue growth of 24% at CER, and hematology increased by 24%, and our combined hemophiliae portfolio increased by 25% as Altaboxy continued its strong launch momentum and is now launched in all major EU markets. It's an obsolete increase by 44% at CER, driven by strong growth in all three regions. And Asperalli 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 Trigulsa 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 Bay Fortress royalties. Operating expenses excluding non-recurring items and amortization for the quarter increased by 15% at CER compared to Q125, 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 Altevoxt, Aspavelli Nephrology, NASP, and Tringolsa. And R&D expenses increased by 22% at CR, excluding non-recurring items, mainly due to the addition of off-road seat development programs, as well as increases related to Trinconza and Bonjour. And as a result, the adjusted EBITDA for the quarter amounted to $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 1.1 billion. Higher operating profit was offset by high working capital build-up due to three main items, authority transaction-related payments, inventory prepayments, and lower Bay Fortis royalty payments following lower sales last year. And as a result, the net debt at the end of the quarter was just below 18 billion. Net debt to EVTA ratio of one and a half times. Please turn to the next slide. And 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 CR 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 without the box being a continued key growth driver. Bay Fortress, 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 Astor Valley and ASP. While we had some of those costs in Q1, they will continue to accelerate as we get approval in additional countries across the valley and as we get fully staffed for NASP closer to launch. Second, filing and pre-launch costs related to Tringolsa in SHCG. In March, we submitted to EMA for the indication expansion for SHCG, so we will also continue to see the additional costs moving forward as we near launch. Third, the acquisition of Arthrosi, as the R&D costs of two ongoing phase three studies and preparation for regulatory submission. Finally, we're also planning the continued development of Gamifund 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 Ido.

speaker
Guido Oerker
CEO

Thank you. Thank you, Hendrik. And let me close by summarizing the key messages from today and a brief recap from our recent CMD. First, Q1 2023. 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 Sobe. As outlined in our Capital Market 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 a new launch for Asper Welle and Nethrology, the filing for Tringosa and SHTG, and the launch of FCS. We continue to see strong momentum in Aalto, Vogt, and Gamifund. We have strengthened our position in GAUT through the acquisition 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 our Q&A.

speaker
Operator
Conference Operator

Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may press star N1 on their telephone. you will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. Anyone who has a question may press star and one at this time. The first question comes from Shirley Chen from Barclays. Please go ahead.

speaker
Shirley Chen
Analyst, Barclays

Hi, thank you so much for taking my question. May I ask about Asper Valley C3G launch? Could you please share with us a bit more initial market and commission feedbacks on these new indications? And also, just wondering how do you find the competition dynamics so far in your launched countries? Thank you so much.

speaker
Guido Oerker
CEO

Yeah, thank you. I mean, we have, you know, we have just recently performed a survey across various countries around the market in... in Germany, obviously, always being the first, and then also in the other two German-speaking countries. So, you know, we can see some feedback, and in various international markets. And the feedback actually across, you know, the survey, but also from the conferences and airports that we have is that there is a very strong preference for Asper Valley versus other new launches or a new launch in this indication. And 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. 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, you know, when it comes also to community-based nephrologists. But, you know, our approach was more top-down. We're very happy with where we stand right now. And, you know, when you think about, you know, overall magnitude, I mean, this is really early days. I mean, we didn't, you know, launch in Germany until, you know, the late second half of January. And already, you know, what we have achieved is moving our performance, you know, we outlined this, you know, we were probably more stable at P&H. And, you know, this early launch is already moving the product by 21%. And that gives you, let's say, a take that the product is quite, that the launch is quite meaningful, granted it's early days. But we don't want to get ahead of ourselves. But, you know, we are very pleased. So performance, number of patients, feedback from physicians are very consistent and very excited to take the product forward. Next question, maybe?

speaker
Operator
Conference Operator

The next question comes from Christopher Yudi from SEB. Please go ahead.

speaker
Christopher Yudi
Analyst, SEB

Hi there. Thank you very much for taking my questions. Christopher Yudi from SEB. My first question, and I guess they'll both be on the pipeline, so probably for Lydia, I guess. As due to Nured, would you please tell us how you view the bar for success there And also in terms of the timing of reduce one, 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 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 Kinneret did in its trial, but I'm curious to hear what the 120-day looks like. Thank you.

speaker
Lydia Bart-Franzsch
Head of R&D and Chief Medical Officer

Hi. Hello. 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 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, and the only reason why we follow up until day 120 for safety to reassure the safety profile of hemopalumab is because of the long half-life of hemopalumab. If hemopalumab 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 gamifan in IDF has not increased any safety concerns. When it comes to pot de TINRAD, as you know, the primary endpoint is the reduction in serum uric acid. And what we've seen so far is the phase two 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 five reduction and the DOHAI resolution and the flare reduction. So 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, our GAUD franchise team, together with the ex-Earth Rosi 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 of you know. But for the time being, we are planning for the end of Q2.

speaker
Christopher Yudi
Analyst, SEB

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 STAT-SIG? Thanks.

speaker
Lydia Bart-Franzsch
Head of R&D and Chief Medical Officer

Yeah. So, what we expect is it's what we have from the previous trials. And again, this is a large pivotal trial, two 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 Yeah, very short, a few months.

speaker
Gerard

Thank you so much.

speaker
Operator
Conference Operator

The next question comes from Kirstie Ross-Stewart from BNP Paribas. Please go ahead.

speaker
Kirstie Ross-Stewart
Analyst, BNP Paribas

Hi, thanks for taking my questions. Kirstie Ross-Stewart from BNP Paribas. So with respect to Asperveli, the step up in Q1 sales is impressive given the expectations for a 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 to 500 nephrology patient target that you set for the year? And then on Altivoct, 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 Hume portfolio. So just wondering how long you anticipate you can sustain that double digit growth in the Hume franchise. Thanks very much.

speaker
Guido Oerker
CEO

Yeah, thank you. I mean, let's start with the easy bit. But, you know, I mean, let's, you know, we obviously, you know, don't want to reset expectations three months into the year for Asper Valley. But 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 rate. I mean, this is... I mean, if anything, our confidence to make Asper Valley an important product for SOBE in nephrology has significantly increased based on the data points we have collected in the first quarter. But, you know, we will update you in Q2. But we are on a very, very important slope. And we also outlined that we are ahead of our internal expectations. With regard to I2V, we have not reached. I think we can look forward to significant growth in the years to come. 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 the second wave countries or in the later stage opportunities like France. We still have significant room for growth in Spain and in the UK. And let's say Italy. This strong growth momentum that you see is is clearly going to be with us and you know for me gratifying is you know when you look at the you know uh at the quarterly business size of the hemophilia a business and the momentum of i2 worked you know we are clearly on track for our ambition that we set out that we believe you know that uh our hemophilia a franchise is going to be a blockbuster franchise and you know so so very you know very strong momentum and uh Very optimistic for this franchise. I hope I could give you some sense because typically we don't re-forecast during the first quarter on a product level.

speaker
Kirstie Ross-Stewart
Analyst, BNP Paribas

Sure.

speaker
Operator
Conference Operator

Thanks very much.

speaker
Guido Oerker
CEO

Thank you. Next question, maybe.

speaker
Operator
Conference Operator

The next question comes from Matthias Heikblom from Handelsbanken. Please go ahead.

speaker
Matthias Heikblom
Analyst, Handelsbanken

Thanks so much, Matthias Heikblom, Handelsbanken. Two questions, please. First on Altevocht, so Roche said on their earnings call last week that strength in Hemlibra for the quarter had been driven by switches back from Altuveo or Altevocht, and mentioned the fact that Hemlibra doesn't cause inhibitors as one of the drivers. So could you comment on what switching dynamic you see in your region, plus also remind me what real-world evidence suggests for inhibitor incidents among Altevocht patients? And then secondly, again on Asta Valley, During 2025, product was largely flat until Q4 when there was a sequential decline, quarter over quarter. But in Q1, sales up sequentially significantly, well 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 P&H was stable? And was C3G all demand driven, or was there any stocking to call out?

speaker
Guido Oerker
CEO

Yeah. Let's start with the easy bit, you know. With ITIL work, you know, when you grow 186%, 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%, yeah. I mean, so, you know, I take the 99 any day, and... So we don't have a problem with switching whatsoever. And obviously, we don't see a problem of inhibitors. I mean, anyway, this is a known risk, obviously, that you have this factor. But what we see, though, is a lot of very positive feedback from patients who are on the product and actually have switched from M-Libra 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 pray about bleeding, particularly during exercise. So, you know, I think maybe, Lydia, you want to comment on the risk of inhibitors? Sure.

speaker
Lydia Bart-Franzsch
Head of R&D and Chief Medical Officer

Yeah. So, obviously, hemoliver does not get the risk of 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 SNPC. 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 Altivox, they already had previous inhibitors with other factors. There are others that develop an inhibitor while being on Altivox, but receiving different factory products because an emergency situation that did not have at hand the products So there are multiple confounding factors that reassure us on the benefit-risk profile of Altivog that remains unchanged when it comes to inhibitor development.

speaker
Guido Oerker
CEO

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

speaker
Matthias Heikblom
Analyst, Handelsbanken

Very good. Thanks so much.

speaker
Guido Oerker
CEO

Thank you. May we go to the next question?

speaker
Operator
Conference Operator

The next question comes from Harry Gellies from Barenburg. Please go ahead.

speaker
Harry Gellies
Analyst, Berenberg

I actually have one question on Dr. Lett, 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 products overall sales. Could you maybe provide us some sort of information on the split regarding the US and ex-US just as we approach 27 and that US 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, Aster Valley ahead of internal expectations, Altamont 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 NASP launch as well, potentially benefiting the end of the year? Thank you.

speaker
Guido Oerker
CEO

Thank you. You know, with regard to Dr. Lin, I mean, at this stage, you know, what we can say, the majority is still coming from our U.S. business. And 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. But, you know, what you can expect, because, you know, the growth of Dr lead in in international markets has not been dissimilar to our item of course or oil and. If anything better than it, that tells you that you know we that that ratio is gonna. Favor obviously the outside of US markets and and so that basically when you will think about next year that that impact may not be as as large as as to be we will do everything we can. I mean, so, you know, we'll probably provide a good view when, let's say, when we talk about guidance for next year, but at this stage, I think we won't do this. And with regard to, you know, guidance improvement, I mean, we obviously take this quarter by quarter, and let's hope we have a good quarter next quarter, and then I think we may be in a good informed decision. You know our patterns from the past. We are historically a bit of a slow start when it comes to guidance upgrades.

speaker
Harry Gellies
Analyst, Berenberg

Can I just ask one follow-up? Did you just say the DOT to let LOE is second half of next year? Can you provide any more specifics on the exact timing?

speaker
Guido Oerker
CEO

I mean, Gerard, what is our messaging there? Maybe you could.

speaker
Gerard

Yeah, it's mid-next year. It's in the second half. We haven't been specific on the month, but it's the summer next year that it goes that way.

speaker
Harry Gellies
Analyst, Berenberg

Yeah. Thank you. Thanks very much.

speaker
Operator
Conference Operator

Yeah. The next question comes from George from ABG. Please go ahead.

speaker
George
Analyst, ABG

Hi, this is George from ABG. Congrats on a strong quarter. I have two questions, please. So first, the gamma event a year or a year ago was still very strong, however, somewhat short of expectations after two quarters with very strong sequential growth, too. So do we already start to see some signs of plateauing in secondary HLH in the U.S., or are there some other temporary slowing drivers this quarter? And then secondly, regarding SPA Valley in C3G and ICMPGN, when do you expect to secure reimbursement in the major markets outside Germany on a country-by-country basis? Thank you.

speaker
Guido Oerker
CEO

Yeah, I think, you know, with regard to GAMI Fund, you know, I wouldn't see the 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, but, 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, Gummy Fund has a bit of still like historical lumpiness due to the dependency on heavier patients. And, well, you know, I think it will be a very important opportunity for us this year. I mean, this one you can see, and obviously there will be a base effect at one stage, but we can still, you know, we look forward to a very important year for Gammifront. As far as Asparbelli is concerned, the Sorry, your main angle regarding Aspavelli, can you just quickly remind me? Just excuse me.

speaker
George
Analyst, ABG

Yeah, that was regarding reimbursement in the major markets.

speaker
Guido Oerker
CEO

Oh, the reimbursement, yeah, sorry.

speaker
George
Analyst, ABG

On a time-to-time basis, if you have the time.

speaker
Guido Oerker
CEO

So, 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 UK. And also major markets, I will not, you know, we are not yet announcing here the list of all markets. But, you know, also EU5 markets, they will be the next in line during this year. Great. Thank you. Thank you.

speaker
Operator
Conference Operator

As a reminder, if you wish to register for a question, please press SA and 1 on your telephone. We now have a follow-up question from Christopher Yudi from SEB. Please go ahead.

speaker
Christopher Yudi
Analyst, SEB

Yeah, thanks for taking my follow-up. On Tring goals, 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.

speaker
Guido Oerker
CEO

Yeah, I mean, we had, you know, we have a very good uptake in the, in the launches in the in the launch countries. I mean, granted, this is now Germany, Holland, Austria. And, and basically, you know, building building up this franchise, I mean, the, the benefits of the product versus the existing one of a Libra 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 SHCG next year. And I think that the connectivity works out very well. And the feedback we got from the product is very positive. on the tolerability. But, you know, it's a small indication, so, you know, hence, you know, sales were not yet too large. But, you know, I think for us, the key is we have also quite a number of patients on managed access and early access programs. That number will increase. So, you know, we use the time wisely now to prepare ourselves for the for the large indication next year. Thanks a lot.

speaker
Operator
Conference Operator

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

speaker
Guido Oerker
CEO

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 it will be worth your while. Thanks for your attention. Look forward to be in dialogue with you very soon. Thank you.

Disclaimer

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