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Operator: Ladies and gentlemen, welcome to the Sobi Q2 2025 Conference Call and Live Webcast. I'm Valentina, the Chorus Call operator. [Operator Instructions]. And the conference is being recorded. [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.
Guido Oelkers: Yes. Thank you. Hello, everybody. This is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the second quarter 2025 conference call for investors and analysts. We posted this presentation to sobi.com earlier. Forward-looking statement, as per usual, please take note of this. And with this, let's go right into the next slide. Today, we plan to cover key aspects of our Q2 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 3:00 p.m. CET. [Operator Instructions]. And we ask you to only ask -- really request only to ask one, maximum two questions at a time. Let's go to Slide #4. The second quarter, when you elevate yourself was really for us about strong economics, drive important pipeline milestones and create economic preconditions to support our future growth ambitions. So with regard to the first subject, strong economics, we delivered SEK 6.2 billion revenues, representing a 22% growth at constant currency, and our adjusted EBITA was at around 34%. I think it's important to note that our strategic growth portfolio or portfolio is accounting now for 55% of total revenues and grew impressively 65%, and this supports our quest of transforming Sobi into the next phase. And the growth was driven by Altuvoct, Doptelet, Aspaveli and Gamifant. Vonjo had a slower quarter and showed a 4% decline, and we'll talk more about it because it's primarily driven by the gross-to-net effect. On the R&D milestone side, we were able to show an approval of Gamifant in HLH/MAS in Still's disease by FDA, marking a significant expansion of our potential market. We were able to complete the filing for NASP with the FDA in an uncontrolled gout. And we were also able to present very strong 52-week data for Aspaveli in the 2 nephrology indications. As regards to economic preconditions to support our launches and our ongoing R&D projects primarily, we were able to sign a royalty agreement that we will talk more about with Apellis, and we were taking out costs in the organization in a very selective way, and Henrik will talk more about this. On guidance, we have obviously a strong momentum, and we are very confident about our business also growing this into the future. But at this moment of time, we feel it's prudent let's say, to give -- confirm the guidance that we set out earlier and not going ahead of ourselves. So let's turn to Slide #5. Let's look at the overall performance in more detail. We saw Sobi's continued performance in haemophilia with strong 27% growth and the combined haemophilia franchise growing at 24%, portraying a robust growth of Altuvoct in haemophilia A. Immunology has grown at 11% by strong performance of Gamifant and Kineret. And geographically, Europe's growth of 21% has been propelled by -- primarily by Altuvoct and Doptelet during the second quarter. North America and International have been contributing growth of 16% and 44%, respectively. And the growth of North America is primarily driven by Doptelet and Gamifant. Let's move to the next slide. Focusing a bit more across the portfolio in the second quarter, we have seen good growth momentum and strong progress for Altuvoct launch within the haemophilia A franchise, we have demonstrated growth of 32%. And we believe that this is really just the beginning for Altuvoct because the growth in the first, let's say, 2 quarters was really primarily driven by 3 markets. And we have now 17 markets on stream, but most of these markets are at a very early stage. So [ their ] best is still to come. Doptelet showed continued strong demand across all regions, including the U.S., with 43% growth in 2024. This highlights the continuous confidence in the product efficacy and an expanding reach. For Aspaveli, we are pleased to see continued growth in the number of patients across markets, even though we are facing competitive pressure in the PNH space by orals. We are seeing more pressure in Europe than in international markets, but believe that we can continue driving growth with this important product for us. Vonjo experienced a 4% decline, whilst demand was increasing significantly versus Q2 last year. The decline is attributed to gross- to-net adjustments, which we are closely monitoring. Gamifant and Kineret continue to show good demand in the U.S. Gamifant delivered an exceptional performance in Q2 with 33% growth driven by robust demand. Overall, these results underscore the strength of our portfolio and our ability to navigate in competitive markets effectively. Please turn to Slide #7, Altuvoct. So let's turn now our attention to the continued success of Altuvoct. In the second quarter, haemophilia A sales as reported of Altuvoct and Elocta grew impressively 32%. This growth is a testament to the strength of our portfolio and the successful launch of Altuvoct. Focusing on Altuvoct specifically, the product achieved sales of SEK 627 million in Q2, reflecting a strong growth momentum. Launches are progressing well across Europe and the Middle East. And as mentioned, we have now 17 countries on stream, whilst the growth, the actual sales are really primarily driven at this juncture by Germany, Switzerland and Spain. And we are also excited to announce a full launch in the U.K. this July, which we anticipate will further drive adoption. Overall, the launch of Altuvoct is progressing exceptionally well, and we remain focused on expanding access and delivering meaningful benefits to patients in our territories and look forward to continuing to add launch countries in the second half of this year. Please turn to Slide #8, Aspaveli. Let's now review the latest updates on Aspaveli, starting with PNH. We continue to see strong year-on-year growth across markets driven by increasing adoption of therapy. However, we are also navigating growing competitive pressure in Europe. Moving to nephrology, we are excited about the progress in this area. In the EU, we anticipate a CHMP opinion by the end of 2025, which we will -- which will be a key milestone for our portfolio. Our confidence in the product is bolstered by the 52-week VALIANT data, which were presented at ERA 2025. These results reinforce the product's best-in-class profile, positioning it as a leading option for patients in this space. Lydia will cover the results in more detail in her presentation. Additionally, we have made a significant update to our royalty agreement with Apellis. Under this new agreement, we have achieved a 90% reduction in ex U.S. royalty obligations until defined caps are reached. After these caps are achieved, the royalties will revert to original license agreement. This agreement involved an upfront payment of $275 million in cash with an additional $25 million contingent upon EMA approval in nephrology. We will offset the upfront by having lower royalties, both from cash flow perspective on our P&L moving forward. This deal reaffirms our commitment to our ongoing partnership with Apellis and our belief in the product's potential to deliver significant benefits to patients and to Sobi's long- term growth. Let's turn to Vonjo, where we continue to see a positive momentum despite external challenges. Demand for Vonjo increased quarter- on-quarter, reflecting its growing adoption. However, this growth was outweighed by continued impact of health care reforms, primarily to mention here is the reform in Medicare and the 340B scheme. In patients with below 50,000 platelets, Vonjo has achieved a significant market share, underscoring its strong position in this patient population. Looking ahead, our strategic focus for Vonjo is firmly focused on a number of elements. First, we want to continue to grow in the below 50,000 platelet population whilst expanding into the 50,000 to 100,000 platelet population in alignment with the NCCN guideline. Second, we are committed to generating additional data to support potential label expansion and to complete the PACIFICA trial, which is critical for achieving full approval status and broadly internationalizing the product. Third, we plan to leverage the PACIFICA data as mentioned, to broaden the product on a global scale. And finally, we are exploring new indications. And in this context, we need to mention the PAXIS study where we start to enroll. These initiatives reflect our commitment to maximizing Vonjo's long-term potential and delivering meaningful benefits to patients across a range of indications. Let's turn to Slide #10, Gamifant. I'm thrilled to share a significant milestone for Gamifant and the patients we serve. The FDA approved Gamifant as the first-ever treatment for adults and children with macrophage activation syndrome in Still's disease. This approval addresses a critical unmet medical need where we have demonstrated compelling results. 54% of patients achieved a complete response, highlighting the therapy's effectiveness in resolving MAS symptoms at week 8 and 82% of patients achieved clinical MAS remission. This approval not only validates the strength of our clinical data, but also reinforces Gamifant's potential to transform the lives of patients with HLH and MAS in Still's disease. We look forward to further unlocking the unique anti-interferon gamma mechanism of this molecule in the future. Let's turn to Slide #12. You have seen in the first quarter that we have now made tremendous progress in our key building blocks with the approval of Gamifant and completing the filing in the U.S. with NASP. We continue to focus on 2 launches in the future now on 3 launches, including Gamifant in secondary HLH. Aspaveli is on track and a CHMP opinion is expected by end of year. And 4 innovative development programs are on track with first patient in achieved for the PAXIS study in VEXAS during this quarter. These initiatives reflect our commitment to drive innovation, expand our portfolio and to deliver transformative treatments and therapies to patients worldwide. With these investments, we are well poised to achieve sustained growth and make a meaningful impact in the years ahead. Let's turn to Slide #12. And now I'd like to hand over to Henrik, our CFO.
Henrik Stenqvist: Thank you, Guido, and hello, everyone. So please turn to Slide 13, and we will take a look at some key financial metrics for the quarter. So in Q2, our revenues of SEK 6.2 billion corresponded to a revenue growth of 22% at constant currencies with growth across the portfolio. Growth has been driven by our haemophilia franchise, including a continued strong launch of Altuvoct as well as Doptelet and Gamifant. In addition to strong revenue growth, we delivered an improved Q2 adjusted EBITA margin of 34% compared to 28% last year. So if we look at the bar chart on the left with revenues by quarter and business area, we see a solid growth in Hematology of 27% in the quarter at CER, including our haemophilia A products, Elocta and Altuvoct increasing by 32% at CER. And we continue to see strong momentum for Altuvoct in the markets where we have launched to date. In addition, we continued strong growth in Doptelet of 43% at CER due to growth both in the U.S. and ex U.S. as well as with Aspaveli, driven in large part by our international region. Vonjo demand decreased quarter-on-quarter but was negatively impacted by gross-to-net adjustments, mainly related to Medicare redesign. Immunology grew at 11% in the quarter due to double-digit growth in Kineret and our highest quarter of sales to date in Gamifant. And sales in our international region was another positive for Gamifant. And as a reminder, Beyfortus sales and the royalties we received from Sanofi are seasonal in the second half of the year. Referring back to the table on the right and the adjusted gross margin of 77% in the quarter, a slight improvement from Q2 last year. Gross margin was positively impacted by product and country mix effects, offset by products return in Synagis. And looking at the operating expenses for the quarter, we observed a 7% growth at CER compared to the same period in 2024. SG&A, excluding nonrecurring items and amortization, increased by 14% at CER in the quarter driven by launch and prelaunch costs for Altuvoct, Aspaveli in nephrology and NASP. And this was partially offset by lower costs for Synagis and Elocta. R&D expenses declined by 8% at CER, excluding nonrecurring items, mainly due to NASP programs that are now complete. And this was partially offset by post-approval development costs for Altuvoct and development costs for Gamifant and Vonjo. And we are also investing in the 4 innovative programs for Vonjo in VEXAS and CMML, Altuvoct in synovitis and Gamifant in IDS. Operating cash flow for the quarter was SEK 1.4 billion. The decrease from last year is mainly due to the seasonal shift of RSV revenues to the second half of the year, partially offset by higher operating profit and lower interest payments. Net debt continues to go down, ending the quarter at SEK 11.4 billion, corresponding to a net debt-to-EBITDA ratio of 1.1x. Please turn to Slide 14. And I would like to take a moment to address the restructuring charges of SEK 208 million recorded this quarter, and you will find additional detail on Page 3 of our report. And this was a proactive and strategic decision aimed at positioning our organization for long-term success. As Guido mentioned earlier, we are in a phase with 2 major launches, 3 key filings and 4 high-priority development programs. These initiatives require focused investments and organizational agility. We see it as a reallocation of resources, prioritizing areas that will drive innovation and deliver the greatest impact. While these decisions are never easy, they are necessary to ensure responsiveness and focus on the right key priorities going forward. Next slide, please. And we will now discuss the financial outlook for the full year 2025. As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITA margin. For the full year 2025, our outlook is unchanged. We anticipate revenue to grow by high single-digit percentage at CER and an adjusted EBITA margin in the mid-30s percentage of revenue. The key considerations for our outlook have not changed since Q1. To start, the royalties we received from Sanofi for Beyfortus sales remain the largest uncertainty, both for revenue and EBITA margin guidance. While our view on Beyfortus is clearly positive, we do not control the outcome. And there are unknowns related to new competition in this space as well as other factors within the U.S. health care landscape. However, we are continuing to see strong patient uptick in out-of-box markets where we have launched with more major markets launching in the second half of the year. We also expect continued progress with our current commercial portfolio. In regards to our EBITA margin guidance, we will increase investments in our prelaunch assets, specifically NASP and Aspaveli in nephrology in the second half of the year. In R&D, we have the 4 priority development projects. On a final note, these are uncertain times for forecasting with everything that is going on in the world and in our industry. And many of these topics are still unknown and speculative, making them difficult to quantify and comment on. Having said that, and as evidenced by our Q2 report, we have very strong momentum in our business going into the second half of 2025. And I will now hand over to Lydia. Thank you.
Lydia Abad-Franch: Hello, everyone, and thank you, Henrik. We start with the pipeline milestone on the next slide, please. I'm excited to share that we had a very productive second quarter with regulatory successes and important clinical progress. Starting with Aspaveli/Empaveli, in June, we presented at ERA, the 52-week data of the pivotal VALIANT study in C3G and IC-MPGN. They showed sustained efficacy consistent with the 26-week results, and I will go into more detail in a minute. In TA-TMA, the Transplant-associated Thrombotic Microangiopathy, following completion of the Phase II study and a strategic assessment of the treatment landscape, we decided together with our partner, Apellis, to discontinue the development for pegcetacoplan in this indication. In the Phase II study, pegcetacoplan demonstrated favorable safety and tolerability, consistent with its established safety profile. Moving to Gamifant. The FDA extended the indication for Gamifant to HLH/MAS in Still's disease at the end of June. Importantly, this is the first FDA-approved treatment for this condition, which is serious and potentially life-threatening. We are truly excited to provide a new therapeutic option that helps control hyperinflammation and can reduce reliance on high-dose glucocorticosteroids. Also at the end of June, we completed the rolling submission for NASP in uncontrolled gout and the next step will be the FDA validation of the application. For Vonjo, the VEXAS syndrome proof-of-concept study called PAXIS enrolled their first patient. Notably, this is the first clinical trial for treatment in this condition, and we see very high interest in the scientific community. And lastly, we continue our focus on joint health for Altuvoct. Bleeding into joints is the major and most common clinical manifestation in haemophilia patients. Preventing them is the focus of Sobi's Phase IV activities for Altuvoct. The ALTITUDE study is a low interventional study to understand how Altuvoct can prevent joint bleeds in the real-world setting, and we enrolled the first patient already in May. Next slide, please. We presented new pegcetacoplan sets of data from the VALIANT Phase III pivotal study at the European Renal Association Congress in the late-breaking session. They included several new subgroup analysis at week 26 when the randomized placebo-controlled period ended shown on this slide and the final 52-week data, which also includes the additional 26-week open-label period when all patients received pegcetacoplan, and I will present this on the next slide. Looking at the various patient groups, pegcetacoplan shows consistent efficacy regardless of disease type, age or transplant status. The first column on this slide shows the data for the overall population at week 26. And Aspaveli demonstrated a statistically significant 68 proteinuria reduction versus placebo and improved estimated glomerular filtration rate as well as histology (sic) [ histopathology ] improvement with more than 70% of patients having no C3 (sic) [ C3G ] staining in the biopsies, which is truly impressive. The new subgroup analysis at week 26 shown in the next 3 columns makes it clear that the effects are very consistent. The second column shows patients in the nephrotic range, where kidney damage has already progressed, and we see a similar improvement across all parameters, proteinuria, eGFR and histology. Many C3 (sic) [ C3G ] and primary IC-MPGN patients are currently treated with immunosuppressive therapies. On the third column, you see how pegcetacoplan is clearly efficacious across all parameters shown regardless of whether patients are already on immunosuppressant or not. And finally, both C3G and primary IC- MPGN are often diagnosed in adolescents. As a reminder, 44% of VALIANT participants were between 12 and 17 years old with the same picture of efficacy again, as shown on the right-hand side column on this slide. This robust reduction of proteinuria and stable kidney function across a broad patient population of patients is very encouraging and highlights the potential of Aspaveli. Next slide, please. The effects I just described were sustained at 1 year. Patients receiving pegcetacoplan for a year saw a proteinuria reduction of 67%, and they continue to achieve a stabilization of kidney function as measured by the eGFR. Biopsies were only available at week 26, so there is no 1-year data. According to the recently published Kidney Health Initiative Consensus paper, a favorable effect on the 3 endpoints of one, proteinuria reduction; two, eGFR stabilization; and three, histopathologic improvement provides convincing evidence of efficacy for treatments targeting the complement pathway. In addition, patients who switched from placebo to Aspaveli at the start of the open- label period experienced a similar magnitude of benefit in proteinuria reduction and the stabilization of kidney function. With our submission to EMA at the beginning of this year, we hope to offer this new treatment option to patients very soon. Next slide, please. Looking ahead, we anticipate progress with the major regulatory submissions to FDA, EMA and PMDA. In the U.S., the focus will be now on the NASP regulatory review, while we expect a decision for Doptelet in pediatric ITP very soon. In Europe, we anticipate the CHMP opinion on Aspaveli in nephrology by the end of this year. We also anticipate an EU decision for our newly partnered product, Olezarsen. In Japan, we plan to submit Gamifant in HLH/MAS as well as Aspaveli in C3G and primary IC-MPGN. And furthermore, we anticipate the submission of Kineret in Still's disease and a decision on Doptelet in ITP. We are also planning to advance the clinical projects with a host of exciting developments. This includes the first Phase IIa data on Gamifant in interferon gamma-driven sepsis from our research collaboration that will inform our decision on the next development steps. Another milestone will be the readout of the LOTIS-5 study of Zynlonta in second-line diffuse large B-cell lymphoma next year. And with that, I would like to hand back to Guido. Thank you.
Guido Oelkers: Yes. Thank you, Lydia. So summing it up, let's move to the next slide. We are really pleased with Sobi's development in the second quarter and so far in the first half of this year. As you can see in quarter 2, 22% growth, 65% growth of our strategic portfolio. I mean they speak for themselves and they demonstrate that the company has a very material momentum. Our R&D pipeline has shown tremendous progress, and we have continued launch success with Altuvoct in Europe. And as you have seen, I mean, 3 products -- the 3 countries are currently the main source of Altuvoct's growth, 17 have come on stream. U.K. comes on stream now in July. So that gives you a bit of a flavor that the best is still to come. We've got the approval of Gamifant for MAS in the U.S. We have completed the filing of NASP in uncontrolled gout in the U.S. So we look forward to complete the review of NASP with the FDA and Aspaveli with EMA and bring these important medicines to the market in 2026. At the same time, we are continuing to push forward with our 4 priority development projects, and it was gratifying to see that we had the first patient for -- in this quarter for Vonjo in the PAXIS study for the potential treatment of VEXAS. And we are also making good progress with the IDS study. So with all these activities, we are preparing the organization and ensuring and prioritizing that we are fit for purpose and also with the economic space that we have created that we can take advantage of these opportunities that are ahead of us. The organizational changes were necessary to do so, but they are only a retooling of the organization that allows us now to take advantage of these development projects that are ongoing, the ongoing launches and the forthcoming launches. We have a very strong momentum in the Sobi business, as you have seen, is in pipeline development, and we look forward to continuing this journey with our colleagues and stakeholders around the globe. With this, I would like to open the call for questions. And I'd like to refer back to the operator.
Operator: [Operator Instructions]. The first question comes from Gonzalo Artiach from Danske Bank.
Gonzalo Artiach Castanon: I have a couple of them. The first one is on your guidance. Does the lack of top line guidance upgrade come only due to questions or uncertainty on Beyfortus' performance in the second half now that there is a competitor around? Or is there anything else that we are missing or being overoptimistic right now and should be more cautious? And my second question also related to guidance, is on your EBITA margin. I mean, I guess that one of the main reasons for keeping it at mid-30s is due to the base assumption that you guys will receive priority review for SEL-212, which would imply, I would say, high OpEx already in H2 ahead of launch in early 2026. But if you guys do not secure priority review, what will be the impact in your adjusted EBITA margin since the potential approval would come then in mid-2026, if I'm not wrong? Would it make sense to assume you would push SG&A to next year, which would raise your adjusted EBITA margin for 2025 mechanically?
Guido Oelkers: Yes. Thank you. I mean this is -- let's put it this way. With regard to the guidance, we are not aware that products are under threat or under pressure that should make us more cautious about the prospects of our product beyond what we are disclosing, obviously, in the report. And let's say, with regard to Beyfortus, I mean, the only thing I can say is that it's in the hands of Sanofi. They seem to be confident about the product, not heard anything else. So they are confident. I have no reason to be not confident simply because they used to be the largest vaccine company in the world and probably are still in this prevention market now. So there's nothing to it. It's more prudent at this stage, let's say, because there are so many elements, but clearly not related to our portfolio. The EBITA margin, it's true to say that when you believe in a bolus of Beyfortus coming in, in the second half and you have the effects, as we pointed out, that it may be beneficial to EBITA margins. But we have not only the NASP launch that we may have to prepare. We have obviously the C3G launch where we may have to step up because the opportunity is just so vast, and we are understanding more the competitive dynamics, and we have a potential readout on IDS. But all of these reasons, you want us to spend some money. So that's the reason why we are not as specific on the mechanics of the uplift of the guidance. But everything we are doing right now is pointing -- is positive, and we will ring-fence those investments. So we are not spending freely. I hope that gives you a flavor for the company.
Operator: The next question comes from Mattias Häggblom from Handelsbanken.
Mattias Häggblom: Mattias Häggblom, Handelsbanken. I have 2, please. So firstly, Roche presented data from a Phase I/II study for its next-generation bispecific [presented] at ISTH. The majority of patients developed antidrug antibodies against the therapy to the extent that their PK data was affected. I was curious if Lydia had any thoughts at this stage of a candidate with such a profile and what to look for in the future programs? And then secondly, with regards to Vonjo, I can't recall we spoke about the confirmatory PACIFICA trial for a long period of time, ClinicalTrials.gov listed it as a reading out late '26. I'm not sure that's up to date. How is the trial enrolling? What are the time lines? Have you activated more sites than originally planned? It's not listed as a pipeline event on the news flow slide. So I guess it's later than '26. That's it.
Guido Oelkers: Maybe Lydia, direct to you.
Lydia Abad-Franch: Yes. I'm really sorry, I couldn't hear. So you mentioned an ISTH presentation of data, but I couldn't understand which asset did you talk about? I'm sorry.
Mattias Häggblom: Yes. Sorry for being confusing here. So Roche bispecific next-generation 007 (sic) [ NXT007 ] a majority of patients developed ADAs. I was just curious to hear how you thought about that to the extent that PK was affected on the therapy.
Lydia Abad-Franch: Yes, yes. Sorry. Sorry that I couldn't understand. So yes, we are always careful in analyzing and interpreting data from competitors, especially when it's so early. These are assets that initially are very promising. But as you referred to, there are many things that can happen during a development program. So it's something that we are monitoring and that we are cautious. We still believe that the future as also at ISTH and there are some publications coming up on really the normalization and the new class of Factor VIII therapies to really bring the patients to those very high levels of protection. So to me, it's a little bit early to comment on, but we will obviously keep monitoring these developments.
Mattias Häggblom: And then PACIFICA, any update on time lines when we should expect data from this confirmatory trial for Vonjo?
Lydia Abad-Franch: So for Vonjo, the confirmatory trial, it's -- we are seeing a further acceleration coming from international markets. So we are adding additional markets where we see -- we are seeing a lot of traction. And so we are very hopeful that we will be bringing the time lines even further ahead of what we originally planned. But it will depend if the acceleration that we are seeing now keeps continuing. So I think it would be better like as we meet on a quarterly basis, we will continue confirming if that acceleration track is continuing and if we see this acceleration materializing. But so far, yes, we are very happy with the new additional countries that we are including. And yes, that's why we expect data now probably most likely in 2027.
Operator: The next question comes from Christopher Uhde from SEB.
Christopher Winston Uhde: Two, if I may. Altuvoct, the first and then the reorganization, the second. So Altuvoct continues to impress, of course. How much of the sequential growth is Germany, Switzerland and how much the other countries? Or put another way, how do the initial launch trajectories in other markets, especially Spain, compared to that of Germany? And my second question is, so the market seems to be interpreting the reorganization and maybe in combination with the Apellis renegotiation pretty negatively as if you're, I don't know, looking for ways to squeeze more margin for something you hadn't previously planned. Could you expand on the reasons for the reorganization and negotiation, particularly what you might use any added margin headroom for, if anything? And perhaps given that you've got 3 launches, to what extent has your thinking and expectations changed around those launch costs over time?
Guido Oelkers: Yes. Thank you, Christopher. So with regard to the launches, the -- I mean, Germany, Switzerland and Spain is clearly the vast majority of our business right now, north of 80%. So that's the reason why the next phase of launches will obviously do well for the overall performance of Altuvoct also moving forward because there were some questions. Also now the U.K. is obviously expanding that pool of patients pretty materially. And then we expect also France coming on stream in the second half at one stage. So this is -- which is also not part of the 17 countries right now. So it's a normal European rollout and that will propel it, but it is really primarily driven by those 3 countries, while the Spanish market is smaller, probably also partially driven by the history with the plasma-derived product years ago where unfortunate things happened. And let's say, but the best is de facto still to come. But it is these 3 countries that are driving it. And then the other markets will pay more dividends in the second half and then in the quarters to come. And with regard to the reorganization, I think this is a little bit misunderstood or blown out of proportion. I mean it affects 5% of our headcount. It's a trimming exercise as many companies are doing on a regular basis every 4, 5 years. And it's just good practice to make sure that you create space then also for new talent base, the organization is changing, the business is changing, so do we. And that means that we need to adjust -- and it creates obviously the space. I mean, we mentioned earlier the last launch where we need new talent. We probably need to expand a bit more in the C3G launch in Europe. And then we need to also have some readiness should the IDS data come out well in the fourth quarter. So we plan for success. Hence, we create -- we have created some space, but this is not in proportion, it's not really extraordinary. Maybe, Henrik, you want to comment also.
Henrik Stenqvist: Yes. No, I think you covered it. It's getting the priorities right simply and a normal trimming exercise that most companies do. So nothing to add really.
Guido Oelkers: Good. I hope this gave you a flavor, Christopher. Maybe then we move to the next question.
Operator: The next question comes from Harry Gillis from Berenberg.
Harry MacKinnon Gillis: I had another one just on the top line guidance, which obviously you guys reiterated. And of course, there's the uncertainty with Sanofi sales of Beyfortus being a major cause of uncertainty in the rest of the year. But would it be fair to say that the rest of the business has exceeded your expectations in the first half of the year? And then my second question is on Gamifant. You've seen very solid growth in Q1 and Q2 above 30%. So I was just wondering how much of that is off-label use in the secondary HLH indication versus the original label? And then is that a growth rate we should forecast to continue into the sort of near to medium term?
Guido Oelkers: Yes. Thank you. I mean I think it's fair to say that the first half of most of our products, I mean, we clearly -- we were hoping for it, but we probably didn't plan all of that. So it's a very solid growth. You take away the extraordinaries that we had also in Q1. So it's a very consistent, very, very strong underlying performance driven by the new products. Altuvoct launch is exceptional. And as I said, we don't see here a plateauing effect. We see it -- we keep it -- we're expecting it to keep growing. With Gamifant, if you can afford to have a more not quarter-on-quarter perspective, but more of an annual perspective, and this is what we have guided the market. We said essentially last year, the new indication is going to double the potential for Gamifant and admitting obviously, that some of the patients have been treated where the border lines between primary and secondary HLH can be blurred and physicians have to make -- physicians are making decisions. Yes, so basically, there is partially probably this is already in, but we think that there's also for Gamifant in the next 3 to 4 years, there's very significant growth, whilst there's always a bit of risk of lumpiness on a quarterly basis given the small number of patients overall. But the new indication is significantly increasing the potential for the product. So if you have a more midterm outlook, yes, it will propel the product to a larger level. I hope this gives you some flavor.
Operator: The next question comes from Alistair Campbell from RBC.
Alistair David Campbell: I've got 2, please, if possible. Just first of all, I wonder, Henrik, if you could give us a bit of thinking about medium-term R&D expenditures [Technical Difficulty] stepped up quite a bit in the last couple of years, partly after the CTI deal. But what should I be thinking about absolute R&D expenditure maybe for the next sort of 2, 3 period? Is there much more to come in terms of an uplift there? And then secondly, Guido, I'm sure your business development teams are as busy as ever. I just wonder if what you've experienced with CTI, are there any learnings from that acquisition from the process there that you've taken forward to inform BD activity and your thoughts on future deals?
Guido Oelkers: Henrik?
Henrik Stenqvist: Yes, shall I start on the expenditure going forward? Well, you know that we talk a lot about upcoming launches in 2026 with both NASP and the nephrology for Aspaveli. When it comes to R&D, we also have these 4 priority development projects that we are running. So there will be R&D next year as well. For further more specific guidance on margins, we will have to come back to that as we usually do.
Guido Oelkers: Yes. And then maybe with regard to the learnings from the CTI deal. We have now done 10 deals. I think 9 of them have been very successful. Now there are some question marks with regard to the CTI deal. So what are the learnings? I mean, first of all, you do these deals -- we do these deals with a probabilistic approach. I mean if you are the -- if you can and then you make decisions because if you want to have 100% certainty, that is unfortunately not part of the game. So what we -- where we have some learnings is clearly on the integration management side. I think it is there we could have done on hindsight, we could have institutionalized this better and let's say, being more welcoming to some of the team members and have been -- should have probably getting our arms around them in a better way. And then from the deal perspective, on hindsight, it looks like we underestimated the opportunities related to the GSK product. Yes, it's true they had -- they got a much bigger, broader label. We didn't see that coming. So you could say, be mindful when you're thinking about conditional approvals. But it's now -- it's pretty mute at the time that didn't look like a likely probability when we looked at this. So I think it is not belaboring it. We have -- yes, we could have done a bit better, but there is a residual risk with all of these deals. We have probably learned in terms of vigilance a bit but we also need to take some chances. And right now, I mean, I would also like to say that we are not singing sayonara to Vonjo by any respect. We are investing into VEXAS. We are working as we speak on label and guideline expansion. Once we can compete on, I think you see the competitive strength of Sobi. Right now, we are -- it's just a bit harder. And then let's see what we can squeeze out internationally. So I think judge -- it's not satisfactory. I see this, but judge us -- give us a little bit more time. I know that in today's world, that time is a luxury, but the case deserves a little bit more time. So there are some learnings, but it's not like we can point to a complete blunder. All right. Maybe we have a -- maybe another question.
Operator: The next question comes from Viktor Sundberg from Nordea.
Viktor Sundberg: I also have another Vonjo question just on the same topic, you mentioned some of the unforeseen events here for Vonjo that we're now seeing in the numbers. So I don't know if you can answer this, but just wondering what risks should we have in our model for any kind of impairment on CTI? I mean if it keeps underperforming in H2, we could see negative growth on this asset on a year-over-year basis, which I guess was not part of your forecast when you acquired the asset. So just wondering how we should view that risk of any kind of trigger event for any impairment? And then also a second one, perhaps on VEXAS syndrome also. Even if prevalence numbers are out there, I guess, very few receive actual treatment today. So do you have any data on how many patients are confirmed by UBA1 gene testing and have a confirmed VEXAS diagnosis? And how much work do you expect you need to kind of create awareness of this product and have doctors start testing for UBA1 gene to formally diagnose patients?
Guido Oelkers: Thank you. I mean with regard to impairment, I think why don't we have this discussion, let's say, because the team is bullish to make the product grow on a year-to-date basis during the course of this year. So I think -- and they have been bullish before. Why this time? I mean we made some changes. I think maybe we have some additional data, give it a shot. I don't think it's a time to think about impairment. With regard to VEXAS, we have set out some prevalence number. There is an increasing interest in this, and we have -- we know now of diagnostic companies who are offering these tests. So as the increase of awareness of the disease is happening, and we have a few years until we sell this. This is going to be a very material indication. I mean, Lydia, do you want to add something on the medical awareness of the disease?
Lydia Abad-Franch: So we see, I think, 2 really indicators on how the interest in the scientific community is growing. On one end, it's the scientific communications at congresses. And we saw it at EULAR before, and it's going to come as well as both ACR and ASH how really the number of communications is exponentially increasing and the sessions are extremely well attended. But the second thing that I would like to mention is that we have -- as I mentioned, we have started recruiting patients. And we had -- we hosted investigator meetings in different geographies, regional ones. And I think it was the first time in probably many, many years that I saw that everyone attending were all the principal investigators together with co-investigators, there is a huge interest with the feeling that really this is -- we are making history. Obviously, we are running the trial because we believe in the potential of Vonjo. You never know, as I mentioned before, until you finalize the study. But what is clear is that there is a very high awareness and it's really increasing. So also talking to investigators, once they know how to diagnose, it's very easy to have access to this genetic testing. So we know that we need to invest in medical affairs in disease awareness, but it's also clear that there is a trend in the community and this really interest on this new disease because it's really compromising patients and having an alternative treatment option and a clinical trial that they can participate, it's really driving a lot of this interest.
Guido Oelkers: Yes. To your point, I mean, I don't see -- I don't have a data point on hand. But based on the reasoning and let's say, there will be -- there is no shortage of the number of patients. It's then obviously the identification and having a more standardized diagnosis program and protocol is helping. I think this will -- if we have strong data in our study, we don't -- we will not have to -- we don't have to worry about finding enough that there are enough patients. Right now, we know that there are a couple of -- that there are quite a few patients, but this is below 1,000 that will get some form of treatment, but not approved. So I think the opportunity is very material for us. And we just want to give it a go, but the risks -- there's still obviously risk involved. But as Lydia said, the ground is fertile. We will -- as soon if we have strong data, but we will -- I think what you will see is already that the product will get used.
Operator: The next question comes from Kirsty Ross-Stewart from BNP.
Kirsty Ross-Stewart: Kirsty Stewart from BNP Paribas. So just on your expectations for NASP, given that your submission is now completed, I was hoping you could talk to kind of your launch expectations for the product and also your longer-term confidence in exceeding the SEK 500 million peak sales number that you've previously mentioned, especially in light of KRYSTEXXA, which is already doing over SEK 1 billion? Or would you point to kind of some elements of differentiation in terms of maybe your expectations for positioning and uptake of the product? And then hopefully, time for a quick last one, just on Doptelet dynamics for the rest of the year. I understand that it's not that simple to switch from Doptelet onto a generic or Promacta to the currently treated population are relatively protected, but could you clarify that that's the correct understanding? And it would also be great if you could touch on your expectations to kind of grow this product beyond the SEK 1.2 billion run rate you've seen over the last few quarters in light of the generic entry for Promacta?
Guido Oelkers: Yes. Thank you. I mean the -- with regard to NASP, the -- I mean, we believe that we have a unique proposition. Amgen with KRYSTEXXA have around 6,500 patients. We believe based on market research that we conducted that around 15,000 patients would be eligible for pegylated uricase therapy. As you know, that KRYSTEXXA is mostly prescribed in conjunction with methotrexate, which then has some shortfalls and is contraindicated for a number of patients of this community. So what we would expect is a relatively quick uptake in patients that will be eligible for therapy but currently cannot take it in conjunction with methotrexate and have an immunogenicity issue. And so the hope is that we can position NASP very well in those patients. We also think that the competitive profile, given the dose advantage is quite robust based on market research. So we think that we can attract some patients to switch, but there's a significant large blue ocean. And with regard to uptake, I think we will do further studies, but we think that there is a group where we can penetrate quite quickly. And then we'll provide guidance at a further stage, particularly when we have got approval or when we know when approval has been given. With regard to Doptelet, we think the product is well differentiated. So with regard to the generic entry for Promacta, we think that in the United States that we can still hold on to the product, keep growing. Growth, obviously, then forward-looking will become more difficult, but we think that we can defend our patients. And obviously, then we have international and also Europe market where there's -- where we can keep driving the product and we have exponential growth in those markets. So we think that the product -- and by the way, I mean, what we set out for Doptelet was excluding the CIT indication at the time that didn't come, we basically gave guidance to SEK 500 million. And if you extrapolate where we are today and give us some credit for growth, then maybe this SEK 500 million is not too far away. And so we are -- we believe that the product is meeting expectations for us. And we obviously took into consideration that there's going to be a generic with Promacta, but we think that the product profile will hold. Good. I think we are now -- maybe we have room for one more question.
Operator: We have a follow-up question from Christopher Uhde from SEB.
Christopher Winston Uhde: I'll keep it very short. Could you just tell us what the bar for success is in your view for Gamifant in IDS for the Phase II?
Guido Oelkers: Lydia, do you want to comment?
Lydia Abad-Franch: Yes. So as you know, this is a proof-of-concept study, meaning that we cannot do the standard calculations for the probability of success. We know that 20% of patients with sepsis probably is driven by this increased interferon gamma. So there is a very strong rationale, and that's why we have entered this research collaboration to explore. But from there, to give you a specific target number of what's the probability of success, that's something that we cannot do at this stage.
Christopher Winston Uhde: Yes, sorry, that's actually not what I meant. I meant more in terms of what would you be looking to see in terms of driving a go/no-go decision on Phase III? Sorry about that.
Lydia Abad-Franch: Okay. So we are looking at the data in terms of how patients will respond obviously, the first thing is the safety, and that's what we are looking at, making sure that Gamifant is not being detrimental for this group of very severe patients. And once we have established the safety profile and the dose response, then we will -- that's what is going to drive our go/no-go decision, making sure that there is no harm for patients and that we see a dose proportionality in the response so that then we can plan for the next Phase IIb program.
Guido Oelkers: Yes. Thank you. Yes, maybe we round it off given that our time is up. When you think about us, I mean, 22% growth and 34% EBITA at this point of time, we thought that this is more a reason to celebrate than anything else, but we understand the concerns. But I think when you look at the overall performance of the company in a very robust state, we are delivering in our key milestones, and we are taking action to be very competitive to take advantage of the opportunities ahead of us. And so we also believe at least that industrially, even though we may have not done the perfect job to explain it, that industrially, we do the right job to build this company for success. So I look forward to further interactions. And if you have further questions, please let us know and we're happy to answer them. And thanks for your interest. Have a great day. Thank you.
Operator: 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.