Ladies and gentlemen, Welcome to the Sobi Q4 2025 Report Conference Call and Live Webcast. I am Valentina, the conference call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead.
Yeah. Thank you, Valentina. Hello, everyone. This is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the Fourth Quarter and Full Year 2025 Conference Call for investors and analysts. We posted this presentation to sobi.com earlier today. We would like to remind you of usual provisions on statements about expectations and projections of future events. Unless otherwise stated, we will make comments mostly relate to the second quarter at constant currency or fourth quarter, apologies, and in SEK million. Today, we plan to cover the key aspects of our Q4 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 session until around 2:00 P.M.
For those on the phone, please join the queue for questions by pressing star one. We propose you ask only one question or two max at a time. So with this, let's go straight to the key takeaways for the fourth quarter. It has been a quarter for Sobi along various dimensions, you know, financially, strategically, and scientifically. And I'm pleased to say that we demonstrated significant progress along all these three areas in 2025. In the fourth quarter, we delivered 16% revenue growth at constant currency, driven by exceptional 37% growth of our strategic portfolio. This reflects the consistent execution we have shown all year and the fundamental demand for innovative medicines we bring to patients.
For the full year, we delivered 15% growth at constant currency, with a significant contribution from every region, and we maintained a 40% adjusted EBITDA margin, driven by demonstrated operational excellence and also targeted cost alignment. We also strengthened our immunology, respectively, gout franchise, with the acquisition of Arthrosi, adding a late-stage gout asset that aligns perfectly with our long-term strategy and positions Sobi for leadership in a large, underserved patient population. We received EU approval of Aspaveli in nephrology with a broad label that we believe will reshape the treatment in both C3G and IC-MPGN. A strong quarter, a strong year, and a business entering 2026 with strong momentum. We are excited to have launched Olezarsen in FCS in Germany, while the main indication will be SHTG, or as we called it previously, MCS, above 880 milligrams per deciliter.
Expected, by the way, in Q1 2027, the launch. We are happy to make the drug available and inform the medical community about this breakthrough molecule. In addition, we achieved positive proof-of-concept data for Gamifant in interferon gamma-driven sepsis, which is, which is an area with high unmet medical need. Let's turn to slide number five. Let's have a closer look at the Q4 performance. Growth across the, it was in broad but also balanced. Each region contributed as earlier outlined, and our key products continued to scale effectively. Our strategic portfolio is now the central engine of Sobi's performance, representing a shift towards high value, high innovation assets, now representing 65% of our total revenues in Q4. Please turn to slide number six. For the full year 2025, Sobi delivered 50% growth at constant currency.
This is a meaningful, broad-based growth across all therapeutic area, areas, hematology, immunology, and specialty care. Each of these pillars contributed significant value, and each has multiple drivers still at early stages of the life cycle. Our strategic portfolio has become 59% of our total business and it's increasing as the Q4 numbers indicate. Our strategy to deliberately shift towards best-in-class, next-generation therapies is paying off. This performance provides a solid foundation as we now move into 2026 with a richer pipeline, more launches, and more geographic expansion. Please turn to slide number seven. Turning to Altuviiio and Elocta, as two stand out in our portfolio. In Q4, Altuviiio exceeded SEK 1 billion in sales and full-year hemophilia A revenues surpassed SEK 6.8 billion. This trajectory reinforces Altuviiio as a best-in-class therapy and one that is increasingly becoming standard of care in many markets.
Our regional launch strategy foresees a rollout in three waves. Wave one includes the early launch countries, the DACH region, and Spain. Wave two, with France launching in Q4 and Italy launching in January, is just beginning to unlock its full potential. These are major hemophilia markets, and we are only at really early stages of penetration. Wave three, the remaining European countries and international markets, represents an additional runway of growth over the next several years. Please turn to slide number eight. Doptelet is another strong performer for Sobi quarter-over-quarter. It continues to deliver in Q4, and it grew 47% at constant currency. Doptelet has become a truly global brand with performance across Europe, North America, and international. One should highlight Japan, that launched in Q4 and demonstrated impressive uptake.
As more international markets come online, we expected Doptelet's growth to remain strong, while we may see some moderation in the US growth due to the Promacta generics in 2026. Please turn to slide nine. Aspaveli reached an important milestone in January with the EU approval for C3G and IC-MPGN. Our launch strategy in Germany is underway. A recent survey has shown that the awareness on pegcetacoplan's best-in-class efficacy has rapidly grown among nephrologists in Europe. The recent publication of the VALIANT data in the New England Journal of Medicine was very helpful in this regard. However, it will take a while till this indication will change the economics of Sobi as we are building a new market with specific requirements prior to use and will obviously follow the usual launch sequence in Europe.
Notwithstanding, Aspaveli will become a key growth driver for Sobi during the coming years, and we are very pleased with the progress year to date. Please turn to slide number 10. Now turning to Beyfortus, where we see a decline in Q4 revenues compared to a very strong Q4 2024. Seasonality and inventory fluctuations have influenced the sales evolution on this category, but none of these dynamics has changed our view on the long-term adoption curve or on the fundamental demand outlook. While there has been some changes to the overall vaccine policy, it is important to remember that the guidelines for RSV has remained as before. Beyfortus is still recommended for all newborns, unless the mother has received a maternal RSV vaccine. Support from the pediatric associations and U.S. healthcare providers remains strong, as does the continual the real-world evidence readout from Beyfortus.
Real-world evidence across 85,000 infants show an 83% reduction in RSV-related hospitalization. We wanted to take a pulse on how prescribers are feeling about the next RSV season, and our survey included more than 100 U.S. physicians. 80% expect RSV immunization volumes in 26 out of 27 to match or exceed the current season, and 90% expect Beyfortus to remain the product of choice, indicating a strong preference for the treatment, a perspective that appeared to be supported by recent reports. Please turn to slide number 11. Gamifant has accelerated growth in Q4 again. We saw 70% growth in Q4, driven by the U.S. launch in MAS. Gamifant is the first approved therapy for macrophage activation syndrome, and education efforts are resonating strongly with hematologists, oncologists, and rheumatologists.
We now completed filings in Europe and Japan for HLH, MAS, which will significantly broaden the patient reach and accelerated international growth. We're excited about Gamifant's expansion over the next 2 quarters and look forward to the progress in 2026. You will hear more from Lydia on exciting developments in sepsis for the potential utility of Gamifant in- as an interferon gamma scavenger. Please turn to slide number 12. Looking ahead, Sobi is entering an unprecedented launch cycle. Between now and 2028, we expect six high-value medicines to reach the market by 2028. The acquisition of pozdeutinurad strengthen our long-term position in gout, while Olezarsen positions us for leadership in severe hypertriglyceridemia. Our latest launch, Aspaveli in nephrology, targets an underserved patient population with substantial scientific and commercial potential. These six launches will radically transform Sobi's trajectory well into the 2030s.
To realize this potential, the potential of these assets, we need to commit significant resources for development, medical, and commercial efforts in 2026. These commitments have been partially funded by our annualized impact, impact of our cost alignment program in 2025 and business growth. However, it will also moderate our expected EBITDA margin in 2026. Please turn to slide 13. As we look forward to 2026, our strategic priorities are pretty clear and are the following: We will continue the strong rollout of Altuviiio, expand Gamifant in HLH/MAS in the U.S., execute the European launch of Aspaveli in C3G. We are preparing for the NASP launch in the United States. We will advance Gamifant into the next phase of IDS.
We will continue to progress our development programs for Vonjo and Altuviiio, and importantly, we plan to integrate our Arthrosi Therapeutics and conclude its phase three program. These priorities position Sobi for rapid, sustainable growth, not just in 2026, but also propel Sobi into the next decade. However, the size of the opportunities correlates with the necessary commitments. Coming from a very strong financial base and profitability in 2025, trade-off decisions between today, tomorrow, and tomorrow after tomorrow needed to be made. Erik will explain the economics of these choices in 2026 in more detail during this call at a later stage. However, it is a happy problem to have, and we are excited to progress such an impressive number of projects of transformational nature. Hence, I'd like to now hand over to Lydia, who will share her perspective from an R&D perspective of our portfolio. Lydia?
Thanks, Guido, and hello, everyone. So let's start with the pipeline milestone on the next slide, please. We are carrying a very strong momentum, and here's what happened in the fourth quarter. Aspaveli in C3G and primary IC-MPGN received CHMP positive opinion in the European Union and was submitted to PMDA in Japan, with a pivotal VALIANT study published in the New England. And I will come back to this asset in more detail. Gamifant moved forward in HLH/MAS with filings in both Japan and Europe. We also got positive top-line data of for Gamifant in interferon gamma-driven sepsis that enable us to move forward with the program. And the Olezarsen pivotal data from the core and core two studies in severe hypertriglyceridemia was also published in the New England.
We started building our R&D hub in Japan in 2022, and the submissions of Aspaveli and Gamifant in parallel to the European submission show that this approach is paying off and will enable us to earlier launches. Finally, the two New England papers published last quarter also demonstrate that Sobi, together with our partners, are at the forefront of science, driving strong, clinically meaningful data. Let's now have a deeper look at Aspaveli in nephrology, Gamifant in IDS, and Olezarsen in severe hypertriglyceridemia. Next slide, please. The global launch of Aspaveli in nephrology is now taking place. In 2025 and January this year, it was approved for both C3G and primary IC-MPGN in the European Union, Australia, Brazil, Saudi Arabia, South Korea, and Switzerland. We're also having ongoing submissions in Japan, UK, Canada, and other global markets.
There is a very strong interest in the medical and patient community. From recent insights among physicians who treat these diseases, the vast majority believes that complement inhibition will lead to earlier diagnosis and screening strategies, and will reduce the need to initiate immunosuppressive therapy. We have also positive reports of the first infused uses in Brazil and South Korea. The rollout of this on-body device to simplify the infusion will take place in parallel with the launch of the nephrology indications. The phase III VALIANT data published in the New England, together with the recently updated 1-year follow-up, is very encouraging. We plan to publish further long-term data from our phase III extension trial, and we are setting up a phase 4 clinical program to create further evidence on the use of pegcetacoplan in real clinical practice. Next slide, please.
Turning to Gamifant in interferon gamma-driven sepsis, this could address a significant unmet medical need and an important burden to healthcare systems. Sepsis is a life-threatening medical emergency, which arises when the body's response to infection causes injury to its own tissues and organs. This can lead to shock, multi-organ failure, disability, and death, especially if it's not recognized early and treated promptly. Sepsis is a leading cause of death worldwide, responsible for about one in five deaths. Almost 50 million people suffer from this condition, and 11 million die from it. It also leads to high healthcare costs, with an estimated $60 billion of hospital costs in the US alone. The Hellenic Institute for the Study of Sepsis, or HISS, identify an endotype of sepsis, which is characterized by elevated CXCL9 and interferon gamma and an increased risk for 28-day mortality.
We investigated this subset of sepsis patients in a research collaboration with HISS in a study called EMBRACE. The EMBRACE exploratory phase II-A study has now shown an improvement in organ dysfunction and patient survival with emapalumab treatment. This top-line data supports the proof of concept and allow us to advance the development of Gamifant for this indication. We have started initial interactions with regulators, and we'll discuss the next step for clinical development with them. The data will be presented at the ISICEM Conference in Brussels next March, and you will hear about this exciting new indication at our Capital Markets Day on February 18. Next slide, please. Another example of our scientific advancements is Olezarsen in severe hypertriglyceridemia.
In November, the New England Journal of Medicine published the CORE and CORE 2 studies, the pivotal data of olezarsen in this indication, and it was simultaneously presented at the American Heart Association conference. Severe hypertriglyceridemia is characterized by triglyceride levels above 500 milligrams per deciliter. It's a very severe condition. Patients face an increased risk of acute pancreatitis, which is a medical emergency that frequently requires hospitalization. It is associated with higher morbid mortality compared to acute pancreatitis of other causes. CORE and CORE 2 evaluated olezarsen added to standard of care. The placebo-adjusted triglyceride lowering achieved in this trial was approximately double what is currently achievable for patients with severe hypertriglyceridemia. It resulted in a reduction of triglycerides up to 72%, with a durable response at 12 months.
The primary purpose for hypertriglyceride lowering, lowering in severe hypertriglyceridemia is basically to reduce the risk of acute pancreatitis, which can be life-threatening. Current therapies have more modest triglyceride-lowering effects in these patients and have not been proven to reduce the incidence of pancreatitis. The current KORE 2 data demonstrated that Olezarsen reduced the rate of acute pancreatitis by 85% in patients with severe hypertriglyceridemia, meaning that Olezarsen is the first and only treatment that reduces acute pancreatitis risk in this group of patients. This makes a strong case, which will be the basis for our European submission later this quarter in patients with severe hypertriglyceridemia, with triglyceride levels above 880. Next slide, please. Looking ahead, we anticipate continued momentum with the major regulatory submissions in the 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 EU submission of Olezarsen in severe hypertriglyceridemia above 880, and the LOTIS-5 data readout in relapsed refractory diffuse large B-cell lymphoma. Later in the year, we will see initial study data from the Altuviiio freedom study, including important joint health data, the Japanese regulatory decisions for Aspaveli in the nephrology indications, and Gamifant in HLH MAS, and we do expect EU CHMP opinion on Gamifant late in the year or early in 2027. With that, I would like to hand over to Henrik. Next slide, please.
Thank you, Lydia, and hello, everyone. So please turn to slide 21. We will now take a look at some key financial metrics for the quarter. In Q4, our revenues of SEK 7.8 billion correspond to a revenue growth of 16% at constant currencies. Hematology increased by 25%, the CER, driven by the strong launch of Altuviiio and continued progress in Doptelet across all three regions. In immunology, we saw strong double-digit growth in both Gamifant and Kineret, offset by lower RFD royalties. In specialty care, we initiated the launch of Olezarsen in the FCS indication.
If we look at the table on the right and the adjusted gross margin, which was 81% in the quarter compared to 78% last year, we saw an improvement in gross margin from positive product and country mix effects, but this was somewhat offset by the Synagis royalties and FX impacts. Operating expenses, excluding non-recurring items and amortization for the quarter, increased by 3% at CER compared to Q4 2024. SG&A, also excluding non-recurring items and amortization, increased by 6% at CER, driven by launch and pre-launch costs for Altuviiio, Aspaveli in nephrology, NASP, and Trigolza. This was partially offset by lower costs across Vonjo, Doptelet synergies, and Elocta, and the cost savings initiative we outlined in Q2.
R&D expenses declined by 2% at CER, excluding non-recurring items, mainly due to NASP programs that are now complete, as well as the cost savings initiative from Q2. This was partially offset by development programs in Vonjo and Gamifant. As a result, the adjusted EBITDA for the quarter amounted to SEK 3.2 billion, equal to a margin of 41%, compared to 34% for the same period last year. Operating cash flow for the quarter was close to SEK 3 billion, compared to SEK 1.8 billion last year, driven by improved operations. Net debt at the end of the quarter was about SEK 10 billion, and net debt to EBITDA ratio of 0.9 times. This does not reflect the expected acquisition of Arthrosi, which is planned to add about SEK 9 billion of debt, or less than 1 times EBITDA. Next slide, please.
If we now turn to full year performance, we delivered strong profitable growth in 2025, and we exceeded our updated guidance from Q3 on revenue and margin. For the full year 2025, we achieved just above SEK 28 billion in revenue, equal to growth of 15% at CER. This growth was driven by double-digit growth in each of our three regions, outlining the advantages we have in our portfolio and geographic diversification. From a product perspective, Altuviiio, Doptelet, and Gamifant were the main drivers, more than offsetting lower revenue from RSV and Vonjo. In 2025, we saw 0.8 percentage points increase in gross margin, driven by products and country mix.
The adjusted EBITDA margin for the full year was 40%, an increase of 4 percentage points versus last year, as we saw strong operating leverage with revenue growth of 15% and OpEx growth of 4% at constant currencies. Within R&D, spend decreased by 3%, mainly due to lower NASP development costs, as well as the impact of our cost control measures. In SG&A, OpEx increased by 8%, driven by launch of Altuviiio, but also pre-launch of Aspaveli in nephrology and NASP, as well as higher activity for Gamifant. These activities were partly offset by the cost measures we put in place in Q2, as well as generally a rigorous cost control. Please turn to next slide. We come to 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, we anticipate revenue to grow at low double-digit % at CER and an adjusted EBITDA margin in the mid-60s % of revenue. On the revenue guidance, we certainly expect continued progress with our existing commercial portfolio, where Altuviiio is now approved and reimbursed in all major European markets, and we expect the product to continue to be a major growth driver in 2026, as markets still have plenty of room to grow. We expect additional revenue benefit in the launches of Aspaveli in nephrology and Beyfortus, although mainly in the second half of the year, due to the Beyfortus PDUFA date expected in late June, as well as the phased launch of Aspaveli across European markets as we get reimbursement country by country.
Beyfortus, as before, remains difficult for us to forecast since we are not running that business, but we don't believe that fundamentals have changed with regards to competition, recommendations, and reimbursement. In regards to our EBITDA margin guidance, I want to highlight some key investments 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 in PNH, both visible in 2025, but set to accelerate in 2026. Second, with the strong data from the phase III trials of Olezarsen in FCS and SHTG and the opening of a large market opportunity, we will have costs in 2026 related to filing and pre-launch activities of that indication.
Third, we expect to finalize the acquisition of Arthrosi, and if so, we will be completing two ongoing phase III studies and prepare for regulatory submission, adding those costs to our R&D line. Finally, we've included a continued development of Gamifant in IDS. We are still in discussions with health authorities, but we have assumed, considering the positive signals from the phase II-A study, that we will take it to the next phase of development, and further details are to be confirmed. All these investment areas will be partly offset with reallocation of resources and cost containment in the rest of the business, including the full year impact of the cost-saving initiatives from 2025. To conclude, it is, of course, critical that we adequately invest in these new areas in 2026 to position Sobi for the future. With this, I hand over to Guido. Thank you.
Thank you, Henrik. Please turn to slide number 25. To summarize, we not only demonstrated strong results in Q4 and for the full year in 2025, but we also achieved significant pipeline milestones that bolster our medium- and long-term outlook. We are broadening our portfolio in nephrology, immunology, and specialty care, and we continue to bring transformative therapies to patients. While we have shown you a more conservative perspective of our financial outlook in 2026, we do not want to miss the opportunity to familiarize you with the potentials that we will realize during the forthcoming years. This will require more time than we typically have during an earnings call.
Hence, we would like to share our thinking of this exciting, innovative portfolio and our midterm outlook during a Capital Markets Day with you here in Stockholm and in a live web cast two weeks from now. We will be joined by clinical experts in areas such as gout, SHTG, and sepsis. We are very much looking forward to the dialogue as we transition Sobi into the next phase of economic transformation. With this, we can now open the line, and we are happy to answer your questions. Thank you.
We will now begin the Q&A session. Anyone who wishes to ask a question may press star and one 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 Christopher Uhde from SEB. Please go ahead.
Hi there. Thank you very much for taking my questions. Christopher Uhde from SEB. So I guess, first for Lydia, on Gamifant. You've talked about potentially resubmitting this product for years, I guess, to the EC. And so how sanguine are you on approval now? And I guess if positive, what's different about it this time around? And then I don't know if you're able to say on Embrace in IDS, but did you see a dose response or reach a maximally tolerated dose? So that's the first question. The second one is just on Altuviiio. Is there any stocking in hemophilia A in general across both products? And how does demand in France look like? Is it like Elocta and Hemlibra? Do you have any indications yet? Thank you.
So hi, Christopher. This is Lydia. So, your first question was on Gamifant, in Europe, the submission on the, HLH MAS indication, if I'm correct, and then the second was on IDS. So for Gamifant in secondary HLH MAS, obviously the data is based on the clinical trials, both study 14 and study 06, and you know that we got approval in the US. So we went through the review and, and all the approval process, with FDA. So we feel confident that this is going to be, something that, is going to be well received by regulators also in Europe. And we just submitted in December, so it's something that we are now in the starting phase of the discussions.
When it comes to IDS, we will be presenting the data, as I mentioned, at the ISICEM conference in Brussels, which is the intensive care conference, the 45th congress. So there we will be presenting the data. You know, this is a proof of concept study, that it was not powered for statistical significance, but what we see is that there is a clear signal on benefit, both in organ dysfunction improvement and also in terms of mortality. But I cannot provide more details at this point in time because we will be presenting the data at the clinical congress, and we will be sharing also some details at the Capital Markets Day. So Guido, I think the next one-
Yeah.
On Altevogt.
Yeah, and with regard to Altuviiio, you know, the, there has not been any material stocking and, in the extraordinary course. And, and the good news is, even though France is, heavily penetrated obviously by non-factor therapy, the launch uptake was, was very encouraging. So we have a very positive, momentum also in France that reflects the launch curves actually of, previous countries. So, you know, it's a it's, it's not, just, you know, an inverted commas, a tremendously German success, but it's carried. And, you know, the first signals of the French launch is, very, very encouraging. Yeah. And you know, maybe just, rounding it off, we wouldn't file in Europe if you would not think that there's a promise then. So, maybe we could move then to the next question. Thank you.
The next question comes from Gonzalo Artiach from Danske Bank. Please go ahead.
Hi, guys, and thank you for taking my questions. Gonzalo Artiach from Danske Bank. First one is on Altuviiio, very strong quarter. I guess that it's reflecting that the drug is already out there in the main EU markets, but have you felt any plateau in any of the main initial markets? And can we say that your initial peak sales expectations were too low, and now you're looking to a higher peak sales goal? And my second question is more of a broad one. It would be great if you guys could shed some light on the type of organization you have to build around Olezarsen. How many people do you have to add to the team for this launch during this year? Thank you so much.
Yeah. Thank you for your questions. I mean, you know, we have seen now in Germany market shares, you know, of above 60% in prophylaxis, well above. And, you know, and obviously numerically, it just becomes more difficult because there seems to be a natural ceiling. And to grow at the same exponential rate. But we are seeing continuous explosive growth, obviously, in the earlier launch countries. So we are not seeing a plateau on a total level whatsoever. But obviously And we don't see a plateau yet in the earlier launch countries. We just see that the growth is not as rapid because, yeah, numerically, it just becomes more difficult.
And then with regard to Tringalza, you know, right now, we obviously, you know, this is, we set up an organization in the light of the FCS launch and, you know, and preparing the communication. So this is a, I mean, this is for the company we are a significant team, but it's by no means, you know, it's still comparable to what, you know, you, Ionis has indicated at this point of time for the US. But it is enough to cover well the 600 lipid centers in Europe, which is the primary focus of us today, and we will ramp up the organization.
I mean, we have a very good sense, you know, let's say, as we then get closer to the launch of the SHTG indication above 880 milligrams per deciliter. Yeah, so we are not setting out, but, you know, we will be competitively positioned. And, you know, the other thing is, Tringalza is not a product that Sobi will not be able to do, yeah. This we can see already because the main decision-making is today in these lipid centers, so we will have to build a more peripheral referral system in phase I.
And at one stage, I think, you know, you have to assume that the treatment is more democratized, and then you're talking, obviously, broader, broader teams. And how we solve this in this, in that, in that phase, well, we have to figure out. We know how to do it. I mean, we have sized it already very clearly, so it's, but it's not a skyrocketing calculation. But, you know, it is something we want to look at at the right time. Next question, maybe?
The next question comes from Erik Hultgård, from DNB. Please go ahead.
Yes. Hi, thanks for taking my questions. I have two, if I may. First, on Aspaveli, I was wondering how much. Obviously, there is a huge opportunity to commercial within rare kidney. But I was just wondering how much we should expect Aspaveli to contribute in 2026, given some of the bottlenecks that you highlighted, including market access and other requirements for dosing, such as vaccination. Then, my second question relates to Gamifant, and if you could comment a bit on the sales split in the U.S. between primary and secondary HLH, and what penetration level you have achieved so far in MAS. Thank you.
Thank you. Yeah, no, I mean, the when you think about, you know, the rare kidney, I mean, we said that it will probably not—this product is not gonna change the economics of Sobi at scale in 2026. And I think it's just by the launch sequence, by the virtue of the launch sequence, it's by the fact that, you know, you need to go through a vaccination schedule that will take some time, and we will need to activate patients for this new therapy to actually be referred, mostly in both areas, from the community nephrologist to the key centers. That will take, will take a this activation will take a bit of time.
But nonetheless, you know, we would expect, you know, to seek to create in Europe a very significant number of patients that is ahead of what we have achieved year to date in PNH. Yeah? So that gives you a it gives you, gives you a feel so that, you know, we, we, we believe that this is an important indication. Now, many of these patients will not start on January one. Yeah, so that's the reason why or why the economic effect will be more moderated, but by no means are we holding back or believe that this is a small, small opportunity for Sobi. So it but, you know, the, it becomes a material then in, in the following year, 2027.
With regard to Gamifant, you know, essentially, it's today, it's probably more like 50/50, primary/secondary, because, you know, we had also some patients in the past. But, you know, and that basically tells you that, you know, we, of the, of the potential in secondary, we probably have less than 50%. And this is in MAS. And, you know, that would not include, obviously, utility of Gamifant in other areas. So, you know, the, our. You know, we, we are by far not there, exploiting the full potential of Gamifant, Erik, yeah.
All right. Thank you so much.
Thank you. Thank you so much, Erik.
The next question
Please, the next question.
Yeah, the next question comes from Mattias Häggblom, from Handelsbanken. Please go ahead.
Thank you so much. I have two questions, please. So, firstly, on RSV, I'm curious to better understand what's embedded in the guidance based on the survey you referenced. So, royalty rate is going up in the year. I guess we should assume 27%.
Yes.
Not this weekend. What is our dollar denominated, I would presume, but then with regards to penetration in the next RSV season and the new vaccine schedule, your partner, Sanofi, last week said, and I quote: "What extent the vaccine will create confusion for parents and physicians is too early to say." So is it fair to say that you are more optimistic than Sanofi, or is your guidance helped by your partner? And then secondly, for Henrik, consensus appears to model roughly SEK 2 billion OpEx increase in 2026. Is there any way you can help us understand to what that, to what extent that, that captures your current plans? Thanks so much.
Yeah. Maybe I'll start with the easy bit. You know, I mean, we, to be honest, for us, Beyfortus, we have a couple of classes. You know, we, we see an increase of our royalties rates. We also see that 2025 was artificially negatively influenced by various factors, late onset of season. I mean, you just saw the recent surge of RSV again in, in January and, you know, by CDC data, so, you know, clearly it's an unusual season, but also, you know, clearly, as you know, clarified by various parties, it was an inventory effect, probably not insignificant. Yeah.
So by definition, you would see a positive out of this, and this has to be then, you know, balanced with a potential effect of competition and with a potential effect of muted immunization rate because of the ongoing debate in the United States. Now, what we try to clarify is that at least the physicians who are in charge, they feel undeterred at large to prescribe the product and provide access to it. We also wanted to clarify that, you know, at least there's no restrictions of reimbursement, and there's also an unbroken preference share for Beyfortus. Now, how does this play out? I mean, just as, you know, if, Sanofi will provide guidance from what I understand in Q2, I would not like to say.
I mean, we don't have exaggerated growth expectations for Beyfortus and whatsoever, because we look at this more as a catalyst to fund our growth drivers that we have pointed out. That's for us, you know, part of our plan. But, you know, we will see that there is some, you know, that the factors favoring a positive evolution of Beyfortus are not insignificant, and we don't see we have not been able to point too many headwinds, so it's probably more moderate, positive, optimistic, but, you know, we don't have any exaggerated expectations, on the other hand, either. But, you know, we are really here also dependent. We are triangulating different data points. We are dependent, obviously, on Sanofi, who is promoting this product, and I'm sure they will enlighten us, but we are more cautiously optimistic, yeah. Henrik, you were to cover?
Yeah, sure. Well, it's difficult to comment on individual lines in the consensus forecast, particularly since I understand that consensus isn't totally updated. But I guess if you have the top line number, or you have the top line growth, and then you have a growth margin which, you know, remain in the high 70s, you know, sure, mathematically, you know, more or less what numbers to have at OpEx to get to the mid-30s guidance. And of course, we are, you know, as I said, we are adding very important investments in 2026, where Arthrosi then is expected to be the largest on among these new items. I can't really give you a bit more precise there on a particular number for OpEx.
Thanks so much.
Thank you, Mattias, for the question. Next question, please.
The next question comes from Harry Gillis from Berenberg. Please go ahead.
Very much for taking the questions. Can I just follow up on the 2026 guidance, particularly on the margin? Can you quantify what impact the Arthrosi acquisition is there, either in percentage terms or in absolute OpEx spend in 2026, just to try and figure out what the margin would have been ex Arthrosi? And then a quick one on Gamifant. I know you talk about communicating next steps in due course. Is the debate here whether you go straight to a pivotal trial or require phase II-B before pivotal? Thank you.
Henry?
You know, we don't want to give specific number on specific items here in the guidance, because as you know, we guide on revenue growth and margin. But I think you know more or less the starting point here and as I said, Arthrosi is the largest among the new investments compared to 2025.
Yeah. And on Gamifant, you know, we are encouraged, as Lydia pointed out, to think about the next step, which, you know, and validates this further with with EMA, which could well be a a pivotal trial, yeah.
Yeah. So basically, based on the unmet medical need and the strength of the data, that's the discussion that we are going to have, and we are looking into all options, and obviously one could be going directly to pivotal. It will be too early to say anything before we complete the conversations that we have already started with the regulators.
Thank you.
Thank you. Next question.
Next question comes from Kirsty Ross-Stewart from BNP Paribas. Please go ahead.
Hi there. Yes, thanks for taking my questions. Kirsty Ross-Stewart from BNP Paribas. Just a quick one, Guido, on your comments around Beyfortus. You said that kind of you don't have exaggerated growth expectations. So can we take this to mean that you're kind of expecting a small amount of growth or more reasonable to assume that the Beyfortus royalty revenues remain flat in 2026? And then also on the margins, would you be able to give us some color on how we should think about the evolution of this in the kind of midterm?
Should be thinking about 2026 as a transition extraordinary year, given the big step up in investment, and then return towards the 40% margin longer term. I just think conscious, you know, would like some color given the, the, launches that are being approached. And then lastly, on Vonjo, saw a slightly stronger quarter in Q4, and GSK have made some comments that are noticing some competition stepping up, for their product, Ojjaara. So could you just talk to the changes you've made in the commercial organization behind that product and whether we could expect that to return to growth in 2026? Thank you very much.
Yeah, thank you. I mean, you know, the what I meant is, I mean, we don't typically provide guidance on individual products. I think, you know this, you know, I cannot provide more color. I mean, it's clearly not a growth driver, yeah, for Vonjo, but it's also not maybe we don't expect a decline in product either. Yeah. And basically, you know, with regard now to the midterm outlook, I mean, that's the reason why we actually wanted to have a Capital Markets Day to provide you a perspective, how we see the evolution of Vonjo towards 2030 at least, and you know, and how we see the long term. So basically, you know, the segregation of our forecast, you know, into tomorrow, tomorrow after tomorrow, and you know, reflecting on today.
With regard to Vonjo, I mean, we made some changes. We have a new leader of this business unit, and you know, he has clearly the right degree of tenacity and mental readiness to try to take this product on. I think it's important, you know, that we accelerate now PACIFICA, which is then a stepping stone in conjunction with the other data that we have generated to get on equal terms in terms of label, as we outlined earlier, and then obviously in guideline recommendation. But, you know, we believe that Vonjo is a growth product for us this year.
Yeah, it's and that we are, you know, that the benefit from the volume growth that we had also last year, but you know, A, the volume growth will be amplified, and B, we will not have this significant negative effect of gross to net adoption, which then led to price reductions then at scale. So we believe that, you know, Vonjo should be better performing for us this year. But, you know, the turnaround, the inflection, we don't expect this year. We expect it once we have each reached equal status in terms of label and guideline recommendations, then you will see whether Vonjo can be competitive in this area. Next question?
The next question comes from Viktor Sandberg , from Nordea. Please go ahead.
Yes, hi. Thanks for taking my questions. So, just curious here also on your guidance in terms of, the growth numbers, you provided. So on Beyfortus, it sounds like you estimate a stable market, heading into 2026. So in light of that, what, what kind of pulls have you expected that hold you back a bit of not having even higher growth goal if you have some flat or slightly increasing Beyfortus sales? And, maybe related to that too, when, when you talk about margins, it looks like hematology margins have steadily moved up to, to 40%, but, you highlight some, you know, higher OpEx here. So I just wonder if these OpEx costs are, expected to come, early in the year or, more to the second half of the year? That would be interesting to hear. And then I have a quick follow-up on Gamifant as well. Thanks.
Yeah, I mean, you know, But, you know, we are entering, I think, for Sobi at least, anyone, and at least, you know, the last eight and a half years, I, I think we never had the foresight to launch six products. Yeah. And some of these launches are ongoing and six by 2028. And of these launches, products that have I mean, an unprecedented potential for the company that we are today. I mean, you know, in terms of size, these products, I mean, and, you know, product of this size, you know, potential blockbusters are not, you know, just happened by a fluke.
They have to be created, and we have to show commitment and in terms of resources and effort, and we are ready for this. This is what basically now happens to us in 2026, that we provide these resources to build Sobi for the future. And these were conscious trade-off decisions, yeah. And that's the reason why our forecast or our guidance is lower than, you know, the 2025 actual, and that basically is incorporated. And you know, so maybe Henry, you want to comment more on the OpEx side and provide more color?
I think you referenced also hematology profitability development, and that is the It's clearly up compared to a year ago, but that's a very natural consequence of you know the uptake in revenue from Altuviiio and also obviously products like Alprolix. And so when it comes to the split the OpEx over the year, I mean, it's clear that some of these items that I mentioned start to build up later in the year. Because if you take Arthrosi, for example, we haven't yet closed that transaction, so obviously it cannot be a full quarter in Q1. You know, similarly with IDS for example, you know, hasn't we're still in discussions with the regulators. So obviously this will ramp during the year.
Yeah.
Okay, thanks. And just a quick one on Gamifant also. You know, just trying to understand maybe your view of the commercial opportunity for this product with expectations on this product being a hot topic among investors in Sobi. I guess if you're in the camp that's more negative, you would point to that it's an acute, not chronic condition. Pricing could perhaps be a bit challenging, even though we, of course, don't have the data yet. But, I'm just curious how you see the commercial opportunity in sepsis from your perspective. Thanks.
Yeah, I think the commercial opportunity is incredible, yeah. I mean, it's not you know, we don't want to, you know, tell you now that it's completely off the charts, but, you know, it is clearly, when you look, just look at the stats, you know, two million patients in Europe take away 20% of those with interferon gamma driven sepsis, simple math, that's a lot of patients. And yes, and when you apply the dosing regime, you know, that was used in this proof of concepts trial, and, you know, the, and the irony is, you know, the not and you may not even have to adjust on a price per unit because you need less units to match versus where we are today. So, you know, this is the way we have priced Gamifant. So it is, but it's still a very, very significant opportunity for us.
But, you know, we need to hold our horses now. We need to get into the next trial. But a nd, you know, we are excited, you know, to share with you the, let's say, the next set of data at the Capital Market Day and obviously looking forward very much to March ISICEM, like Lydia pointed out. Yeah, so but the opportunity is massive, yeah. I mean, clearly, you know, beyond if it would come and if the pivotal data would support, you know, what we have, what the early signals we have seen, then clearly multi-billion-dollar opportunity. It's can't avoid it, yeah. But it's early days. Yeah. So, you know, we need to now do the next step and be a little bit patient, but it is a spectacular opportunity for the size of company we are.
Great. Thank you very much.
Thank you.
We now have a follow-up question from Mattias Häggblom, from Handelsbanken. Please go ahead.
Yeah, thank you so much for taking, squeezing me in. Two quick follow-ups if I may. So, so first on sepsis. So with a CMD in mid-February, is it really realistic to assume you've received feedback from both EMA and FDA prior to the CMD to help you guide the path forward, or, or will insight from EMA be enough? And then secondly, with the conference, with, with full disclosure from the proof of concept trial in mid-March, help us frame expectations, what clinical data you can actually share at the CMD in February. Thanks so much.
Yeah. Thank you. Mattias, you know, we are in constant dialogue, and we will see whether we can synchronize this, and Lydia can talk about EMA and her expectations for EMA and FDA feedback in a moment. You know, what can you expect at the conference? You know, there needs to be a little bit of mystery in life, and, let's say, to create a bit of suspense. But no, realistically, we will provide, you know, a few data that will help you to share the excitement we have in the company. That's this one I think we can safely say, because, you know, I mean, it's a small study, but, you know, it's, we are very satisfied with the outcome. You know, otherwise we would not have indicated what we have indicated. Julia, what do you think in terms of feedback from EMA and FDA?
So maybe to comment on the regulatory side, we are moving full steam ahead. So we have already started the discussions and we will have consultation with both agencies. So we are trying to move as fast as possible based on how, as I mentioned before, how large the unmet medical need is and the signal from the study. I maybe just wanted to maybe remind everyone on the call that obviously what you've seen and what we've seen, it's like top-line data of the 28 days, which was the primary endpoint at 28 days, on the SOFA score and mortality.
But the study has a follow-up up to 120 days. So we also want to see the full data set, because that will be doing additional data on mortality, not on the primary and secondary endpoints. But just to remind everyone that we will need to wait also until March to have the full data set. So we will share what we can at the Capital Markets Day, and obviously, there will be more discussions on the data at the conference in Brussels.
Yeah. Yeah, I think. Thank you, and thanks for your interest. I think we have now reached the end of this video conference. I hope you share our excitement around the company. We at least are, I mean, you know, and looking really at unprecedented opportunities, as you can see, for the group, for the company we are, and very much look forward to continuing the dialogue. I mean, please contact our IR, and we can provide separate insights. Other than this, we would be excited to welcome you in Stockholm on the eighteenth of February. Thank you so much, and wish everybody a fantastic week.
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