Swedish Orphan Biovitrum AB (publ)

Hello, everyone. This is Guido Erckes, 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 a million Swedish krona. Today we plan to cover the key aspects of our Q4 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Abarth-Franz, head of R&D and chief medical officer. We plan to review the presentation first and then have a question an answer session until around 2 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 Suvi 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 medicine 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, and positions solely for leadership in a large, underserved patient population. We received EU approval of Aspavelli in nephrology with a broad label that we believe will reshape the treatment in both C3G and ICMPGN. A strong quarter, a strong year, and a business entering 2026 with strong momentum. We are excited to have launched Tringolsa in FCS in Germany, whilst the main indication will be SHTG, or as we called it previously, MCS, above 880 mg 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 gamifont in interferon gamma-driven sepsis, 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. It was 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 service 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 2022, This is a meaningful broad-based growth across all therapeutic 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 is 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 the richer pipelines, more launches, and more geographic expansion. Please turn to slide number seven, turning to AltaWalk as two stand out in our portfolio. In Q4, Altowalk exceeded one billion kroner in sales and full-year Haemophilia A revenues surpassed 6.8 billion kroner. This trajectory reinforces Altowalk 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 2 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. And Wave 3, the remaining European countries and international markets, represents an additional runway of growth over the next several years. Please turn to slide number eight. Dr. Lett is another strong performer for Sobi quarter on quarter. It continues to deliver in Q4 and it grew 47% at constant currency. Dr. Lett 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 Doctilence growth to remain strong, whilst we may see some moderation in the US growth due to the Promecta generics in 2026. Please turn to slide number nine. Aspa Valley reached an important milestone in January with the EU approval for C3Gs and ICMPGL. Our launch strategy in Germany is underway. A recent survey has shown that the awareness on Paxetaco plant's best-in-class efficacy has rapidly grown amongst 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 until 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, as per Willi, we've become a key growth driver for SOVI during the coming years, and we are very pleased with the progress here today. Please turn to slide number 10. Now turning to before this, 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. Bay Fortis 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 remain strong, as does the continual real-world evidence readout from Bifortis. 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 US physicians. 80% expect RSV immunization volumes in 26 out of 27 to match or exceed the current season, and 90% expect Bifortis 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. GAMIFund has accelerated growth in Q4 again. We saw 70% growth in Q4, driven by the US launch in MAS. GAMIFund 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 accelerate international growth. We are excited about Gamifund's expansion over the next two 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 Gamifund as an inter-reform gamma scavenger. Please turn to slide number 12. Looking ahead, SUBI 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 POIS Dirtinerate strengthens our long-term position in gout, while Stringolza positions us for leadership in severe hypertriglyceridemia. Our latest launch, Aspervillian Nephrology, targets an underserved patient population with substantial scientific and commercial potential. These six launches will radically transform SOVI'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 of our cost alignment program in 2025 and business goals. 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 ALTOVOGT, expand GAMIFUND in HLH MAS in the US, execute the European launch of ASPA Valley in C3G. We are preparing for the NASP launch in United States. We will advance GAMIFUND into the next phase of IDS. We will continue to progress our development programs for WONJUR and ALTOVOGT. And importantly, we plan to integrate through the therapeutics and conclude its phase three program. These priorities position SOBE for rapid, sustainable growth, not just in 2026, but also propel SOBE into the next decade. However, the size of the opportunities correlates with the necessary commitment. 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. Henrik 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. 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 RD's perspective of our portfolio. Lydia?

Thank you, Guido. 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. Astabelli in C3G and primary ICMPGN 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. Gamifund moved forward in HLH mass with filings in both Japan and Europe. We also got positive top-line data for gamifan in interferon gamma-driven sepsis that enabled us to move forward with the program. And the Tringolza Pivotal data from the CORE and CORE2 studies in severe hypertrophic uridemia was also published in the New England. We started building our R&D hub in Japan in 2022, and the submissions of Aspaveli and gamifan 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 SOVI, together with our partners, are at the forefront of science, driving a strong clinically meaningful data. Let's now have a deeper look at Astavelli in nephrology, Gamifan in IDS, and Tringolza in severe hypertriglyceridemia. Next slide, please. The global launch of Astavelli methodology is now taking place. In 2025 and January this year, it was approved for both C3G and primary ICMPGN 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 these on body device to simplify the infusion will take place in parallel with the launch of the nephrology indications. The phase three Valium data published in the New England, together with the recently updated one-year follow-up, is very encouraging. We plan to publish further long-term data from our phase three extension trial, and we're setting up a phase four clinical program to create further evidence on the use of pexetacuplant in real clinical practice. Next slide, please. Turning to gamifan in interferon gamma-driven sepsis, this could address a significant 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 the 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 U.S. alone. The Hellenic Institute for the Study of Sepsis, or HISS, identify an endotype of sepsis which is characterized by elevated CXL9 an interferon gamma, and an increased risk for 28-day mortality. We investigated this subset of sepsis patients in a research collaboration with Heath in a study called EMBRACE. The EMBRACE exploratory phase IIa study has now shown an improvement in organ dysfunction and patient survival with hemopalumab treatment. This top-line data supports the proof of concept and allow us to advance the development of gamifan 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 ECCAM conference in Brussels next March, and you will hear about this exact new indication at our Capital Market Day on February 18th. Next slide, please. Another example of our scientific advancements is Tringulsa in severe hypertriglyceridemia. In November, the New England published the CORE and CORE2 studies, the pivotal data of olivarsin 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 CORE2 evaluated oligosarcin 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 of 12 months. The primary purpose for hypertriglycerides 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 core 2 data demonstrated that olisarcin reduced the rate of acute pancreatitis by 85% in patients with severe hypertriglyceridemia, meaning that olisarcin 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 herpetrythroceridemia with triglyceride levels above 880. Next slide, please. Looking ahead, we anticipate continued momentum with the major regulatory submissions in the US, 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 Tringolsa 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 ALTBOX Freedom Study, including important joint health data, the Japanese regulatory decisions for in the nephrology indications and gamifan in HLH mass. And we do expect EU CHMP opinion on gamifan late in the year or early in 2027. With that, I would like to hand over to Henrik. Next slide, please.

Henrik Henrik. 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. So, in Q4, our revenues of 7.8 billion correspond to revenue growth of 16% at constant currencies. Helitology increased by 25% at CER, driven by the strong launch of Alkabot and continued progress in Dobsonet across all three regions. In immunology, we saw strong double-digit growth in both Gamifant and Kynret, offset by lower RFD royalties. And in specialty care, we initiated the launch of Trigosa 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 FOTUS royalties and FX impacts. Operating expenses, excluding non-recurring items, and amortization for the quarter increased by 3% at CER, compared to Q4-24. SG&A, also excluding non-recurring items, and amortization increased by 6% at CER, driven by launch and pre-launch costs for Outerbox, Testa Valley, Inifrology, NASP, and Trinolsa. And this was partially offset by lower costs across Bongeo, top-select synergies, and in Okta, 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. And this was partially offset by development programs in Mongeau and Gallifant. And as a result, the adjusted EBITDA for the quarter amounted to $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 $3 billion, compared to $1.8 billion last year, driven by improved operations. And net debt at the end of the quarter was about $10 billion, and net debt to EBITDA ratio of 0.9 times, This does not reflect the expected acquisition of Arthrosy, which is planned to add about $9 billion of debt or less than one 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 28 billion in revenue, equal to growth of 15% at CER. And 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, Altegopt, Optelet and Gamifund were the main drivers, more than offsetting low revenue from RSV and Bonjo. In 2025, we saw 0.8 percentage points increase in gross margin driven by products and country mix. And 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 obvious growth of 4% at cost of 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. And in SG&A, OPEX increased by 8%, driven by launch of Altabox, but also pre-launch of Espavelli in nephrology and NASP, as well as higher activity for Gamifant. And 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 the next slide. And we come to the financial outlook for the full year 26. And 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 percentage at CER and an adjusted EBITDA margin in the mid-30s percentage of revenue. On the revenue guidance, we certainly expect continued progress with our existing commercial portfolio, where AltaVox 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. And we expect additional revenue benefit in the launches of Aspa Valley in nephrology and ASP, although mainly the second half of the year due to the NASP PDUFA date expected in late June, as well as the phased launch of Aspa Valley across European markets as we get reimbursement country by country. Bay Fortress, 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 Asper Valley and NASP, both visible in 2025, but set to accelerate in 2026. Second, with the strong data from the pivotal phase three trials in Trigolsa, in SHGG, 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 three studies and prepare for regulatory submission, adding those costs to our R&D line. And finally, we've included a continued development of Damifant in IDS. We're still in discussions with health authorities, but we have assumed, considering the positive signals from the phase two 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. And to conclude, it is of course critical that we adequately invest in these new areas in 2026 to position so before the future. And 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. Whilst 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 early call. Hence, we would like to share our thinking of this exciting, innovative portfolio and our mid-term outlook during a capital market day with you here in Stockholm and in a live webcast two weeks from now. We will be joined by clinical experts in areas such as gout, With this, we can now open the line and we are happy to answer your questions. Thank you.

We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 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 2. 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 1 at this time. The first question comes from Christopher Ude from SED. Please go ahead.

Hi there. Thank you very much for taking my questions. Christopher Ude from SED. So I guess first for Lydia, on GammaFendt, you 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, if you're feeling positive about it, 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 Altivac. Is there any stocking in hemophilia A in general across both products? And how does demand in France look like? Is it like Elacta and Hemlibra? Do you have any indications yet? Thank you.

So, hi, Crystal. This is Lydia. Your first question was on Gamifan in Europe, the submission on the HLH mass indication, if I'm correct. And then the second was on IDS. So for Gamifan in secondary HLH mass, obviously the data is based on the clinical trials, both Study 14 and Study 06, and you know that we got approval in the U.S. So we went through the review 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 IBS, we will be presenting the data, as I mentioned, at the ICICAM conference in Brussels, which is the intensive care conference is 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 market day. So Guido, I think the next one is on Altubox.

Yeah, and with regard to Altubox, you know, there has not been any material stocking in the extraordinary cause. And the good news is, even though France is launch uptake 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 not just, you know, an inverted comma. It's a tremendous German success, but it's carried. And, you know, the first signals of the French launch is very, very encouraging. Yeah. And you don't maybe just, you're running it off, you wouldn't file in Europe if you would not think that there's a promise. So, maybe we could move then to the next question.

Thank you. The next question comes from Gonzalo Arteac from Danske Bank. Please go ahead.

Hi, guys, and thank you for taking my questions. First one, 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 pixel expectations were too low, and now you're looking to a higher pixel 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 Tringolda? How many people do you have to add to the team for this lunch 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, obviously numerically, It just becomes more difficult because there seems to be a natural ceiling to grow at the same exponential rate. But we see continuous explosive growth, obviously, in the earlier launch countries. So we are not seeing a plateau on a total level whatsoever. And we don't see a plateau yet in the earlier launch countries. We just see that the growth is not as rapid because numerically it just becomes more difficult. And then with regard to Tringolsa, you know, right now, we obviously, you know, this is, we provide, we set up an organization in the light of the SCS launch and, you know, and preparing the communication. So this is, I mean, this is for the company we are, it's a significant team, but It's by no way still comparable to what 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. We have a very good sense, let's say, as we then get closer later. We are not setting out, but we will be competitively positioned. The other thing is Tringolsa is not a product that we will not be able to do. This we can see already because the main decision making is today in these lipid centers. We will have to build a more peripheral referral system in phase one. And at one stage, I think you have to assume that the treatment is more democratized. And then you're talking, obviously, broader teams. And how we solve this in that phase, we have to figure out. We know how to do it. I mean, we have sized it already very clearly. But it's not a skyrocketing calculation. But it is something we we want to look at at the right time. Next question, Maggie.

The next question comes from Eric Hulgaard from DNV Carnegie. Please go ahead.

Yes, hi. Thanks for taking my questions. I have two, if I may. First, on Aspa Valley, I was wondering how much, obviously, there's a huge opportunity commercial within rare kidney. But I was just wondering how much we should expect Aspirella 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 Gammifant, 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 mass. Thank you.

Thank you. Yeah, I mean, when you think about the rare kidney, I mean, we said that it will probably not, this product is not going to change the economics of SOBI at scale in 26. And I think it's just by the launch sequence, by the virtue of the launch sequence, 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 those areas from the community nephrologists to the key centers. This activation will take a bit of time. But nonetheless, we would expect to create in Europe a very significant number of patients that is ahead of what we have achieved year to date in PNH. So that gives you a feel so that we believe that this is an important indication. Now, many of these patients will not start on January 1. So that's the reason why the economic effect will be more moderated, but by no means are we holding back or believe that this is a small opportunity for SOBI? But, you know, it becomes a material then in the following year, 27. And with regard to GAMI Fund, you know, essentially it's today, it's probably more of 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 potential in secondary, we probably have less than 50%. And this is in MAS. And, you know, that would not include, obviously, utility of GAMIFAN in other areas. So, you know, we are by far not there exploiting the full potential of GAMIFAN, Eric.

All right. Thank you so much.

Thank you. Thank you so much, Eric.

The next question comes from Mattias Heggblom from Handelsbanken. Please go ahead.

Thank you so much. I have two questions, please. So personally on RSV, I'm curious to better understand what's embedded in the guidance on the survey you referenced. So royalty rate is going up in the year, I guess we should assume 27%. Dollars weakened, royalties are dollar denominated, I would presume. But then with regards to penetration, in the next ROC 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 2 billion OPEX increase in 2026. Is there any way you can help us understand what that, To what extent that captures your current plans? Thanks so much.

Maybe I start with the easy bit. To be honest, for us, by Fortis, we have a couple of pluses. 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 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 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 at least there's no restrictions of reimbursement. And there's also an unbroken preference here for Bifortis. Now, how does this play out? I mean, 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 Bifortis 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 defectors favoring a positive evolution of bifortis 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 also dependent. We are triangulating different data points. We are dependent obviously on Sanofi who is promoting this product. I'm sure they will enlighten us, but we are more cautiously optimistic. Henrik, you want to come on?

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 gross margin, which, you know, remained 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 the 2026 world. Othrose then is expected to be the largest among these new items. I can't really give you, be more precise there on a particular number for OPEX.

Thanks very much. Thank you, Mattias, for the question. Next question, please.

The next question comes from Harry Gillis from Burenberg. Please go ahead.

for taking the questions can i just follow up on the 2026 guidance um particularly on the margin can you quantify what impact the arthrosy acquisition is there either in percentage terms or an absolute opex spend in 26 just to try and figure out what the margin would have been x arthrosy and then a quick one on gamma fans 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 2b before pivotal. Thank you.

Henry?

I, you know, we don't want to give specific number of 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, Othrose is the largest among the new investments compared to 2025.

And on Gamifund, you know, we are encouraged, as Lydia pointed out, to think about the next step, and validates this further with EMA, which could well be a pivotal trial here. 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, but 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 on your comments around Bay Fortis. You said that you don't have exaggerated growth expectations. So can you take this to mean that you're kind of expecting a small amount of growth or more reasonable to assume that their Bay Fortes 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 mid-term? Should we be thinking about 26 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 would like some color given the launches that are being approached. And then lastly, on Zomjo, saw a slightly stronger quarter in Q4, and GSK have made some comments that are noticing some competition stepping up for their product, Ajara. 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, what I meant is, I mean, we don't typically provide guidance on individual products. I think, you know, there's, you know, I cannot provide more color. I mean, it's clearly not a growth driver, yeah, for Zuby. But it's also not, maybe, we don't expect a declining product either, yeah. And basically, With regard now to the mid-term outlook, I mean, that's the reason why we actually wanted to have a capital market day, to provide you a perspective how we see the evolution of SOVI towards 2030 at least, and how we see the long term. So basically, the segregation of our forecast into tomorrow, tomorrow, after tomorrow and reflecting on today. And with regard to Bonjo, I mean, we made some changes. We have a new leader of this business unit and he has clearly the right degree of tenacity and mental readiness to try to take this product on. I think it's important 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 guideline recommendation but you know you we believe that one is a gross product for us this year and that we are you know that the benefit from the volume growth that we had also last year but but you know A, the volume growth will be amplified, and B, we will not have this significant negative effect of cross-to-net adoption, which then led to price reductions. So we believe that WONDRA should be better performing for us this year. But the turnaround, the inflection, we don't expect this year. We expect that once we have reached equal status in terms of labor, And you will see whether or not we can be competitive in this area. Next question.

The next question comes from Victor Sandberg from Nordea. Please go ahead.

Yes, hi. Thanks for taking my questions. So, yes, curious here also on your guidance in terms of the growth numbers you provided. So, on Bay Fortress, it sounds like you estimate a stable market heading into 2026. So, in light of that, 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 Bay Fortress sales? And maybe related to that too, when you talk about margins it looks like hematology margins have steadily moved up 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 I started that maybe Henrik can talk about OPEX as well but you know

We are entering, I think for SOVI at least, and at least the last eight and a half years, I think we never had the foresight to launch six products. And some of these launches are ongoing, and six by 2028. And of these launches, products that have an unprecedented potential for the company that we are today. in terms of size. These products, I mean, 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. And this is what basically now happens to us in 2026, that we provide these resources to build SUBI for 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

I think you referenced also hematology profitability development and that is it's clearly up compared to a year ago but that's a very natural consequence of you know the the uptake in revenue from from out the box and also obviously products like like the obsolets and so When it comes to the split of 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 off ROSI, for example, we haven't yet closed that transaction. So, obviously, it cannot be a full quartering in Q1. You know, similarly with with IDS, for example. We're still in discussions with the regulators. So obviously this will ramp during the year.

Thanks. And just a quick one on Gamifent also. Just trying to understand maybe your view of the commercial opportunity for this product with expectations of this product being a hot topic among investors in Sobe. 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. 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 just look at the stats, you know, 2 million patients in Europe take away 20% of those with interferon gamma-driven sepsis, simple meth. 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 the irony is, you know, you may not even have to adjust on the price per unit because you need less units too much versus where we are today. So, you know, with the way we have price coming from. 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. And, but I knew we are excited, you know, to share with you the, let's say, the next set of data at the capital market day. And, and obviously looking for very much forward to March easy cam, like Lydia pointed out. But the opportunities is massive here. I mean, clearly, you know, beyond if it would come, and if the if the pivotal data would support the early signals we have seen, clearly a multi-billion dollar opportunity. Can't avoid it. But it's early days. So 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.

Thank you very much.

Thank you.

We now have a follow-up question from Mattias Hagblom from Andelbanken. Please go ahead.

Yeah, thanks so much for taking me, squeezing me in. Two quick follow-ups if I may. So first on sepsis, so with the CMD mid-February, it is really realistic to assume you received feedback from both EMA and FDA prior to the CMD to help you guide the path forward, or will insights from EMA be enough? And then secondly, with the conference, with full disclosure from the approval concentrate 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, Matthias. 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, 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. This one, I think we can safely say. because it's a small study, but we are very satisfied with the outcome. Otherwise, we would not have indicated what we have indicated. Lidia, what do you think in terms of feedback from EMA and FDA?

Maybe two comments on the regulatory side. we are moving fully 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 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 is like, top-line data of the 28 days, which was the primary endpoint at 28 days on the SOFA score on 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 during additional data on mortality, not on the primary and secondary inputs. 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 Market Day, and obviously there will be more discussions on the data at the conference in Brussels.

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 had these, I mean, you know, Looking really at unprecedented opportunities, as you can see for the company we are, and very much look forward to continuing the dialogue. I mean, please contact our AIR and we can provide separate insights. Other than this, we would be excited to welcome you in Stockholm on the 18th of February. Thank you so much and wish everybody a fantastic week.