Good morning, everyone, and thank you for joining us today to the Sobi presentation. My name is Apolline Gilbert, and I will be moderating today's presentation. With that, I'm happy to leave the floor to Guido Oelkers, CEO of Sobi, that will then be joined by Gerard Tobin, Head of IR. Guido, over to you.
Yes, thank you so much, and welcome to this year's presentation. It's really a joy to be here. And just to set the scene, I would like to share some slides with you on where we are, and you know then to promote a little bit of the discussion. Forward-looking statement, as per usual. So you know maybe some key takeaways you know as we start kicking off 2026. I mean, we can't talk about the Q4. We'll announce our Q4 guidance on the 5th of February. But you know as you can see, you know we had a spectacular Q3 you know with very strong underlying growth and very gratifying that our strategic portfolio was growing at 39%, making it now over 60% of our total business. With regard to acquisition, as you probably have read, we acquired Arthrosi, and we'll talk a little bit more about this.
And this will allow us to strengthen our gout franchise. We think it was a fantastic opportunity that we should have not missed out on. With regard to pipeline, we'll talk a little bit more about it later. We had some nice readouts for most more recently, the readout in IDS, interferon gamma-driven sepsis, that I'm sure will spark maybe the one or the other question. And so we carry quite a lot of momentum now into 2026. So you will see that we are quite bullish about our future. So this is now, let's say, just a little flashback Q3. As you can see, the growth is carried by quite a number of products. And now the strategic growth portfolio, as I alluded to earlier, 64% of the total business. So these are all products that have not been around seven years ago.
With regard to the regional contribution, you can see it's quite evenly spread. We had a fantastic Q3 in North America, in Europe, but all regions, and obviously in international, are performing extremely well. Straight to Arthrosi, what did we see in this product? We are very happy that we were able to sign this agreement. We have not yet closed. Just be mindful of this. We think it's a really highly selective next-generation URAT1 inhibitor and has best-in-class potential. We think it's a product that fits beautifully to our program called NASP and will be in second line. There's a very strong scientific rationale. I mean, we alluded to when we did the announcement that we have spent nearly a year on this acquisition on and off before we then were able to conclude the deal. And we think it's addressing an underserved and growing population.
And it will become, in the years to come, very accretive. And it's a long patent life. So it will propel growth for us into the 2030s. So when you think about the treatment paradigm, as you can see here, quite illustrative, it sits beautifully in second line. And the product is a redesign of an earlier URAT1 inhibitor. And therefore, we believe it avoids some of the issues that were associated with those products. And we think that we could convince ourselves that it's a safe product with potentially high efficacy. And it beautifully helps us to provide an entire franchise. Just to remind you, we believe that we have PDUFA in June for NASP so we can offer an entire franchise and go fully behind this.
So when you think about us now moving into the next couple of years, it's quite gratifying for us that we have a swell of launches. The launch for Altuviiio ongoing. We still had in the second half of last year quite a few new countries coming on stream, such as the U.K., France, and in December, Italy. So this product will remain a growth driver for the company. We have the secondary HLH indication for Gamifant launch. We believe it's going to be very important for us as we move forward. We are launching now, as we speak, in C3G/IC-MPGN, February in Germany, and already launched in some of the Middle Eastern countries. We have mid-of-year NASP in the U..S in chronic refractory gout, third line, going after the Krystexxa opportunity.
And then in Q3, we have already launched Tryngolza, so I should say, in an indication that we know very well called FCS, because we have the preceding product with Waylivra, so very high triglyceride patients. And we are expecting the launch of MCS, meaning a product for patients above 880 mg /dL of triglycerides. We are thinking of launching in Q1 next year. And then obviously have pozdeutinurad in Q1 2028. So I guess you can see it's a nice, fully loaded launch schedule that gives us reasons to believe that we have a nice growth evolution of the company into the 2030s. And very happy that we have been able to accumulate such a late-stage pipeline. But this is one part. So these are six launches that you can look forward to. And then there is another part.
This is the priority development projects that we are also focusing on. Here, I just want to focus on one area, because we just had recently a phase II-A readout of Gamifant in interferon gamma-driven sepsis. Maybe go straight into the next slide. We believe that this could become a game changer for the company. Obviously, it's early days. When you just look at the stats, it's a very significant patient population, between 1.5 million-2 million in Europe or the US. 20% of those patients have what we believe the endotype IDS. This has been confirmed by a study, by a pre-study with 5,500 patients. You have mortality of around 40%-50%. Very significant, high unmet medical need.
We believe that the product here, by having an interferon gamma scavenger, we could potentially make a significant difference. Now, we have had a readout recently with the EMBRACE study, phase II-A study. This were 75 patients, three arms. What we found is that we saw a strong signal with regard to the change of daily organ failure assessment, daily sequential organ failure assessment, SOFA score. We had a secondary endpoint. We saw also a very strong signal on mortality. Now, this study was not powered, obviously, to show significance, I mean, 75 patients. But the signals were so strong that we felt compelled to make an announcement. As we speak, we are consulting with the agencies, given the high unmet medical need.
And once we have done this, we will obviously come back to the community and will make the announcements on the next steps. Now, for us, we will make an announcement in February 5. We will talk a little bit about the guidance also for this year. And on February 19, we will talk about, at the Capital Markets Day, or February 18, sorry, we will talk about how we see the evolution, how we see the economics of this playing out. But it's obvious that this is a very significant opportunity for the company, in particular in conjunction to the six launches that I just displayed. So basically, as we go now into the next phase, what are the milestones and the momentum that we want to carry into this year? I focus more on the 2026 side. We have the ongoing launch.
We are expecting a regulatory for C3G/IC-MPGN. We got an EU approval. We are expecting a Japan regulatory decision. And we are very happy to work here with our partner, Asahi, on this. Gamifant in HLH and MAS is ongoing. We expect also here a regulatory decision in Japan. And we will submit in Europe for a secondary HLH, and trying to make the product available as well. We have obviously completed IDS, the phase II-A study. We will have the follow-up data for the 120 days and will then announce soon. We expect the publication on the 28-day data and possibly also the 120-day data at ISICEM in March. And with regard to NASP, 27th of June is PDUFA date. And then we hope to launch the product swiftly thereafter.
Zynlonta, it's not a product that we typically talk a lot about, but we believe it's actually also an opportunity that we will not ignore. So we will get the second line, the LOTIS-5 trial data readout as ADC expects them in the first half this year. And obviously, we hope to close the transaction with Arthrosi in Q1 as well. So a lot to do and a lot to look forward to. And this gives us the reasons why we are going into this year with a lot of optimism. So pretty strong momentum. We did, I think, a very thoughtful acquisition. We preempted here before the phase III data. But we felt if we wanted to acquire this product and if this was meant to be ours, we had to do this ahead of the phase III data.
But we felt that we could take this risk because we reasoned it and we did quite a bit of work, as previously outlined on the science, to establish safety and also have a good understanding of efficacy. So, quite a few news coming through. And as I mentioned earlier, we feel that we have now enough to talk about to justify a Capital Markets Day on the 18th of February and to provide further orientation as we speak. I think this sets the scene. And maybe we can go into a Q&A session.
Thank you. Thank you very much, Guido. Will the audience have any questions to start with? Otherwise, I can kickstart with one, maybe.
Regarding Altuviiio, now that you have launched in 20 countries, do you have maybe an idea of how much the current growth is going to come from patients that are switching from Elocta versus entirely new patients?
Yeah. I mean, we alluded to this in Q3. The majority now of patients come from competition. And at the beginning, it was more like 50/50. Now we get probably more like 70/30 from other therapies. And I mean, it's just an evolution. At the beginning, the switch from Elocta is so much easier. But we are also getting now quite a few patients from non-factor therapy. And very pleased with the evolution. I mean, we are very we talked about this. We have over 60% market share now in the early launch countries. And we think that we in prophylaxis. And we think that the best is still to come.
Okay. Great.
Regarding the Arthrosi acquisition, you mentioned that it was more in terms of a timeline, but you felt that it was a good moment. Do you have maybe other strategic advantages that you saw to proceed to the acquisition ahead of the phase III?
Yeah. No, it's one of those things. Typically, mid-cap would not take a company of this size out ahead of phase III data. But we felt, in today's world, this is a pretty competitive environment. But we saw the opportunity. We felt if we wanted to have a chance to score this acquisition, we had to do this ahead of phase III data. Because if the phase III data turned out the way we believe that it could turn out, it would have been not our deal anymore. And it would have been a multiple of what we have paid at the time.
So, it was for us: are we committed to this indication? We have spent quite a few years now on chronic refractory gout with NASP. So we feel that we have some internal knowledge about the disease. We looked at the data as they are available and spent quite a bit of time with the company. We think it's a spectacular asset and can only congratulate the organization that is thrilled to what they have built up.
Okay. And regarding Tryngolza, you're in the middle of a launch prep ahead of the launch in 2027. Can you maybe touch on a bit on that?
Yeah. I mean, for us, it's a spectacular opportunity. We know FCS. This is around, depending on which source you take, 1,000-3,000 patients in Europe, which is a very specialized disease area. We are now in the midst of the launch already.
But I think it's a marketer's dream because you pre-launch in a way the bigger indication. And the centers, the lipid centers, are also the main audience. It's a center of the next indication. So for us, it's a beautiful way to introduce the product, to prepare the larger indication. This indication will take us a little bit out of our comfort zone. It's just to orientate everybody in Europe alone, that's a million patients. You need to have a bit of a liberal stretch whether this is rare. And so it's not really rare. But it's rare at core. And when we looked at how we can move this indication, we think that we can have a right to play here. And we can build up a team that we can support and we can fund. And we can go after.
And the data with 85% pancreatitis reduction is just spectacular. And over 70% triglyceride reduction in these patients at risk. And so we feel it's an opportunity we don't want to miss. We have a spectacular partnership with Ionis. And we will give this our best shot. We even create an internal organization for it. We call it an incubator because it is a different way to think about. And we are currently preparing the organization at scale to prepare this launch.
Okay. Amazing. Well, maybe one last question from me. And if nothing from the audience, maybe we can wrap up and give everyone a bit more time.
Yeah. Sure.
Could you maybe touch on quickly the Beyfortus development?
Yeah. I mean, there's obviously a lot of debate, public debate on RSV prevention. And you could get the impression that the world has changed a little bit.
But as I think eloquently was articulated yesterday by Sanofi, I mean, one thing has not changed. What has changed is actually that you avoid today 50,000 hospitalizations in the U.S. alone. That's not so bad. And particularly when you look at the baby intubated, particularly preterm babies, it's not really a spectacular image that you will have in mind. What has also not changed is actually when you look at the new guidelines, that actually they are still endorsing Beyfortus for preterm babies and other babies. So it has not changed. And reimbursement has not changed. And we performed a study, obviously, in Q3 that we presented and where we saw an unchanged commitment of physicians to the disease. And we didn't see any limitation of access for patients to the products. And reimbursement hasn't changed.
So the way we look at it is, while there has been a lot of discussion and debate, the actual facts, the fundamentals really have not changed. And so for us, we are quite happy to have this earning stream because we use it as a catalyst to build this, what we believe is a relatively ambitious program of transforming the company and investing into our future. So we are very happy to have it. And we are confident that in our books, this doesn't need to be an exuberant growth portfolio. We have as an insulation of risk, we have an increasing royalty rate until 2028 that was helping us to offset potential negative effects, whether that's competitive nature. But again, there's a very strong preference share for Beyfortus over other antibodies.
And then we think that the minimum, a base case, is that this is a stable earning stream for us in the years to come with a possibility to grow. But it doesn't need to grow because, as you have seen, we have lots of other opportunities that will propel the company into the future. So we are actually quite, whatever you call it, at least we are not feeling beaten up. Or we are positive about the announcements that were recently made.
Yeah. I just wanted to add, I mean, also when you look at it from a medical and local and state level, actually, what I've seen is the AAP is fully behind the full recommendations. All this, I read last night, 17 of the states are saying that they will keep the recommendations as is overall for vaccines.
So you do see, I mean, full support for RSV to the point that it was a category label change. But other than that, the actual fundamental indication itself has not changed.
Okay. Amazing. And yeah, as you mentioned, you have your CMD coming up. So I'm sure there will be a lot of surprises from you both then as well.
Yeah. No, I mean, we felt compelled, given the number of new products and new modalities, that we spend a little bit more time than usually available in different settings to talk about these products. And we'll provide some KOL perspective as well and how we want to think about it into the future and what is our ambition also for 2030.
Okay. Amazing. Are there any additional questions? No? Well, Guido, Gerard, thank you so much for your time. It was great having you. And all the best.
Yeah. Thank you so much.