Yes, so welcome everybody to Carnegie's Healthcare Seminar 2025. My name is Erik Hultgård. I'm part of the equity research team here at Carnegie. The first company to present at the seminar today is Sobi. So very pleased to be joined here by the team today, Henrik Stenqvist, CFO. We have Gerard Tobin from IR, and we also have Sofiane Fahmy from Heading of Europe for Sobi, responsible for very important launches, ALTUVOCT, and also preparations for Aspaveli in rare kidney. So a warm welcome, guys. Before we get into the Q&A, maybe you can take, Henrik, a few minutes to set the stage, introduce the company, maybe talk a bit about where you are on executing on your strategy and where you're going the next few years. Thank you, Erik, and good morning, everybody. This is a short introduction to Sobi, so we're a global biopharma company, and we're into the development and commercialization of rare disease therapies. Our business model consists of three pillars. It is sourcing, development, and commercialization. In sourcing, we have a successful track record in BD, building a portfolio of both pipeline assets and on-market assets. In development, we have a deep clinical stage pipeline in various rare diseases with a focus on hematology and immunology, and we have on-market 13 medicines that we are commercializing. 2024 was a very strong year for Sobi, both in terms of financial performance, but also pipeline progress that I will touch upon, but we also expect multiple catalysts occurring this year, 2025. Sales in 2024 was SEK 26 billion, corresponding to a growth of 19% at constant currencies. Head office here in Stockholm, as most people know, but we also have very important hubs in Basel, Switzerland, and Waltham, Massachusetts. We are blessed by a strong product portfolio that is supporting our growth strategy. We have foundation products, that is the foundation, about 50% of our revenues, consisting of older products, we should say, like Kineret, but also the hemophilia products, Elocta and Alprolix, and our specialty care franchise. On top of that, we have what we call the strategic growth portfolio, which are our products that we are launching. It's currently Aspaveli in PNH. It's ALTUVOCT, it's VONJO, it's Doptelet, Gamifant and Zynlonta. Soon to be supplementing the strategic growth portfolio are products from our near-term pipeline. That is Aspaveli in nephrology. It is NASP, formerly known as SEL-212 in chronic refractory gout, and Gamifant extending into secondary HLH. We also have very important royalty streams, both from hemophilia, but also RSV, Beyfortus from Sanofi. These royalty streams play an important role for us, supporting our growth with maintained very strong margins. Some data about 2024, as I said, revenues of SEK 26 billion, 19% up at constant currencies, delivered with an adjusted EBITDA margin of 36%. Very strong growth in our strategic portfolio, 87%, including the royalties, strong growth rates for all our products. On top of that, some very important milestone achievements from our pipeline, where we have Gamifant, the submission for secondary HLH in the U.S., where we got priority review granted, the initiation of the filing of NASP for chronic refractory gout in the U.S., and importantly, the submission of the nephrology indications of Aspaveli in Europe. For ALTUVOCT, which is the follow-on product of our product Elocta in hemophilia, we not only got that approved, we also managed to launch it in a couple of markets, not least very successfully in Germany and Switzerland. For VONJO, we got the IND clearance from the FDA for the first indication outside of myelofibrosis, that is VEXAS disease. The outlook and the guidance to the market for 2025 is high single-digit revenue growth at CER to be delivered with an Adjusted EBITDA margin in the mid-30s. Following the solid progress of the pipeline in 2024, we do expect more news flow in 2025, very importantly related to the FDA decision for Gamifant in secondary HLH, where the FDA has validated our submission and given us a PDUFA date at the end of June this year. Furthermore, we expect the regulatory decision for the nephrology indications of Aspaveli in H2, but also the submission in Japan, and last but not least, we expect to finalize the NASP submission in the U.S. in H1 already this year, so in terms of the outlook and some flavor to it for this year, key factors for our growth will, of course, be the continued launch progress of ALTUVOCT. We got off to a good start, but during the year, we will gradually add new markets throughout the year, mainly in Europe. We, of course, also depend on a continued momentum for the rest of the commercial portfolio. Important factors impacting our margin this year will, of course, be the major ongoing registrational activities that I mentioned related to Gamifant, ALTUVOCT, and NASP. We are very conscious of the opportunities that we see in nephrology for Aspaveli, but also NASP. We want to give those opportunities justice, and that will take launch preparation work. We obviously don't expect to see any revenues starting until 2026. This will have an impact on our margin. We are also into new studies, phase IV studies for ALTUVOCT, generating data for this important opportunity, and then also the two rare hematologic indications, VEXAS and CMML, for VONJO. Just a few words to sum up. We are in the rare disease space. We think that it's a very attractive market, and it's expected to grow faster than the general pharma market. We have a strong portfolio of medicines and also a solid pipeline for future growth. We are globally diversified. We are present in about 30 markets, but we sell through third parties in many more markets. And we have traditionally very strong financial performance. So thank you. That was the introduction. Thank you, Henrik. Thank you so much. There is an opportunity to ask questions. Just raise your arm, and there will be a microphone delivered. There is also an opportunity to ask questions online for those of you that listen digitally. Maybe we can start to talk a bit about some of the most important value drivers from a stock market perspective, at least. Since we have Sofiane Fahmy here, maybe we can start to talk a little bit about ALTUVOCT. Obviously, it has been a very successful rollout and one of the, I would say, from a stock market perspective, one of the biggest positive surprises in the second half of last year. Can you talk a bit about your experience from launching in Germany? Why has this product been so successful, and why are you gaining so much market share? Indeed. So good morning, ladies and gentlemen. My name is Sofiane Fahmy. I've been working for Sobi over the past 11 years. So happy to be here with you and answer your questions, particularly on the two main priorities for Europe, which are ALTUVOCT and Aspaveli in nephrology. So to your point, Erik, yes, I mean, we are super excited with the launch of ALTUVOCT in Germany. It has been a very successful launch with a strong uptake. And I think if you look to the trajectory of sales, it went beyond our expectation because we've been benchmarking with the most recently launched product like Hemlibra. Over a year, over the course of a year, they achieved 11% market share. And I think with ALTUVOCT, just to give like a comparison, over the eight month, we achieved 40% market share with ALTUVOCT only. And that's really how we appreciate the success because beyond this 40% market share ALTUVOCT, we've also been growing overall hemophilia franchise in Germany up to 54%. So that's also a contribution from Elocta. So that means we've been able to drive both products to grow. So growing ALTUVOCT while maintaining Elocta. And that comes with a very thoughtful strategy we have rolled out some months ago when it comes to the pre-launch because we've been very, very strong in positioning the product around, for those who are familiar with hemophilia, normalized hemostasis. So probably to make it simple, hemophilia A, patients suffer from a deficiency of factor VIII, which is a protein, and you need to infuse the factor VIII to get it to a certain level that protects the patient. All products before achieved 1%, 3%, 5%, but that's not enough. The innovation with ALTUVOCT is that it helps patients achieve in the normal range. So once receiving ALTUVOCT, the patient will become normal like you and me. And that's really a game changer. So I think how to anchor this in the value of the product and how to help patients and doctors understanding that we are shifting the paradigm. We're not treating with 1% and 5%. We're treating to the normal range. And that's for us the approach that has worked very well. And together with this, we have helped the doctors being part of clinical trials and hands-on clinical experiences with some studies, but also some early access programs where we have offered the product for doctors to use it before commercialization. And I think the combination of this has really strengthened the positioning and doctors understand the value of the product. So then comes the other part, which is important, is the access because here we've been also able to accelerate the access in Germany, but also in some other markets by a few months. And that's really important in the competitive landscape. And then we've been also able to educate patients to understand the value of the product. So that also comes with patient demand that we have prepared for the launch. So I think the combination of these three elements has made it really a strong uptake, as I said, beyond the standard that we've seen over the past years. How have you been able to accelerate the access in Germany, for example? Is that something that we could expect also in the other top five European markets? That's part of our strategy. Yeah, we've been just thinking out of the box, right? And we've been exploring regulatory pathways that are different from what we used to do in the past. So in Germany, we have decided to not go through the AMNOG system, but we went through a price reference system. And that's had provided us, as we had Elocta already marketed with a price that has offered us a very accelerated path to access and reimbursement. And then we have done also the same in other countries. Yeah, the second big five countries that launch is Spain in January. And then we've been able to accelerate the launch by almost 11 months. So if you take the normal path, it would have taken like 15 months before launch in Spain. We are happy to say that we have launched it in December and now we start to see also a nice uptake in Spain. How would you sort of compare the uptake that you've seen in Germany compared to the Sanofi launches in the U.S., for example? Is it better or is it similar? My feeling is that we have done much better. But as you know, we cannot disclose, and particularly I don't know the numbers from Sanofi because they don't share. So I cannot really provide a much more precise answer, but I think yes. We've been able to achieve in a few months what probably achieved over a few more months. So Germany is considered sort of a specific market in Europe. I assume that it's a bit more decentralized. You have smaller clinics. And also there has been a lot of plasma use in the past. So how is Germany sort of an outlier or should we expect a similar uptake and similar market share gains in the other top markets? I will start answering the first part of your question, and then I will provide some explanation on the second part because, yeah, when it comes to Germany, you should know that Germany is the largest market in Europe, so that's the biggest one. And the market archetype is different as is for other markets when it comes to competition and market share of competitors. If you take Hemlibra, Factor VIII ratio is different from one market to another one. In Germany, it happens that it's still like a majority of Factor VIII. And as you mentioned, in the eastern part, even plasma products. So that's the starting point we had. And as you may imagine, I mean, with ALTUVOCT, Factor VIII that reaches the normalizations, I mean, it was really easy to move very quickly all patients that are the majority that are treated with Factor VIII. So that's an easy and, let's say, the low-hanging fruit. And there are also some patients coming from non-factor therapies as well, but we believe that will take a little bit longer, and that's our next potential growth. So that's for Germany. It is decentralized, yes, because we do have many centers. And then we've been able to move really the biggest centers almost. I mean, more than 100% of centers now have used ALTUVOCT so far. Which of the European countries do you expect to be slower? I mean, given what you mentioned about the ratio of factor VIII versus Hemlibra, what will be sort of the uphill battle for you guys? Yeah, we don't aim to be slower. It is just like the market architect. We will make it slightly different. Why? Because if you consider countries like Italy or Spain, yeah, once you get the national reimbursement, you need to go through the regional reimbursement because each of the regions will act as a payer as well, where you will need to go through some formalities and administrative work, submissions, etc., and that takes time, so yeah, we consider that the time is needed is almost six months before we see the real uptake, so first six months will come like a little bit shy because that's all the administrative work that needs to be done, and then we hope to see at least the same as in Germany. So maybe we can talk a bit about where you're sort of getting those patients from. What proportion of patients are coming from Factor VIII products and what proportion in Germany are coming from Hemlibra, roughly? Yeah, in Germany is the only country where we do have, let's say, enough sales background to be able to look to this. As I said, it will come different in other countries. But in Germany, what we've seen so far is 50%, let's say 45% coming from Elocta and 55% from competition. So you see that the biggest part is coming from competition, though. And the majority within this competition is, as you mentioned, Erik, is plasma, is short half-life product, and extended half-life product. And we do have Hemlibra, but this is in the range of, let's say, 5% to 8%, but still quite a good signal. Are you being able to sort of convert patients on plasma products as well and short half-life products, or is it more easy to sort of put out the message around ALTUVOCT compared to the extended half-life product? That's where you see you get the bulk of the patients. I think, I mean, with ALTUVOCT, our objective is to normalize the patient, and that means all hemophilia A patients. We don't go after one specific segment or niche because we don't want and we don't need to niche the product. So for us, every single patient, we need to get normalized when it comes to this hemophilia A deficiency, and that applies for every single patient, including non-factor. It's just the time and the behavior of doctors that needs to change, but to your point, plasma, the plasma product is a factor VIII. The only difference is the price because sometimes the plasma are very, very cheap and even sometimes given for free. And this is where hospitals and doctors will need to make the trade-off and decide whether they would like to go with normalization, and that's the maximum benefit for patients, or whether they stick to economic aspect and perspectives. But that's the only limitation I would see. You mentioned early in your sort of remarks that Spain is launched in January. So what will be the launch sequence this year in Europe? Where will you have access and when? So for 20. What five markets? 2024, we launched in Germany, Switzerland, Ireland. In 2025, we will have many, many majority of other countries to come. In the first semester will be Spain, as I said. In January, there will be U.K. and some other. And then when? The U.K. will be. We got the MHRA approval two weeks ago and a NICE also recommendation when it comes to the price. We will need for NICE to have 90 days because there is a 90 days before it gets to formulary in hospitals, so we expect to have like the full launch starting from July, mid-year, and then the other countries will come like Italy and France late end of this year or early next year, so that will depend on the price negotiation. Great. Is there any questions in the audience regarding ALTUVOCT? Maybe as the final one on what should be our expectations for Elocta in three to five years' time? Will there be patients that continue to take that? Obviously some, but I mean, will it be a big product for Sobi in three years' time? I think, if we understand the value of ALTUVOCT, yeah, you want every single patient to move on ALTUVOCT, but there are some considerations that come out of the medical benefit, which is like an economic benefit. That's what could make it like Elocta a best product for some patients in some areas or in some situations where the cost is important. The same as for patients, we know that once they are used to one product and they like it, and if everything is fine, yeah, they are not willing to change. That's the situations where I would see Elocta remaining as a reasonable share. I would say probably around maybe 20%. That's the maximum that we can expect. Like 20. Hemophilia A franchise. All right. Fair enough. So maybe just a final one on hemophilia for Henrik, on the profitability of this business, given that you price it on a comparable level for the year, but still you use less because it stays in the blood for a longer time. Is there a gross margin benefit or I mean, will this be equally profitable in the long run or more profitable if you adjust for the royalties? Yeah, there isn't a huge difference here to be factored in. It's about the same. Similar. All right. Fair enough. Just a quick one. You were mentioning pharmacoeconomically that plasma is much cheaper. Is this possible to get an approximation on the percentage of times plasma is preferred to ALTUVOCT in Germany, for example, for pharmacoeconomic reason? This is very, very minor. And it is, as I said, in the eastern part and only a few centers that are used from the past history with plasma. And also because of the patients who are treated with this product are elderly and they don't want to change because if you remember from the hemophilia scandal, the contamination, those patients probably are contaminated and they don't want to change because they don't have any trust on any kind of product and they don't want to change for many of these reasons. So there is an economic part and also patients that are sticking to those products. But this is really when it comes to economics, this is really minor. I mean, it's less than probably 5% of the total market plasma in Germany. Thank you. So great. For the sake of time, maybe we should switch topics a bit and talk a bit about Aspaveli and rare kidney and what you're doing there in terms of launch preparations and when we could expect to see first sales in Germany. Yeah, no, actually this is the second priority for us in Europe, and we are also excited to bring this innovation to the market because here we are talking about patients C3G, IC-MPGN, and these R2D kidney diseases where there is no treatment. We can treat symptoms, but we don't treat the disease, and that's really important because it tells you how much unmet need there is out there, so patients are there, physicians are waiting for innovation, and I think we just need to connect the dots nicely to make them understand the value of the product and how our product is different from competition and what is the cost-effective value of this product for the patients, so we spend a lot of time after the data readout because for those of you who are familiar with this, you've seen our clinical data, which are really outstanding. We start to prepare the market. We start to understand the patient journey and try to identify patients, accounts, and customers and start to engage with KOLs. So that's all the pre-launch activities we started to go through. We are now building up capabilities in the countries. We're going to start to pre-launch the product to first the medical narrative and disseminating our data and start to engage with those centers and customers because we are new in nephrology. That's really where we spend a lot of our time here. So we have a clear understanding of the market, of the opportunity. Then we start to see through some market research, clear understanding and mapping out the centers, the accounts, where to go. And now we are training, building up our teams to go after the centers and meet and start to disseminate the data and explain the value of the product. We may have seen in the media that we have also submitted 4th of February to EMA. And then if everything goes well, you may expect that 12 months later, we can come with the approval, hopefully Q1 2026. And that's the time, well, for us the race will start because then we can go out first in the country like Germany. And we hope to have the same success that we've seen with ALTUVOCT. Obviously, there has been a debate, at least in the financial market, about the number of patients that would be addressable. And you guys have done a lot of work to sort of market research. So when you're now out in the centers, you're identifying physicians and patients more. Have you grown more or less confident in the 8,000 patients that you sort of the number you set out earlier? Absolutely. So far, so good. We stick to our 8,000 because we have done a great job identifying and understanding this. There have been many debates, but we are still confident with this 8,000 because the first approaches to the market research and also patient journey through these companies like IQVIA, etc., help us also clarifying and confirming our target of 8,000, so this 8,000 could change, right? Because this is a disease where everything will change in the future because we're going to bring in treatment, doctors we would like to treat, and they will have more patients to treat because many of those patients, C3G, IC-MPGN, are underdiagnosed. You say that this is actually a low-balling type of number, or is it? No, it comes with stretch ambition, to be honest, because some of those needs to be found, to be honest. We do have some low-hanging fruits, but I'm just thinking of if you start from the prevalence to the diagnosed, there is 50% of patients missing. That's why I'm saying that the work, once we have launched the product and we get access to those that are easy to access to because they are diagnosed, there are areas where we will need also to explore further how to increase the diagnosis. Transplanted patients is, I guess, one of the subpopulations where it's easier to sort of identify patients. Yeah, the. Share that view, or? Yeah, the transplant patients will come at the end of the treatment path because they've been treated and fortunately didn't work, so they went through dialysis, then transplant, right? So that's the one that are very easy because they're already there. And hopefully with our label, we have a broad label compared to competition because we have both two indications. We have C3G and IC-MPGN, and we have the broadest age group starting from 12 years old. And then we have native kidney and we have post-transplant patients. So we have almost all patients population. That's why this 8,000 is in our shop. Okay. So talking a bit, one of the topics talk about Sobi is obviously VONJO, and the big question is when will the growth accelerate and will it ever accelerate? So maybe I could ask that. Yeah, I'll try and I have the honor to take that one. Yeah, no, absolutely. I think it's fair to say that there won't be any major change in market dynamics from one quarter to the other. It's really about for our sake to continue the penetration with the on-label population, the severe cytopenic patients, and doing that through mobilizing the patient switches from the low-dose Jakafi. And then obviously also broadening the base here in the next category, the less severe patients between 50 and 100 through enhanced medical activities, but also through the gathering of real-world data that is happening. So that is kind of the short-term answer to the question. So continued growth, but sort of more linear. Yeah, no inflection points in the short term. You still believe that you can reach the sort of pre-acquisition type of consensus expectations of $500 million? Yeah, I mean, we for sure still have very strong confidence in the product, including, of course, also the new indications outside of myelofibrosis that we are now pursuing. So maybe finally touching on M&A, obviously it's part of your strategy, so I assume there will be more deals. I mean, given the launches, important launches that you have both in the U.S. and Europe this year and also going into next year, when do you feel, obviously you have a good balance sheet, but when do you feel that it's the right time? When do you need to make deals? Yeah, I mean, we haven't done a deal here for quite a while. And as a result of that, we are, of course, by now financially very ready with a leverage of 1.6. It's not very high for a company like us with a model. We also think that we are ready from an organizational perspective. But as you say, we have a lot on our plate. And in order to do something, we need a very strong conviction, and it needs to fit very well with our therapeutic areas and with our infrastructure so that we can capitalize from what we have. And it is part of the business model. We don't have any early R&D. We have a lot to do also in the pipeline, but going forward, there will be M&A. Would it make more sense to do like a late-stage pipeline deal so you're not disrupting the launches, but you still sort of have the potential for additional growth once Doptelet loses patent protection in 2028, for example? Yeah, we do that and we also take advantage of the assets we have, so not only buying new stuff, but actually developing the products we have into new indications, which we've done quite successfully. Great. So time is running quickly. But thank you so much, guys, for coming. Thank you, Sofiane and Henrik and Gerard. And thank you, everybody, for participating. Thank you. Thank you very much.