Swedish Orphan Biovitrum AB

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Ladies and gentlemen, welcome to the SOBI Q1 2025 report conference call and live webcast. I'm Sandra, the chorus call operator. I would like to remind you that all participants have been listened only mode and the conference has been 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 Oelker, CEO. Please go ahead, sir.

Thank you, Sandra. Hello, everyone. This is Guido Oelker, CEO of Sobi. We are delighted to welcome you to the first quarter video conference of 2025 Call for Investors and Analysts. We posted this presentation to Sobi.com earlier today. And, you know, straight to the forward-looking statement, We would like to remind you of the usual provisions on the statement about expectations, projections of future events. Unlike stated otherwise, we will be making comments that most relate to the first quarter at constant exchange rate in million Swedish krona. Let's move to the agenda. Today we plan to cover the following key aspects of the Q1 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Bart-Franch, head of R&D and chief medical officer. We plan to review the presentation first and then have Q&A until around 4.30 Swedish time. For those on the phone, please join the queue for questions by pressing star one. we propose that you only ask one, maximum two questions at a time. Let's go to slide number four. I mean, as you have seen, you know, this has been a pretty strong quarter with solid performance that we started in 2025. You know, and the stats are as follows, you know, 3% total growth, but I will talk more a little bit about it, and an EBITDA margin of 36%. but the portfolio grew 23% if you exclude the RSV seasonal products and the discontinued refacto manufacturing revenues. This reflects a solid performance across the strategic portfolio that grew at 46% and is now close to 50% of our entire business. And the hematology was driven by continued growth of Doctelet, Asper Valley, and the launch of Altoworked that generated $455 million in the first quarter. We continue to build and deliver on our clinical development milestones and look forward to seeing the progress of our pipeline with the exciting potential for Gamifund, Asperveli and NASP. And, you know, when you go a little bit more deeper into the different business areas, you know, obviously we look forward to continue driving the AltaWork launch. We'll talk more about it. And, you know, when you think about, you know, immunology and also a little bit more later, I mean, Gummy Fund with over 30% in kindred have performed extremely well. So in terms of pipeline, I think, you know, our progress with filing gamifond for HLHMAS and still disease in the U.S. receiving a priority review with a PDUFA date late June was clearly a highlight and Asper Valley was submitted to EMA for the potential treatment of C3G and ICMPGN. And we'll continue the discussion with health authorities and look forward to bringing this product to the market pretty soon. So overall, it's a combination of strong business momentum whilst hitting important milestones in development and filing. Let's move to slide number five. And when we look into the performance in more detail, as you can see here by business area, very strong momentum in hematology, hemophilia here slightly reduced by the discontinuation of the manufacturing. But when you think about hemophilia A products growing at 29%, I think this speaks for itself. And immunology, let's say down, But if you take away the synergist sales that we have now consolidated de facto in Q1, due to the obviously incoming bifortas, basically immunology is growing over 20%. And this shows that there's robustness across board. When you think about the geographic split, Europe having obviously a fantastic quarter with 19%, And if you take away the synergies effect on North America growing at 24% and international at 38%, I mean, these are very strong numbers and speak for a very strong commercial execution. Let's move to the next slide, number six, focusing more a bit on the portfolio. And, you know, I'd just like to highlight, you know, the performance of Altevocht, the performance of Dr. Lid with 47%, the performance of Asper Valley with 39%, the performance of Kinneret with 16% and the performance of Gamivant with 31%. So, very strong quarter and we'll talk about the performance of Wonjo in a moment. So, let's move to the next slide and a more specific review by product. We are pleased with the continued strong growth of Altowagt and the rapid adoption in quite a few markets, but foremost in Germany. And there we have achieved a market share position of 57% after nine months within the launch phase. And this shows what is possible with this product. This is over 24% market share gained within the space of time. And we see very promising trends also in other markets. So we look forward to bringing this important medicine to more markets across Europe and other SOBI territories. Let's move to Asper Valley. And, you know, what we are facing with Asper Valley, obviously quite a bit of competition from new oral medicines. We continue seeing significant growth and you can see that we had a pretty strong Q1. And this is more primarily driven by progress in international markets. But I think, as we always said, the primary story for us is really about the nephrology indication that we are looking forward to. And we are very keen now, let's say, to bring this product to the market because the combination of very significant reduction in proteinuria, clearance of C3 staining, from the kidney in a high percentage of patients and the stabilization of EGFR at such an early point of time make us really excited and make us believe that this is an important product in those two indications. So we look forward to working with the regulatory authorities to move this forward in parallel and being, let's say, building an internal infrastructure and nephrology to prepare the launch, and this is what we are currently doing across the organization. Let's talk about Wanzhou. So the demand for Wanzhou grew quarter on quarter, even though you see here a minus six in Q1 versus previous year. However, these sales were pretty much impacted primarily by stocking and partially by gross-to-net adjustment, including Medicare Part D reform in the US. And this led to a decline of 6% in revenues, and we aim to resolve this in the coming quarters. Our ambition remains unchanged, and our near-term focus is to continue growing in myofibrosis, leverage the guidelines, the NCCN guidelines, and ultimately see growth outside of the restricted area of below 50,000 plate lengths that we have on label. So, and you know, the growth strategy is more explicit than on the next slide. So, as you can see, you know, our glass for Bonjour is clearly not even half full, and there's clearly a thirst for So looking at Juonjo overall, we still see significant potential to be unlocked in myofibrosis. But we realize also that leapfrogging in terms of performance will really take a change of guidelines and label expansion. And we are working on this. This year we'll launch in some of the additional smaller countries outside of the US, but ultimately we need the PACIFICA Phase III study for both full approval in the US and filing in Europe and Japan. The next step is also to broaden the use of WONJO. And we have started a Phase III study for WONJO assessing its potential in vexers. and it's an area with currently no approved treatments, and we have a strategy with CMML, and we believe that there's a very strong mechanistic rationale for Bonjo in this space, and there's also broad overlap of prescribers with myofibrosis. So let's move to Bifortis. As the headline describes, Bifortis now follows much more the seasonal sales pattern of vaccines. And, you know, as illustrated in the graph, the sales predominantly occur in Q3 and Q4. And, you know, this is new for us at Sobe because, you know, with Synergis, we obviously had also always a very strong Q1. But given that this product is only given once a season and not five times, obviously the sales pattern has changed. So important to note that our share of sales by Fortis goes from 25% in 2024 by a tiered rate starting this year until 28, reaching a range of 30 to 35% of net sales. Beyond 2028, the royalty rates will remain fixed at these levels. So we obviously are here very much dependent on the performance of Sanofi. But for us, we may be benefiting not only from the business growth, but also from a royalty improvement. So let's move to immunology and to Kineret and Gummy Fund. And as the headline suggests, our immunology revenues grew 22% in Q1 when you exclude the RSV revenues. So outside of RSV in immunology, both Kinrad and Gamifund have shown strong and sustained performance. Gamifund continues to exhibit significant growth despite high penetration in the primary HLH market. And we are looking very much forward to the launch of secondary HLH indication with a regulatory decision to be expected by the end of June. So far, we have seen no delays and the filing Spares all on track to meet the PDUFA date of June 27th, 27th of June. Let's move to the next slide. So when you think about us or Sobi moving into the future, I think it's nice to just think of a very simple formula. Two, three, four. Because when you think about us right now, we have two major launches ongoing. One of them displaying exuberant growth with Alturoct, as you have seen. One still, you know, we have some work cut out for it. But we have very important filings ongoing with Gamifund entering secondary HLH. With Aspavelli, let's say entering into, or we have filed for the really primary indication for us in nephrology, in the two nephrology indications. and NASP, which will be also a very material product to us, as we believe, in chronic refractory gout. And then we have four projects in development, and here we're taking a stand that we take our existing compounds into settings of high unmet medical need, into IDS, interferon-driven sepsis, into Wanzhou into Vexus, as we pointed out, Wanzhou into CMML, and taking AltaWorks into survival.