Teqnion AB (publ)

Ladies and gentlemen, welcome to the SOBE Q3 Report 2025 Conference Call and Live Webcast. My name is Sandra and I will be the operator for your call today. 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.

Yeah, thank you, and hello, everyone. I'm really delighted. We are all delighted to welcome you to the third quarter 2025 conference for investors and analysts. As usual, we posted the presentation beforehand. As far as the next slide is concerned, the disclaimer, we would like to remind you of the usual provisions on statement about expectations, projections of future events. And unless stated otherwise, we will be making comments that must relate to the third quarter at constant currency rate in Swedish krona. Today, we plan to cover the following key aspects of our Q3 report. I'm joined by Henrik Stenquist, our CFO, and Lydia Abarth-Franch, head of R&D and chief medical officer. We plan to review the presentations first and then open up for Q&A at around or until around 2 p.m. For those on the phone, please join the queue for questions by pressing star 1. we propose you ask one or two correction max at a time. So with this said, let's go straight to the presentation. As we want to cover quite a few topics today on the quarter, I would like to provide you with an overview before diving into the specifics. So first, We delivered an outstanding Q3 performance with 21% growth at constant currency. This was driven by a remarkable 39% growth of our strategic growth portfolio and a clear validation of our innovation-led strategy and commercial execution. Adjusted EBITDA with 47% on sales shows strong, obviously, business momentum, but also cost discipline. We took an impairment on one job, reflecting the deferred uptake. We'll explain later on how we drive growth moving forward. Material progress in our pipeline, let's say foremost, the scheduled PDUFA date of NASP in June 26, and the approval of Olezarsen in FCS, as well as the readout of two Phase III studies in severe levels of triglycerides. The momentum in so many different areas of our business have prompted us to increase guidance in terms of top and bottom line. Please turn to slide number five. Let's have a closer look at our Q3 performance. We delivered net sales of over 7.7 billion SEC in the third quarter, representing a 21% increase at constant currency rate compared to last year. This growth is driven by continued success of our strategic growth products, as earlier mentioned, which account now for 64% of total sales. Whilst nearly all products performed well, the fantastic performance of Dr. Landgame Fund and Alta Group should be noted. Regions have performed well, growth rate of 37% in the US, 21% in Europe, and 43% in international demonstrate that the engine of our company is very productive. Let us go through the specifics by product. Turning to Doctelet, our largest product and key contributor to our growth story. In Q3, Doctelet delivered 46% growth at constant currency, continuing its strong trajectory. as can be seen in the chart on the left, reflecting consistent demand and market expansion. This growth is underpinned by Dr. Lett's differentiated profile in ITP. Excellent efficacy and fewer dietary restrictions make it a compelling option for both physicians and patients. Dr. Lett has performed well in the U.S., but the growth has been carried by all regions, including international markets. Japan launched one month ago and already showing very promising signals. Please turn to slide number seven. In Q3, Bifortis delivered just over 1.16 billion sec in the early part of the season. RSV immunization rate for the 24-25 season stood at 57%, indicating significant headroom for further growth. In view of the debate regarding the use of prevention medicine, we commissioned an independent survey with over 100 physicians. The summary of the findings are as follows. Bifortus has been recognized as a competitive product with a high preference share of over 90% amongst HEPs. HEPs did not see restrictions or limitations in terms of access for patients and physicians. And thirdly, from the survey, we also saw that physicians expect no decline in RSV cases for the season, although the season does seem to be starting later, according to the latest CDC data. In summary, Bifortis appears to be well positioned as the season begins, supported by strong clinical fundamentals and high prescriber confidence. Our take is that there is a typical uncertainty around the start of the RSV season and stocking levels. This was something we also saw with Synergis. Sanofi, as a product owner, may provide additional color to the status during their report. Let's turn to page number eight. Altawork delivered 769 million SEC in sales, resulting in hemophilia A sales of 1.6 billion in the quarter, representing 31% year-on-year growth. On an annualized basis, we may exceed 6 billion of hemophilia A sales this year. The market dynamics, as we talked about throughout the year, are continuing with continuous switches from Elocta to other competitors, including non-factor products. which reinforce Altovox's competitive edge. Our launch strategy is progressing in three ways. We wanted to give some orientation that our current growth is primarily coming from early launch countries and obviously more to expect during this year and the years to come. We expect to launch in Italy and France during this year. And when you look to the left of the slide, You can see, let's say, an increase in Q1 on Elocta. This was primarily driven by tenders at the time, and this will normalize throughout the year. So, in summary, a very encouraging story with Altovox and the overall Hemophilia A franchise. Let's turn to slide number nine, Gummy Funds. which continues to deliver exceptional growth and strategic progress. In Q3, Gummy Fund generated $733 million in sales, sex sales, up 98% year-over-year. A key milestone this quarter was the U.S. launch of Gummy Fund for Macrophage Activation Syndrome in Stills Disease. This marks the first-ever approved treatment in both adult and pediatric patients with masks and it gives us confidence to grow in HALH overall. Looking ahead, we are advancing our Gummy Fund IDS program, targeting immune dysregulation in sepsis. The EMBRACE Phase II AE trial is actively recruiting with a primary endpoint expected by the end of 2025. We will provide a market update in our Q4 earnings. While still early, this product has obviously very material space and potential in this indication. In the U.S. alone, there are approximately around 2 million sepsis patients hospitalized annually, while nearly 1 million require ICU care. IDS represents around 20% of these patients, and these patients have a mortality of 40%, highlighting the significant unmet medical need and the potential impact that Gamifan could make in this space. Looking forward to updating you latest by the Q4 reporting. Please turn to slide number 10, one joke. OneJoy has demonstrated solid demand growth of 9% for the quarter versus previous year, but was down 11% due to growth of gross to net adjustments primarily related to 340B and Medicare redesign. The disadvantage with regard to a narrower labor versus competition, despite the overall strong body of evidence, has not allowed us to achieve our own ambitions yet. As a result, we have recorded an impairment charge of 6.6 billion SEC. Consequently, we focus on broadening our label NMF and internationalizing the product. Pacifica has been accelerated and will become the key cornerstone in this regard. Bidia will give you an overview later in this regard. In addition, the development of the VEXAS indication is making significant progress. The chart should illustrate and outline that we still expect Wonjo to become an important growth driver for Sowie, but later. Please turn to slide number 11. We have seen the positive margin in evolution in our press release, and Henrik will cover it in the financials in more detail. This was driven by relative OPEX reduction from 38% to 33% over sales, driving margin improvement to 47%. I just want to make a point that the efficiency program reported in Q2 helped us with the earnings this quarter, but more importantly, will give us headroom to support an important portfolio of launches and development projects in the years to come. Hence, this initiative was an important strategic move for the company's evolution. Please turn to slide number 12. We have shared quite a few insights on our portfolio at previous events. Just to emphasize, five key and planned launches and four priority clinical projects evidence a strong ambition and commitment for the group. Before closing my section, I want to shed light on the opportunity with regard to Trigulza or Olisarcin. Please turn to slide number 13. Just to give a quick perspective on the disease area, we have got an approval for Trigulza in Europe in FCS. an area that we are very familiar with, via the preceding product called VeLivra. In September, the data from the Core 1 and Core 2 study, both Phase 3 studies were announced, which included over 1,000 patients with SHTG, including MCS patients, and showed that 72% placebo-adjusted reduction in fasting triglycerides. Equally important, we observed an 85% reduction in acute pancreatitis events compared to placebo. These data suggest a major breakthrough for patients with MCS and severe hypertriglyceridemia, while occurrence of acute pancreatitis is a major medical issue. The full data will be presented at the podium on November 8th at the American Heart Association Conference. These results position Tringosa as a potential game changer in MCS treatment. Please turn to slide number 14. Let's now look at the commercial opportunity for Tringosa, which we believe is highly significant in the treatment of MCS. meaning with more than 880 milligram per deciliter triglycerides. We have performed two deep dives on the disease over the last couple of weeks. In Europe, the cutoff point for the treatment of this patient will be at higher triglycerides level, as mentioned before, for multiple hylomicronemia syndrome, or MCS, with a cutoff of 880 milligram per deciliter. In this indication, the number of patients in Europe 5, the leading five countries, are around 700,000 patients. The product will become very important for those poorly controlled with a high risk of acute pancreatitis, so meaning for a subgroup of those patients, round about one-third. Considering all these factors, the product will have a peak sales potential of over 5 billion SEG in EU5 alone. Please keep in mind that our territory extends to all Europe and most of the international markets, so a total patient population of 4 million, which obviously need to be then adjusted for the ability to purchase or the ability to get reimbursement. We will submit in EMA in 2026 for the MCS indication. But in totality, you can get, I think, a sense that this is a major opportunity for SOAP. I want to close my presentation by emphasizing that we had a very strong business performance in Q3, as you can see on the left. 21% growth, 47% adjusted EBITDA. We had significant pipeline progress. Given our momentum, we increased also our guidance for sales and EBITDA. On this note, I would like to hand over to Hendrik, who will lead you through the financials. Thank you.

Thank you, Guido, and hello, everyone. Please turn to slide 17. We will now take a look at some key financial metrics for the quarter. In Q3, our revenues of $7.8 billion correspond to a revenue growth of 21% at cost of currencies and 30% excluding seasonal base mortgages royalties. We saw double-digit growth across all three segments and in each region. From the product perspective, growth was created by out-of-box tops that I scanned. Thank you for that. If we look at the table on the right, and the adjusted gross margin of 80% in the quarter compared to 81% last year. We saw an improvement in margin from positive mix effect and the new Estabelli royalty agreement, but this was offset by lower May 40s royalties. Operating expenses for the quarter were flat to last year at CER, SG&A, excluding non-recurring items, and amortization increased by 3% at CER, driven by launch and pre-launch costs for Altebox, Asta Valley, Nephrology, and NASP. And this was partially offset by lower costs across Bongeo, Dobsonet, Synergis, and Deloxa, including the cost savings initiative we outlined earlier this year. R&D expenses declined by 6% at CER, excluding non-recurring items, mainly due to NASP programs that are now complete, as well as the cost savings initiative and Bonjoe and Gunnifeld. And as a result, the adjusted EBITDA for the quarter amounted to 3.7 billion, equal to a margin of 47%, compared to 43% for the same period last year. The Q3 net earnings number is a reported loss of 2.9 billion, and this is due to the impairment chart for Bonjoe of 6.6 billion. We remain confident that Bonjoe will be a long-term growth driver, but also acknowledge that all expectations from our original case have not materialized. The future growth opportunity comes from potential border label and international expansion. We also continue the development of Mongeau in potential new indications in CNNL and Vexus. And excluding the impairment and other one-off items, the adjusted EPS grew by 40% in Q3. Operating cash flow for the quarter was 1.8 billion compared to 1.2 billion last year driven by improved operations. And that gave a net bet at the end of the quarter of 12.2 billion, maintaining the net bet to ETA ratio from Q2 of 1.1 times. Please now turn to slide 18, and we will discuss the financial outlook for the full year 2025. And as usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. Over the whole year 25, we have upgraded the revenue guidance from high single-digit percentage to low double-digit percentage growth at CR. We've also upgraded our adjusted EBITDA margin guidance from in the mid-30s percentage of revenue to to mid to high 30s percentage of revenue. Through the first three quarters, we saw strong momentum across our portfolio with 15% growth at CER. We expect continued growth into Q4 across our commercial portfolio, primarily in Outerbox, Dopplet, and Gamifund. And this guidance also reflects adjusted expectations for Bonjo, reflecting the year-to-date performance. Our year-to-date adjusted EBITDA margin of 40% gives us confidence that we will be able to deliver a full year margin in the mid to high 30s. We will benefit in Q4 from expected continued revenue growth, but in addition, we see lower operating expenses than previously planned, mainly due to the realignment of SG&A and medical activities for NASP following the June 2026 PDUFA dates. as well as an accelerated impact from the restructuring activities that we announced in Q2, and this together with a disciplined cost control. Despite this OPEX development, OPEX are expected to increase in Q4, quarter over quarter. In SG&A, costs will ramp up in Q4 for our two key launches, NASP in uncontrolled gout in the US, and in Europe for Aspen Valley in nephrology. In R&D, we will continue to invest in our priority development projects at a slightly higher pace than in Q3. In addition, we'll be preparing for regulatory submission of Tringolsa, Olesarsen, and MCS. And with this, I now hand over to Lydia. Thank you.

Thank you, Henrik, and hello, everyone. We start with the pipeline milestones on the next slide, please. In the third quarter of this year, we have continued the progress across our portfolio, and I would like to highlight several key achievements. NASP for uncontrolled gout has reached an important regulatory milestone with the FDA's acceptance of our biologics license application. For Doctylet, we received FDA approval for an extension of the indication and launched a new sprinkle formulation designed specifically for pediatric patients with immune thrombocytopenia. Additionally, Dr. Lett's indication for ITP was approved by PMDA in Japan, further expanding its reach in international markets. And continuing in Japan, we have submitted our application to a PMDA for Kineret, seeking authorization to treat Stills disease. We're also pleased about the EMA approval of Tringolsa, for familial chylomicronymia syndrome. We will soon transfer the marketing authorization from our partner, Ionis, to SOVI. Finally, as Guido already discussed, Ionis reported positive top-line data for tringulosa in severe hypertriglyceridemia, which paves the way for expanding its indication. In addition to these milestones, we also see progress in other areas. Our studies for Bonjo in NFM vexes are accelerating, We will present new data from several assets at ACR this week, and our reputation with patient groups has received good marks. So in this slide, we will talk about Bonjo and the clinical program that is gaining speed. For the Pacifica study, our expansion efforts have accelerated recruitment even further, with the new countries and sites being successfully onboarded. Enrollment rate in the third quarter was 50% faster than in previous quarters. We remain on track to complete enrollment in 2026 and aim to get there earlier. With respect to the PAXIS proof-of-concept study, recruitment is already ahead of schedule thanks to strong interest from the VEXAS community. The full interim analysis group of 30 patients have been recruited in the first four months. And we anticipate the interim analysis for futility and safety in the first half of 2026. The research collaboration on CMML is also progressing with a planned first patient in this year. This means we will soon have new evidence on myelofibrosis, VEXs, and CMML. And this will help us to further improve Bonge's positioning in clinical practice and engage with regulatory authorities. Next slide, please. Bonjo Invexas, together with Gamifan in HLH Mass, will also be a topic at the ACR Congress this week, where we will have several oral and poster presentations. For our NASP program, we will have two oral presentations at ACR, demonstrating the robust efficacy of NASP on key parameters and clinical manifestations, such as serum uric acid levels, blood flours, and patient-reported outcomes. Today, I would like to highlight the long-term data for NASP, which will be one of our poster presentations. This is data from the 48-week extension to Dissolve-1, our pivotal trial to assess long-term efficacy and safety of NASP in uncontrolled gout. As discussed at our investor call in September, NASP demonstrated a rapid and sustained serum uric acid reduction through 24 weeks of treatment. Similarly, there was a reduction in gout flares, and about a third of patients had complete resolution of their TOFI. Participants of the DISSOLVE-1 trial continue on to the blinded extension portion of the study for another 24 weeks of treatment. On the left side, you see the long-term durability of NASP, consistently maintaining low serum uric acid levels. During the 48-week study period, serum uric acid levels consistently stayed at or below 2.4 mg per deciliter for NASP, whereas the placebo group maintained levels comparable to their baseline value. In addition, there was also a reduction in gout flares. All patients in the NASP high-dose arm were flare-free at the end of the study, while 23% of patients on placebo experienced flares. NAS was generally well tolerated with low discontinuation rates during the extension phase, and no new safety signals were observed. Overall, these results confirmed the durability of efficacy of NAS in uncontrolled gout. Alongside the oral presentation, poster sessions will also be featured, focusing on NAS and uncontrolled gout, including a new measure of caregiver burden. This focus on patients and caregivers brings me to the next slide, please. If you can move to the next slide, please. Thank you. I'm proud to share that the rare disease patient groups have rated SOVI the most reputable rare disease company out of 31. This was the first time we appear in the patient view survey. This survey shares the perspective of 518 rare disease patient groups from 58 countries. Together, they represent the voice of 2.4 million patients. The groups rated SOBI highly on having a patient-centered approach and collaboration on quality and safety, as well as access, information, and integrity. This is very encouraging. It reflects our long-standing commitment to patients and our systemic approach on working with them. Our Unite for Red program bundles our activities in this area. It was co-created with patient organization representatives and has four pillars. We aim to deeply connect with patient communities worldwide, including those that are typically undeserved. We also nurture our partnership with patient organizations in a sustainable and ethical way that helps them thrive. We collaborate with and involve patients in the development of our medicines. For example, in the design of our Soviet-sponsored clinical trials. And we innovate in the way we work, creating an environment that enables engagement with patients. We are honored by this feedback and inspired to become even better. Next slide, please. Looking ahead, we anticipate progress with the major regulatory submissions in the US, Europe, and Japan. We plan to end this year with the Aspavelli CHMP opinion for C3G and ICMPGN, the Japanese submission of Aspavelli in these nephrology indications, the submission of gamifan in HLH mass also in Japan, and the IDS pipeline data. As Guido said, we aim to give you an update with the Q4 figures. Next year, we will be ready to launch NASP in the U.S., Aspavelli in C3G and ICMPGN both in Europe and Japan, as well as gamifan in Japan. And finally, we plan to submit gamifan in HLH mass and tringulosa in multifactorial chylomicronymia syndrome to EMA. And with that, I would like to hand back to Guido. Thank you.

Yeah, thank you, Julia. So, you know, just summarizing maybe on the next slide, as you know, percent growth, reaching an EBITDA margin of 47 percent and over sales. As explained, this is driven by operating leverage, but also discipline in terms of cost and position as well for the future to support what is important to us. We had to rebase, obviously, Wonjo, but I hope we clarified that we believe that Wonjo remains a gross product. Obviously, we have to wait for the readout of Pacifica and then for a broader label and internationalization to come to a material inflection point. But overall, we believe that this is an important product for us and then we'll see what will come out of the new indications. We're progressing right now very well And, you know, here foremost, we would like to draw your attention to all of us and to NASP. So we're business, but so we have strong momentum. We have pipeline development. And, you know, and as a consequence, we also were able to increase our guidance. And we look forward to your questions as you may have some. Thank you so much. And maybe we'll now do the Q&A session.

Thank you, sir. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the telephone. You will hear a tone to confirm that you have entered a queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume of the webcast while asking a question. Anyone with a question may press star and one at this time. Our first question comes from Ben Jackson from Jefferies. Please go ahead.

Brilliant. Thank you for the question. Just two quick ones, if I may. Firstly, could you just talk about your assumption of Bay Fortis that is in the current guidance and the upgraded guidance that you gave for the year? Obviously, you're talking about physicians saying that they're still expecting to see the same number of RSV cases. Does that mean you're expecting this large to be a phasing thing with regards to this quarter? And then secondly, could you also just talk about the relative contribution of the realignment, the accelerated impact of the restructuring and also the cost control that you implemented with regards to the EBITDA margin, how it came out this year, just trying to get a sense of in 4Q, is that a reasonable exit rate to go into next year when thinking about costs and costs ramping up? Is that a fair assumption? And then if I could just squeeze a third one in, sorry, just to clarify, you said that you were going to update either on the market or update the market on the GammaFant study at 4Q. Could you just clarify whether you were going to update the market on the results or whether you were going to update what your thoughts are around how big the market could be at 4Q? Thank you.

Yeah, maybe I'll start with the easy one, and then Henrik will talk about, let's see, the financial part, and then Lydia maybe on what you can expect from us in Q4. You know, on Bay Fortress, I mean, we always see don't control the product, and what we try to allude to the fact is, you know, from what we can see based on this interview, nothing wrong with the product. The product has a high preference share, is... let's say there's no limitation of access, all the worries that for some time people had for patients as well as for physicians. Physicians feel that there's going to be more patients even though there has been a slow start of the season. And then it's a question of how much inventory is in the trade, which we cannot tell you. And then there's a question you know, how quickly the season is going to pick up. What we hear from the physicians is, you know, that they are confident that this season will pick up. That does not necessarily mean that the calendar year is showing what, you know, the equally good results like last year. So that is a question really for Sanofi. But, you know, what we can say is, you know, and he felt, you know, that's the reason why we have also performed this survey, because We are not in charge of the business, obviously, but we wanted to get a feel. Is there something we should take note of that should change our view of the product? Now, that doesn't help, obviously, with judging a calendar year. But, you know, what we found at least is that there's nothing wrong with the product. And then the question is, will that compensation, compensatory effect, happen in Q4 or next year. And this is really something you have to ask Sanofi. But at least what we can say is that the product is in a good shape. And maybe now to Henrik with regard to the financial question.

Yeah. So if I understood you well, you wanted an understanding on the relative importance of the realignment of NASP spend to the standard review time by the FDA and our restructuring activities. Is that right?

Yeah, that's right. Thank you.

Yes. And then the answer is that the realignment of NASP spend was the larger of the two.

Got it. Thank you.

The next question comes from Kirstie Ross-Stewart from BNC.

Sorry, there was what? Yes. So there was one question related to IAS.

Okay, then I reopen up the line of the first questioner. Okay, second number.

Yeah, so basically what we will have to share by Q4, it's the top-line data that we will be seeing. So the study is finalizing the recruitment. We will have the top-line data by the end of these years. So that's what we will be able to share, what it's – the data that we've seen and that will serve us to inform the next steps in terms of the development of GAMIFON in the IDS program.

And sorry, just to be clear, that's at 4Q results or within 4Q you expect that top line?

That would be at Q4 when we communicate the results.

Thank you. You're welcome. Good. Maybe we go to the next question.

The next question comes from Kirstie Roth-Stewart from BNP Paribas. Please go ahead.

Hello, and thanks for taking my questions. Maybe a first one just on capital allocation. In light of the launches that you've got coming next year and now pursuing the Olazarsen indication in MCF, Can you just provide an update on your appetite to do further M&A? I know that that was on the cards. I'm just wondering if your perspective on this is the same or has changed in light of the evidence you're making, in the investments you're making next year, or whether you've still got the capacity to continue to build out the portfolio further. And the second one on Bonjo, can you just confirm whether the Pacifica trial itself, do you believe, will give you the potential to gain the broader label authorisation? I noticed that the chart in Slide 10 indicates that you're kind of expecting still an inflection in Bon Jovi next year. And just want to understand and how to reconcile that with the trial inclusion criteria, which I think has the same platelet count as the current label. And then just a very, very quick one on Bay Fortis. Can you just remind us on how the tiered royalty is set? Is the lower sales that we may have seen this quarter lower? Could that result in a lower royalty rate for the year, or the step-ups from last year's 25% royalty set, regardless of the revenue? Thank you very much.

Yeah, let's start with the... Let's, you know, basically, maybe with Wonjo, you know, and let's say there, basically, what we see is that the inflection, you know, Pacifica, in conjunction... with the other evidence may be enough to give us a label extension, not on itself. It's a confirmatory trial, but if you are... But, you know, as we are right now, we got a conditional approval. Even with the additional evidence that we have generated, we cannot... We are a little bit stuck to get a label extension. Julia, you want to comment on this?

Yes. So... As you said, you know, Pacifica is a confirmatory trial with the platelet count that we already have in the label. But what we have already started some discussions with the FDA in terms of what could be the totality of the data that we could present, including existing data that we have already gathered from previous studies on patients with platelets above 50,000 plus real-world evidence and additional sources of data. So we are working on that, and that's what we would like to use as a basis for an expanded label. But obviously, the first step for everything is to complete the recruitment of Pacifica to get the confirmatory data, and then we can add the additional sources of data.

So with regard to BD, I mean, I think we see this more like this. We have obviously now a lot to do with polysacin, with the C3G ICMPGN launch, you know, which we will start early next, first quarter next year. We then have NASP in, you know, BLA expected in June next year. And then all of us submitted in Q1 and then probably becoming a launch then, early 27. So, you know, it's, you can, and, you know, you have the ongoing launches for Altuwacht and the GAMI fund. So quite a bundle. And so what we, what we are looking for is architecturing, obviously the company for long-term growth. And, and, you know, we can see that we will, you know, with these initiatives, we will soon have again, bandwidth definitely in the R&D organization for, additional projects in terms of pipeline. And we like to architecture growth, you know, that stretches then into the, you know, beyond the mid-30s. And this is what we are currently looking at when we look at opportunities. And obviously we have a broad ambition, which is to become a leader in rare disease. And there's still some room. But, you know, it's not size for the sake of size. We need to be sure that we can manage this. And, you know, as you have seen sometimes, in most cases we have got it right. No one cares. We have a deferred uptake and we need to take this. But mostly I think it was 21% growth. It's not so bad. And let's say so, you know, so we probably get more right than we get wrong. And then with regard to the Bifortis royalties, you know, One is time, and the other one is size. And there's a mechanism that potentially goes up to 35, but in the blended, it's probably, you know, the lower 30s. And so the royalty is going to increase for Belfortis. All right, let's move on to the next question.

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

Yes, hi, thanks for taking my questions. So first one on the gamifant, it's quite a pickup in sales here in Q3, and you referred to some impact from your extended approval into macrophage activation in Stills disease. So I was just wondering, was this a major driver here, or was it other factors? And just in general, how the initial uptake is for this indication. And then I also have a second one on gamifant, but I can start here.

Yeah, I mean, basically the uptake, you know, as you have seen, you know, the previous quarters were all very strong. So it's not just the launch. I mean, it is the value system, the way the organization is currently set up is very strong medical access. And obviously commercial team is paying here dividends. And then the new indication helped. But, you know, the company was, the team was on a fantastic trajectory beforehand and Just now, this 90% quarter-on-quarter growth clearly has benefited from the launch and the broadening of the indication. But, you know, as basically we are on track, you know, as we always said, you know, that we said, you know, with the new indication, we think that we have, we can double the opportunity. You know, we stand by this and all indications point into the right direction.

Okay, great. And also another one here on Gamifant. As you mentioned, we have the EMBRACE trial coming up. And I guess, you know, sepsis is still quite a heterogeneous patient population, even if you account for your biomarker selection with comorbidities, etc. So I just wanted to understand your thinking if results, you know, show trends, but not statistically significant benefits on the SOFA score, would you still jump into phase three? And do you see this trial as more of a chance of getting important data points for moving the program further. And maybe on the other hand, if the results are very robust, what's your thinking here of using accelerated approval in that case? I'm just trying to understand what outcomes that are on the table for this readout. Thank you.

Yeah, I mean, you know, we debated it and then Lydia will comment on this in a minute. I mean, we'll see, you know, the bar for other treatments is not incredibly high in terms of mortality reduction, you know, because it's a devastating disease. And, you know, many companies have, you know, for many products, it has been a bit of a graveyard. Now, we are more confident. Otherwise, we would have not endeavored this if there wasn't this pre-trial, you know, where, you know, we screened with Professor Giammarolo's 5,500 patients, understood the endotype, And as a consequence, you know, you narrow down the funnel quite considerably and believe that there's a mechanistic evidence of interphone gamma involved. You know, from my perspective, you know, we'll really have to see what is the mix of SOFA score improvement and whether we see any signals of on mortality. and then make sure, you know, that we do a sound decision. But, you know, Professor Jamarellos is the president of the Zepsys Association in Europe. He's a very, you know, well-known KOL who has a lot of experience, and we will discuss this with him and obviously other KOLs what the appropriate step is. I'm not sure that we have already the metrics in place. So, Lydia, you want to comment?

Sure, thanks. Basically, sepsis is a very complex disease, as you mentioned in your question. With this biomarker, we are really following this in vitro study and really targeting those patients where there is an increase in CXCL9. The study, as you mentioned, it's based on the primary endpoint. It's the SOFA score, and it's we will see some data on mortality. But obviously, as we know, these are very complex patient population. And I think we, knowing how complex the disease is and the treatment landscape, what we need to do is really not to jump ahead. So we will really look at the data step by step. In the meantime, there is an independent data safety monitoring board that has reviewed the data and has agreed that the study can continue with enrollment to finalize as we expected very soon. So I think it will be premature to say, oh, we have clear the path of if this is the target SOFA score improvement, this is how we are going to proceed. So we will be really discussing, A, with KOLs, as Guido mentioned, but also with regulators. And based on that, we will make the decision on the next steps. So I'm sorry to be a little bit vague, but due to the complexity of these disease, I think it would be premature to really adventure some more specific endpoints here.

Great. Thank you very much. Thank you. Any next question?

The next question comes from Henrietta Berg from Deutsche Bank. Please go ahead.

Hi, thank you for taking my questions. Just one on what extent can we extrapolate the 2025 margin performance exceeding expectations? And if you could talk about the margin outlook over the coming years, given the need to invest behind the gout and the C3G launches, that'd be helpful. And then I guess just to follow up on the sepsis data in Q4. So we'd have to wait till a follow up, maybe 2026 for the phase three details. Thank you.

Yeah. So let's start with margin expectations. I mean, what we have done is that we said mid to high 30s. And, you know, there is nothing more to say. I mean, you know, right now, I mean, we come up with the year-to-date performance. You have seen the margins are ahead. We have, on the other hand, we have two launches that we are now preparing, one in NASP in the new therapy area and one in nephrology in Europe. And this will require some investment. We haven't decided yet what to do, what to put in now. We know that we will definitely support the nephrology launch already this quarter now because it's basically under portals. But, you know, I don't think, Henrik, you want to comment on the margin?

No, I mean, that's right. And we also have, obviously, the preparations for Ole Sarsen in MCS. But also going into 2026, we expect, you know, continued strong momentum on the top line.

Yeah. I mean, you know, that's the reason it came a bit short. Obviously, the savings have made a significant difference. But, you know, for that... quarter, the expense line had a higher impact, but that doesn't mean that the savings that we have ring-fenced are not significant enough. They will help us, but business is increasing. We expect a good, strong momentum that will give us some room to grow. And then we have some ring-fenced savings. We will give you margin guidance and And, you know, with regard to the data now, that's Q4 earning report, then we will come latest with the Gummy Fund data. And if you can report something earlier, let's say we will report earlier. I mean, but, you know, I think, Livia, you want to comment?

Yeah, I think, again, it's back to the data. Obviously, if there is outstanding data, maybe regulators want us even to move faster, but without data, I think we need to be cautious and just wait so that then we will be happy to report as soon as we can.

Yep. Great. Thank you.

Thank you. Another question?

As a reminder, if you wish to register for a question, please press star followed by one. The next question comes from George Tyganoff-Birke from ABG. Please go ahead.

Hi, this is George from ABG. Thank you for taking my questions. I have two. So first, have you seen any price pressure for before this? And secondly, regarding the submission of Gamifam in HLH in the EU, To what degree, if any, are you awaiting a final decision here until you have more visibility in the path forward for interferon gamma-driven sepsis as a strong readout potentially could make sense then to await the submission HLH in order to maximize exclusivity period in interferon gamma-driven sepsis? Thank you.

Thank you. I mean, with the price pressure, you know, Sanofi, Canon, and will not discuss these things with us. We have not heard via our informal channels of this, but, you know, that doesn't mean, I would not exclude that there is, you really have to ask them, let's say, but, you know, we are not aware of it. And then with regard to HLH in Europe, I mean, you know, we have supported now over 100 patients in Europe, with primary and secondary HLH in Europe, we feel that it's, you know, that we owe it to the patients. And let's say that we get the product registered based on the data that we have generated that led to the approval in Europe. And, you know, you will hear from us, Lili, over the comment of this effort.

Yeah, sure. So, basically, and... The approval of gamifan in the U.S. is based on the study 06 and the study 14, where many of the patients, I would say most of the patients on the study 14 were coming from Europe. So there is a strong interest in Europe of having access to this treatment because obviously these patients are having a condition that is life-threatening. This is our commitment to patients, and we have now data that has led to an approval by the FDA and that's why we want to bring it to patients in Europe. We do have a managed access program, compassionate use program in Europe, and we have provided access to treatment because of our intention to bring it to the different markets in Europe. So I think it's really our responsibility as a company to bring the product as soon as we can, and obviously we are in conversations with EMA and with strong support from the community and that's our commitment to the HLH community, and that's what we want to do as a first step.

And with regard to IDS, let's look at the results, and then, you know, there will be, you know, if the product works well, for sure, you know, we will be in very close dialogue with regulators given the high unmet medical need in this area, then we'll update you, obviously. Next question.

So far, no further question. Back over to you for any closing remarks.

Yeah. Thank you so much for your interest. I mean, we had quite a lot of items today and very much appreciate that you stay tuned. You know, we are excited about this company. As you can see, you know, not only from today's perspective, but also from tomorrow and tomorrow, after tomorrow's perspective, looking at our pipeline. And we are here to build this business. And we feel that we have momentum. It's pointing into the right direction. We obviously have a bolus of new assets. But I think this is a happy problem to have. And let's say that we will figure out how to manage financial expectations that a lot of people have for us. On this note, I wish you a great week. And thanks for being so flexible and joining our earnings Thank you so much. Wish you a great day.

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