Ladies and gentlemen, welcome to the Sobi Q3 Results 2026 conference call and live webcast. I am Matilda, the call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being 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 is my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.
Yeah, thank you and hello everyone. This is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the third quarter 2026 conference call for investors and analysts. Our presentation was posted to sobi.com earlier today. With this having said, let us go straight to slide number two. Forward-looking statement as per usual, and unless stated otherwise, we will be making comments that mostly relate to the third quarter at constant currency rate and in million SEK. Please turn to slide number three. Today, we plan to cover the key aspects of our Q3 reports. I am joined by Henrik Stenqvist, our CFO, Lydia Abad-Franch, Head of R&D and Chief Medical Officer. We plan to review the presentation first and then have Q&A until around 4:00 P.M. CET. For those on the phone, please join the queue.
For questions, please by pressing star one and, please remember, ask only one, maximum two questions. Let us turn to slide number four to the content. We had very strong portfolio growth and that prompted us to increase guidance. Let me start with some key messages. We have been raising the revenue outlook and improving obviously the probability to achieve our ambition for 2030. Q3 was all about improving the company along three vectors. Overall performance and launch performance, pipeline, and international diversification. Regarding performance, please keep three numbers in mind. Q3 revenues grew 16% excluding the RSV effect and we will come to this later, we grew 26%. Year-to-date performance is 23% growth performance, and our adjusted EBITA in the quarter was 45%. The 16% includes the material impact of phasing of RSV royalties. Without RSV, we would have been able to grow 26%.
This number reflects the performance of our commercial engine consisting of our three regions. Kineret continues exponential growth trajectory and Aspaveli showing a material uplift, and has reached its full year 2026 patient target in nephrology patients by the end of Q3. Beyond the numbers, the quarter brought a series of important milestones that I would like to highlight. Regarding the pipeline, we should mention first the positive CHMP opinion for Tryngolza in the treatment of severe hypertriglyceridemia, and we expect to accelerate the launch by two months. Second, in Japan, we received the approval for Gamifant in HLH/MAS and for Aspaveli in C3G/IC-MPGN. These approvals will unlock material opportunities in one of the largest rare disease markets. Third, we completed the transaction with Pint Pharma. This creates an exciting launch platform in a dynamically growing environment of Latin America.
Concluding, we have made material progress across multiple dimensions and building further confidence to achieve our 2030 ambition. Let's turn to slide five. Total net sales in the quarter were SEK 9.1 billion, up from SEK 7.8 billion a year ago. The growth was delivered, as you can see across the portfolio, but also across all regions. The mix is also shifting into the right direction. Our strategic portfolio contributed 69% of sales. From a geographic perspective, growth was strong across all regions. Europe contributed 25%, North America 19%, and international markets grew by 58%. Taken together, this is a growth profile that is diversified, sustainable, and increasingly driven by high-value innovative medicines. Please turn to slide six. The slide also shows our timelines of launches and pipeline events. Three updates since last quarter. In gout, pozdeutinurad is progressing well. Filing remains on track for mid-2027.
For NASP, after the FDA issued a complete response letter, we are in the midst of the FDA meetings and agree on the filing files. I will not preempt that discussion today or the discussion we also had end of last week, and we will update you when we have more clarity. Gamifant. The preparation of the phase IIb, phase III pivotal trial for IDS is on the way and is now called EVEREST. Lydia will give a more comprehensive update on this pathbreaking development. lacutamab, the partnership is signed and with a potential U.S. accelerated approval filing planned for 2027. Let's look at the few products in more detail and turn to slide seven. Altuvoct continues to perform extremely strongly and is establishing itself as a best-in-class product in the prophylaxis of hemophilia A.
Sales grew to 125% at constant currency, and our total hemophilia A sales were SEK 2.345 billion, up 48%. We have now launched in 32 countries, including key European markets, and we are progressing through a structured three-wave launch strategy that we have outlined in previous meetings. The takeaway is that we still have significant room to grow in wave 2, and wave 3 is really still ahead of us. So we are not at the end of this launch. This performance reflects a strong clinical profile of Altuvoct and a very disciplined approach to execution of this fabulous launch. Aspaveli. Turning to Aspaveli, sales were SEK 417 million for the quarter, up 32%. We were very gratified that we have reached our 2026 target of 400-500 nephrology patients already by the end of Q3. One quarter ahead of the full year timeframe.
I am very proud of the team's execution. Reimbursement is available in several markets, including Germany, Spain, and Japan. Three further points. PNH performance remains stable. We continue the international roll- out of the enFuse device. We continue to demonstrate a strong clinical profile, and as demonstrated at the ESPN conference, where we presented additional 52-week adolescent data from the VALIANT and VALE studies. Let's turn to slide nine. Beyfortus obviously matters to Sobi through the royalties we receive, and those royalties are an important catalyst for the strategic evolution of the company. The U.S. RSV season, as every year, is now beginning, and the RSV activity is rising across many states. Although a competitor is now fully launched and on the market, this is not necessarily negative as it may help to boost the share of voice and improve immunization.
In order to provide more clarity on the situation, we performed a survey with, again, around 100 HCPs. The outcome is that 85% of the respondents said that the immunization rate is either stable or growing. 60% out of those 85% actually believe that it is increasing. There is a very high preference share amongst physicians, and they believe that over 90% will choose Beyfortus. 52% of the accounts are expecting to place additional orders, while 48% believe that they have sufficient stock. What it means is that we cannot detect at least any issue with the product as such. If anything, there is a phasing primarily related to inventory levels. But the season is obviously starting, and we need to remain vigilant and seeing how it plays out. Let us turn to slide number 10. Briefly, with regard to Doptelet and Gamifant.
These two brands continue growing at a very gratifying rate. Doptelet grew in Q3 at 29% to SEK 1.8 billion. Growth was strongly and sustained across all three of our major regions. We are also continuing to expand our international launches over time, and we expect these to significantly increase the ex-U.S. contribution. For Gamifant, sales were SEK 834 million, up 12%. Strong patient demand continues to drive growth. International markets are supporting growth following the FDA label. As mentioned earlier, Gamifant is now approved in Japan for HLH and MAS. The EU filing is under review and providing additional further growth opportunity. Just to note, the product has been growing for the year 28% year-to-date performance. Together, these two brands show the breadth of our portfolio.
One is growing across regions and still expanding internationally, the other addressing a high need population and is moving into new geographies. Let us turn to slide number 11. As a pillar of our strategic international expansion, let us say, is the progress now that we have made in Latin America and Japan. Let us start with Latin America. We have now been able to complete the transaction with Pint Pharma and assumed full ownership, and using now this really dynamically growing region as a launch platform for our product. The transaction was completed on the 2nd of October and is 100% in line as previously outlined. In Japan, we are making great progress with three approvals in 2026 that expand our international reach with Kineret, Aspaveli, and Gamifant, building on a successful launch performance with Doptelet in 2025.
On the development side, the Doptelet phase II, phase III study in aplastic anemia is enrolling and had its first patient in September 2026. This study is focusing on Asia, where the incidence of this disease is significantly higher than other parts of the world. Taken together, this shows that we are building a next layer of growth, and we add new geographies through ownership and local presence, new indications throughout approvals, and new opportunities through clinical development. Sobi and Innate Pharma partnership, as mentioned earlier, lacutamab is an investigational antibody being studied in cutaneous T-cell lymphoma. In Sézary syndrome, lacutamab has already received strong regulatory support with PRIME designation from the EMA and a fast track designation in breakthrough therapy designation from FDA.
Phase II data are already available, and the partnership allows Innate Pharma to start a phase III program and file for accelerated approval in the U.S. for its first indication, Sézary syndrome. Sobi receives global commercial rights upon potential accelerated approval, and we are eligible for full global development rights following positive phase III results. The potential indication expansion in mycosis fungoides could create a very meaningful product for Sobi. In summary, this is an attractive addition to our portfolio of investigational programs in rare diseases, which has the potential to already start generating revenues in 2028. Let's go to guidance upgrade. We had obviously very strong performance this year. This brings me to the outlook. The strong year-to-date performance with overall revenue growth of 23% across the portfolio prompted us to increase guidance.
The revenue upgrade reflects the performance of a large portfolio of growth products such as Altuvoct, Aspaveli, Doptelet, Gamifant, Kineret, and other strategic brands, together with a strong growth trajectory across all three regions. We have kept the adjusted EBITA margin unchanged mid to high 30s, and we want to invest into our launches and key studies. Henrik will discuss further this topic and we will continue investment, as mentioned, into our future, because we believe that we owe it to the company and to patients to build the company up for scale. With this having said, I would like now to hand over to Lydia.
Thanks Guido, and hello, everyone. I will start with the pipeline milestones on the next slide, please. We continue to make good progress during the third quarter. For Gamifant, we received PMDA approval in Japan for HLH macrophage activation syndrome in Still's disease, which adds to our growing presence there. We also presented new HLH data at the Histiocyte Society meeting and made progress in our malignancy-associated HLH and sepsis programs, which I will detail later. The second approval in Japan was for Empaveli/ Aspaveli in C3G, IC-MPGN. We also enrolled the first patient in our global phase IV PRISM-C3 study in these nephrology indications. For Altuvoct, the phase IV ALTITUDE study in hemophilia completed enrollment. FDA granted Fast Track designation to Vonjo in VEXAS syndrome, a serious autoinflammatory disease with high unmet medical need.
We will see the top-line results of the PAXIS phase IIa study next year. For Doptelet, the first participant was enrolled in the Asia-Pacific aplastic anemia study. We are conducting this study in Japan, South Korea, and Taiwan, as the incidence of refractory aplastic anemia in Asia is three to four times higher than in Western populations. Finally, Tryngolza received positive CHMP opinion in severe hypertriglyceridemia earlier than expected. We also presented the interim 53-week data from the CORE and CORE2 studies at EASL, which I will cover in more details shortly. Turning to Gamifant on the next slide, please. We are preparing two new phase III label-enabling programs for Gamifant. Both are in diseases driven by interferon gamma, which Gamifant blocks, and neither disease has an approved targeted treatment today. Our biggest near-term opportunity is in malignancy-associated HLH.
It's a form of secondary HLH where the disease is triggered by underlying cancer and not by a genetic defect or an autoimmune disease such as Still's. Currently, around 1,500 patients in the U.S. develop it each year, and the number is growing. That's as many as primary HLH and HLH/MAS combined, the two forms of HLH for which Gamifant is currently approved. Our pivotal phase III study, SAPPHIRE, will include around 80 patients with malignant HLH, and we will compare their results with around 160 matched patients in OPAL, our external control study. The primary endpoint is survival at day 60. In the SAPPHIRE study, we will also explore Gamifant in other forms of secondary HLH and in hyperinflammatory complications of CAR T therapy. We plan to recruit the first patient in Q1 2027, with top-line data in 2028, a potential FDA submission in 2029.
Real-world evidence from patients with HLH in the U.S. has shown significant improvement in 60-day overall survival for patients treated with Gamifant. In the historical cohort without emapalumab, overall survival was 38%, versus 75% overall survival in the emapalumab group, with patients being dosed by their CXCL9 level. Moving into sepsis, Gamifant targets a subgroup of patients whose disease is driven by interferon gamma. Today, these patients only receive supportive care. We're expanding our phase IIb/III EVEREST study to sites outside Europe, with the first participant anticipated in mid-2027. We will discuss the program with the FDA in the first quarter of next year. A phase IIb analysis in 2028 will shape the phase III part of the study. Together, these two studies could bring Gamifant to many more patients with interferon gamma-driven diseases. Next slide, please.
Tryngolza received CHMP opinion for treatment of severe hypertriglyceridemia, or sHTG, and we are looking forward to the EC approval later this year. Severe hypertriglyceridemia is characterized by triglyceride levels above 880 mg per deciliter. In September, we also presented interim one-year results from the CORE open label extension study, confirming long-term efficacy and safety of olezarsen in sHTG. In the graph, you see the design of the CORE and CORE2 studies with three arms during the first year, followed by the two-year extension with only one open label arm. In the extension study, all patients were receiving olezarsen 80 mg. Data shows profound and sustained TG reductions. After 53 weeks of open label treatment, 90% of patients reached TG levels below 500, and 58% below 150, which is in the normal range.
There was also a rapid response for patients switching from placebo to olezarsen 80 mg, who quickly reached the same level of TG reduction as those treated with olezarsen from the start of the study. The effect then held steady through the end of follow-up. Regarding the fatty fraction, this interim data showed only a modest increase of less than 2% over two years of treatment. You can see from the figure that also patients in the 80-mg group who had an initial increase returned to these low levels afterwards, confirming the transitory nature of these observed effects. Olezarsen was generally well-tolerated with no safety findings. Treatment compliance was 98% at a median of 10 months. Together with the positive CHMP opinion, this data strengthens our confidence in Tryngolza as an important new therapeutic option for people living with severe hypertriglyceridemia. Next slide, please.
Looking ahead for the next 15 months, we are planning for a steady stream of pipeline milestones throughout all our therapeutic areas. In the fourth quarter of 2026, we expect two key events. The European regulatory decision for Tryngolza in severe hypertriglyceridemia above 880, following the recent positive CHMP opinion. In gout, the REDUCE top-line data for pozdeutinurad will be presented in the late-breaking abstract oral session at ACR on November 11th. Moving into 2027, we expect momentum to continue across the portfolio. Key anticipated milestones include for pozdeutinurad in progressive gout, data from REDUCE-1 and REDUCE-2, and the planned BLA submission to the FDA. The planned FDA resubmission for NASP in uncontrolled gout, the European regulatory decision for Gamifant in HLH/MAS in Still's disease, and for Vonjo, the PACIFICA phase III readout in myelofibrosis, and top-line data from the PAXIS phase II study in VEXAS syndrome.
The pipeline process we have sustained throughout 2026 shows how broad our portfolio has become, and that we keep delivering innovation for people living with rare and debilitating diseases. With that, I would like to hand over to Henrik. Thank you.
Thank you, Lydia. Hello, everyone. Please turn to slide 20. We will take a look at some key financial metrics for the quarter. In Q3, our revenues of SEK 9.1 billion correspond to revenue growth of 16% at constant currencies. As we heard, if we exclude Beyfortus royalties, growth was 26% at CER. Hematology increased by 29% at CER, and our combined hemophilia A portfolio increased by 48%. Altuvoct strong momentum continues as we roll- out this product across major markets. Doptelet also increased by 29% at CER, where we continue to see strong growth across all regions. Aspaveli increased by 32% at CER, reflecting new nephrology patients. In immunology, we saw double-digit growth in both Kineret and Gamifant, offset by lower royalties from Beyfortus.
Gamifant growth was driven by new patients treated for MAS and Still's disease in the U.S., and Kineret continues to see strong growth across regions. Royalties from Beyfortus came in 39% below prior year. As Sanofi indicated, there may be different phasing this year between Q3 and Q4, and that competition and immunization rates remain uncertain for the season. As before, we have limited visibility as we only receive royalties. Specialty care increased by 23% at CER, driven by new patients in Tryngolza on FCS and patient growth in other specialty care medicines. If we look at the table on the right and the adjusted gross margin of 79% in the quarter, the slight decrease compared to last year was mainly driven by lower share of Beyfortus royalty revenue. The operating expenses, excluding non-recurring items and amortization for the quarter, increased by 24% at CER compared to Q3 2025.
SG&A, also excluding non-recurring items and amortization, increased by 16% at CER, driven by launch and pre-launch costs for Aspaveli in nephrology and Tryngolza. These costs were partially offset by lower costs for Doptelet. R&D expenses increased by 41% at CER, excluding non-recurring items, mainly due to the addition of pozdeutinurad development programs. As a result, the adjusted EBITA for the quarter amounted to SEK 4.1 billion, equal to a margin of 45% compared to 47% for the same period last year. Operating cash flow for the quarter was SEK 1.9 billion, which is in line with the same period last year. Net debt at the end of the quarter was just below SEK 15 billion, a net debt to EBITA ratio of 1.1 times. Please now turn to slide 21 and the financial outlook for the full year 2026.
As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITA margin. For the full year 2026, we have raised the outlook for revenue. The outlook for the adjusted EBITA margin is unchanged. We anticipate revenue to grow at high teens to low 20s percentage at CER, and previously mid to high teens percentage, and we anticipate EBITA margin to be in the mid to high 30s percentage of revenue, which is unchanged. For some additional context related to revenue, we saw 23% growth at CER year to date through the end of Q3. In Q4, we expect momentum to continue with large impact products, Altuvoct, Doptelet, and Gamifant, for example, and we expect to benefit from the addition of the Pint Pharma business.
As I stated last quarter, and we saw in Q3, on a percentage basis, we are up against higher comps in H2, which will naturally bring down the revenue growth in Q4 compared to earlier in the year, even with strong performance. Beyfortus remains difficult for us to forecast, and particularly for an individual quarter, and we expect to learn more from Sanofi in their Q3. Related to adjusted EBITA margin guidance, our margin year to date is 40%. In Q4, we will see increased investments in operating expenses. In SG&A, we expect an acceleration of the investment in Aspaveli and Tryngolza. Aspaveli will continue its standard launch in Europe, and we will accelerate launch preparations for Tryngolza given the recent positive CHMP opinion for the treatment of sHTG in Europe. In R&D, we will advance the phase IIb study in IDS.
Finally, as usual, we continue to be diligent with cost containment in the rest of our business. With this, I now hand over to Guido. Thank you.
Sorry, I was a little bit muted here. Let me close the prepared remarks by connecting this quarter where Sobi is heading. In February, at our capital market, we set out an ambition of SEK 55 billion of revenues by 2030. How are we doing in Q3 in 2026? Let me frame it according to four points. Revenue grows up 23% year to date. This is clearly ahead of the needed CAGR of 15% to reach our ambition. Launches are progressing very well. Aspaveli showing an inflection in a number of markets, the approval of Aspaveli and Gamifant in Japan will further enhance our growth profile. Tryngolza is making good progress in a rather narrow FCS indication, and as outlined earlier, we have obtained a positive CHMP opinion in Europe, giving us the opportunity to launch two months ahead of our expectations. Third, pipeline pozdeutinurad.
You heard the outline from Lydia. Pozdeutinurad is progressing well with filing on track for mid-2027. The Gamifant EVEREST program in IDS is advancing towards startup, and look forward to the first readout already in 2028. The Innate partnership on lacutamab further expands our pipeline in heme-onc while thoughtfully managing our risk profile. Then reach, the completion obviously of Pint Pharma acquisition very much complements our global presence and creates a launch platform in a dynamically growing region. In summary, Q3 underpins our strong growth trajectory with a thoughtfully diversified business and a really exciting outlook. Material launches are ahead of us, and we are proud about our de-risked pipeline project that addresses very much areas of high unmet medical need. On this note, I would like to close the session and maybe open up for Q&A.
As earlier mentioned, please press star one, and if possible, keep it to one, maximum two questions. Back to the operator.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. Anyone who has a question may press star and one at this time. The first question comes from the line of Kirsty Ross-Stewart from BNP Paribas. Please go ahead.
Hi. Thank you for taking my questions. Kirsty Ross-Stewart from BNP Paribas. Maybe just one quick one on the margin first. With 40% margin year to date and Q4 tending to be a kind of higher margin quarter, it is quite hard to see how the bottom end of your margin guidance range is realistic. Could you maybe just bless the assumption that you are tracking to the top end of that guidance range and clarify in a little bit more detail what it is that held you back from upgrading the margin at the quarter? Then, sorry, just a very quick second one on Aspaveli.
I understand that not all of the patients being treated right now are paying patients, so just wondering if you could clarify how long it tends to take to transition people off early access programs and when we can expect patients to all be paying. Super. Thank you.
Yeah, maybe I will start with the easy part of the question here, but then refer to Henrik. Basically, with regard to Aspaveli, it depends obviously on reimbursement approval, so there is no general answer. We have two-thirds of those patients, roughly, as we outlined are commercial. The 1/3 will blend in during the course of next year. Obviously we will further expand, as you can imagine. So let us say the product is actually on a nice trajectory now. It takes a while. These rare disease launches, even though you prepare them well, take a while until you get familiarity with the audience. Then in this case, obviously, as we outlined earlier this year, it takes a while to get these patients through the vaccination programs.
Then in the German launch, which was the first launch, more important launch, it takes a while also to locate the patients because they are diagnosed in the center, but the vast majority is actually treated by community-based physicians. This creates a little bit, takes some time to locate them and build a referral network. So that is the reason why you see now more of an uptake and the belief that this will continue. With regard to margins, it is obvious that we are trending extremely well, but we have a significant investment program ahead of us into our launches and into our clinical trial as outlined. Henrik, you want to bring more color to it?
No, but that is of course the case, considering where we are coming now very close to the launch in sHTG. Obviously the continued efforts around Aspaveli. We expect significant acceleration in Q4. So that is the reason. Then on what prevented us from increasing the guidance. Well, Beyfortus is an uncertainty, of course, for us in Q4. Our own business we obviously understand very well and have a very good understanding of what we think about the quarter.
Yeah. But it is fair to say that we are working towards the higher end. But Beyfortus we can't influence. Maybe another question?
Thank you.
Yeah. Thank you.
The next question comes from the line of Christopher Uhde from SEB. Please go ahead.
Hi there. Hope you can hear me.
Yes.
Chris Uhde from SEB. Thanks for taking my questions. I just want to start by thanking you, Guido, for showing us over the years how a biopharma growth story can successfully be built exclusively through M&A. It's not that many examples of success there. My question is on international. I'm afraid it does have a couple parts. It has been a big driver. It's set to be a big driver, and it's been really consistently underappreciated going back to before your 2020 guidance for 2025. Help us understand what's going to happen there. The moving parts I see are obviously the Pint acquisition that you've highlighted, but also the potential perhaps you could talk about of the Asahi partnership, and also Korea. How much can they contribute to 2030?
Don't you need to start breaking out sales by region at the product level so the market can get a better grip on this to better price the shares? Short-term for Pint, do you expect stable revenue from their non-Sobi base from 2025 or growing or shrinking? Does it go into specialty care? Is there a significant seasonality in the portfolio, that sort of thing, that can help us model it? Thank you.
Yeah. Thank you. When you look at international portfolios, you look at these markets in more mature organizations, and granted, we started from a very humble beginning. I remember the days where this part of our portfolios was more to the tune of SEK 50 million. Obviously, it has come a long way. But the percentage that you would typically get out of this international region is significantly higher than what we get today. If you can afford a longer time horizon, forget about now 2030, because I think this is for my successor then to tell you how he thinks about it. But let's say you take a 10-year horizon. In a 10-year horizon, you would assume that this business is at least as large as our European business, if not larger, just by the dynamics and the market potential in this region.
Japan is obviously a very important factor in this regard. There were rare disease companies where, for instance, one of the examples was Shire, where Japan was the second largest market for them. I think that over time the Japanese market will grow into an area where it's beyond our largest European markets. You have to assume this just by the numbers and also for certain new products that favor price conditions. There's a strong dimension, of course. When you think about Pint, to be honest, we didn't buy it to administer it and sitting on the asset and like a hen on the eggs and not doing anything with this business. There will be some luggage as you always have to, as with every acquisition. But ultimately, this is a business that will grow for us.
If you have a more longitudinal perspective, very strong double-digit growth. So it will be a very strong, formidable growth pillar. Latin America is obviously characterized, as many of us have seen over the weekend with the Brazilian election, by more volatility. You need to be able to afford this. But the good news is if you have A, a more longitudinal perspective and B, if you look at it as a portfolio, it seems that it will balance it off. So I'm very excited, for instance, by the opportunity for Tryngolza in Mexico. I think it's a very material opportunity for the company, probably larger than some of the larger European markets for us. So I think this will be another pillar for us, and the diversification of this international division will give it strength.
It's fair to say that the current geopolitical environment is not conducive always. But there are always pockets that offset each other. Luckily, we are in an environment or in an industry. It's very hard to make trade-off decisions here with our products if you don't want to directly jeopardize health. So, in the pyramid of needs, we're at least not at the bottom. I think to what extent we will break out this further, I think next year will be a very important growth year again for international for obvious reasons. I think then the new management will have to make a decision in what way they should more break it out according to regions as some of the other global companies do. At this stage, probably it's a bit premature, but I hope that the international business will grow into this size. Yeah.
Thank you.
You're welcome.
We now have a question from the line of Kapoor from H.C. Wainwright. Please go ahead.
Hi, this is Jan Siess sitting in for Mitchell Kapoor. Thanks for taking my question. My question concerns Tryngolza. The positive CHMP opinion, how are you thinking about the initial reimbursed population for Tryngolza? Would it be based on your peer discussions so far? Do you expect access to extend to patients being treated to prevent a first pancreatitis episode or to be concentrated initially in those with a prior one? Thank you.
Thank you. We expect to get a label reimbursed or a reimbursement in line with the label, which would be above SEK 880, regardless of an event of pancreatitis or not.
The next question comes from the line.
Thanks a lot.
The next question comes from the line of Gonzalo Artiach from Danske Bank. Please go ahead.
Hello. Thank you for taking my question, Gonzalo Artiach from Danske Bank. One on Tryngolza to start. With the sHTG launch now expected in early 2027, most likely, how are preparations progressing and what level of interest are you seeing from physicians? How much work is still needed to identify eligible patients and establish referral pathways versus having a market that is already waiting for treatment? I am just trying to understand what would be reasonable to expect around the dynamics at launch. A second question on Kineret. It had a particularly strong quarter in Q3, which you attribute to increased demand across regions. Could you give us some color on how much reflects underlying patient demand versus standard timing or inventory movements? Is Q3 a reasonable base for quarterly sales going forward, or should we expect some level of normalization? Thank you so much.
Yeah. Thank you. I will start with Tryngolza. Tryngolza, the preparations are in full swing. We make an extraordinary effort, which is reflected in our earnings expectations for Q4 now to build a formidable team. We are already having the full team, for instance, in place in Germany, which really significantly increased our overall footprint. We are now in preparation to do so across all the markets that are launching sooner or where we believe that we need to perform a very strong pre-launch. For us, we think it is one of the biggest opportunity the company has. With regard to the number of patients, what we do, we have obviously performed various market research. We are in contact with these 700 lipid centers across Europe on a regular basis. In fact, probably by now in many cases definitely on a weekly basis, if not daily at times.
We think that we understand this area. We are obviously quite happy that we were able to launch the FCS indications in many markets. That gave us quite a bit of visibility here, and we have visibility already of eligible patients for the larger indication, grant we need to get reimbursement approval first as you need to do in Europe. There will be quite a few patients that will be put on treatment. There is quite a bit of pull for the product. As we had to do it in nephrology, also here we give the team a little bit of time to build these referral networks. Yes, this is probably a faster uptake launch given that there is no vaccination than you would have had maybe with us, but really in C3G.
It is a new scale for the company, but we are ready and we walk the talk here. We believe this need to go for it. The other one with Kineret, we do not see any extraordinary inventory movements. This is more the general interest in the product and an optimized commercial execution.
Thank you very much.
You are welcome.
We now have a question from the line of Mattias Häggblom from Nordea. Please go ahead.
Yeah. Thanks so much for taking my question. Firstly for Guido, it has been a blast covering Sobi during your tenure, so best wishes for your future challenges. Then two questions from me, please. Firstly on pozdeutinurad, the first phase III trial was reported by the company roughly two months after it was finalized. For REDUCE-1, it says on clinicaltrials.gov that the study has been completed in late August, which following the same logic would point to late October or early November. So you are guiding for top-line results first quarter 2027. So help me understand why it takes longer to compile the results from a U.S.-only study. Any clarity there would be appreciated. Then secondly on Gamifant and IDS, I appreciate the added color around plan meeting with FDA in Q1 2027. But why not earlier, given that you met with EMA already this spring?
Was it Sobi knew the agency would want to see certain data set including long-term safety from the phase Ib trial, or was there anything else that you can help me understand the timing of this? Thanks so much.
Thank you, Mattias, for the introduction. These are great questions for Lydia, so thanks for saving me today.
Thank you, Guido. Thanks Mattias. Maybe for IDS, as you know, we met with EMA and the Emergency Task Force, and we got very encouraging feedback. That was our first step. Before going to FDA, because as you know, EMBRACE was very, let's say, European and Greek focus. What we have done before going to FDA, and we have almost all the work done on the preparation, has been to have discussions with numerous KOLs from the U.S. because treatment patterns might differ from different countries and different centers. We wanted really to inform all our documentation in order to have the discussion with FDA based not only on the initial feedback from EMA, but also from KOLs from the U.S. Not driven by any safety data request of longer observation period or anything like that. That is when it comes to IDS.
We will keep you updated on the next calls. For the Kineret, as I said, and I think we have both mentioned it very, both Guido and myself, filing is expected mid next year. The only reason why we have moved a few months the REDUCE 1, compared to previous communication is due to keeping the data blinded until all the scans are completing on the secondary endpoint. We wanted to make sure that, yeah, there is no quality compromise on any end. As long as we keep the submission date, we are confident that everything will go well, and we will be presenting some of the data on REDUCE-2 that you have already mentioned as well at ACR in a couple of weeks, as I mentioned during the call. Thank you.
Thanks so much. Thank you.
Thank you.
The next question comes from the line of Georg Bjerke from ABG. Please go ahead.
Hi, this is Georg Tigalonov-Bjerke from ABG. Congrats on a strong quarter. I have two questions, please. Firstly, I am wondering if you would be able to provide a very rough split of how much of the Doptelet growth came from the U.S. versus ex-U.S. And secondly, if we keep increased investing in Q4, as you have mentioned several times, out of the equation, how much of isolated OpEx savings in Q3 should be extrapolated? Thank you.
Yeah. I just start with Doptelet. The U.S. growth in percentage term is more or less in line. It is a little bit less than the average growth that we have shown, but more or less in line, yeah. The growth engine is international, that is far ahead here, and that will be coming then the main growth driver for the future and where you have also longer patent life. With regard to the operating expense structure, maybe Henrik, you want to provide more color?
Yes, Georg, could you please repeat your question? I did not quite follow.
Okay. Yeah, sure. As you mentioned several times, you will invest heavily in Q4. If you just speed that out of the equation, I am wondering how much of isolate OpEx savings that you were able to make in Q3. I mean, very rough size here that potentially should be extrapolated. Just to understand different moving parts here going forward.
You mean how much of Q3 spend that was delayed into Q4 and will go into Q4?
Yeah, or also the Doptelet decrease cost you mentioned or other things that obviously there was a very big beat here versus expectations. So of course, just trying to understand here how much of that is just a simple delay from Q3 to Q4 and how much is other underlying actions that you have taken, and then to what extent those should be extrapolated. Yeah.
Q3 came in a little lower. Part of that is expenses that now will occur in Q4 instead.
We now have a question from the line of Benjamin Jackson from Jefferies. Please go ahead.
Thank you for the question. Just a couple from me. The first is following up on that operating expense question. I guess a different way to ask it would be if you knew that Tryngolza was getting a recommendation two months earlier.
In hindsight, would you have spent more in Q3 on the launch investments, or do you think what you spent anyway was representative of whether it was two months earlier or what you expected before? Secondly, just obviously a quick question on CEO search. What are the expectations in terms of profile? Is this internal or external? What can we anticipate in terms of timing? Then third, just a quick clarification. On the Beyfortus slide, you report preference amongst physicians who actually express a product preference. So what proportion of physicians in your survey were actually agnostic to either of the two available antibodies? Thank you.
Yeah. Let's start with Tryngolza. I think in hindsight, we were planning for success. It's a very large team that we, for instance, in the first launch country in Germany, we put up. Maybe we could have had a month or two earlier. We could have started earlier. But I think the timing, in terms of materiality for Q3, yeah, maybe it would have been a little bit more, but it would have not moved materially the needle. It's more now the consecutive expenses that come also with external spend, because the team is now in place. It has been in place end of September and has been trained by end of September. So, they are in the field. Yeah, you could have maybe started a month earlier or so. It could have bumped up. But, for me, difficult to quantify now.
Maybe Henrik can later come back to this. With regard to the CEO search, I am obviously not part of the search committee. But what I can tell you is, let us say that they are working very extensively. There is a strong field of interested parties, and there is an expectation, not a guarantee, to have a name to report back before the end of year. But ultimately, it needs two consenting parties. But that is what the teams are working towards, too. And in terms of profile, definitely somebody who can run a business and has experience in this, and has an affinity to further develop business and find new opportunities for the company. And ideally, somebody with experience also in rare disease. With regard to Beyfortus, so relatively straightforward. There is a 90% preference rate, that means 10% were indifferent.
Thank you.
You are welcome.
The next question comes from the line of Viktor Sundberg from Arctic Securities. Please go ahead.
Yeah. Hi. Thanks for taking my questions. I have two. Also on Doptelet, but maybe on a different angle. The patent expiry is coming up next year. Can you give us your view on how you see that playing out? What is your split, for example, with non-U.S. sales here that it is exposed? I also wonder if there are any exclusivities that could protect you in any way, pediatric ITP, for example. I will start with that one. Thanks.
Mm-hmm. Henrik, you want to give a comment on this? How you see this?
Sorry, the split U.S., non-U.S. for which product?
Doptelet.
For Doptelet. As we said before, it is a majority of sales in the U.S., but where growth is clearly stronger outside of the U.S. We will see where we stand as we lose exclusivity in July next year, because the U.S. share is likely to become smaller over time.
Yeah. Thanks.
I think, the Doptelet share outside is going to increase the one already by the time the expiry is happening. Then you will have an effect obviously on the U.S. business. It is very straightforward. You have at least more than half a year, and then you will have erosion. You can model it according to the different erosion curves applicable in this context.
Okay. Thanks. Just a quick one on Aspaveli. Great to see progress is so quick on C3G. Maybe if you can provide some more color just on the uptake here, physician feedback maybe on the preference there versus the oral alternative that you are seeing in this early launch phase. Thanks.
Thank you. The product is very well received. We have very strong also here preference share in these centers. That is very helpful when you have a more concentrated audience where the market is really driven by these centers. As you know, for instance, in Spain, where we also got now recently reimbursement and quite a few other markets like France, which is not yet on the stream. In Germany, though, it is helpful. There you have a very strong support in the center, but it needed some time, let us say, to connect, obviously, these reference center. But if our intel is correct, our launch trajectory now, for instance, in Germany, looks very competitive, if not superior to what an earlier launch in the same indication has achieved at the same point of time. We are actually quite pleased with this.
But it takes some time, now you can see the inflection. But the reception in the centers is good. You just need also to get the guys who are sitting on the patients right now wanting to support us then moving patients into the center. That needs some orchestration, that is what is now happening on an increasing rate. But this is the overall preference for pegcetacoplan, as evidenced by many surveys ahead of other alternative treatments in C3G, is very compelling. So are the data. The data speak for themselves, the community has accepted them.
Thank you very much.
You are welcome.
We have a follow-up question from the line of Christopher Uhde from SEB. Please go ahead.
Hi again. Thanks so much for taking my follow-ups. One on Gamifant and one on NASP, please. Malignant HLH, I guess they're both for Lydia. Malignant HLH, your earlier data in that indication was rather discouraging. What have you learned about how Gamifant works in this population that gives you confidence that you can now succeed there? Does it bear on any other indications? For NASP, the application, what can you tell us now that you've met with FDA about the CMC deficiencies in the last application, and what has FDA said about what you still need to do? The H2 2027 submission is a long wait that implies rather a lot was not satisfactory, I guess. It's important for us to understand what you're doing to ensure the processes that let it through be clearly addressed. Thank you.
Thank you. Yes, you're right. The previous study in malignant HLH, it was in a, let's say, very concentrated into a single center experience and with a very small number of patients. Now there is much more real-world evidence that it's really giving us the confidence on the effect of Gamifant for this subtype of HLH driven by malignancy, by cancer. On the NASP CRL, we are, as we've communicated before, in the middle of the interactions with FDA, and we are collecting the data that FDA requested in the CRL, mostly related to CMC. There were also some non-approvability issues that we will be discussing coming up very soon on hepatic impairment and on the PK profile, on the dosing. Those are ongoing conversations that we are moving ahead.
The only thing I can share is that we are continuing having the open conversation with FDA, and that we are following their advice in order to resubmit on time. No more specific details, but clearly progress in the right direction.
Okay.
Thank you very much. Best of wishes to you.
Yeah, thank you so much. Guys, this has been a spectacular journey. By the time I leave, which will be in January next year, it has been nearly 10 years, and I appreciate that you have spent time with us and with me. It has been a spectacular journey. I hope I made a difference for Sobi, but clearly Sobi made a huge difference for me, the way I think about life and clearly about patient orientation, that we brought this to another level. So I would like to thank you for staying tuned with us. This is a fabulous company, as you can see, strong performance, great pipeline ahead, and material pipeline that can shake, again, various segments in this market. The whole thing is only possible because we have a fantastic team. So one person leaves.
By the time I leave, we probably have 2,300, maybe 2,400 people. We seem to expand now a little bit more. Anyway, on this note, I wish you all the best, and we will probably stay in touch. We will see each other in one or the other format, but I will not be part of the next format, the next quarterly. Then you will get enthused by a new team. I think it is time that you get exposed to new ideas and new perspective on Sobi. For me, at least, I can say I hope I walk through the front door, and I am not going to get carried out of the office, hopefully. Anyway, on this note, I wish you all the best, and talk to you soon, guys. Yeah.
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