BIOVF (BIOVF) Q3 2026 Earnings Report, Transcript and Summary

The conference will begin shortly. Thank you. Ladies and gentlemen, welcome to the Sobi Q3 Results 2020 Conference Call and Live Webcast. I am Matilda, the Chorus 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. 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.

Yes. 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. And with this having said, let's go straight to Slide number 2. Forward looking statement as per usual. And unless stated otherwise, we will be making comments that must relate to the third quarter at constant exchange rates, and revenue in SEK 1 million. Please turn to Slide number 3. Today, we plan to cover the key aspects of our Q3 report I am joined by Henrik Stendquist, our CFO Lydia Abad-Franch, Head of R&D and Chief Medical Officer plan to review the presentation first. and then have a Q&A until around 4 p. M. CET. For those on the phone, please join the queue. For questions, please press star 1. And please remember, ask only 1, maximum 2 questions. Let's turn to Slide number 4. To the content. The we had very strong portfolio growth and that prompted us to increase guidance. So let me start with some key messages. We have been raising the revenue outlook and improving by improving now and improving, obviously, the probability to achieve our ambition for 2030. Q3 was all about improving the company along 3 vectors. Overall performance, and launch performance, pipeline, international diversification. Regarding performance, please keep 3 numbers in mind. Q3 revenues grew 16%, excluding the RSV effect, we will come to this later, we grew 26%. Year to date performance is 23%, Gross performance and our adjusted EBITDA for the quarter was 45%. The 16% includes a 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 3 regions. Altuvoct continues its exponential growth trajectory And as per valley, 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 2 months. Second, in Japan, we received the approval for Gamifant in HLH mass and for Aspaveli in C3G ICMPGN. These approvals will unlock material opportunities in 1 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 number 5. Total net sales in the quarter were SEK 9.1 billion up from DKK 7.8 billion a year ago. And the growth was delivered, as you can see, across all across the portfolio. But also across all regions. The mix is also 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%. Taking together, this is a growth profile that is diversified sustainable and increasingly driven by high value innovative medicines. Please turn to Slide number 6. The slide also shows our time lines of launches and pipeline events. 3 updates since last quarter. In gout, positinirate is progressing well. Filing remains on track for mid 27. For NASP, after the FDA issued a complete response letter, We are in the midst of the meetings and agree on the filing price. I will not preempt that discussion today or the discussion we also had at the end of last week. And we will update you when we have more clarity. GummyFront. The preparation of the Phase 2b/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. Lacturumab, 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 number 7. Altuvoct continues to perform extremely strongly and is establishing itself as a best in class product in the prophylaxis of hemophilia. 125% at constant currency, and our total hemophilia A sales were 2.35 billion SEK. Up 48%. We have now launched in 32 countries, including key European markets and we are progressing through a structured 3 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 and a very disciplined approach to execution of this fabulous launch. 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 to 500 nephrology patients already by the end of Q3. 1 quarter ahead of the full year time frame. I am very proud of The Team's Execution. Reimbursement Is Available in several, including Germany, Spain and Japan. 3 further points. PNH performance remained stable. We continue international rollout of the infused 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 Vail studies. Let's turn to slide number 9. 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 it does 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. So 52% of the accounts are expecting to place additional orders while 48 believe that they have sufficient stock. So 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's turn to slide number 10. Briefly, with regard to Doptelet and Gamifant. These 2 brands are continue growing at a very gratifying rate. The Doptelet grew in Q3 at 29% to SEK 1.8 billion. Growth was strongly and sustained across all 3 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. And as mentioned earlier, the Gamifant is now approved in Japan for HLH and MAS. The EU filing is under review and providing a further growth opportunity. And just to note, the product has been growing for the year at 28%. Year to date performance. Together, these 2 brands show the breadth of our portfolio. 1 is growing across regions and still expanding international. The other addressing a high need population and is moving into new geographies. Let's turn to slide number 11. As a pillar of our strategic international expansion, let's say, the progress now that we have made in Latin America and Japan. Let's 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 October 2. And is 100% in line, as previously outlined. In Japan, we are making great progress with 3 approvals since 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 2, phase 3 study aplastic anemia is enrolling and has 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 opportunity through clinical development. So we made a partnership, As mentioned earlier, lacutamab an investigational antibody being studied in cutaneous T cell lymphoma. In Cesare syndrome, lacutamab has already received strong regulatory support with prime designation from the EMA and the Fast Track designation and Breakthrough Therapy designation from FDA. Phase 2 data are already available. And the partnership allows Innate to start a Phase III program and file for accelerated approval in The U. S. For its first indication, Sézary syndrome. So we received 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 a potential to already start generating revenues in 2028. Let's go to guidance upgrade. And bring and we had a very strong performance this year. This brings me to the outlook. So 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 our large portfolio of growth products such as Altuvoct, Aspaveli, Doptelet, Gamifant, Kineret and other strategic brands together with a strong growth trajectory across all 3 regions. We have kept the adjusted EBITDA margin unchanged mid- to high-30s, and we want to invest into our launches in key studies. Henrik will discuss this topic further, 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, you know, 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 Histocyte 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 Aspaveli/Empaveli in C3G IC-MPGN. We also enrolled the first patient in our global Phase 4 PRICE-3 study in this nephrology indication. For Altuvoct, the Phase 4 ALTITUDE study in hemophilia completed enrollment. FDA granted Fast Track designation to Vonjo in Vexas syndrome, a serious auto inflammatory disease with high unmet medical need. And we will see the top line results of the PAXIS Phase 2a study next year For Doptelet, the first participant was enrolled in the Asia Pacific anemia study. We are conducting this study in Japan, South Korea and Taiwan, as the incidence of refractory aplastic anemia in Asia is 3 to 4 times higher than in Western populations. And finally, Tryngolza received positive CHMP opinion in severe hypertriglyceridemia earlier than expected. And we also presented the interim 53-week data from the and cohort studies at EAS, which I will cover in more detail shortly. Turning to Gamifan on the next slide, please. We are preparing 2 new Phase III label-enabling programs for Gamifant. Both are in diseases driven by interferon gamma with Gamifan blocks and neither disease has an approved targeted treatment today. Our biggest near term opportunity is in malignancy associated HLH. it is 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 1.5 thousand patients in The U. S. Develop it each year, and the number is growing. that is as many as primary HLH and HLH MAS combined, the 2 forms of HLH for which Gamifan is currently approved. Our pivotal Phase III study, SAFFIRE, will include around 80 patients with malignant HLH, and we will compare their results with around 160 matched patients in our OPAL external control study. The primary endpoint is survival at day 60. In the SAFFIRE study, we will also explore gamifan 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 percent, versus 75% overall survival in the emapalumab group. With patients being dosed by their CXCL9 level. Moving into sepsis, Gamifan targets a subgroup of patients whose disease is driven by infer from gamma. Today, these patients only receive supportive care. We are expanding our Phase 2b/3 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 2b analysis in 2028 will shape the Phase 3 part of the study. Together, these 2 studies could bring Gamifan 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 milligrams/deciliter. In September, we also presented interim 1-year results from the core open label expansion study. Confirming long term efficacy and safety of olezarsen in sHTG. The graph, you see the design of the core and core 2 studies with 3 arms during the first year, followed by the 2-year extension with only 1 opioid 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 at those treated with olezarsen from the start of the study. The effect then held through the end of follow-up. Regarding the path of reduction, this interim data show only a modest increase of less than 2 percent over 2 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 this observed effect. Olezarsen was generally well tolerated with no safety findings. Treatment compliance was 98% at the median of 10 months. Together with the positive CHMP opinion, this data strengthens our confidence in Tryngolza as an important new 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 26, we expect 2 key events, The European regulatory decision for Tryngolza in severe hypertriglyceridemia above 880, following the recent positive CHMP opinion. And in gout, the reduced top line data for selatogrel will be presented in a late-breaking abstract oral session at ACR on November 11. Moving into 2027, we expect momentum to continue across the portfolio. Key anticipated milestones include for podetiristat in progressive gout, data from REDUCE 1 and REDUCE 2 and the planned BLA submission to the FDA. The planned FDA resubmission for efpeglenatide in uncontrolled gout the European regulatory decision for Gamifan in HLH MAS in Still's disease and for Vonjo, the PACIS-2 Phase 3 readout in myelofibrosis and top line data from the PAXIS Phase 2 study in VEXAS. The pipeline progress 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, and hello, everyone. And please turn to Slide 20. And we will take a look at some key financial metrics for the quarter. So in Q3, our revenues of SEK 9.1 billion correspond to revenue growth of 16% at constant currencies. And 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 royalties 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 I 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 nonrecurring and amortization for the quarter increased by 24% at CER compared to Q3 2025. SG&A, also excluding nonrecurring items and amortization, increased by 16% at CER, driven by launch and prelaunch costs for Aspaveli in nephrology. And Tryngolza. And these costs were partially offset by lower costs for Doptelet. R&D expenses increased by 41% at CER, excluding nonrecurring items mainly due to the addition of posetiristat development programs. As a result, the adjusted EBITDA 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. And net debt at the end of the quarter was just below SEK 15 billion, a net debt to EBITDA ratio of 1.1x. Please now turn to Slide 21 and the financial outlook for the full year 2026. And as usual, this outlook is based on revenue growth at constant exchange rates, and adjusted EBITDA margin. For the full year 2026, we have raised the outlook for revenue. The outlook for the adjusted EBITDA 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 EBITDA 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 on their Q3 call. Related to adjusted EBITDA 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 in 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/III study in iDS. And finally, as usual, we continue to be diligent with cost containment in the rest of our business. And with this, I now hand over to Guido.

Thank you. Henrik. I was a little bit muted here. So let me close the prepared remarks by connecting this quarter where Sobi is heading. In February, at our Capital Markets Day, we set out an ambition of SEK 55 billion of revenues by 2030. So how are we doing in Q3, let's say, in 2026? And let me frame it according to 4 points. So growth revenue growth 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 Asper Valley and Gamifant in Johan will further enhance our growth profile Tryngolza is making a 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 2 months ahead of our expectations. Third pipeline, posetiristat as per the outline from Lydia, posetiristat 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 hem-onc while thoughtfully managing our risk profile. And 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 a thoughtfully diversified business. And then really exciting outlook Material launches are ahead of us. And we are proud of our. about our de-risked pipeline projects and that addresses very much high areas of high unmet medical need. On this note, I would like to close the session and maybe open up for Q&A. And as earlier mentioned, press 1 if possible, keep it to 1. Maximum 2 questions. Back to the operator.

We will now begin a question-and-answer session. And eventually turn off the volume from the webcast while asking a question. The first question comes from the line of Kirsty Ross-Stewart Stuart from BNP Paribas. Please go ahead.

Hi, thank you for taking my questions. Kirsty Ross-Stewart from BNP Paribas. Maybe just 1 quick 1 on the margin first. So with 40% margin year to date in 4Q tending to be a kind of a higher-margin quarter it is quite hard to see how the bottom end of your margin guidance range is realistic. So could you maybe just bless the assumption that you are tracking to the top end of that guidance range and clarify in a little more detail what has held you back from upgrading the margin at the quarter? And then sorry, just a very quick second 1 on Aspaveli. I understand that not all of the patients being treated right now are paying patients. So just wondering if you clarify how long it tends to take to transition people off early access programs. When can we expect patients to all be paying? Super. Thank you.

Yes. Maybe I will start with the easy part of the question, and I am going to hand over to Henrik. I mean, basically, regard to Aspaveli, it depends obviously on approvals, reimbursement approvals. So there is not a general answer. I mean, we have 2-thirds of those patients roughly as we outlined, are commercial. The 1-third will blend in during the course of next year. And obviously, we will further expand, as you can imagine. So let's say, so the product is actually on a nice trajectory now I mean, it takes a while. These rare disease launches, even though you prepare them well. Take a while until you get your familiarity with the audience And, you know, in this case, obviously, as we outlined, earlier this year, it takes a while to get these patients through the vaccination programs. And then in the German launch, which was the first launch, more important launch, it takes a while also to locate the patients. Because they very they are diagnosed in the center, but the vast majority is actually treated by community based physicians. And this creates a little bit. You know, it takes some time to locate them and build a referral network. So, you know, that is the reason why you see now more of an uptake and, you know, the belief that this continue. With regard to margins, I mean, 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, do you want to bring more color to it?

Norbert, but that is, of course, the case. Considering where we are coming now very close to the launch in FTG. And obviously, the continued efforts around Aspaveli. We expect significant acceleration in Q4. So that is the reason. And on what prevented us from increasing the guidance, Well, Beyfortus is an uncertainty, of course. For us in Q4. Our own business, we is we obviously understand very well and have very good understanding of what we think about the quarter.

Yes. But it is fair to say that we are working towards the higher end. But Beyfortus, we can influence. Maybe another question. Thank you.

Thank you. The next question comes from the line of Christopher Ode from SEB. Please go ahead.

Hi there. Hope you can hear me. Christopher Uhde from SEB. Thanks for taking my questions. I just want to start by thanking you Guido for showing us over the years how our biopharma growth story can successfully be built exclusively through M&A. it is not that many examples of success there. My question is on international. I am afraid it does have a couple of parts. It has been a big driver. it is been. it is set to be a big driver and it is been really consistently underappreciated going back to before 2020 guidance for 2025. Help us understand what is going to happen there. I mean, the moving parts I see are obviously the PINT acquisition that you have highlighted, but also the potential that you could talked about with the Asahi partnership And also Korea how much can they contribute to 2030? And do not 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? And then short term for PINT, what 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 Thank you.

Yes. Thank you. Yes. Norbert, I mean, the when you look at international portfolios, let's say, you look at these markets in more mature and granted we started from a very humble beginning. I mean, I remember the days where this part of our portfolios was more to the tune of SEK 500 million. Obviously, has come a long way. And but the percentage that you would typically get out of this international region is significantly higher than what we get today. Mean, it should clearly not if you can afford a longer time, horizon, I mean, forget about now 2030 because I think this is for my successor than to tell you how he thinks about it. But if you take a, let's say, 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. Johan is a. Is obviously a very important factor in this regard. There were rare disease companies where, you know, for instance, 1 of the examples was Shire where Johan was the second largest market for it. And I think that over time, the, you know, the Japanese market will grow into a in an. Into an area. With beyond our largest European markets. You have to assume this just by the numbers and also for certain new products, favorable price conditions. So there is a strong dimension of growth. Then when you think about PIN, to be honest, we did not buy it to administer It is sitting on the asset and like a hand on the accent and not. And, you know, not doing anything with this business. This is a business that needs to you know, once, you know. There will be some luggage as you always have to you know, as every. The. A very 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 a lot of by more volatility. And you need to be able to afford this, but the good news is if you have a more a, a more longitudinal perspective, and b, if you look at it as a portfolio, it seems that it will balance it off. So we are very excited for instance, by the opportunity for Twinklosa in Mexico. I think it is a very material opportunity for the company probably larger than some of the larger European markets for us. So you know, so I think this will be another pillar for us. And then the diversification of this international division will give it strength And it is fair to say that the current geopolitical environment is not conducive always. But, you know, it is. There are always pockets offset each other. And luckily, we are in an environment or in an industry, it is very hard to make trade off decisions here with our with our product if you do not want to directly jeopardize health. So, you know, in the in the pyramid of needs, you know, we at least not at the bottom. So I think to what extent we will break out this further, make it more-- I think now we need to I think next year will be a very important growth year again for international and for obvious reasons. And I think, you know, then the. I guess, 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. I mean, at this stage, probably it is a bit premature, but I hope that the international business will grow into this size. Thank you. You are welcome.

We now have a question from the line of Kapoor from Wainwright. Please go ahead.

Hi, this is Emran in for Mitchell Kapoor. My question concerns Tryngolza. So with the positive CHMP opinion, how are you thinking about the initial reimbursed population for Tryngolza Would it be based on your peer discussion so far? Do you expect access to extend to patients being treated to prevent a first pancreatitis episode or to be, you know, concentrated initially in those with a prior 1. Thank you.

Thank you. I mean, we expect get a label reimbursed and reimbursement in line with the label, which would be above 880 mg/dL, regardless of an event of pancreatitis or not.

The next question comes from the line of Gonzalo from Danske Bank. Please go ahead.

Thank you for taking my question. Gonzalo Artiach from Danske Bank. 1 on Tryngolza. To start. With the SDG launch now expected, in early 2027, most likely, how are preparations progressing? And what level of interest are you seeing from physicians? How much 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 a reasonable to expect around the dynamics at launch. And a second question on Kineret. It had a particularly strong quarter, Q3, which you attribute to increased demand across regions. But could you give us some color on how much reflects underlying patient demand versus tender timing on or inventory movements. Is Q3 a reasonable base for quarterly sales going forward? Or should we expect some level of normalization Yes. Thank you.

I mean, I will start with Tryngolza. I mean, Tryngolza, the preparations are in full swing. We make an extraordinary effort, which is reflected in our earning expectations for Q4. Allow to build a formidable team. I mean, we have we are already having the full team, for instance, in place in Germany. Which really, you know, significantly increased our overall footprint And we are we are doing. We are now in preparation to do those cross all the markets that are launching sooner or where we have where we believe that we need to perform a very strong prelaunch. So this is, for us, we think it is 1 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 circa 700 lipid centers across Europe on a regular basis. I mean, in fact, probably by now, in many cases, on a nearly definitely on a weekly basis, if not daily at times. So we think that we understand this area. Obviously are 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. Granted we need to get reimbursement approvals first as you need to do in Europe. So there will be quite a few patients that will be put on treatment there is quite a bit of pull for the product. But we also keep as we have to do in nephrology. Also here, give the team a little bit of time, you know, to build this referral network. But, you know, yes, this is probably know, faster uptake launch than you given that there is no vaccination than you would have had. Maybe with in C3G. But it is still it. You need to. it is a new in the. You know, it is a new scale for the company. But we are ready And you know, we believe. We walk the talk here. We believe this need to go for it. The other 1 with Kineret, we do not see any extraordinary inventory movements. So this is more the general interest in the product. And, you know, 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. Mattias Häggblom: Yes. Thanks so much for taking my question. Firstly, Guido. it is been a blast covering Sobi during your tenure, so best wishes for your future challenges. And then 2 questions for me, please. Firstly, on posetiristat. The first Phase III trial was reported by the company roughly 2 months after it was finalized. For REDUCE-1, it says on clinical trial .gov that it 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. And then secondly, on Gamifant and IDS, I appreciate the added color around the planned meeting in Q1 2027. But why not earlier given that you met with EMA already this spring, was it because Sobi knew the agency would want to see certain data setting to the long term safety from the Phase 1b trial? Or was there anything else that you can help me understand the timing of this? Thanks so much.

Yes. Thank you, Mattias, for the introduction and these are great questions for Lydia. So thanks for saving me today. So thank you, Guido.

Thanks, Mattias. So 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. And before going to FDA, because as you know, Embrace was very, let's say, European and Greece Greek focus. What we have done in the 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 different countries and different centers. So we want really to inform all our documentation in order to have the discussion with the based not only on the initial feedback from EMA, but also from KOLs from The U. S. So not driven by any safety data request of longer observation or anything like that? that is when it comes to iDS, so we will keep you updated on the next calls. For the Trinra, as I said, and I think we have both mentioned it very. Both Guido and myself, filing it is expected next year. And the only reason why we have moved a few months, the reduced 1, compared to previous communication is due to keeping the data blinded until all the scans are completing on the secondary endpoint. So we wanted to make sure that. Yeah. There is no quality compromise on anything. 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. 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 Bjerke from ABG. Congrats on a strong quarter. I have 2 questions, please. So firstly, I am wondering 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 increasing investment in Q4, as you have mentioned several times, Out of the equation, how much of your isolated OpEx savings in Q3 should be extrapolated? Thank you.

Yeah. I will just start with Doptelet. The U. S. Growth is in percentage term is more or less in line, a little bit less than the average growth that we have shown, but more or less in line. The growth engine is international. That is far ahead here. And that will then be coming as the main growth driver for the future and where you have also longer patent life And with regard to the operating expense structure, maybe Henrik, you want to provide more color.

Yes. George, could you please repeat your question? I did not quite follow. Yes, sure. So as you mentioned several times, you will invest heavily in Q4. So if you see the speed up out of the equation, I am wondering how much of isolate OpEx savings that you were able to make in Q3? Mean, very rough size here that potentially should be extrapolated. So that 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? Yes. Or also the dotlet decrease costs you mentioned or other things that obviously, was I mean, 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 that what extent those should be extrapolated. But we 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.

Just a couple from me. The first, just following up on that operating expense question. I guess a different way to ask it would be, if you had known that Tryngolza was getting a recommendation 2 months earlier, In hindsight, would you have spent more in 3Q on the launch investments? Or do you think what you spent anyway was representative whether it was 2 months earlier or what you expected before? Secondly, then 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? And then third, just a quick clarification on the Beyfortus slide you report preference amongst physicians who have who actually express a product preference. So what proportion of physicians in your survey were actually agnostic to either the 2 available antibodies? Thank you.

Yeah. I mean, let's start with Tryngolza. I mean, we In hindsight, I mean, we were planning for success. You know, we. And we have now we. And it is a very large team that we, for instance, in the first launch country in Germany, put up it maybe we could have had a month or 2 earlier. We could have started earlier, but you know, I think the timing, you know, in terms of materiality for Q3, maybe it would have been a little bit more, but it would have not moved materially. it is 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 end of September. So they are in the field You could have maybe started a month earlier. So could have. It could have bumped up. But, you know, for me, difficult to quantify now, maybe, and we can later come back to this. With regard to the CEO search, I am obviously not part of the search committee But, you know, what I can tell you is that we let's say that we have let's say, that they are working very extensively. They have a strong field of interested parties and there is a expectation, you know, expectation, not a guarantee to have, you know, a name to report back. Before the end of year. Yeah. But, you know, this is. Ultimately, it needs 2 conceding parties And so there, it is always with a But that is what the teams are working towards too. And in terms of profile, you know, definitely somebody who can run a business and has experience in this and has an affinity to further develop business and find opportunities for the company. So somebody ends, ideally, you know, somebody with a an with an ex. With a with a experience also in rare disease. With regard to Beyfortus, you know, 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 Security. Please go ahead.

Yes. Hi. Thanks for taking my questions. I have 2. Also on DOPTELET, but maybe on a different angle. So the patent expiry is coming up next year. So can you give us your view on how you see that playing out? What is your split, for example, with U. S. Non U. S. Sales here that is exposed And also wonder if there are any exclusivities that could protect you in any way pediatric ITP, for example. I will start with that 1. Thanks.

Mhmm. Any of you want to give a comment on this?

Henrik, the split U.S. versus non-U.S. for which product? Talk to that for DOPTELET. As we have 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.

Yes. Thanks. So I think the Doptelet share outside is going to increase. The 1 already by the time they expiry is happening and then you will have an effect obviously on the U.S. business. it is very straightforward. It will follow but, you know, the business is, you know, so 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.

And just a quick 1 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 their preference here versus the oral alternative. That you are seeing in this early launch phase? Thanks.

Thank you. I mean the product is very well received. We have very strong, also here, preference share in these centers. Now that is very helpful when you have a more concentrated audience where the market is really driven by these centers. As for instance, in Spain, we also got now recently reimbursement And quite a few other markets like France, which is which is not yet on stream. And in Germany, though, you know, it is it is helpful. There you have a very strong support in the center. But it needed some time to connect obviously these reference center. But if our intel is correct, you know, you know, 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. Yeah. So we are actually quite, pleased with this. Yeah. But it took a it takes some time, and now you can see the inflection. But reception in the centers is good. Just need also to get the guys who are sitting on the patients right now wanting to support us and then moving patients into the center that needs orchestration. And 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. Let me So are the data. The data speak for themselves and 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. 1 on Gamifant and 1 on efpeglenatide. Please. Malignant HLH, I guess they are 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? And for efpeglenatide, the application, what can you tell us now? That you have met with FDA about the CMC deficiencies in the last application and what has FDA said about what you still need to do? Because the 2027 submission is a long wait that implies rather a lot was not satisfactory, I guess. And it is important for us to understand what you are doing to ensure the processes that let it through are thoroughly addressed. Thank you.

So thank you. So yes, you are right. And the study previous study with malignant HLA, it was in a let's say, very concentrated. It was single center experience. And with a very small number of patients. So and now there is much more real-world evidence that is really giving us the confidence on the effect of gamifan for this subtype of HLH driven by malignancies by cancer. And then on the efpeglenatide CRL, we are. As we have communicated before, in the middle of the interactions with FDA. And we are collecting the data that FDA requested in the CRL. And mostly related to CMC. There were also some non-operability issues that we will be discussing coming up very soon. On hepatic impairment and on the PK profile on the dosing. So those are ongoing conversations that we are moving ahead. And the only thing I can share is that we are following that we are continuing having the conversations, the open conversation with FDA. And that we are following their advice in order to resubmit on time. So no more specific details, but clearly progress in the right direction. Okay.

Thank you. Best of wishes. We do not-- Yeah. Thank you so much. And, you know, 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. And, you know, it has been a spectacular journey. You know, 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 a another level. So, you know, like to thank you for being 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 And the whole thing is only possible because we have a fantastic team So 1 person leaves. By the time I leave, probably have 2.3 thousand maybe 2.4 thousand people We seem to expand now a little bit more. So anyway, on this note, I wish you all the best, you know, and we will probably stay in touch. We will see each other in the 1 or the other format. But I will not be part of the next format the next quarterly you will get infused by a new team. And, you know, I think it is time that you get exposed to new ideas and new perspective. And so we And for me, at least, I can say I hope I walk out 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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