Swedish Orphan Biovitrum AB (publ) (SOBI) Earnings Call Transcript

Ladies and gentlemen, welcome to the Sobi Q3 Results 2026 Conference Call and live webcast. I'm Mathilde the Chorus Call operator. [Operator Instructions] And the conference is being recorded. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

Yes. Thank you, and hello, everyone. This is Guido Olkers, 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 #2, forward-looking statement. As per usual, and unless stated otherwise, we will be making comments and was related to the third quarter at constant currency rates and million Swedish krone. Please turn to Slide #3. Today, we plan to cover the key aspects of our Q3 report. I'm 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 1. And please remember, ask only one, maximum 2 questions. Let's turn to Slide #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. The -- 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 and international diversification. Regarding performance, please keep 3 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% gross performance and our adjusted EBITA in the quarter was 45%. The 16% includes a material impact of phasing of RSV royalties. With RSV, we would have been able to grow 26%. This number reflects the performance of our commercial engine consisting of our 3 regions. Idea continues exponential growth trajectory and Aspeale 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 MAS and for Aspaveli in C3GICMPGL. These approvals will unlock material opportunities in one of the largest rare disease markets. Third, we will -- 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 #5. Total net sales in the quarter were SEK 9.1 billion, up from SEK 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 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 #6. The slide also shows our time lines of launches and pipeline events, 3 uptides since last quarter. In gout, postatinoate 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 price. I will not preempt that discussion today or the discussion we also had last -- 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. Julia will give a more comprehensive update on this pathbreaking development. Lacumumab, 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 #7. Altuvoct continues to perform extremely strongly and is establishing itself as a best-in-class product in the prophylaxis of hemophilia A. Sales grew 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 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 Altuvoct and a very disciplined approach to execution of this fabulous launch. Aspaveli. Turning to Aspperveli. 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'm very proud of the team's execution. Reimbursement is available in several markets, including Germany, Spain and Japan. Three further points, PNH performance remained stable. We continue the international rollout of the INFUSE 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 Variant and VEO studies. Let's turn to Slide #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 every year is now beginning and the RSV activity is rising across many states. Although a competitor is not 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's 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, whilst 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 #10. Briefly with regard to Doptelet and Gamifant. These 2 brands are 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 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, rgamifant is now approved in Japan for HLH and mass. The EU filing is under review and providing additional further growth opportunity. And just to note, the product has been growing for the year, 28% year-to-date performance. Together, these 2 brands show the breadth of our portfolio. One 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 #11. As a pillar of our strategic international expansion, let's say, is 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 the 2nd of October and is 100% in line as previously outlined. In Japan, we are making great progress with 3 approvals in 2026 that expand our international reach with Kineret, Aspaveli 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 has had its first patient in, 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 Innate partnership. As mentioned earlier, LactamMerck is an investigational antibody being studied in cutaneous T-cell lymphoma. In Sezary Syndrome, LactamMab has already received strong regulatory support with prime designation from the EMA and the Fast Track designation and breakthrough therapy designation from FDA. Phase II data are already available and the partnership allows Innate to start the Phase III program and file for accelerated approval in the U.S. for its first indication, Sezary 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. And to bring -- and we had obviously 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 a large portfolio of growth products such as Alta, Aspaveli, Doctoet, Gamifant, Kineret and other strategic brands, together with a strong growth trajectory across all 3 regions. We have kept the adjusted EBITA margin unchanged, mid- to high 30s, and we want to invest into our launches in key studies. Henrik will discuss further this topic, and we will continue investing, as mentioned, into our future because we believe that we owe 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 Gamifan, we received PMDA approval in Japan for HLH macrophage activation syndrome in Astillase, which adds to our growing presence there. We also presented new HLH data at the Histicyt 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 EPAVELli in C3G-ICMTGN. We also enrolled the first patient in our global Phase IV PRINSE-C3 study in these nephrology indications. For Alto, the Phase IV ALTITudDE study in hemophilia completed enrollment. FDA granted Fast Track designation to Bonjo-Bet syndrome, a serious auto inflammatory disease with high unmet medical need. And we will see the top line results of the TACI 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 3 to 4x higher than in Western populations. And finally, Trinvolza received positive CHMP opinion in severe hypertriglyceridemia earlier than expected. And we also presented the interim 53-week data from the CORE and CORE2 studies at EAC, which I will cover in more details shortly. Turning to Gamifant 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 gammifon blocks and neither disease has an approved targeted treatment today. Our biggest near-term opportunity is in malignancy-associated HLA. 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 stills. 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 must combined, the 2 forms of HLA for which Gamifant is currently approved. Our pivotal Phase III study, SAPPHIRE, will include around 80 patients with malignant HLH. -- and we will convert the 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 gamifan in other forms of secondary HLA and in hyperinflammatory complications of CAR-T therapy. We plan to recruit the first patient in Q1 '27 with top line data in '28 a potential FDA submission in '29. Real-world evidence from patients with HLH in the U.S. has shown significant improvement in 60-day overall survival for patients treated with Damian in the historical cohort without emapalumab overall survival was 38% versus 75% overall survival in the emapalumab group. we plan to record the first patient. Moving on to the first patient on '27 with top line by record the first we supplying data in '28 a potential Phase III EVEREST study 2 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 2 studies could bring Gamifant to many more patients with interferon gamma-driven diseases. Next slide, please. Tongala received CHMP opinion for treatment of severe hypertrademia or SHTG, and we are looking forward to the AC approval later this year. Severe fertiliser bema is characterized by triglyceri levels above 880 milligrams per deciliter. In September, we also presented interim 1-year results from the core open-label extension study, confirming long-term efficacy and safety of resort in HTG. In the graph, you see the design of the court and CORI studies with 3 arms during the first year, followed by the 2-year extension with only 1 open label arm. In the expansion study, all patients were receiving olesorsen 80 milligrams. Data shows profound and sustained PG 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 all resourcing 80-milligram who quickly reached the same level of TG reduction as those treated with olifersen from the start of the study. The effect then held steady through the end of follow-up. Regarding the path traction, this interim data show only a modest increase of less than 2% over 2 years of treatment. You can see from the figure that also patients in the 80-milligram group who had an initial increase return to these low levels afterwards, confirming the transitory nature of this obserffect. Allison 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 SINGolSA as an important new threptic option for people living with severe hypertradedemia. 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 2 key events. The European regulatory decision for Tringolta in severe hypertriglyceridemia, above 880 following the recent positive CHMP opinion. And in golf, the reduced top line data for poddetinorad will be presented in the late-breaking abstract oral ization at ACR on November 11. Moving into 2027, we expect momentum to continue across the portfolio. Key anticipated milestones include for Podetinoradin progressive gout, data from REDUCE 1 and REDUCE 2 and the planned BLA submission to the FDA. The planned FDA resubmission for mass in uncontrolled gout the European regulatory decision for Gamifan in HLH main steel disease and for Bongo, the Pacifica Phase III readout in myelofibrosis and top line data from the PAX Phase II study indexes. 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, Lidia and hello, everyone. And please turn to Slide 20. I we will take a look at some key financial metrics for the quarter. So in Q3, our revenues SEK 9.1 billion correspond to a revenue growth of 16% at constant currencies. And as we heard, if we exclude Fortis royalties, growth was 26%. That's. Hematology increased by 29% at CER, and our combined hemophilia A portfolio increased by 48%. Altabox 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. As the value increased by 32%, at CER, reflecting new nephrology patients. In immunology, we saw double-digit growth in both Kindred and Gamifant, offset by lower royalties from the quarters. Gamifant growth was driven by new patients treated for LAS and still disease in the U.S., and Kindred continues to see strong growth across regions. Royalties from Bay 4s came in 39% below prior year. As Sanofi indicated, there may be different phasing this year between Q3 and Q4. And and the 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% of CER driven by new patients nin Prinos on SCS and patient growth in other specialty care medicines. If we look at the table on the right, the adjusted gross margin of 79% in the quarter, the slight decrease compared to last year was mainly driven by lower share of BeFortes royalty revenue. The operating expenses, excluding nonrecurring items 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 -- after Valley in nephrology and Tringalsa. And these costs were partially offset by lower costs for Doptelet. R&D expenses increased by 41% of CER, excluding nonrecurring items, mainly due to the addition of postered development programs. And 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. And net debt at the end of the quarter was just below SEK 15 billion a net debt-to-EBITA 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 EBITA margin. For the full year, 2036, we've 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 year-to-date through the end of Q3. In Q4, we expect momentum to continue with large impact products out the box Doptelet and Gamifant for example, and we expect to benefit from the addition of the pain Pharma business. As I stated last quarter, and we saw in Q3 on a percentage basis, we're 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. Therefore this remains difficult for us to forecast and particularly for an individual quarter, and we expect to learn more from Sanofi in their. 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 Aster Valley and Tringalsa. AspaValle will continue its standard launch in Europe, and we will accelerate launch preparations for Tringalsa given the recent positive CHMP opinion for the treatment of SAG in Europe. In R&D, we will advance the Phase IIb 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.

Sorry, I was a little bit muted here. So let me close the prepared remarks by connecting this quarter where Sobi is setting. In February, at our Capital Markets, we set out an ambition of SEK 55 billion of revenues by 2030. So how are we doing in Q3 lets in 2026. And let me frame it according to 4 points. So gross 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 as per very showing an inflection in a number of markets, the approval of Aspeale and Gamifant in Japan will further enhance our growth profile. Trials 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, pattern the outline from Lidia for Sutent is progressing well with filing on track for mid-2027. The Gammaraas program in IDS is advancing towards start-up and look forward to the first readout already in 2028. The Nate partnership on au further expands our pipeline in Hemang while thoughtfully managing our risk profile and then reach the completion obviously of in 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 of our -- about our derisked pipeline project and that addresses very much high areas of high unmet medical need. On this note, I'd like to close this session and maybe open up for Q&A. And as earlier mentioned, please press star 1, and if possible, keep it to 1 maximum 2 questions. Back to the operator.

[Operator Instructions] The first question comes from the line of Kirsty Ross-Stewart from BNP Pariba.

Kirsty Ross-Stewart from BNP Paribas. Maybe just 1 quick 1 on the margins first. So with 40% margin year-to-date in 4Q tending to be a kind of higher margin quarter. It's 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're 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? And then sorry, just a very quick second 1 on steel 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 kind of all be paying?

Yes. Maybe I'll start with the easy part of the question, I will then refer to Henrik. I mean basically, with regard to Asper Valley, it's -- it depends, obviously, on approval, reimbursement approval. So there is not a general answer. I mean we have 2/3 of those patients roughly as we outlined our commercial the 1/3 will blend in during the course of next year. And obviously, we will further expand as you can imagine. So the, 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 tender take a while until you get your familiarity with the audience. And 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 are very -- they're diagnosed in the center, but the vast majority is actually treated by community-based physicians. And this creates a little bit -- it takes some time to locate them and build the referral network. So that's the reason why you see now more of an uptick in believe that this will continue. With regard to margins, I mean, it's 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.

No. But that is, of course, the case, considering where we are coming now very close to the launch in STG. And and obviously, the continued efforts around Aster Valley. We expect a significant acceleration in Q4. So that is the reason. And on what prevented us from increasing the guidance. Well, Bart is an uncertainty, of course, for us in Q4. Our own business is -- we obviously understand very well and have a very good understanding of what we think about the quarter.

But it's fair to say that we are working towards the higher end, but by fortes, we can't influence. Maybe another question. .

The next question comes from the line of Christopher Uhde from SEB.

I hope you can hear me. Chris Udhe from SEB. I just want to start by thanking Guido for showing us over the years how 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 of parts. It has been a big driver -- it's been -- it's had 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. I mean 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 Assai partnership and also Korea, how much can they contribute to 2030? And 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? And then short term, for Pint, do you expect stable revenue from their non-Sobi-based 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?

Yes. Yes. No, I mean, the -- 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 mean I remember the days where this part of our portfolio was more to the tune of $50 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. I 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 and to tell you how he thinks about it. But if you take -- 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, 1 of the examples was Shire where Japan was the second largest market for them. And I think that over time, the Japanese market will grow into an area where it's beyond our largest European market. You have to assume this just by the numbers and also the for certain new products to favorable price conditions. So there's a strong dimension of growth. Then when you think about pit, to be honest, we didn't buy it to administer sitting on the asset and like a hand on the ag and not doing anything with this business. This is a business that needs to -- once -- there will be some luggage as you always have to every 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 -- 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 Twins 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 then the diversification of this international division will give it strength. And it's fair to say that the current geopolitical environment is not conducive always. But there are always pockets than offset each other. And 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 sell. So in the pyramid of needs, we are 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 here again for international for obvious reasons. And I think 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's a bit premature, but I hope that the international business will go into this size.

We now have a question from the line of Kapur is from Wainwright.

This is Yan Zi siting in for Mithapur. My question concerns Trimble. So the positive CHMP opinion, how are you thinking about the initial reimbursed population for Trina would it be based on your payer 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 the prior one.

Thank you. I mean we expect to get a labor reimbursed -- reimbursement in line label, which would be above 880 irregardless of an event of pancreatitis or on .

The next question comes from the line of Gonzalo that from Danske Bank.

One on Kingold to start. With the STG 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 established referral pathways versus having a market that is already waiting for treatment. I'm just trying to understand what would be reasonable to expect around the dynamics at launch. And the second question on Kineret. It had a particularly strong quarter in Q3, which you attribute to increased demand across regions. But 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.

Yes. Thank you. I mean I'll start with String also. I mean, Pingora, the preparations are in full swing. We make an extraordinary effort which is reflected in our the earnings expectations for Q4 now to build a formidable team. I mean we have -- we are already having the full team, for instance, in place in Germany which really significantly increased our overall footprint. And we are doing -- we are now in preparation to do those as costs 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 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 700 lipid centers across Europe on a regular basis. I mean, in fact, probably by now, in many cases, on definitely on a weekly basis, if not daily at times. So we think that we understand this area. We're 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, 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 -- as we have to do in as we had to do in nephrology. Also here, we give the team a little bit of time to build this referral networks. But yes, this is probably a faster uptake launch than you given that there is no vaccination that you would have had maybe with Aspeale in C3G. But it is still you need to -- it's a new scale for the company, but we are ready. And we believe if we walk the talk here, we believe this need to go for it. The other 1 with Kineret we do not see, I mean, any extraordinary inventory movements. So this is more the general interest in the product. And and an optimized commercial execution.

We now have a question from the line of Matthias Hedblom from Nordea.

Firstly, for Guido. It's been a blast covering Sobi during your tenure, so best wishes for your future challenges. And then 2 questions for me, please. Firstly, on Postnord. The first Phase III trial was reported by the company, roughly 2 months after it was finalized. For REDUCE-1 it says on clintrials.gov that has been completed in late August, which following the same logic would point to late October or November. So you're guiding for top line results first quarter '27. 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 Gamma and I appreciate the added color around planned meeting with in Q1 2027. But why not earlier, given that you met with EMA already this spring, -- was it caused so now the agency would want to see certain data set into the long-term safety from the Phase Ib trial? Or was there anything else that you can help me understand the timing of this?

Yes. Thank you, Matthias, for the introduction, and these are great questions for Lidia. So -- thanks for saving me here.

Thank you, Gio. So -- and maybe for IBS, as you know, we met with EMA and the emergency taskforce and we got very curating feedback. That was our first step. And before going to FDA because as you know, embrace was very, let's say, European and Greece great focus, what we've done before going to FDA, and we have almost all the work done on the preparation has been to have discussions with numbers KOLs from the U.S. because treatment patterns might differ from different countries and different centers. So we wanted really to inform our -- all our documentation in order to have the discussion with FDA based not only on the initial feedback from EMA but also from Keralfrom the U.S. So not driven by any safety data request of longer observation period or anything like that? That's when it comes to ideas. So that's -- we will keep you updated on the next calls. For the inner as I said, and I think we both mentioned it very both Guido and myself, filing it's expected next year. And the only reason why we have moved a few months, the reviews. One compared to previous communication, is due to keeping the data blinded until all these scans are completing on the secondary end points -- so we wanted to make sure that, yes, there is no quality compromise on any end. And 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've already mentioned as well at ACR in a couple of weeks as I mentioned during the call.

The next question comes from the line of Greg Barker from ABG.