Swedish Orphan Biovitrum AB

Ladies and gentlemen, welcome to the SOBE Q3 Results 2026 conference call and live webcast. I am Mathilde, the course 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 1 on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

Yeah, thank you. And hello, everyone. This is Guido Oelkers, CEO of Sobe. We are delighted to welcome you to the third quarter 2026 conference call for investors and analysts. Our presentation was posted to sovi.com earlier today and with this having said, let's go straight to slide number two. Forward-looking statement as per usual. and unless stated otherwise, we will be making comments and most relate to the third quarter at constant currency rate and a million Swedish Krona. Please turn to slide number three. Today, we plan to cover the key aspects of our Q3 reports. I'm joined by Henrik Stenqvist, our CFO, Lydia Bartrand, head of R&D and chief medical officer, We plan to review the presentation first and then have Q&A until around 4 p.m. CET. For those on the phone, please join the queue. For questions, please by pressing star one. And please remember, you know, ask only one, maximum two questions. Let's turn to slide number four, you know, to the content. You know, 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 by improving now 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%, gross performance, and our adjusted EBITDA 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. Itowog continues exponential growth trajectory and Aspirelli 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 Tringosa in the treatment of severe hypertriglyceridemia and we expect to accelerate the launch by two months. Second, in Japan, we received the approval for Gamifront in HLH mass and for Asper Valley in C3G ICMPGL. These approvals will unlock material opportunities in one of the largest rare disease markets. Third, We completed the transaction with Pin 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 five. Total net sales in the quarter were 9.1 billion, up from 7.8 billion a year ago. And, you know, 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%. Taking together, this is a growth profile that is diversified, sustainable, and increasingly driven by high-value innovative medicines. Please turn to slide number six. The slide also shows our timelines of launches and pipeline events. three uptides since last quarter. In gout, post-retinoid is progressing well. Filing remains on track for mid-2027. For NASP, after the FDA issued a complete responsible 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. Gummy Fund. The preparation of the Phase 2b, Phase 3 Pivotal Trial for IDS is on the way and is now called Everest. Lydia will give a more comprehensive update on this pathbreaking development. Lacturimab. The partnership is signed and with a potential US accelerated approval filing planned for 2027. Let's look at a few products in more detail and turn to slide number seven. Itovoct continues to perform extremely strongly and is establishing itself as a best-in-class product in the prophylaxis of Haemophilia A. Sales grew 125% at constant currency and our total Haemophilia A sales were 2.345 billion SEK. 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, you know, we still have significant room to grow in wave two, and wave three is really still ahead of us. So we are not at the end of this launch. This performance reflects a strong clinical profile of Altevox and a very disciplined approach to execution of this fabulous launch. Asper Valley. Turning to Asper Valley, sales were 417 million SEC for the quarter, up 32%. We were very gratified that we have reached our 2026 target of 4 to 500 nephrology patients already by the end of Q3, one quarter ahead of the full year timeframe. 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 remains stable. We continue the international role 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 VALE studies. Let's turn to slide number nine. Bifortis obviously matters to the royalties we receive, and those royalties are an important catalyst for the strategic evolution of the company. The US 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's a very high preference share amongst physicians, and they believe that over 90% will choose Bay Fortis. 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's 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, you know, with regard to Dr. Lennon-Gammefeld. These two brands are continue growing at a very gratifying rate. The adopted it grew in Q3 at 29% to 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-US contribution. For Gummy Fund, sales were 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 Yagami Fund is now approved in Japan for HLH and MAS. The EU filing is under review and providing additional further growth opportunity. And, you know, just to note, you know, 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's turn to slide number 11. As a pillar of our strategic international expansion, let's say, is, you know, 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 Pin 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 Kinneret, Asper Valley, and Gummy Fund, building on a successful launch performance with Doctylet in 2025. On the development side, the Doctylet phase two, phase three study in a plastic 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. Taking 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. So we innate a partnership, as mentioned earlier, LactoMARC is an investigational antibody being studied in cutaneous T-cell lymphoma. In cesarean syndrome, LactoMARC has already received strong regulatory support with prime designation from the EMA and a fast-track designation and breakthrough therapy designation from FDA. Phase II data are already available, and the partnership allows Innate to start a Phase III program and five for accelerated approval in the U.S. for its first indication, Cesare's syndrome. Sobe receives global commercial rights upon potential accelerated approval and we are eligible for full global development rights following positive phase three results. The potential indication expansion in mycosis fungoides could create a very meaningful product for Sobe. 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, you know, and we had obviously very strong performance this year. This brings me to the outlook. This 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 Altawalk, Aspar Valley, Doctovit, Gamifund, Kineret and other strategic brands together with a strong growth trajectory across all three regions. We have kept the adjusted EBITDA 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 investing, 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 Gamifan, we received PMDA approval in Japan for HLH macrophage activation syndrome in a still disease, which adds to our growing presence there. We also presented new HLH data at the Histiocytes 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 Mpavelli-Aspavelli in C3G-ICMPGN. We also enrolled the first patient in our global phase four C3 study in these nephrology indications. For Altubox, the Phase IV altitude study in hemophilia completed enrollment. FDA granted fast-track designation to Bonjo in Vexus syndrome, a serious autoinflammatory disease with high unmet medical needs. And we will see the top-line results of the Paxys 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. And finally, Tringolsa received positive CHMP opinion in severe hypertriglyceridemia earlier than expected. And we also presented the interim 53-week data from the core and quartus studies at EAC, which I will cover in more details shortly. Turning to gamifan on the next slide, please. We are preparing two new phase three label enabling programs for gamifan. 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'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 combine, the two forms of HLH for which Gamifan is currently approved. Our pivotal phase three study, Staphire, will include around 80 patients with malignant HLH, and we will compare the results with around 160 matched patients in OPAL, our external control study. The primary endpoint is survival at day 60. In the SAFIRE 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 Q127 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 gamifan. 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 levels. Moving into sepsis, gamifan targets a subgroup of patients whose disease is driven by interferon gamma. Today, these patients only receive supportive care. We're expanding our Phase 2b3 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 two studies could bring gamifan to many more patients with interferon gamma-driven diseases. Next slide, please. Tringolza received CHMP opinion for treatment of severe hyperglyceridemia, or SHCG, and we are looking forward to the EC approval later this year. Severe hyperglyceridemia is characterized by triglyceride levels above 880 milligram 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 olisarcin in SHTG. In the graph, you see the design of the core and core two 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 olisarcin 80 milligrams. 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 Olisarcin 80 mg, who quickly reached the same level of TG reduction as those treated with Olisarcin from the start of the study. The effect then held steady through the end of follow-up. Regarding the Pathifact 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. Olesarsen 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 Tringulsa 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 mice throughout all our therapeutic areas. In the fourth quarter of 2026, we expect two key events. The European regulatory decision for Tringolza in severe hypertriglyceridemia above 880, following the recent positive CHMP opinion. And in GALP, the reduced top-line data for poditinorad 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 Fort Pot Deteriorating Progressive Gout, data from Reduce 1 and Reduce 2, and the planned BLA submission to the FDA. The planned FDA resubmission for MAF in Uncontrolled Gout, the European Regulatory Decision for Gamifan in HLH MAF in Stills Disease, and for Bonjo, the Pacifica Phase III readout in myelofibrosis and top-line data from the Paxys Phase II study in vexostimulant. 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.