Swedish Orphan Biovitrum AB

Hello, everyone. This is Guido Oerker, CEO of Sobe. We are delighted to welcome you to the first quarter 2026 conference call for investors and analysts. Our presentation was posted on Sobe.com earlier today. Please turn to the next slide. We would like to remind you of the usual provisions on statements about expectations and projections of future events. unless stated otherwise, we are making comments that most relate to the first quarter at constant exchange rates in million Swedish krona. Please turn to the next slide. Today, we plan to cover the key aspects of our Q1 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Bart-Franzsch, head of R&D and chief medical officer. We plan to review the presentation first and then have a Q&A until around 1.30 p.m. Central Eastern European Time. For those on the phone, please join the queue for questions by pressing star one. We propose that you ask only one, maximum two questions at a time. Please turn to the next slide. We have delivered a very strong start in Q1 2026, operationally and financially, with 24% revenue growth at constant exchange rate and an adjusted EBITDA at 38%. Reflecting strong commercial execution across the portfolio, disciplined cost management, continued strategic investment for long-term growth, these numbers speak for the resilience of our portfolio in turbulent times. The thing important to note is the progress we have made with our six launches, And, you know, the strategic portfolio grew by 55%, contributing 63% of our total business. This dynamic growth was driven by key launches, including AlteWacht, Gamifund, and now the European and international launch of Asper Valley and C3G ICMPGN. In addition, we have been able to achieve our milestones for Ringgold and SHDG and submitted and launched FCS, as well as completed the transaction of our Throsy, which is obviously an important milestone for us that enhances both the breadth of our pipeline, but also our long-term growth trajectory. Overall, Q1 demonstrates strong execution across the business, and I would like to reiterate the resilience of our business, even in ambiguous times, and we continue progressing our momentum for the years to come. Please turn to the next slide. Let's take a closer look at the Q1 performance. Growth was well diversified across regions and segments. Each region contributed and our key products continue to scale effectively. Our strategic portfolio is now the central engine of SOBE's performance representing our shift towards high-value, high-innovation assets, and as mentioned, representing 63% of our revenues in Q1. All regions delivered solid growth and continue to build momentum quarter after quarter. Let me take you now through some of the key products, but before doing this, let's reiterate, let's turn to the next slide and review what our program is ahead and that we have shared with you during the recent capital market day. Looking ahead of our priority programs and launch cadence, we continue progressing a broad set of opportunities, creating material opportunities for growth and diversifying our portfolio. We had a very good start with Aspavelli in Q1 and are in the process to roll out the indication C3G and ICMPGN across our territory. With regard to NASP, we wait for FDA's decision before end of Q2 and discuss the first data readout for prostitinerate in the latest by the end of Q2. For Tringolsa, we have had a good start to the FCS launch in Europe and continue building relationships with key lipid centers. The launch of FCS is an important foundational step for the planned launch of SHGG. In the quarter, we also filed Tringolsa in Europe in the indication SHGG. Overall, this pipeline represents a strong and diversified set of launches throughout 2028, supporting our ambition to reach approximately 55 billion of revenues by 2030. Please turn to page 7 for the next slide. AltaVox, you know, continues to be a true standard in our portfolio. In Q1, AltaVox continued to show exuberant growth with 186% and is consistently gaining market share as the launch progresses. We have also launched across the major EU5 markets, although it's worth mentioning or noting that some of these launches are still at a very early stage of rollout. During the quarter, our combined Haemophilia A business grew by 25% at CER. This performance reflects a strong clinical profile of AlteWorks and the disciplined launch execution. We have now launched in 27 countries with key markets such as UK, Italy and France being at an early stage. We can expect to demonstrate exuberant growth in Wave 3 and Wave 2 countries for some time. Overall strong momentum and clear paths for sustained growth. Let me now move to Gummy Fund. In the first quarter, Gummy Fund delivered 734 million SEC in sales, up 47% at constant exchange rate. Growth is driven by the U.S. launch in MAS, where Gummy Fund is now the first approved treatment for both adults and children with MAS and Stills disease with an uptake continuing to build awareness will increase. From a regulatory perspective, we have completed filings in both the US and, sorry, in both in Europe and Japan in Agile Agent MAS, supporting further geographic expansion. We are now also progressing in interferon gamma-driven sepsis, where the Phase IIa EMBRACE study has shown proof of concept, and we are now engaging with regulators on next steps and will provide an update latest by Q2 reporting. Overall, Gamma Fund is delivering strong commercial momentum today with multiple longer-term growth opportunities ahead. Please turn to the next slide. Let me turn now to Asper Valley. In Q1, we are encouraged by the strong uptake of Asper Valley in C3G. The product delivered 371 million in revenues, representing 21% growth versus last quarter. This performance reflects the new momentum from our European and international launch in C3G and ICMPGN, whilst P and H remain stable in line with our expectations. As a reminder, C3G and ICMPGN are areas of high unmet medical need. Today's standard of care does not adequately hold long-term progression and disease progression, and this is something that both physicians and patients are acutely aware of. ASPA Valley directly addresses a key driver of the disease biology, supported by what is believed to be best in class. During the quarter, we began our nephrology launch in Europe, with Germany as an initial focus. I'm pleased to say that the launch is tracking ahead of our internal expectations. We see very positive feedback from the market, including some engagement from nephrologists and a clear preference share for Aspervalli among HCPs from recent research findings. These initial segments improve our belief in the long-term potential of Aspervalli nephrology. For orientation, our 2026 target is to have 400 to 500 patients on Aspervalli therapy. Please turn to the next slide. Dr. Lett continues to deliver very strong growth momentum. In the first quarter, sales reached 1.4 billion SEC, up 44% at constant exchange rates. This performance is driven by strong clinical profile with high efficacy and fewer dietary restrictions, making it an important option in IT fields. Dr. Lett has become a truly global franchise with growth across all three regions, but in particular strong growth in the international region. While demand in the US is consistently expanding, we continue to increase penetration in Europe and experience exponential growth in international markets, particularly in Asia, meaning Japan, and strong growth potential opportunity. Consequently, we expect a material increase of the International's contribution in 2026. Overall, Dr. Lett in 2026 remains a key growth server supported by both established and newly launched markets. Please turn to the next slide. Our Thoroughly Therapeutics is an important step in building our leadership in gout and broaden our immunology therapy area. We completed the acquisition during the quarter, added a high-quality, late-stage portfolio targeting significant unmet medical need. The portfolio is anchored by two complementary programs. Firstly, NASP. We have a CUDUFA date on June 26th and expect feedback from the FDA during the forthcoming weeks. We are ready to launch in chronic refractory gout during Q3. Second, podstertinerate. next-generation once-daily URAD1 inhibitor for progressive gout with a planned launch in 2028. Postdoitinerate represents the primary economic opportunity for SOBI in our gout franchise. For postdoitinerate, the key phase 3 readouts are coming this year, including reduce 2 data in Q2 and reduce 1 in the second half. We are eagerly looking forward to sharing the data when available with you. Overall, this acquisition strengthens our pipeline, expands our presence in Goud, and adds multiple value-creating milestones in the years to come. Please turn to the next slide, and I'd now like to hand over to Lydia.

Thank you, Guido. Hi, everyone. As per usual, I will start with the pipeline milestone. On the next slide, please. We started the year on a very strong foot. As Pavelli in the nephrology indications, C3G in primary ICMPGN was approved in the European Union in January, one month ahead of this schedule timeline. We got positive top-line data for interferon gamma trigamycin and interferon gamma-driven sepsis that enable us to move forward with the clinical development program. And we also got some new data from the EMBRACE study, which I will talk about shortly. We submitted Tringolza for severe hypertriglyceridemia to the European Medicine Agency. And we also fully enrolled all patients in the PACIFICA trial of Bonjo in chronic myelofibrosis. PACIFICA is our confirmatory phase three trial. key to get full FDA approval, and our attention is now on preparing for database log and subsequent submission next year. Next slide, please. Turning to gamifan and interferon gamma-driven sepsis, the initial data from the EMBRACE proof-of-concept study was presented last month in Brussels at ECCAM in the International Symposium on Intensive Care and Emergency Medicine. During our Capital Markets Day, we already share the key study results of EMBRACE that show an improvement in organ dysfunction, as measured with the SOFA score, and patient survival with emupadumab at the end of treatment on day 28. 60% of patients in the high-dose emupadumab arm achieved the primary endpoint of decrease in SOFA score, compared to 40% in the standard treatment plus placebo. This is shown in the left chart, which was presented at ECCAM. These results translate into five patients needed to treat to improve organ function of one patient, which is very encouraging in sepsis. Last week, the long-term mortality follow-up was presented at the World Sepsis Congress. It confirmed a maintained survival benefit with a Mopalumab high dose, as you can see on the right chart. At the end of the study treatment, day 28, we saw a 12% point benefit of the high-dose treatment. And very similar results were seen in the follow-up period, showing maintained survival benefit at days 60 and 90. This further supports the proof of concept and our belief in advancing the clinical development of gamifan for interferon gamma-driven sepsis. Next slide, please. Looking ahead, we anticipate continued momentum with major regulatory milestones across U.S., Europe, and Japan, as well as key clinical data. In the first half of 2026, we plan for the NASP FDA decision in June, the first poditinerate readout from the reduced to pivotal trial in progressive gout, and the LODIS 5 data readout in relapsed refractory diffuse large B-cell lymphoma. Later in the year, we expect the Japanese regulatory decisions for both aspaveli in the nephrology indications and for gamifan in HLH mass. We will see the second poditineral readout, in this case from the reduced one pivotal trial. And finally, the Tringolsa CHMP opinion in severe hypertriglyceridemia is also expected before end of the year. And with that, I would like to hand over to Henrik. Next slide, please.

Thank you, Lydia. And hello, everyone. Please turn to the next slide. And we take a look at some key financial metrics for the quarter. So in Q1, our revenues of 7.2 billion correspond to revenue growth of 24% at CER, and hematology increased by 24%, and our combined hemophiliae portfolio increased by 25% as Altaboxy continued its strong launch momentum and is now launched in all major EU markets. It's an obsolete increase by 44% at CER, driven by strong growth in all three regions. And Asperalli Nephrology, as we saw, is now launched in its first market with positive feedback. In Immunology, we saw strong double-digit growth in both Gamifant and Kineret, offset by lower RSV royalties. Specialty care also increased by 24% at CER, driven by new patients in Trigulsa on FCS and patient growth in some other specialty care medicines. If we look at the table on the right, then the adjusted gross margin of 77% in the quarter is in line with last year. Gross margin was positively impacted by product mix and country mix effects, offset by lower Bay Fortress royalties. Operating expenses excluding non-recurring items and amortization for the quarter increased by 15% at CER compared to Q125, reflecting the increased activity level in the company. SG&A also excluding non-recurring items and amortization increased by 12% at CER, driven by launch and pre-launch costs for Altevoxt, Aspavelli Nephrology, NASP, and Tringolsa. And R&D expenses increased by 22% at CR, excluding non-recurring items, mainly due to the addition of off-road seat development programs, as well as increases related to Trinconza and Bonjour. And as a result, the adjusted EBITDA for the quarter amounted to $2.8 billion, equal to a margin of 38% compared to 36% for the same period last year. Operating cash flow for the quarter was 1.1 billion. Higher operating profit was offset by high working capital build-up due to three main items, authority transaction-related payments, inventory prepayments, and lower Bay Fortis royalty payments following lower sales last year. And as a result, the net debt at the end of the quarter was just below 18 billion. Net debt to EVTA ratio of one and a half times. Please turn to the next slide. And the financial outlook for the full year 2026. As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2026, the outlook remains unchanged. We anticipate revenue to grow at low double-digit percentage at CR and an adjusted EBITDA margin in the mid-30s. percentage of revenue. The key drivers for the 2026 outlook that we discussed in connection with the Q4 report in February are still relevant. On the revenue guidance, we expect continued progress with our existing commercial portfolio without the box being a continued key growth driver. Bay Fortress, not to be too repetitive, remains difficult for us to forecast, but we don't believe that the fundamentals have changed with regards to recommendations and reimbursement. Regarding our EBITDA margin guidance, I want to reiterate some key costs that we will have in 2026 that are new or accelerated compared to 2025. First, we have the pre-launch and launch cost for Astor Valley and ASP. While we had some of those costs in Q1, they will continue to accelerate as we get approval in additional countries across the valley and as we get fully staffed for NASP closer to launch. Second, filing and pre-launch costs related to Tringolsa in SHCG. In March, we submitted to EMA for the indication expansion for SHCG, so we will also continue to see the additional costs moving forward as we near launch. Third, the acquisition of Arthrosi, as the R&D costs of two ongoing phase three studies and preparation for regulatory submission. Finally, we're also planning the continued development of Gamifund in IDS, and this is something we will come back to after our interactions with regulators. And all these costs will partly be offset with reallocation of resources and cost containment in the rest of the business. including the full-year impact of the cost savings initiatives from 2025. With this, I now hand back to Ido.