Swedish Orphan Biovitrum AB

Hello, everyone. This is Guido Erckes, CEO of Sobi. We are delighted to welcome you to the fourth quarter and full year 2025 conference call for investors and analysts. We posted this presentation to sobi.com earlier today. We would like to remind you of usual provisions on statements about expectations and projections of future events. Unless otherwise stated, we will make comments mostly relate to the second quarter at constant currency, or fourth quarter, apologies, and a million Swedish krona. Today we plan to cover the key aspects of our Q4 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Abarth-Franz, head of R&D and chief medical officer. We plan to review the presentation first and then have a question an answer session until around 2 p.m. For those on the phone, please join the queue for questions by pressing star one. We propose you ask only one question or two max at a time. So with this, let's go straight to the key takeaways for the fourth quarter. It has been a quarter for Suvi along various dimensions, you know, financially, strategically, and scientifically, and I'm pleased to say that we demonstrated significant progress along all these three areas in 2025. In the fourth quarter, we delivered 16% revenue growth at constant currency, driven by exceptional 37% growth of our strategic portfolio. This reflects the consistent execution we have shown all year, and the fundamental demand for innovative medicine we bring to patients. For the full year, we delivered 15% growth at constant currency with a significant contribution from every region, and we maintained a 40% adjusted EBITDA margin driven by demonstrated operational excellence and also targeted cost alignment. We also strengthened our immunology, respectively gout, and positions solely for leadership in a large, underserved patient population. We received EU approval of Aspavelli in nephrology with a broad label that we believe will reshape the treatment in both C3G and ICMPGN. A strong quarter, a strong year, and a business entering 2026 with strong momentum. We are excited to have launched Tringolsa in FCS in Germany, whilst the main indication will be SHTG, or as we called it previously, MCS, above 880 mg per deciliter, expected, by the way, in Q1 2027, the launch. We are happy to make the drug available and inform the medical community about this breakthrough molecule. In addition, We achieved positive proof-of-concept data for gamifont in interferon gamma-driven sepsis, which is an area with high unmet medical need. Let's turn to slide number five. Let's have a closer look at the Q4 performance. It was broad, but also balanced. Each region contributed, as earlier outlined, and our key products continued to scale effectively. Our strategic portfolio is now the central engine of service performance, representing a shift towards high value, high innovation assets, now representing 65% of our total revenues in Q4. Please turn to slide number six. For the full year 2022, This is a meaningful broad-based growth across all therapeutic areas, hematology, immunology, and specialty care. Each of these pillars contributed significant value and each has multiple drivers still at early stages of the life cycle. Our strategic portfolio has become 59% of our total business and is increasing as the Q4 numbers indicate. Our strategy to deliberately shift towards best-in-class next-generation therapies is paying off. This performance provides a solid foundation as we now move into 2026 with the richer pipelines, more launches, and more geographic expansion. Please turn to slide number seven, turning to AltaWalk as two stand out in our portfolio. In Q4, Altowalk exceeded one billion kroner in sales and full-year Haemophilia A revenues surpassed 6.8 billion kroner. This trajectory reinforces Altowalk as a best-in-class therapy and one that is increasingly becoming standard of care in many markets. Our regional launch strategy foresees a rollout in three waves. Wave one includes The early launch countries, the DACH region and Spain, Wave 2 with France launching in Q4 and Italy launching in January, is just beginning to unlock its full potential. These are major hemophilia markets and we are only at really early stages of penetration. And Wave 3, the remaining European countries and international markets, represents an additional runway of growth over the next several years. Please turn to slide number eight. Dr. Lett is another strong performer for Sobi quarter on quarter. It continues to deliver in Q4 and it grew 47% at constant currency. Dr. Lett has become a truly global brand with performance across Europe, North America, and international. One should highlight Japan that launched in Q4 and demonstrated impressive uptake. As more international markets come online, we expected Doctilence growth to remain strong, whilst we may see some moderation in the US growth due to the Promecta generics in 2026. Please turn to slide number nine. Aspa Valley reached an important milestone in January with the EU approval for C3Gs and ICMPGL. Our launch strategy in Germany is underway. A recent survey has shown that the awareness on Paxetaco plant's best-in-class efficacy has rapidly grown amongst nephrologists in Europe. The recent publication of the valiant data in the New England Journal of Medicine was very helpful in this regard. However, it will take a while until this indication will change the economics of SOBI as we are building a new market with specific requirements prior to use and will obviously follow the usual launch sequence in Europe. Notwithstanding, as per Willi, we've become a key growth driver for SOVI during the coming years, and we are very pleased with the progress here today. Please turn to slide number 10. Now turning to before this, where we see a decline in Q4 revenues compared to a very strong Q4 2024. Seasonality and inventory fluctuations have influenced the sales evolution on this category, but none of these dynamics has changed our view on the long-term adoption curve or on the fundamental demand outlook. While there has been some changes to the overall vaccine policy, it is important to remember that the guidelines for RSV has remained as before. Bay Fortis is still recommended for all newborns unless the mother has received a maternal RSV vaccine. Support from the pediatric associations and U.S. healthcare providers remain strong, as does the continual real-world evidence readout from Bifortis. Real-world evidence across 85,000 infants show an 83% reduction in RSV-related hospitalization. We wanted to take a pulse on how prescribers are feeling about the next RSV season, and our survey included more than 100 US physicians. 80% expect RSV immunization volumes in 26 out of 27 to match or exceed the current season, and 90% expect Bifortis to remain the product of choice, indicating a strong preference for the treatment, a perspective that appeared to be supported by recent reports. Please turn to slide number 11. GAMIFund has accelerated growth in Q4 again. We saw 70% growth in Q4, driven by the US launch in MAS. GAMIFund is the first approved therapy for macrophage activation syndrome, and education efforts are resonating strongly with hematologists, oncologists, and rheumatologists. We now completed filings in Europe and Japan for HLH-MAS, which will significantly broaden the patient reach and accelerate international growth. We are excited about Gamifund's expansion over the next two quarters and look forward to the progress in 2026. You will hear more from Lydia on exciting developments in sepsis for the potential utility of Gamifund as an inter-reform gamma scavenger. Please turn to slide number 12. Looking ahead, SUBI is entering an unprecedented launch cycle. Between now and 2028, we expect six high-value medicines to reach the market by 2028. The acquisition of POIS Dirtinerate strengthens our long-term position in gout, while Stringolza positions us for leadership in severe hypertriglyceridemia. Our latest launch, Aspervillian Nephrology, targets an underserved patient population with substantial scientific and commercial potential. These six launches will radically transform SOVI's trajectory well into the 2030s. To realize this potential, the potential of these assets, we need to commit significant resources for development, medical, and commercial efforts in 2026. These commitments have been partially funded by our annualized impact of our cost alignment program in 2025 and business goals. However, it will also moderate our expected EBITDA margin in 2026. Please turn to slide 13. As we look forward to 2026, our strategic priorities are pretty clear and are the following. We will continue The strong rollout of ALTOVOGT, expand GAMIFUND in HLH MAS in the US, execute the European launch of ASPA Valley in C3G. We are preparing for the NASP launch in United States. We will advance GAMIFUND into the next phase of IDS. We will continue to progress our development programs for WONJUR and ALTOVOGT. And importantly, we plan to integrate through the therapeutics and conclude its phase three program. These priorities position SOBE for rapid, sustainable growth, not just in 2026, but also propel SOBE into the next decade. However, the size of the opportunities correlates with the necessary commitment. Coming from a very strong financial base and profitability in 2025, trade-off decisions between today, tomorrow, and tomorrow after tomorrow needed to be made. Henrik will explain the economics of these choices in 2026 in more detail during this call at a later stage. However, it is a happy problem to have. are excited to progress such an impressive number of projects of transformational nature. Hence, I'd like to now hand over to Lydia, who will share her perspective from an RD's perspective of our portfolio. Lydia?

Thank you, Guido. Hello, everyone. So let's start with the pipeline milestone on the next slide, please. We are carrying a very strong momentum, and here's what happened in the fourth quarter. Astabelli in C3G and primary ICMPGN received CHMP positive opinion in the European Union and was submitted to PMDA in Japan with a pivotal valiant study published in the New England. And I will come back to this asset in more detail. Gamifund moved forward in HLH mass with filings in both Japan and Europe. We also got positive top-line data for gamifan in interferon gamma-driven sepsis that enabled us to move forward with the program. And the Tringolza Pivotal data from the CORE and CORE2 studies in severe hypertrophic uridemia was also published in the New England. We started building our R&D hub in Japan in 2022, and the submissions of Aspaveli and gamifan in parallel to the European submission show that this approach is paying off and will enable us to earlier launches. Finally, the two New England papers published last quarter also demonstrate that SOVI, together with our partners, are at the forefront of science, driving a strong clinically meaningful data. Let's now have a deeper look at Astavelli in nephrology, Gamifan in IDS, and Tringolza in severe hypertriglyceridemia. Next slide, please. The global launch of Astavelli methodology is now taking place. In 2025 and January this year, it was approved for both C3G and primary ICMPGN in the European Union, Australia, Brazil, Saudi Arabia, South Korea, and Switzerland. We're also having ongoing submissions in Japan, UK, Canada, and other global markets. There is a very strong interest in the medical and patient community. From recent insights among physicians who treat these diseases, the vast majority believes that complement inhibition will lead to earlier diagnosis and screening strategies and will reduce the need to initiate immunosuppressive therapy. We have also positive reports of the first infused uses in Brazil and South Korea. The rollout of these on body device to simplify the infusion will take place in parallel with the launch of the nephrology indications. The phase three Valium data published in the New England, together with the recently updated one-year follow-up, is very encouraging. We plan to publish further long-term data from our phase three extension trial, and we're setting up a phase four clinical program to create further evidence on the use of pexetacuplant in real clinical practice. Next slide, please. Turning to gamifan in interferon gamma-driven sepsis, this could address a significant medical need and an important burden to healthcare systems. Sepsis is a life-threatening medical emergency which arises when the body's response to infection causes injury to its own tissues and organs. This can lead to shock, multi-organ failure, disability, and death, especially if it's not recognized early and treated promptly. Sepsis is the leading cause of death worldwide, responsible for about one in five deaths. Almost 50 million people suffer from this condition, and 11 million die from it. It also leads to high healthcare costs, with an estimated $60 billion of hospital costs in the U.S. alone. The Hellenic Institute for the Study of Sepsis, or HISS, identify an endotype of sepsis which is characterized by elevated CXL9 an interferon gamma, and an increased risk for 28-day mortality. We investigated this subset of sepsis patients in a research collaboration with Heath in a study called EMBRACE. The EMBRACE exploratory phase IIa study has now shown an improvement in organ dysfunction and patient survival with hemopalumab treatment. This top-line data supports the proof of concept and allow us to advance the development of gamifan for this indication. We have started initial interactions with regulators, and we'll discuss the next step for clinical development with them. The data will be presented at the ECCAM conference in Brussels next March, and you will hear about this exact new indication at our Capital Market Day on February 18th. Next slide, please. Another example of our scientific advancements is Tringulsa in severe hypertriglyceridemia. In November, the New England published the CORE and CORE2 studies, the pivotal data of olivarsin in this indication, and it was simultaneously presented at the American Heart Association Conference. Severe hypertriglyceridemia is characterized by triglyceride levels above 500 milligrams per deciliter. It's a very severe condition. Patients face an increased risk of acute pancreatitis, which is a medical emergency that frequently requires hospitalization. It is associated with higher morbid mortality compared to acute pancreatitis of other causes. CORE and CORE2 evaluated oligosarcin added to standard of care. The placebo-adjusted triglyceride lowering achieved in this trial was approximately double what is currently achievable for patients with severe hypertriglyceridemia. It resulted in a reduction of triglycerides up to 72% with a durable response of 12 months. The primary purpose for hypertriglycerides lowering in severe hypertriglyceridemia is basically to reduce the risk of acute pancreatitis, which can be life-threatening. Current therapies have more modest triglyceride-lowering effects in these patients and have not been proven to reduce the incidence of pancreatitis. The current core 2 data demonstrated that olisarcin reduced the rate of acute pancreatitis by 85% in patients with severe hypertriglyceridemia, meaning that olisarcin is the first and only treatment that reduces acute pancreatitis risk in this group of patients. This makes a strong case, which will be the basis for our European submission later this quarter in patients with severe herpetrythroceridemia with triglyceride levels above 880. Next slide, please. Looking ahead, we anticipate continued momentum with the major regulatory submissions in the US, 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 EU submission of Tringolsa in severe hypertriglyceridemia above 880, and the LOTIS-5 data readout in relapsed refractory diffuse large B-cell lymphoma. Later in the year, we will see initial study data from the ALTBOX Freedom Study, including important joint health data, the Japanese regulatory decisions for in the nephrology indications and gamifan in HLH mass. And we do expect EU CHMP opinion on gamifan late in the year or early in 2027. With that, I would like to hand over to Henrik. Next slide, please.

Henrik Henrik. Thank you, Lydia, and hello, everyone. So, please turn to slide 21. We will now take a look at some key financial metrics for the quarter. So, in Q4, our revenues of 7.8 billion correspond to revenue growth of 16% at constant currencies. Helitology increased by 25% at CER, driven by the strong launch of Alkabot and continued progress in Dobsonet across all three regions. In immunology, we saw strong double-digit growth in both Gamifant and Kynret, offset by lower RFD royalties. And in specialty care, we initiated the launch of Trigosa in the FCS indication. If we look at the table on the right and the adjusted gross margin, which was 81% in the quarter compared to 78% last year, we saw an improvement in gross margin from positive product and country mix effects, but this was somewhat offset by the FOTUS royalties and FX impacts. Operating expenses, excluding non-recurring items, and amortization for the quarter increased by 3% at CER, compared to Q4-24. SG&A, also excluding non-recurring items, and amortization increased by 6% at CER, driven by launch and pre-launch costs for Outerbox, Testa Valley, Inifrology, NASP, and Trinolsa. And this was partially offset by lower costs across Bongeo, top-select synergies, and in Okta, and the cost savings initiative we outlined in Q2. R&D expenses declined by 2% at CER, excluding non-recurring items, mainly due to NASP programs that are now complete, as well as the cost savings initiative from Q2. And this was partially offset by development programs in Mongeau and Gallifant. And as a result, the adjusted EBITDA for the quarter amounted to $3.2 billion, equal to a margin of 41%, compared to 34% for the same period last year. Operating cash flow for the quarter was close to $3 billion, compared to $1.8 billion last year, driven by improved operations. And net debt at the end of the quarter was about $10 billion, and net debt to EBITDA ratio of 0.9 times, This does not reflect the expected acquisition of Arthrosy, which is planned to add about $9 billion of debt or less than one times EBITDA. Next slide, please. If we now turn to full-year performance, we delivered strong profitable growth in 2025, and we exceeded our updated guidance from Q3 on revenue and margin. For the full-year 2025, we achieved just above 28 billion in revenue, equal to growth of 15% at CER. And this growth was driven by double-digit growth in each of our three regions, outlining the advantages we have in our portfolio and geographic diversification. From a product perspective, Altegopt, Optelet and Gamifund were the main drivers, more than offsetting low revenue from RSV and Bonjo. In 2025, we saw 0.8 percentage points increase in gross margin driven by products and country mix. And the adjusted EBITDA margin for the full year was 40%, an increase of 4 percentage points versus last year, as we saw strong operating leverage with revenue growth of 15% and obvious growth of 4% at cost of currencies. Within R&D, spend decreased by 3%, mainly due to lower NASP development costs, as well as the impact of our cost control measures. And in SG&A, OPEX increased by 8%, driven by launch of Altabox, but also pre-launch of Espavelli in nephrology and NASP, as well as higher activity for Gamifant. And these activities were partly offset by the cost measures we put in place in Q2, as well as generally a rigorous cost control. Please turn to the next slide. And we come to the financial outlook for the full year 26. And as usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2026, we anticipate revenue to grow at low double-digit percentage at CER and an adjusted EBITDA margin in the mid-30s percentage of revenue. On the revenue guidance, we certainly expect continued progress with our existing commercial portfolio, where AltaVox is now approved and reimbursed in all major European markets, and we expect the product to continue to be a major growth driver in 2026 as markets still have plenty of room to grow. And we expect additional revenue benefit in the launches of Aspa Valley in nephrology and ASP, although mainly the second half of the year due to the NASP PDUFA date expected in late June, as well as the phased launch of Aspa Valley across European markets as we get reimbursement country by country. Bay Fortress, as before, remains difficult for us to forecast since we are not running that business. But we don't believe that fundamentals have changed with regards to competition, recommendations, and reimbursement. In regards to our EBITDA margin guidance, I want to highlight some key investments that we will have in 2026 that are new or accelerated compared to 2025. First, we have the pre-launch and launch cost for Asper Valley and NASP, both visible in 2025, but set to accelerate in 2026. Second, with the strong data from the pivotal phase three trials in Trigolsa, in SHGG, and the opening of a large market opportunity, we will have costs in 2026 related to filing and pre-launch activities of that indication. Third, we expect to finalize the acquisition of Arthrosi, and if so, we will be completing two ongoing phase three studies and prepare for regulatory submission, adding those costs to our R&D line. And finally, we've included a continued development of Damifant in IDS. We're still in discussions with health authorities, but we have assumed, considering the positive signals from the phase two A study, that we will take it to the next phase of development. and further details are to be confirmed. All these investment areas will be partly offset with reallocation of resources and cost containment in the rest of the business, including the full year impact of the cost saving initiatives from 2025. And to conclude, it is of course critical that we adequately invest in these new areas in 2026 to position so before the future. And with this, I hand over to Guido. Thank you.