New Risk • Jul 17
New minor risk - Financial position The company has a high level of debt. Net debt to equity ratio: 44% This is considered a minor risk. Having a high level of debt increases the company's balance sheet risk. The company has a higher interest repayment burden, leading to the need to allocate a greater amount of its earnings towards servicing the debt, potentially limiting growth options or shareholder distributions. It can also increase the risk of bankruptcy if business conditions deteriorate enough that the company can no longer meet its debt obligations. Currently, the following risks have been identified for the company: Minor Risks High level of debt (44% net debt to equity). Share price has been volatile over the past 3 months (6.5% average weekly change). Large one-off items impacting financial results. Profit margins are more than 30% lower than last year (3.2% net profit margin). Significant insider selling over the past 3 months (€8.2m sold). Reported Earnings • Jul 17
Second quarter 2026 earnings released: EPS: kr3.17 (vs kr1.85 in 2Q 2025) Second quarter 2026 results: EPS: kr3.17 (up from kr1.85 in 2Q 2025). Revenue: kr7.84b (up 27% from 2Q 2025). Net income: kr1.10b (up 73% from 2Q 2025). Profit margin: 14% (up from 10% in 2Q 2025). Revenue is forecast to grow 9.6% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. Announcement • Jul 10
Swedish Orphan Biovitrum AB (publ) Announces Positive Reimbursement Recommendation For EMPAVELI (Pegcetacoplan) For Treatment Of C3G And Primary IC-MPGN In Canada Swedish Orphan Biovitrum AB (publ) announced that Canada’s Drug Agency has issued a positive reimbursement recommendation with conditions for EMPAVELI (pegcetacoplan) for the treatment of adult and adolescent patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria. EMPAVELI is the first treatment authorized in Canada for C3G or primary IC-MPGN. The positive recommendation from Canada’s Drug Agency marks an important milestone in the reimbursement process for public drug plans across Canada. The recommendation was informed by data from the Phase 3 VALIANT study, the largest single clinical trial conducted in patients with C3G and primary IC-MPGN. The study evaluated pegcetacoplan in 124 patients aged 12 years and older and demonstrated clinically meaningful reductions in proteinuria, stabilization of kidney function, and clearance of C3 deposits. C3G and primary IC-MPGN are rare kidney diseases driven by uncontrolled activation of the complement system, leading to inflammation and kidney damage. Approximately 50% of people living with these diseases experience kidney failure within five to 10 years of diagnosis, often requiring dialysis or kidney transplantation. Disease recurrence following transplant is also common. EMPAVELI (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Following Canada’s Drug Agency’s recommendation, reimbursement discussions with participating public drug plans will proceed through the pan-Canadian Pharmaceutical Alliance. EMPAVELI (pegcetacoplan) is the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older approved in the United States, European Union, Canada and other countries globally. EMPAVELI is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in Canada, the United States, European Union, and other countries globally. The VALIANT Phase 3 study (NCT05067127) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated pegcetacoplan efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive pegcetacoplan or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received pegcetacoplan. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline. Announcement • Jun 13
Sobi Presents New Clinical and Real-World Data for Aspaveli, Doptelet, Gamifant, and Vonjo At Eha 2026 Sobi announced that new clinical and real-world data will be presented at the 2026 Congress of the European Hematology Association (EHA2026), taking place June 11–14 in Stockholm, Sweden. The presentations include data across paroxysmal nocturnal haemoglobinuria (PNH), immune thrombocytopenia (ITP), primary haemophagocytic lymphohistiocytosis (HLH), and myelofibrosis. The data include real-world evidence and post hoc analyses for Aspaveli (pegcetacoplan), Doptelet (avatrombopag), Gamifant (emapalumab), and Vonjo (pacritinib). Oral presentation: Doptelet (avatrombopag) Impact of protocol mandated dose holds on platelet response durability in pediatric ITP treated with avatrombopag: AVA 301 post hoc analysis. Poster presentations: Aspaveli (pegcetacoplan) Sustained long-term real-world effectiveness and safety of pegcetacoplan in patients with PNH: COMPLETE Phase 4 study. Aspaveli (pegcetacoplan) Real-world hemoglobin concentrations and transfusion burden in patients with paroxysmal nocturnal hemoglobinuria receiving complement inhibitors: A US retrospective claims data analysis. Doptelet (avatrombopag) Avatrombopag in TPO RA–naive adults in acute, persistent, and chronic phases of ITP: results from the REAL AVA 3.0 retrospective study. Vonjo (pacritinib) Consistency of response by baseline platelet count in pacritinib-treated patients in the real world: MY-PAC Analysis. Publication-only abstracts: Aspaveli (pegcetacoplan) Incidence rates of serious infections in patients with Paroxysmal Nocturnal Hemoglobinuria: A Real-World Comparison using data from TriNetX Across the US, Europe, and Other Regions. Aspaveli (pegcetacoplan) Case reports of pegcetacoplan treatment in paroxysmal nocturnal hemoglobinuria (PNH) – a systematic review. Aspaveli (pegcetacoplan) Real-world physicians and patients perspectives on adherence, satisfaction with pegcetacoplan, and health related quality of life across europe, the United States and Canada: A cross-sectional study. Gamifant (emapalumab) Emapalumab in treatment-experienced primary HLH: Safety, efficacy, and transplant outcomes from the open-label, single-arm post-authorization study Sobi.EMAPALUMAB-104 in Chinese patients. Vonjo (pacritinib) Real-world treatment patterns and outcomes in patients with myelofibrosis treated first-line with pacritinib or ruxolitinib. Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally. It is the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older approved in the United States, European Union, and other countries globally. Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that increases platelet count. It is approved in the United States, European Union and Japan for thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure, and for ITP in adults according to local labeling. In the United States, Doptelet is also approved for pediatric patients 1 year and older with persistent or chronic ITP who have had an insufficient response to a previous treatment. Gamifant is the only approved anti-interferon gamma (IFNy) monoclonal antibody. Gamifant works by binding to and neutralising interferon gamma (IFNy). When interferon gamma (IFNy) is secreted in an uncontrolled manner, hyperinflammation occurs within the body. Gamifant is indicated for administration through intravenous infusion over one hour. Gamifant is approved in the US for the treatment of adult and paediatric patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Gamifant is also approved in the US for the treatment of adult and paediatric patients with haemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still's disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. Vonjo is a kinase inhibitor that is indicated in the US for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Announcement • May 27
Swedish Orphan Biovitrum AB Announces Results From New Analysis Of Tryngolza Phase 3 CORE And CORE2 Trials Swedish Orphan Biovitrum AB announced results from a new analysis of the pivotal Phase 3 CORE and CORE2 trials, showing Tryngolza (olezarsen) reduced the relative risk of acute pancreatitis events by 85% (P<0.001) and reduced triglycerides by 66% in patients with severe hypertriglyceridemia (sHTG) after six months. The pooled subgroup analysis, presented as a late breaking abstract at the European Atherosclerosis Society (EAS) 2026 Congress in Athens, Greece, included 455 patients with baseline triglycerides of =880 mg/dL (~10 mmol/L), defined by the EAS as severe hypertriglyceridemia. At six months, patients randomised to receive olezarsen 80 mg showed a placebo-adjusted reduction in triglycerides of 66%, and those on olezarsen 50 mg a 59% reduction (each P<0.001). Overall, 85% of olezarsen-treated patients achieved triglycerides of <10 mmol/L. Severe hypertriglyceridemia is the third most common cause of acute pancreatitis. The incidence of acute pancreatitis globally has increased at an average annual rate of 3% since the 1960s, contributing to a growing burden on healthcare systems. The results, presented by Dr Andre Zimerman on behalf of the TIMI Study Group, showed olezarsen 80 mg and 50 mg also reduced remnant cholesterol by 64% and 53%, respectively, and non-HDL-C by 35% and 27%. The absolute reduction in pancreatitis events with olezarsen was 12 per 100 patient-years, meaning treating nine patients over one year would prevent one acute pancreatitis event in the type of patients included in the study. The safety profile in the subgroup analysis was favourable and similar to the broader trial population. In March 2026, the European Medicines Agency validated an indication extension application for olezarsen for the treatment of adults with sHTG and triglyceride levels =880 mg/dL (~10 mmol/L), aligned with EAS guidelines. In February 2026 the U.S. FDA accepted for Priority Review a supplemental New Drug Application for olezarsen for sHTG (triglyceride levels =500 mg/dL), with a target action date of June 30, 2026. Olezarsen is developed by Ionis Pharmaceuticals. Sobi and Ionis entered into a license agreement under which Sobi has exclusive rights to commercialise Tryngolza in ex-U.S. geographies except Canada and China. Severe hypertriglyceridemia (sHTG) is defined by severely high triglyceride levels =500 mg/dL (=5.65 mmol/L) and triglyceride levels =880 mg/dL (~10 mmol/L) are often associated with the increased accumulation of chylomicrons in the blood and with an increased risk of acute pancreatitis and other morbidities. Considered a medical emergency, acute pancreatitis causes debilitating abdominal pain that often requires prolonged hospitalisation, can lead to permanent organ damage and can become life-threatening. Preventing the first pancreatitis event is key. Current standard of care therapies for sHTG and lifestyle modifications (such as diet and exercise) do not sufficiently or consistently lower triglyceride levels or reduce the risks in all patients. Approximately 2 million people are living with sHTG in the EU5, including approximately 700,000 with TG levels =880 mg/dL (~10 mmol/L). CORE (NCT05079919; n=617) and CORE2 (NCT05552326; n=446), conducted with The TIMI Study Group, were Phase 3 global, multicentre, randomised, double-blind, placebo-controlled trials investigating the safety and efficacy of olezarsen for sHTG. Participants aged 18 years and older with triglyceride levels =500 mg/dL (5.65 mmol/L) were enrolled. Participants were required to be on standard of care therapies for elevated triglycerides. At baseline, 43% of participants had fasting triglycerides =880 mg/dL (~10 mmol/L). Participants were randomised to receive 50 mg or 80 mg of olezarsen or placebo every 4 weeks via subcutaneous injection for 12 months. The primary endpoint was the percent change from baseline in fasting triglycerides at six months compared to placebo. Olezarsen is an RNA-targeted medicine being evaluated for the treatment of severe hypertriglyceridemia. Olezarsen is designed to lower the body's production of apoC-III, a protein produced in the liver that regulates triglyceride metabolism in the blood. Olezarsen is approved in the U.S., European Union, and other countries as TRYNGOLZA for adults with familial chylomicronemia syndrome (FCS). 
