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). Live News • Jun 02
Sobi Reports Major Risk Reduction With Tryngolza and Progresses on FDA Priority Review Sobi released pooled Phase 3 CORE and CORE2 data for Tryngolza (olezarsen) in severe hypertriglyceridemia, showing an 85% relative risk reduction in acute pancreatitis events after six months of treatment.
The trials reported a 66% reduction in triglycerides for patients with baseline levels at or above 880 mg/dL, with 85% of treated patients reaching triglyceride levels below 10 mmol/L.
Positive efficacy and safety data were also reported for pozdeutinurad in gout, and the FDA has accepted Tryngolza for Priority Review with a decision date set for February 2026.
These data points indicate that Sobi now has late-stage assets with clinically meaningful outcomes in both severe hypertriglyceridemia and gout, as well as a defined U.S. regulatory timeline for Tryngolza.
Investors may want to monitor how the Priority Review process progresses and any additional clinical or safety updates that could influence future positioning of Tryngolza and pozdeutinurad within their respective treatment areas. Announcement • May 28
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). Announcement • May 24
Swedish Orphan Biovitrum AB Announces Positive Topline Results from Pivotal Phase 3 Reduce 2 Study of Pozdeutinurad in Gout Swedish Orphan Biovitrum AB announced positive topline results from the pivotal Phase 3 REDUCE 2 study (NCT06439602) evaluating pozdeutinurad (AR882), an investigational next-generation once-daily oral selective URAT1 inhibitor, in adults with gout including those with uncontrolled gout (also referred to as progressive gout) and inadequately controlled by existing therapies. Both doses of pozdeutinurad met the primary efficacy endpoint, defined as the proportion of patients achieving a serum uric acid (sUA) level <6 mg/dL at month 6, compared to placebo. The study evaluated once-daily oral doses of pozdeutinurad 50mg, pozdeutinurad 75mg or placebo. The primary efficacy endpoint was proportion of participants whose sUA level is <6 mg/dL at month 6. Pozdeutinurad was overall well tolerated, and the safety profile was consistent with previous studies. Recent Insider Transactions • May 11
CEO & President recently sold kr18m worth of stock On the 5th of May, Guido Oelkers sold around 41k shares on-market at roughly kr433 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Guido has been a net seller over the last 12 months, reducing personal holdings by kr123m. Announcement • May 08
Swedish Orphan Biovitrum AB (publ) Elects Board Members Swedish Orphan Biovitrum AB (publ) (Sobi) at its AGM held on May 6, 2026 approved the election of Mikael Dolsten and Åsa Riisberg as new Board members for the period until the end of the next AGM. Announcement • Apr 30
Swedish Orphan Biovitrum AB (publ) Reaffirms Earnings Guidance for the Year 2026 Swedish Orphan Biovitrum AB (publ) reaffirmed earnings guidance for the year 2026. For the year, the company expects revenue to grow at low double-digit percentage at CER. Announcement • Apr 29
Swedish Orphan Biovitrum AB (publ) to Report Q4, 2026 Results on Feb 04, 2027 Swedish Orphan Biovitrum AB (publ) announced that they will report Q4, 2026 results on Feb 04, 2027 New Risk • Apr 28
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). Large one-off items impacting financial results. Profit margins are more than 30% lower than last year (3.2% net profit margin). Announcement • Apr 10
Swedish Orphan Biovitrum AB (publ) Receives Health Canada Approval for EMPAVELI (Pegcetacoplan) for Treatment of C3G and Primary IC-MPGN Swedish Orphan Biovitrum AB (publ) announced that Health Canada has approved EMPAVELI (pegcetacoplan), a complement inhibitor, for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria. EMPAVELI is a targeted C3 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. C3G and primary IC-MPGN are rare kidney diseases affecting approximately 700 patients in Canada. More than half of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy. This approval is based on positive results from the Phase 3 VALIANT study, in which EMPAVELI demonstrated benefits across the three key endpoints identified by the Kidney Health Initiative (KHI) C3G Trial Endpoints Working Group, including significant reduction in proteinuria (68% relative reduction in uPCR), stabilization of kidney function, and substantial clearance of C3 deposits. These positive results were recently published in The New England Journal of Medicine. Sobi and its partner Apellis Pharmaceuticals Inc. have global co-development rights for systemic pegcetacoplan. C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy. Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence. The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe. 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. 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. 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, 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. Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive non-U.S. commercialization rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. Reported Earnings • Apr 01
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: kr1.39 (down from kr11.37 in FY 2024). Revenue: kr28.2b (up 8.5% from FY 2024). Net income: kr478.0m (down 88% from FY 2024). Profit margin: 1.7% (down from 15% in FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 131%. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 10.0% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has increased by 19% per year, which means it is well ahead of earnings. Announcement • Mar 30
Sobi Validates Indication Extension Application for Tryngolza (Olezarsen) for the Treatment of Severe Hypertriglyceridemia Sobi announced that the European Medicines Agency (EMA) has validated an indication extension application for Tryngolza (olezarsen) for the treatment of adult patients with severe hypertriglyceridemia (sHTG) =880 mg/dL (=10 mmol/L). Patients with elevated triglyceride levels have substantially higher risks of all-cause mortality, atherosclerotic cardiovascular events, and acute pancreatitis. The submission is supported by results from the pivotal Phase 3 CORE and CORE2 studies, which were published in the New England Journal of Medicine in 2025. Tryngolza (olezarsen) was approved in the European Union in September 2025 as an adjunct to diet for the treatment of adult patients with genetically confirmed familial chylomicronemia syndrome (FCS). Severe hypertriglyceridemia (sHTG) is defined by severely high triglycerides =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 attack 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, are Phase 3 global, multicentre, randomised, double-blind, placebo-controlled trials investigating the safety and efficacy of olezarsen for severe hypertriglyceridemia (sHTG). Participants aged 18 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 sHTG. 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., Canada, and the European Union as TRYNGOLZA for adults with familial chylomicronemia syndrome (FCS). Announcement • Mar 28
Swedish Orphan Biovitrum AB (publ), Annual General Meeting, May 06, 2026 Swedish Orphan Biovitrum AB (publ), Annual General Meeting, May 06, 2026, at 10:00 W. Europe Standard Time. Location: iva konferenscenter, grev turegatan 16, stockholm Sweden Announcement • Mar 18
Swedish Orphan Biovitrum AB Presents Topline Results from Embrace Phase 2A Study of Emapalumab in Interferon-Gamma-Driven Sepsis Swedish Orphan Biovitrum AB (Sobi) announced that topline results from the Phase 2a EMBRACE study (NCT06694701), evaluating Gamifant (emapalumab) in patients with interferon-gamma (IFN?)-driven sepsis (IDS), were presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) by Professor Evangelos J. Giamarellos-Bourboulis, President of the Hellenic Institute for the Study of Sepsis. The EMBRACE study was sponsored by the Hellenic Institute for the Study of Sepsis (HISS) as part of a research collaboration with Sobi. The EMBRACE Phase 2a study evaluated emapalumab in patients with IDS identified through biomarker profiling. The EMBRACE study (NCT06694701) was a Phase 2a, double-blind, randomised controlled trial conducted at 24 sites in Greece. The study was sponsored by the Hellenic Institute for the Study of Sepsis (HISS) as part of a research collaboration with Sobi. The trial investigated whether Gamifant, an anti-IFN? antibody, can improve clinical outcomes in patients with the interferon gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterised by elevated levels of CXCL9 and detectable IFN? and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aimed to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms (a total of 75 patients enrolled), two groups receiving Gamifant, (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of-care treatment. The primary endpoint was a =1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFN?, and CXCL9. Primary endpoint: improvement in organ function observed in 60% of patients receiving high-dose emapalumab vs 40% with standard of care plus placebo. 28-day mortality: 40% in the high-dose emapalumab group vs 52% in the placebo group. Biomarker response: high-dose emapalumab associated with faster reduction of pro-inflammatory biomarkers linked to interferon-gamma signalling. Emapalumab was generally well tolerated. Emapalumab was generally well tolerated in the EMBRACE study. The safety observations were consistent with the known safety profile of emapalumab, with infections the most common events observed, and no new safety signals identified. Gamifant (emapalumab) is an anti-interferon gamma (IFN?) monoclonal antibody that binds to and neutralises IFN?. When IFN? is secreted in an uncontrolled manner, hyperinflammation occurs within the body. Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). In the USA, Gamifant is indicated for the treatment of adult and paediatric (newborn and older) 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 (newborn and older) 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. Recent Insider Transactions • Feb 27
Director recently bought kr978k worth of stock On the 25th of February, Filippa Stenberg bought around 2k shares on-market at roughly kr408 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold kr249m more in shares than they bought in the last 12 months. Price Target Changed • Feb 10
Price target increased by 9.3% to kr408 Up from kr374, the current price target is an average from 11 analysts. New target price is approximately in line with last closing price of kr400. Stock is up 25% over the past year. The company is forecast to post earnings per share of kr17.10 for next year compared to kr1.39 last year. Announcement • Feb 10
Swedish Orphan Biovitrum AB (publ) (OM:SOBI) completed the acquisition of Arthrosi Therapeutics, Inc. Swedish Orphan Biovitrum AB (publ) (OM:SOBI) entered into a definitive agreement to acquire Arthrosi Therapeutics, Inc. for $1.5 billion on December 13, 2025. Under the terms of the agreement, Sobi will pay $950 million upfront in cash to acquire Arthrosi, together with up to $550 million in cash in clinical, regulatory and sales milestones. Sobi plans to fund the upfront payment mainly through debt in the form of existing credit facilities and a new credit facility provided by Handelsbanken and Danske Bank.
The transaction is subject to the satisfaction of customary closing conditions and is expected to close in H1 2026. The acquisition is expected to be highly accretive to Sobi’s mid- to long-term growth and margin trajectory.
Barclays Bank PLC act as financial advisor, McDermott Will & Schulte LLP act as legal advisor for Swedish Orphan Biovitrum AB. Wilson Sonsini Goodrich & Rosati, P.C. acted as legal advisor to Arthrosi Therapeutics, Inc.
Wenseng “Wendy” Pan, Shoaib Ghias, David R. Chen, Susan Lee, Jacqueline Klosek, April Sun, Nina Ngo, Malhar Naik, Eric Graffeo, Justin C. Pierce, Daniel S. Karelitz, Arman Oruc, Brady Cummins, Kevin Walsh, Robert D. Carroll and Heath R. Ingram of Goodwin Procter LLP served as legal advisor to Arthrosi Therapeutics.
Swedish Orphan Biovitrum AB (publ) (OM:SOBI) completed the acquisition of Arthrosi Therapeutics, Inc. on February 9, 2026. Reported Earnings • Feb 06
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: kr1.39 (down from kr11.37 in FY 2024). Revenue: kr28.2b (up 8.5% from FY 2024). Net income: kr478.0m (down 88% from FY 2024). Profit margin: 1.7% (down from 15% in FY 2024). Products in clinical trials Phase II: 4 Phase III: 3 Post-clinical trial products Pre-registration: 5 Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 131%. Revenue is forecast to grow 8.5% p.a. on average during the next 3 years, compared to a 7.9% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has increased by 17% per year, which means it is well ahead of earnings. Announcement • Feb 06
Swedish Orphan Biovitrum AB (Publ) Provides Earnings Guidance for the Fiscal Year 2026 Swedish Orphan Biovitrum AB (publ) provided earnings guidance for the fiscal year 2026. For the year, Revenue is anticipated to grow at low double-digit percentage at CER. Major Estimate Revision • Jan 30
Consensus EPS estimates upgraded to kr0.22 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -kr0.428 to -kr0.22 per share. Revenue forecast steady at kr28.4b. Biotechs industry in Sweden expected to see average net income growth of 12% next year. Consensus price target broadly unchanged at kr374. Share price was steady at kr337 over the past week. Major Estimate Revision • Jan 22
Consensus EPS estimates fall by 30% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -kr0.505 to -kr0.655 per share. Revenue forecast unchanged at kr28.5b. Biotechs industry in Sweden expected to see average net income growth of 12% next year. Consensus price target of kr372 unchanged from last update. Share price was steady at kr333 over the past week. Announcement • Jan 08
Sobi Announces to Advance Gamifant (Emapalumab) in Interferon-Gamma-Driven Sepsis (IDS) Based on EMBRACE Topline Data Sobi®? announced that topline results from the Phase 2a EMBRACE study evaluating Gamifant®? (emapalumab) for interferon-gamma (IFNg)-driven sepsis (IDS), showed proof-of-concept with observed improvement in organ dysfunction and survival. Based on the observed data from this research collaboration with the Hellenic Institute for the Study of Sepsis (HISS), Sobi and HISS will advance emapalumab in IDS and discuss the next clinical development steps with regulatory authorities. An update on next steps will be provided in due course and data from the EMBRACE study will be published at an upcoming medical conference. Sepsis is a serious condition in response to an infection that can lead to organ failure and is a leading global cause of mortality. A recent large study, published in eBioMedicine in 2024 describes different sepsis endotypes, suggesting varying endotypes require differentiated treatment strategies. Approximately 20% of the patients studied are of the newly described IFNg-driven sepsis (IDS) endotype. IDS is marked by elevated levels of CXCL9 and detection of IFNg and poor clinical outcomes, with a 28-day mortality rate ranging from 40 to 43%. The EMBRACE study (NCT06694701) was a Phase 2a, double-blind, randomized controlled trial was conducted at 24 sites in Greece. The study was sponsored by the Hellenic Institute for the study of Sepsis (HISS) as part of a research collaboration with Sobi. The trial investigated whether Gamifant, an anti-IFNg antibody, can improve clinical outcomes in patients with the interferon gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterized by elevated levels of CX CL9 and detectable IFNg and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aims to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms (a total of 75 patients enrolled), two groups receiving Gamifant, (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of- care treatment. The primary endpoint is a 1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFNg, and CXCL9. Gamifant®? (EMapalumab) is an anti-interferon gamma (IFNg) monoclonal antibody that binds to and neutralises IFNg. When IFNg is secreted in an uncontrolled manner, hyperinflammation occurs within the body. Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). In the USA, Gamifant is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or tolerance with conventional HLH therapy. Gamifant is also approved in the US for the treatment of adult and pediatric (newborn and older) Patients with hemophagocytic lymphohorocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still's disease with an inadequate response or intolerance to glucorticoids, or with recurrent MAS. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. Announcement • Dec 15
Swedish Orphan Biovitrum AB (publ) (OM:SOBI) entered into a definitive agreement to acquire Arthrosi Therapeutics, Inc. for $1.5 billion. Swedish Orphan Biovitrum AB (publ) (OM:SOBI) entered into a definitive agreement to acquire Arthrosi Therapeutics, Inc. for $1.5 billion on December 13, 2025. Under the terms of the agreement, Sobi will pay $950 million upfront in cash to acquire Arthrosi, together with up to $550 million in cash in clinical, regulatory and sales milestones. Sobi plans to fund the upfront payment mainly through debt in the form of existing credit facilities and a new credit facility provided by Handelsbanken and Danske Bank. The acquisition is expected to be highly accretive to Sobi’s mid- to long-term growth and margin trajectory.
The transaction is subject to the satisfaction of customary closing conditions and is expected to close in H1 2026.
Barclays Bank PLC act as financial advisor, McDermott Will & Schulte LLP act as legal advisor for Swedish Orphan Biovitrum AB. Announcement • Dec 13
Sobi Receives Positive CHMP Opinion for Aspaveli®? (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN Sobi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adult and adolescent patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). The positive opinion from the CHMP is now referred to the European Commission for an approval decision, which is expected in the first quarter of 2026. Sobi and its partner Apellis Pharmaceuticals Inc. have global co-development rights for systemic pegcetacoplan. The CHMP recommendation is based on positive results from the Phase 3 VALIANT study, in which Aspaveli demonstrated benefits across three key markers of disease, including significant reduction in proteinuria, stabilisation of kidney function, and substantial clearance of C3 deposits. These positive results were recently published in The New England Journal of Medicine. The VALIANT Phase 3 study (NCT05067127) was a randomised, 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. Study participants were randomised to receive pegcetacoplan or placebo twice weekly for 26 weeks. Following this 26-week randomised 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. 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. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. Aspaveli/Empaveli is also approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally, and for adults and adolescents with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in Saudi Arabia, South Korea and Switzerland. Sobi and Apellis 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. Major Estimate Revision • Dec 03
Consensus EPS estimates fall by 30% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -kr0.549 to -kr0.713 per share. Revenue forecast unchanged at kr28.6b. Biotechs industry in Sweden expected to see average net income growth of 24% next year. Consensus price target of kr361 unchanged from last update. Share price fell 3.6% to kr329 over the past week. Announcement • Nov 17
Swedish Orphan Biovitrum AB (publ) to Report Fiscal Year 2025 Final Results on Mar 31, 2026 Swedish Orphan Biovitrum AB (publ) announced that they will report fiscal year 2025 final results on Mar 31, 2026 Major Estimate Revision • Nov 12
Consensus EPS estimates upgraded to kr0.78 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -kr1.04 to -kr0.782 per share. Revenue forecast steady at kr28.6b. Biotechs industry in Sweden expected to see average net income growth of 22% next year. Consensus price target up from kr351 to kr360. Share price rose 4.1% to kr340 over the past week. Recent Insider Transactions • Nov 04
CEO & President recently sold kr26m worth of stock On the 29th of October, Guido Oelkers sold around 80k shares on-market at roughly kr325 per share. This transaction amounted to 12% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth kr32m. Guido has been a net seller over the last 12 months, reducing personal holdings by kr83m. Announcement • Oct 27
Sobi North America Announces the Presentation of Data Across Its Immunology Portfolio Sobi North America announced the presentation of data across its immunology portfolio highlighting the company's continued leadership in addressing rare and underserved inflammatory conditions. A total of 15 scientific abstracts, including six oral presentations featuring new data from completed and ongoing studies of Nanoecapsulated Sirolimus plus Pegadricase (NASP, formerly SEL-212), Vonjo®? (pacritinib), and Gamifant®? (emapalumab-lzsg), are being presented at the annual American College of Rheumatology (ACR) Convergence 2025 meeting in Chicago, October 24-29, 2025. Presentations of post hoc analysis of the DISSOLVE Trials investigating NASP in uncontrolled gout: DISSOLVE I and II were Phase III replicate, double-blind, placebo-controlled studies evaluating the efficacy and safety of NASP over 24 weeks. No new safety signals were reported. In two oral presentations, data presented from post-hoc analyses evaluated serum uric acid (sUA) levels, joint exam findings, health-related quality-of-life (HRQOL) outcomes, and gout flares in the subgroup of patients with uncontrolled gout who received six doses of NASP or placebo. The U.S. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2026, following the acceptance of the BLA submission on September 10, 2025. Nanoencapsulated Sirolimus Plus Pegadricase Reduced Disease Burden in Patients With Uncontrolled Gout: Results from the Phase 3 DISSOLVE Trials (Abstract Number: 2587). The most common adverse reactions (10%) for Gamifant included viral infection (44%), rash (21%), anemia (18%), leukopenia (15%), bacterial infections (13%), headache (13%), hyperglycemia (13%), hyperglycemic (13%), infusion-related reactions (13%), abdominal pain (10%), hypertension (10%), pyrexia (10%), and thrombocytopenia (10%). The U.S. Food and Drug Administration approved Gamifant as the first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease in June 2025. Emapalumab Treatment for Patients with Differing Presentations of Macrophage Activation Syndrome (MAS) Secondary to Still's Disease: Results from a Pooled Analysis of Two Prospective Trials (Abstract Number: 1671). Data presented reviewed the development of consensus criteria to establish a standardized definition of "flare" in VEXAS for clinical research and patient care. Development of a Disease Activity Index for the Assessment of VEXAS Syndrome (VEXAS-DAI) for measuring disease activity in VEXAS syndrome. Work is ongoing to validate the VEXAS-DAI instrument in the context of a clinical trial and evaluate its potential in advancing the development of therapies in this area of high unmet medical need. In patients with primary HLH receiving Gamifant®? (p<0.0.0.0.2). Recent Insider Transactions • Oct 27
Head of North America recently sold kr32m worth of stock On the 21st of October, Duane Barnes sold around 103k shares on-market at roughly kr312 per share. This transaction amounted to 76% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr85m more than they bought in the last 12 months. Announcement • Oct 25
Sobi Showcases New Data Across Rare Infusion Conditions At ACR 2025 Sobi will be presenting new data across its immunology portfolio at the annual American College of Rheumatology (ACR) Convergence 2025 meeting in Chicago, October 24-29. Sobi is presenting a total of 15 scientific abstracts, with six oral presentations featuring new clinical data from completed and ongoing studies of NASP, pacritinib, and emapalumab-lzsg. Summary of full Sobi data to be presented at ACR 2025: NASP: Nanoencapsulated Sirolimus plus Pegadricase Reduced Disease Burden in Oral Presentation: Patients with Uncontrolled Gout: Results from the Phase 3 DISSOLVE Trials: Abstracts: Metabolic & Crystal Arthropathies - Basic & Clinical; Presenting Author: Puja P. Khanna, MD, MPH, Division of Rheumatology, Science; University of Michigan, Ann Arbor, MI; Session time: 1:00 PM - 2:30 PM CT; andanoencapsulated Siro Limus plus Pegadricase Demonstrates Long Term Efficacy Poster Presentation and Safety in Patients with Uncontrolled Gout; Results from the 24-week Double-blind Extension of the Phase 3 DISSOLve I Study; Metabolic & Crystal Arthroathies - Basic & Clinical Science; and Characterisation of Infusion Reactions within 1 Hour of Treatment with Poster Presentation; and Nanoencapsulated Srolimus Plus Pegadricase: Pooled Results from the Phase 3 DIS Sirolimus Plus Pegadricases: Pooled Results from the phase 3 DISSOLVE II Trials; and II. Presenting Author: Herbert S.B. Baraf, MD, FACP, MACR, The Center for Rheumatology and Bone Research, Wheaton, MD. Announcement • Oct 21
Sobi Announces Resignation of Helena Saxon as Member of Board of Director, Effective October 21, 2025 Sobi announced that Helena Saxon a member of the Sobi board of Directors, has resigned her position effective immediately. She will be nominated for election to the board of another company which is serving the healthcare industry. Helena Saxon has served on the Sobi Board of Directors since 2011. Reported Earnings • Oct 21
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: kr8.40 loss per share (down from kr4.27 profit in 3Q 2024). Revenue: kr7.78b (up 13% from 3Q 2024). Net loss: kr2.89b (down 298% from profit in 3Q 2024). Revenue missed analyst estimates by 6.0%. Earnings per share (EPS) were also behind analyst expectations. Revenue is forecast to grow 8.8% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 14% per year, which means it is well ahead of earnings. Valuation Update With 7 Day Price Move • Oct 03
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to kr314, the stock trades at a forward P/E ratio of 21x. Average trailing P/E is 31x in the Biotechs industry in Sweden. Total returns to shareholders of 48% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at kr506 per share. Announcement • Sep 20
Sobi and Ionis Pharmaceuticals, Inc. Announces Approval in the European Union for Familial Chylomicronemia Syndrome Sobi®? and Ionis Pharmaceuticals Inc. announced that Tryngolza®? (olezarsen) has been approved in the European Union (EU) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The approval follows the positive opinion of the Committee for Medicinal Products for Human Use. The approval is based on positive data from the Phase 3 Balance study, in which Tryngolza 80 mg demonstrated a statistically significant reduction in fasting triglyceride levels at six months that was sustained through 12 months. Additionally, Tryngolza demonstrated a substantial and clinically meaningful reduction in acute pancreatitis events over 12 months. Tryngolza showed a favourable safety and tolerability profile. Study results were published in The New England Journal of Medicine (NEJM). FCS is a rare and genetic form of severe hypertriglyceridemia (sHTG). People with FCS often have extremely high levels triglyceride levels, and are at high risk of developing acute pancreatitis, which can be life-threatening. In the EU, FCS is estimated to impact up to 13 people per million. Sobi has exclusive rights to commercialize Tryngolza in countries outside the U.S., Canada and China. Tryngolza is also being evaluated in patients with sHTG with triglyceride levels 500 mg/dL (5.65 mmol/L), and positive topline results from the Phase 3 studies were announced in September 2025. Balance was global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of olezarsen in patients with FCS with 12-month duration. The primary endpoint was the% change from baseline in fasting triglyceride level at six months compared to placebo. Secondary endpoints included percent changes in triglyceride levels at 12 months, percent changes in other lipid parameters at six and 12 months and adjudicated acute pancreatitis event rates over the treatment period. Following treatment and the end-of-trial assessments, patients were eligible to enter an open-label extension study to continue receiving olezarsen once every four weeks. FCS is a rare, genetic disease characterized by extremely elevated triglyceride levels. It is caused by impaired function of the enzyme lipoprotein lipase (LPL). Because of limited LPL production or function, people with FCS cannot effectively break down chylomicrons, lipoprotein particles that are 90% triglycerides. People living with FCS are at high risk of acute pancreatitis in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. People living with F CS are sometimes unable to work, adding to the burden of fatigue and severe, recurrent abdominal Pain. People living with FCS is sometimes unable to work, adding To the burden of patients with FCS is a rare, gene-related disease characterized by extremely elevated triglycerides. Recent Insider Transactions • Aug 04
Head of North America recently sold kr1.1m worth of stock On the 29th of July, Duane Barnes sold around 4k shares on-market at roughly kr297 per share. This transaction amounted to 9.9% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth kr3.5m. Insiders have been net sellers, collectively disposing of kr127m more than they bought in the last 12 months. Announcement • Jul 25
Sobi North America Announces U.S. Food and Drug Administration Approves Doptelet® (avatrombopag) for the Treatment ofThrombocytopenia in Pediatric Patients One Year and Older with Persistent or Chronic Immune Thrombocytopenia Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immunethrombocytopenia (ITP) who have had an insufficient response to a prior therapy. The approval also includes a new formulation, Doptelet Sprinkle (avatrombopAG) oral granules, for use in children ages one to less than six years. Doptelet Sprinkle is the approved dosage form for patients aged one to less than six years, while Doptelet tablet is the approved dosage form for patient aged six and up. In adult patients with chronic immune thrombocytopenIA, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving Doptelet. Doptelet should not be administered to patients with chronic liver disease or immune thrombocytopENia in an attempt to normalize platelet counts. The most common adverse reactions in clinical trials were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain. To report SUSPECTED ADVERSE REACTIONS, contact Sobi Inc. at 1-866-773-5274 or FDA at 1-800-FDA-1088 or fda.gov/medwatch. A durable response consisted of patients achieving a platelet count =50,000/uL for six of the last eight weeks in the 12-week core phase of the AVA-PED-301 study. ITP can also have a significant impact on quality of life including severe fatigue and restrictions on physical activity due to risk of bleeding. About Doptelet?(avatrombopag). Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of ITP in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It is approved by the US Food & Drug Administration (FDA) for the treatment of throbocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and by the European Medicines Agency (EMA) for the treatment of severe thrombocytopenium (CLD) who are scheduled to undergo an invasive procedure. In June 2019, Doptelet was approved by the FDA for the treatment ofthrombocytopenIA in adult patients with chronic liver Disease (CLD) who have had an insufficient responses to a previous treatment and in 2021, Doptelet was approval by EMA for the treatment of primary chronic ITP in adult patients who are refractory to other treatments (e.1) in adult patients who are ref refractory to other treatments. Recent Insider Transactions • Jul 20
Director recently sold kr2.2m worth of stock On the 16th of July, Sven Ullman sold around 8k shares on-market at roughly kr288 per share. This transaction amounted to 69% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth kr3.5m. Insiders have been net sellers, collectively disposing of kr186m more than they bought in the last 12 months. Reported Earnings • Jul 17
Second quarter 2025 earnings: Revenues in line with analyst expectations Second quarter 2025 results: Revenue: kr6.18b (up 14% from 2Q 2024). Net income: kr636.0m (up 184% from 2Q 2024). Profit margin: 10% (up from 4.1% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue was in line with analyst estimates. Revenue is forecast to grow 9.1% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Sweden. Announcement • Jul 16
Swedish Orphan Biovitrum AB (publ) Provides Unchanged Earnings Guidance for the Year 2025 Swedish Orphan Biovitrum AB (publ) provided unchanged earnings guidance for the year 2025. For the year, revenue is anticipated to grow by a high single-digit % at CER. Announcement • Jun 29
Sobi Announces U.S. Food and Drug Administration Approves Gamifant® (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's Disease Sobi announced that the U.S. Food and Drug Administration (FDA) approved Gamifant®? (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The approval is based on results of the pooled data from two pivotal studies, the Phase 3 study (NCT05001737) and NI-0501-06 (NCT03311854). 54% (21/39) of patients had a complete response at Week 8, and 82% (32/39) achieved clinical MAS remission (VAS 1 cm) at Week 8. Safety and tolerability were consistent with previous clinical studies. In patients with HLH/MAS in Still's disease, the most common adverse events (20%) were viral infections, including cytomegalovirus infection or reactivation, and rash. MAS, a form of HLH, is a severe complication of rheumatic diseases, occurring most frequently in Still's disease including systemic juvenile idiopathic arthritis and adult-onset Still's disease. HLH/MAS is a rare systemic disorder of interferon gamma (IFNy) driven hyperinflammation with common clinical manifestations such as high persistent fever, elevated ferritin, cytopenias, coagulopathies, and hepatosplenomegaly. Gamifant, an interferon gamma ("IFNg)-blocking antibody, is the first and only FDA approved treatment for adult and pediatric (newborn & older) patients with primary HLH with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Macrophage activation syndrome (MAS). Macrophage activation syndrome (MAS) is a severe complication of r heumatic diseases, most frequently in Still's disease includes systemic juvenile idiopathicthritis (sJIA) - a rare systemic disorder of auto-inflammatory nature with common clinical manifestations such as daily spiking fever, typical transient cutaneous rash,ritis, lymphadenopathy, hepatosplenomegally and serositis. MAS is characterized by fever, hepatosplenomeGaly, liver dysfunction, cytopenias, Coagulation abnormalities and hyperferritinaemia, possibly progressing to multiple organ failure and death. Recent Insider Transactions • Jun 18
Head of North America recently sold kr3.5m worth of stock On the 10th of June, Duane Barnes sold around 12k shares on-market at roughly kr297 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr208m more than they bought in the last 12 months. Announcement • Jun 06
Apellis Pharmaceuticals, Inc. and Sobi Announce EMPAVELI®? (Pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN Apellis Pharmaceuticals, Inc. and Sobi®? presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI®? (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membraneoproliferative glomerulonephritis (IC-MPGN). The data were presented as part of a late-breaking session at the European Renal Association (ERA) Congress. In the VALIANT study, EMPAVELI demonstrated a statistically significant 68% proteinuria reduction versus placebo at Week 26, which was sustained at one year. Additionally, patients treated with EMPAVELI continued to achieve stabilization of kidney function as measured by estimated glomerular filtration rate (eGFR). In patients who switched from placebo to EMPAVELI at the start of the open-label period, EMPAVEL I demonstrated a similar magnitude of benefit in proteinuria reduction and stabilization of kidney function. EMPAVELI showed favorable safety and tolerability, consistent with its established profile. There were no new safety signals. Announcement • Jun 04
Sobi Showcases Breadth of Data in C3G/ Primary IC-MPGN at ERA 2025 Sobi®? will have a strong scientific presence at this year's ERA congress in Vienna (4-7 June) with a total of eight presentations: six oral presentations and two posters. The company is proud that two of its abstracts have been recognised in the top 10 abstracts at ERA 2025, as selected by expert reviewers coordinated by the ERA Paper Selection Committee. Notably, 52-week results from the open-label-period (OLP) of the VALIANT Phase 3 study will be presented for the first time. This data will be featured in an oral presentation by Professor Fadi Fakhouri (Lausanne University Hospital and University of Lausanne) during the session "Innovative Kidney Trials", on 6 June 2025 at 15:00 CEST. The VALIANT Phase 3 study (NCT05067127) was a randomised, placebo-controlled, double-blinded, multi-centre study evaluating pegcetacoplan efficacy and safety in 124 patients who were patients with C3 glomerulopathy (C3G) and primary immune complex membraneoproliferative. Room: XWall 1 Mozart Symphony No. 40 glomerulonephritis (IC-MPGN) in the US and Europe. The VALIANT Phase3 study (NCT05067 127) was a randomised, double-blinded, multiple-centre study evaluating pecetacoplan efficacy and efficacy in 124 patients who were treated in the primary primary (Idiopathic) IC-MPGN in the VALIANT Phase 3 trial Room: Hall F1. Pegcetacoplan demonstrates clinically significant Oral presentation responses in C3G and Primary (Idiopathic) Session: FC 14: About C3 and IgA Glomerulonephritis IC-MPGN patients with or without concomitant room: Hall F1 immunosuppression in VALIANT date: 6 June 2025. Association between proteinuria and clinically Poster Presentation meaningful endpoints in patients with C3G /Chronic Kidney Disease. MPGN: a Delphi consensus of European experts Room: Strauss Wiener Blut Presenter: Fernando Caravaca- Fontan Date: 13:06 CEST. MPGN: 52-week results from the phase 3 VALIANT Session: Innovative Kidney Trials trial show sustained efficacy Room: The Square Presenter: Fadi Fakhouri Date: 6 June 2025 Time: 15:00 CEST Targeted Treatment with Pegcetacoplan for post- Focused Oral presentation Transplant Recurrent C3G or Primary (idiopathic) Session: Glomerular & tubulo-interstitial diseasesIC-MPGN in the ValIANT Phase 3 Trial Room: Focused Oral Room 3 Presenter: Michiel Oosterveld. Major Estimate Revision • May 08
Consensus EPS estimates fall by 13% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from kr29.2b to kr28.2b. EPS estimate also fell from kr15.58 per share to kr13.54 per share. Net income forecast to grow 27% next year vs 14% growth forecast for Biotechs industry in Sweden. Consensus price target broadly unchanged at kr355. Share price was steady at kr298 over the past week. Announcement • May 08
Swedish Orphan Biovitrum AB (Publ) Appoints Iris Loew-Friedrich as Board Member The Swedish Orphan Biovitrum AB (publ) at its AGM held on May 8, 2025, Iris Loew-Friedrich was elected as new Board member for the period until the end of the next AGM. Reported Earnings • Apr 02
Full year 2024 earnings: EPS exceeds analyst expectations Full year 2024 results: EPS: kr11.37 (up from kr7.47 in FY 2023). Revenue: kr26.0b (up 18% from FY 2023). Net income: kr3.89b (up 61% from FY 2023). Profit margin: 15% (up from 11% in FY 2023). The increase in margin was driven by higher revenue. Products in clinical trials Phase II: 2 Phase III: 2 Post-clinical trial products Pre-registration: 5 Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.3%. Revenue is forecast to grow 9.0% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 7% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Apr 01
Swedish Orphan Biovitrum AB (publ), Annual General Meeting, May 08, 2025 Swedish Orphan Biovitrum AB (publ), Annual General Meeting, May 08, 2025, at 10:00 W. Europe Standard Time. Location: iva konferenscenter, grev turegatan 16, stockholm Sweden Announcement • Mar 19
Sobi Announces Research Collaboration Involving New Phase 2a Clinical Trial for Gamifant Sobi announced a research collaboration involving a new Phase 2a clinical trial for Gamifant® (emapalumab) for the potential treatment of interferon-gamma (IFN?)-driven sepsis (IDS) which is to be presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) Congress by Prof. Giamarellos-Bourboulis, from the Hellenic Institute for the Study of Sepsis. The study underscores Sobi's commitment to advancing medicine through targeted therapies for severe and complex conditions such as sepsis, a leading cause of mortality globally. Key Highlights: IDS is a new endotype representing approximately 20 percent of sepsis patients and is characterised by detection of IFN? (above lower limit of detection) and elevated levels of the chemokine CXCL9. The EMBRACE phase 2a study will investigate the potential of Gamifant® (emapalumab) in treating a subgroup of sepsis patients driven by the IDS endotype and absence of sepsis-induced immunoparalysis. IDS patients with a low human leukocyte antigen DR (HLA-DR) expression on monocytes characteristic of immunoparalysis will not be included into the EMBRACE study. The potential inclusion of this IDS sub-population into further studies will be evaluated based on the results of EMBRACE. The EMBRACE phase 2a trial was approved in March 2025. The first trial sites have been initiated, and patient screening to identify eligible patients with IDS has started. The EMBRACE study is a Phase 2a, double-blind, randomized controlled trial planned to be conducted at 24 sites in Greece. The trial investigates whether Gamifant® (emapalumab), an anti-IFN antibody, can improve clinical outcomes in patients with the interferon-gamma-driven sepsis (IDS) endotype and absence of sepsis-induced immunoparalysis. IDS is characterized by elevated levels of CXCL9 and detectable IFN? and is associated with poor patient outcomes. By targeting this inflammation pathway, the EMBRACE trial aims to reduce mortality, improve organ function, and accelerate recovery. The trial design includes three arms, and plans to enrol 75 patients, two groups receiving Gamifant® (emapalumab), (low and high doses) alongside standard-of-care treatment, and one group receiving placebo alongside standard-of-care treatment. The primary endpoint is a =1.4-point decrease in the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of treatment (28 days). Secondary endpoints include 28-day mortality, safety, pharmacokinetics, and changes in key inflammatory biomarkers such as CRP, IL-6, ferritin, IFN?, and CXCL9. Gamifant® (emapalumab) is an anti-interferon gamma (IFN?) monoclonal antibody that binds to and neutralises IFN?. In the USA, Gamifant® (emapalumab) is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies. Gamifant® (emapalumab) is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). Announcement • Feb 27
US FDA grants Priority Review to Sobi's supplemental Biologics Licence Application (sBLA) for Gamifant® (emapalumab-lzsg) Sobi announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant® (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The application was granted Priority Review with a PDUFA date of June 27, 2025. HLH/MAS, a form of HLH, is a severe complication of rheumatic diseases, occurring most frequently in Still's disease including systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease (AOSD). HLH/MAS is a rare systemic disorder of hyperinflammation with common clinical manifestations such as high persistent fever, elevated ferritin, cytopenias, coagulopathies, and hepatosplenomegaly. The application is based on results from pooled data from two studies which enrolled a total of 39 patients, the EMERALD (NCT05001737) and the NI-0501-06 (NCT03311854) studies. Fifty-three percent of patients had a complete response at Week 8 and 85% had a complete response at any time during the studies. Weekly mean glucocorticoid doses were reduced by 70.1% after 2 weeks of treatment. Gamifant® (emapalumab-Izsg) a monoclonal antibody that binds and neutralises interferon gamma (IFN-y), was approved by the FDA in 2018 for the treatment of adult and paediatric (newborn and older) patients with primary HLH with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Announcement • Feb 20
Apellis Pharmaceuticals, Inc. and Sobi Announces EMA Validation of Indication Extension Application for Aspaveli®? (Pegcetacoplan) for C3g and Primary Ic-Mpgn Apellis Pharmaceuticals, Inc. and Sobi announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, chronic kidney diseases with no approved treatments. The submission includes positive data from the Phase 3 VALIANT study. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% (pp about the VALIANT Study: The VALIANT Phase 3 study (NCT05067127) is a randomized, placebo-controlled, double-blinded, multi-center study designed to evaluate pegcetacoplan efficacy and safety in 124 patients who are 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 adolescent 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 are able to proceed to a 26-week open-label phase in which all patients receive pegcetacoplan. Major Estimate Revision • Feb 15
Consensus EPS estimates fall by 13% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate fell from kr16.08 to kr14.02 per share. Revenue forecast steady at kr28.7b. Net income forecast to grow 21% next year vs 26% growth forecast for Biotechs industry in Sweden. Consensus price target broadly unchanged at kr370. Share price fell 3.6% to kr309 over the past week. Announcement • Feb 07
Swedish Orphan Biovitrum AB (Publ) Provides Revenue Guidance for the Year 2025 Swedish Orphan Biovitrum AB (publ) provided revenue guidance for the year 2025. For the year 2025, Revenue is anticipated to grow by a high single-digit percentage at CER. Reported Earnings • Feb 06
Full year 2024 earnings: EPS exceeds analyst expectations Full year 2024 results: EPS: kr11.37 (up from kr7.47 in FY 2023). Revenue: kr26.0b (up 18% from FY 2023). Net income: kr3.89b (up 61% from FY 2023). Profit margin: 15% (up from 11% in FY 2023). The increase in margin was driven by higher revenue. Products in clinical trials Phase II: 2 Phase III: 2 Post-clinical trial products Pre-registration: 4 Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 8.0%. Revenue is forecast to grow 9.1% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has increased by 20% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Dec 11
Swedish Orphan Biovitrum AB (Publ) Elects David Meek as Member of the Board of Directors and Chair of the Board of Directors The Swedish Orphan Biovitrum AB (publ) (Sobi®) EGM was convened on 11 December 2024. In accordance with the Nomination Committee's proposals, David Meek was elected as new member of the Board of Directors and Chair of the Board of Directors for the period until the end of the Annual General Meeting 2025. Price Target Changed • Nov 14
Price target increased by 8.2% to kr357 Up from kr330, the current price target is an average from 11 analysts. New target price is 7.5% above last closing price of kr332. Stock is up 35% over the past year. The company is forecast to post earnings per share of kr10.20 for next year compared to kr7.47 last year. Announcement • Nov 05
Swedish Orphan Biovitrum AB (Publ) Announces Annette Clancy Has Informed the Nomination Committee That Will Not Be Available for Re-Election as Chair Swedish Orphan Biovitrum AB (publ) announced that Annette Clancy has informed the Nomination Committee that she will not be available for re-election as Chair or ordinary member of the Board of Directors at the Annual General Meeting 2025. However, she will remain an ordinary member of the Board until that time. 
