Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Corporate Update (September 2025)
30 slides from Swedish Orphan Biovitrum Ab's corporate update, Sep 16, 2025
Slide 1: NASP and Uncontrolled Gout
NASP and Uncontrolled Gout Conference call for investors and analysts September 16, 2025
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains certain forward-looking statements with respect to certain of the Company’s current expectations and projections about future events. These statements, which sometimes use words such as “intend,” “proposed,” “plan,” “expect,” and words of similar
Slide 3: Agenda
Agenda Introduction and agenda Guido Oelkers Chief Executive Officer, Sobi Herbert S. B. Baraf, MD, FACP, MACR The painful burden of Clinical Professor of Medicine, George Washington University uncontrolled gout Associate Clinical Professor, University of Maryland Senior Clinical Advisor, National I
Slide 4: Executive summary
Executive summary The burden of uncontrolled gout1-4 Uricase therapy provides relief5-8 • Uncontrolled gout affects a small but • Uricase therapy is recommended for the significant set of gout patients and is marked treatment of uncontrolled gout and provides by severe pain, serious health complicat
Slide 5: The painful burden of uncontrolled gout (UG)
The painful burden of uncontrolled gout (UG) Herbert S. B. Baraf, MD, FACP, MACR Clinical Professor of Medicine, George Washington University Associate Clinical Professor, University of Maryland Senior Clinical Advisor, National Institutes of Health, NIAMS NIAMS, National Institute of Arthritis and
Slide 6: Gout – Increasing prevalence affects millions globally
Gout – Increasing prevalence affects millions globally1 Gout is a chronic The global prevalence The global prevalence of gout inflammatory disease caused of gout nearly doubles is 3.2x higher in males than by urate crystal buildup2-4 every 30 years1 females and increases with age1 95.8M 55.8M 316.4
Slide 7: Gout – A severely impacted subset develop UG
Gout – A severely impacted subset develop UG1-3 Acute intermittent gout (flares) Pain Levels Body urate pool Asymptomatic Years Chronic polyarthropathy hyperuricemia with tophus formation UG, uncontrolled gout. Schematic representation adapted from Edwards NL. Primer on the Rheumatic Diseases 2008.4
Slide 8: Gout – A severely impacted subset develop UG
Gout – A severely impacted subset develop UG1-3 sUA levels Above target Below Crystal formations4,5 Symptomatic gout5 Uncontrolled gout5,6 sUA (mg/dL) target Crystals found primarily in: Acute flares: Uncontrolled gout: Joints and soft tissues but may also be seen As crystals accumulate, flare-ups D
Slide 9: UG – Systemic inflammation may impact the whole body
UG – Systemic inflammation may impact the whole body1-3 Cardiovascular Disease Metabolic Syndrome Chronic Kidney Disease (CKD) 1.5x higher risk 1.2x higher risk 2x higher risk of heart disease1 of diabetes1 of CKD1 CKD, chronic kidney disease; sUA, serum uric acid; UG, uncontrolled gout. References:
Slide 10: UG – Chronic flares disrupt life and impact well-being
UG – Chronic flares disrupt life and impact well-being Physical Disability1,2 It’s hard to relax, I never know Pain, inflammation, when a flare could happen.” tophi, and comorbidities — Patient, France Impaired Gout stops me from doing everything, apart from sitting down which is all you can do.” Qu
Slide 11: Uricase treatment – Meeting the unmet need in UG
Uricase treatment – Meeting the unmet need in UG1-4 The goal of treatment is to decrease gout flare frequency, reduce tophi, and improve the quality of life for patient through a durable reduction in sUA to <6 mg/dL. First-line therapy1,2 Second-line therapy3,4 Third-line therapy3,4 Xanthine oxidase
Slide 12: Uricase treatment – Rapid results, sustained relief
Uricase treatment – Rapid results, sustained relief1-2 Illustrative Oral ULTs Uricase Oral ULTs sUA (mg/dL) Above Target Below Target Time Benefits Benefits ofof uricase uricase therapy: therapy:rapid Rapid reduction reduction in of uricsUA acid levels, levels, faster fastertophus tophusresolution,
Slide 13: Uricase treatment – Efficacious but underutilized
Uricase treatment – Efficacious but underutilized Key factors limiting uricase uptake by HCPs and patients • Safety concerns about AEs including flares, infusion reactions, <5% anaphylaxis, and loss of efficacy due to anti-drug antibodies (ADAs)2 • Reluctance to use broad and systemic immunosuppress
Slide 14: NASP clinical programme: A new era in uricase therapy
NASP clinical programme: A new era in uricase therapy Rehan Azeem MBBS (MD), MPH Medicine Development Leader— Rheumatology & Specialty Care, Sobi
Slide 15: NASP – Targeted innovation in uricase therapy
NASP – Targeted innovation in uricase therapy1-4 NASP is an investigational uricase therapy administered every 4 weeks through sequential infusion of two components.1,2 1 PLA matrix 2 Uricase Sirolimus PEG PLA-PEG outer layer Nanoencapsulated Pegadricase1 Sirolimus2-4 (Uricase) Sirolimus induces tar
Slide 16: NASP – Protecting and powering uricase
NASP – Protecting and powering uricase1-8 References: 1. Baraf HSB, et al. Rheumatology (Oxford). 2024;63(4):1058-1067. 2. Garay RP, et al. Expert Opin Drug Deliv. 2012;9(11):1319-1323. 3. Kishimoto TK. Front Immunol. 2020;11:969. 4. Kivitz A, et al. Rheumatol Ther. 2023;10(4):825-847. 5. Kivitz A,
Slide 17: NASP – DISSOLVE I and II: Phase 3 trials in UG
NASP – DISSOLVE I and II: Phase 3 trials in UG High-Dose NASP: Sequential infusions, 0.15 mg/kg NAS and 0.2 mg/kg pegadricase* Randomized Low-Dose NASP: 1:1:1 Sequential infusions, 0.10 mg/kg NAS and 0.2 mg/kg pegadricase* Placebo Dosing IV Q4W Week 1 Week 5 Week 9 Week 13 Week 17 Week 21 Primary en
Slide 18: NASP – Demonstrated significant sUA control vs placebo
Intent-To-Treat Population NASP – Demonstrated significant sUA control vs placebo 80 RD 43.0 [28.0, 58.0] P<0.0001* Response rate ( %)‡ 60 RD 35.0 [21.0, 49.0] P<0.0001† 40 20 51% 43% 0 8% High-Dose NASP Low-Dose NASP Placebo (n=87) (n=88) (n=90) Primary endpoint: Treatment response defined as maint
Slide 19: NASP – Immediate impact, maintained over 6 months
On-Treatment Cohort NASP – Immediate impact, maintained over 6 months sUA over time for patients on NASP† Mean sUA reduction High-Dose NASP (On-treatment) Low-Dose NASP (On-treatment) Placebo from baseline to 1 12 hour post first 11 Mean (SD) sUA mg/dL 10 infusion: 9 94% 8 7 6 5 on high-dose NASP 4
Slide 20: NASP – Reduced gout flares over course of treatment
On-Treatment Cohort NASP – Reduced gout flares over course of treatment WEEKS 1-12 35 SIMILAR GOUT FLARES RATES 31 30 NASP & PLACEBO Patients with ≥1 gout flare (%) *† 25 25 22 22 20 20 21 FLARE-FREE AFTER 6 DOSES 16 (Weeks 21-24) 95% 94% 15 13 13 12 13 12 10 11 9 High-Dose NASP 6 on high-dose on lo
Slide 21: NASP – Positive resolution of tophi by Month 6
Received 6 Doses Cohort NASP – Positive resolution of tophi by Month 6 Complete response to treatment of Complete tophus response*† high-dose NASP*† Baseline After 6 Doses High-dose NASP 49% Low-dose NASP 70% Placebo 5% ~10-14 times complete resolution of tophi with high-dose and low-dose NASP vs pl
Slide 22: NASP – Positive data in CKD Stage patients
CKD Stage 3 Subgroup NASP – Positive data in CKD Stage 3 patients1 52% and 61% of CKD Stage 3 patients receiving CKD Stage 3 patients receiving NASP had stable NASP achieved a 6-month sUA response1* eGFR function1*‡ P=0.0041† 80 70 60 P=0.0004† 3.3 mL/min/1.73 m² 3.7 mL/min/1.73 m² 61% IMPROVEMENT I
Slide 23: NASP – A well tolerated therapy
NASP – A well tolerated therapy Adverse Events of High-Dose Low-Dose Placebo Special Interest*† NASP (N= 87) NASP (N = 88) (N=90) (>5% of patients) Gout flares 42.5% 44.3% 43.3% Infections (including viral) 23% 18.2% 16.7% COVID-19 infection‡ 5.7% 5.7% 6.7% Hypertriglyceridemia¶ 6.9% 4.5% 6.7% Stoma
Slide 24: Unlocking NASP's potential for patients with uncontrolled gout
Unlocking NASP’s potential for patients with uncontrolled gout Guido Oelkers Chief Executive Officer, Sobi
Slide 25: Paving the way for NASP – From submission to launch
Paving the way for NASP – From submission to launch Key milestones: NASP FDA BLA NASP FDA BLA Target PDUFA Date: Submission: June 2025 Review Process: Standard June 2026 Launch readiness activities: 1 2 3 4 Highlight Strengthen Mitigate Optimize unmet needs and belief in NASP’s financial and custome
Slide 26: Uricase treatment – A defined, high unmet need market with significant revenue potential
Uricase treatment – A defined, high unmet need market with significant revenue potential1-7 Estimated prevalence of diagnosed gout* Uricase therapy is currently underutilized ~7.1 million and lacks significant penetration in the treatment of UG Estimated cases of UG ~170,000 Current UG market potent
Slide 27: NASP – Enhancing the profile to maximize possibilities
NASP – Enhancing the profile to maximize possibilities Robust lifecycle management plan initiated and underway Enhance NASP Address unique needs of Optimize patient and product profile several uncontrolled provider experience gout special populations Market expansion plans under evaluation Significa
Slide 28: NASP – A key strategic growth driver for Sobi
NASP – A key strategic growth driver for Sobi Investments in 2025 for multiple launches in 2025/2026 2 3 4 Priority development Major launches Key filings projects in area of high unmet medical need 1. Altuvoct 1. Gamifant: HLH/MAS 1. Gamifant: IDS 2. Vonjo 2. Aspaveli: C3G/IC- 2. Vonjo: VEXAS MPGN
Slide 29: NASP – An investigational treatment designed for the safe and effective treatment of UG
NASP – An investigational treatment designed for the safe and effective treatment of UG Effective urate reduction1,2 Alleviation of symptoms2-4 • Shown to rapidly and significantly • NASP treatment greatly reduced reduce sUA levels flares, shrank tophus size, and improved quality of life Low treatme
Slide 30: sob!
sob! Kt
Swedish Orphan Biovitrum AB (Sobi) — Corporate Update (September 2025) on 6ix