Primary EP: [{"id":"harm-ep1","name":"RSV-LRTI hospitalization","type":"PRIMARY","unit":"% reduction","p_value":"<0.001","results":[{"ci":"67.8-92.0","arm":"harm-nirs","label":"83.2% reduction; 0.3% (11/4037) vs

Efficacy: Phase 3b, open-label, randomized (N=8,058; 4,037 nirsevimab, 4,021 standard care). 235 sites in France, Germany, UK. PRIMARY (150 days): RSV hospitalization: nirsevimab 0.3% vs standard care 1.5%. Efficacy: 83.2% (95% CI: 67.8-92.0; p<0.001). Very severe RSV LRTI: 75.7% reduction (95% CI: 32.8-92.9;

Safety: N=4,016 nirsevimab, N=4,018 standard care. Grade 1 AEs: 68.7% vs 67.1%. Grade 2 AEs: 36.0% vs 35.7%. AE rates comparable — no safety signal. 1 possibly related SAE: infantile spasms 23 days post-dose

Primary EP: [{"id":"mel-ep1","name":"Medically-attended RSV-LRTI","type":"PRIMARY","unit":"% reduction","p_value":"<0.001","results":[{"ci":"49.6-87.1","arm":"mel-nirs","label":"74.5% reduction vs placebo","value

Efficacy: Phase 3, randomized, double-blind, placebo-controlled (N=1,490; 994 nirsevimab, 496 placebo). Single IM injection. PRIMARY: Medically attended RSV-associated LRTI through 150 days: nirsevimab 1.2% vs placebo 5.0%. Efficacy: 74.5% (95% CI: 49.6-87.1; p<0.001). RSV hospitalization: nirsevimab 0.6% vs

Safety: N=987 nirsevimab, N=491 placebo. SAEs: 6.8% vs 7.3% (comparable). Most common adverse reactions: rash 0.9% vs 0.6%, injection site reactions 0.3% vs 0%. 97% of reactions mild-moderate. Treatment-relat

Beyfortus - RSV Royalty Revenue Trajectory (vs Enflonsia) Quarterly through 2026

Long-acting anti-RSV monoclonal antibody (F protein). Developed by AstraZeneca, commercialized by Sanofi. SOBI receives royalty on US Beyfortus sales — rate escalates from 25% (2024) to 30-35% by 2028. Replacement for Synagis (palivizumab). Key seasonal revenue component for SOBI. Q4 2025 SEK 849M in Beyfortus royalty (down from SEK 1,207M prior year, attributed to seasonality/inventory effects; management calls this an aberration not a reset).