Biogen (BIIB) Status Update summary

Strategic Pipeline Focus and Expansion

• Felzartamab, an anti-CD38 monoclonal antibody, is advancing into three pivotal Phase 3 trials for rare kidney diseases: late AMR, IgAN, and PMN, with first data readouts expected in 2027 and commercial launches anticipated from 2027 to 2029.

• The pipeline is diversified across neurology, immunology, and rare diseases, with ~50% of revenue now outside multiple sclerosis.

• The acquisition of HI-Bio in 2024 expanded immunology expertise, led to the creation of a West Coast Innovation Hub, and retained over 90% of the acquired team.

• Felzartamab is positioned as a foundational asset for a new franchise in immune-mediated diseases, leveraging Biogen’s global capabilities and HI-Bio’s expertise.

• Additional expansion indications, including lupus nephritis and other IgG autoantibody conditions, are under evaluation, with Phase 1 data in lupus nephritis expected in 2026.

Felzartamab Mechanism, Differentiation, and Safety

• Felzartamab targets CD38, depleting pathogenic plasma cells and NK cells while sparing B cells and maintaining vaccine responses, offering a differentiated approach from CD20/CD19 therapies.

• Engineered for rapid infusion and reduced infusion reactions, with a comprehensive chronic and reproductive tox package supporting chronic use in immune-mediated diseases.

• Ongoing development of a subcutaneous formulation and next-generation anti-CD38 assets to enhance patient convenience and commercial flexibility.

• Across studies, felzartamab’s safety profile was consistent, with most adverse events being mild to moderate and primarily infusion-related.

Clinical Data and Development in AMR (Antibody-Mediated Rejection)

• AMR is a leading cause of kidney transplant failure with no approved therapies; felzartamab phase II showed 82% biopsy-proven resolution at 24 weeks versus 20% for placebo, with improved kidney function and favorable safety.

• Phase III TRANSCEND study is underway, targeting 120 patients, with primary endpoint of AMR resolution at six months and data expected in 2027.

• Felzartamab aims to be the first approved treatment for late AMR, addressing a critical unmet need in transplant care.