Roche (ROG) investor relations material

Strategic and Market Outlook

• Peak sales opportunity for Gazyva in immune-mediated diseases is estimated at above $2 billion, with current consensus for 2030 at CHF 1.7 billion, indicating further upside potential.

• Market for SLE, lupus nephritis, membranous nephropathy, and IgAN in US, EU5, and Japan expected to more than double from $5 billion in 2025 to $11.4 billion by 2030, driven by new therapies and high unmet needs.

• Sefaxersen in IgAN now included in most analyst models, with CHF 400 million forecasted sales by 2030; peak potential seen at $1–2 billion.

• Giredestrant sales expectations increased to $3.2 billion by 2030, while fenebrutinib in MS is forecasted at $1.1 billion.

• Additional upside expected as new data are presented and launches approach.

Strategic Focus and Pipeline Overview

• Aims to become a global leader in immune-mediated kidney and rheumatological diseases, focusing on long-lasting remission and reducing treatment burden.

• Pipeline includes multiple assets targeting SLE, LN, MN, INS, IgAN, and aHUS, with several Phase III trials and filings expected in 2026.

• Multiple innovative approaches in development, including B-cell depletion, complement inhibition, bispecifics, and allogeneic CAR-T therapies.

Immunology Pipeline and Innovation

• Focus on B-cell-targeted therapies and complement inhibition to induce long-lasting remission in immune-mediated kidney and rheumatologic diseases.

• Gazyva, sefaxersen, and other B-cell depleting agents, including bispecifics and CAR-Ts, are in development for chronic autoimmune diseases.

• Afimkimab (TL1A antibody) in Phase II/III for multiple indications, with Phase B readouts in UC and CD expected in 2027.

• New NME in IBD initiated in Phase I; NLRP3 inhibitor in asthma and broader programs in neurology and cardiovascular diseases ongoing.

• Multiple B-cell depletion strategies in development, including bispecifics and allogeneic CAR-T, with ongoing and planned clinical studies.