Roche (ROG) Investor update summary

Ocrevus franchise update

• Ocrevus remains the leading new-to-brand MS medicine, treating 450,000 patients globally.

• Ocrevus is the only approved CD20 antibody for PPMS and is available in both IV and subcutaneous forms.

• Ocrevus Zunovo, a 10-minute subcutaneous injection, saw accelerated uptake in Q4, with over 17,500 patients by year-end 2025.

• Over 50% of global growth in Q4 was driven by Ocrevus Zunovo, with significant adoption in community practices.

• A high-concentration Ocrevus formulation with an on-body injector is in development, targeting a 2028 launch for home/self-administration.

Study background and objectives

• Fenebrutinib is a CNS-penetrant, noncovalent, reversible BTK inhibitor designed to target both relapsing and progressive MS biology, with prior Phase II data showing near-complete suppression of disease activity in RMS.

• The FENtrepid Phase III trial evaluated the efficacy and safety of oral fenebrutinib versus ocrelizumab, the only approved therapy for PPMS.

Study design and population

• FENtrepid was a multicenter, randomized, double-blind, double-dummy, parallel-group Phase III study with 985 adult PPMS patients aged 18–65, EDSS 3.0–6.5, comparing daily oral fenebrutinib to IV ocrelizumab over at least 120 weeks.

• Participants received either fenebrutinib 200 mg BID or ocrelizumab 600 mg IV every 24 weeks.

• Baseline characteristics were well-matched between arms.