Roche (OTCPK:RHHB.F) Update / briefing Transcript

Roche (OTCPK:RHHB.F) Conference Call Summary Company Overview - Company: Roche - Focus: Neurology, specifically Multiple Sclerosis (MS) treatments - Key Products: Ocrevus (ocrelizumab), fenebrutinib Core Industry Insights - Multiple Sclerosis (MS): A significant unmet medical need exists, with approximately 30% of patients on low-efficacy treatments and continuing to progress [10][11] - Treatment Paradigm: Ocrevus has revolutionized MS treatment since its launch in 2017, being the first and only twice-yearly anti-CD20 approved for both relapsing and primary progressive MS (PPMS) [5][6] Key Points from the Call Fenebrutinib Development - Phase 3 FENtrepid Results: Fenebrutinib has shown non-inferiority to ocrelizumab in reducing disability progression in PPMS, with a 12% risk reduction in confirmed disability progression [24][25] - Mechanism of Action: Fenebrutinib is a non-covalent BTK inhibitor that addresses both relapsing and progressive MS biology, potentially impacting disability accumulation [13][39] - Clinical Trial Design: The FENtrepid study was a multicenter, randomized, double-blind trial comparing fenebrutinib to ocrelizumab, with a primary endpoint of confirmed disability progression [19][20] Ocrevus Franchise Update - Current Usage: Over 450,000 patients are currently treated with Ocrevus, which remains the leading new-to-brand medicine in MS [5][6] - Ocrevus Zunovo: A new subcutaneous formulation has shown significant uptake, contributing to over 50% of global growth in Q4 2025, with a projected CHF 2 billion incremental sales opportunity by 2029 [6][7] Safety and Efficacy - Safety Profile: Fenebrutinib showed a higher incidence of liver enzyme elevations compared to ocrelizumab, with 14% of patients in the fenebrutinib arm withdrawing due to adverse events, primarily related to liver enzyme elevations [30][34] - Fatal Events: There were more fatal events in the fenebrutinib arm (7) compared to ocrelizumab (1), but investigators assessed these as unrelated to the study drug [31][32] Future Outlook - Pipeline Expansion: Roche is advancing multiple molecules in neurology, including prasinezumab for Parkinson's and trontinemab for Alzheimer's, alongside fenebrutinib [10][12] - High-Concentration Ocrevus: A new formulation with an on-body injector is expected to launch in 2028, allowing for home administration [7][8] Additional Insights - Market Positioning: Fenebrutinib is positioned as a first-in-class oral therapy for both PPMS and relapsing MS, providing an alternative for patients who may not tolerate or have access to infusions [60][61] - Clinical Practice: The majority of patients in clinical practice are currently on ocrelizumab, with ongoing discussions about the potential for fenebrutinib to be used across a broader population of PPMS patients [69][70] Conclusion Roche's ongoing developments in the MS treatment landscape, particularly with fenebrutinib and the Ocrevus franchise, highlight the company's commitment to addressing significant unmet medical needs in neurology. The promising results from the FENtrepid study and the strategic expansion of their product offerings position Roche favorably in the competitive landscape of MS therapies.