Switzerland · Delayed Price · Currency is CHF Roche Holding AG Earnings Call Transcripts
Fiscal Year 2026
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Phase II results show enicepatide achieved up to 22.7% weight loss at 48 weeks, with strong glycemic improvements and favorable tolerability. Petrelintide demonstrated up to 10.7% weight loss with a placebo-like safety profile, supporting its use for moderate weight loss. Both agents advance to phase III, with combination studies planned.
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Oncology and hematology delivered strong Q1 growth, led by breast and lung cancer therapies and pipeline innovation. Giredestrant showed significant efficacy in adjuvant breast cancer, with multiple ongoing trials to expand its use. Divarasib and other RAS-targeted therapies are advancing, with a focus on combination strategies and new modalities.
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The event outlined a strategy centered on innovation, digital integration, and targeted growth in high-burden disease areas. Key launches like AXELIOS sequencing and CGM are set to drive mid to high single-digit sales growth, with profit outpacing sales, supported by strategic acquisitions and a robust pipeline.
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Sales grew 6% CER in Q1 2026, led by Pharma (+7%) and Diagnostics (+3%), with strong pipeline progress and confirmed guidance for mid-single-digit sales and high single-digit EPS growth. Key launches and positive clinical data in oncology, neurology, and obesity support a robust outlook.
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Fenebrutinib showed strong efficacy in reducing relapses and MRI disease activity in relapsing MS, with a favorable safety profile overall, though an imbalance in fatalities was noted without a clear mechanistic link. The drug is positioned for broad use across MS types, with regulatory filing planned mid-year.
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Peak sales for Gazyva in immune-mediated diseases are projected at $2 billion, with strong Phase III ALLEGORY results in SLE showing significant efficacy and remission rates. The immunology pipeline includes innovative B-cell-targeted and complement therapies, with further upside expected as new data emerge.
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Fenebrutinib showed non-inferiority to ocrelizumab in PPMS, with a 12% risk reduction in disability progression and strong efficacy in patients without gadolinium-enhancing lesions. Safety monitoring via biweekly liver enzyme tests was effective. It is positioned as a high-efficacy oral option for PPMS and RMS, with broad potential uptake.
Fiscal Year 2025
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Group sales grew 7% in 2025, led by pharma (+9%) and diagnostics (+7% ex-China), with core operating profit up 13% and core EPS up 11%. Robust pipeline progress and multiple positive Phase 3 readouts support upgraded guidance and a positive outlook for 2026, with mid-single-digit sales and high single-digit EPS growth expected.
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Giredestrant demonstrated significant improvement in invasive disease-free survival versus standard endocrine therapy in early ER+, HER2-negative breast cancer, with consistent benefit across subgroups and a favorable safety profile. Regulatory filings are planned for the US and Europe, and the drug is expected to become a new standard of care.
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Group sales grew 7% year-to-date, led by 9% growth in pharma and 1% in diagnostics, with diagnostics outside China up 7%. The late-stage pipeline advanced significantly, and core EPS guidance was raised. Key brands and new launches drove performance, while currency and China reforms remained headwinds.
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Phase III data for vamikibart in uveitic macular edema and satralizumab in thyroid eye disease showed robust efficacy and favorable safety, with vamikibart offering a potential non-steroid alternative and satralizumab providing a differentiated safety profile. Regulatory discussions are ongoing, and further pivotal readouts are expected in 2025 and 2026.
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Guidance was updated to extend growth expectations for the on-market portfolio through 2028, supported by a rejuvenated pipeline, disciplined R&D investment, and a robust late-stage portfolio across five core therapeutic areas. The obesity strategy is positioned for leadership, leveraging a broad, differentiated pipeline and significant manufacturing investments.
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Group sales rose 7% year-over-year, led by 10% pharma growth and stable diagnostics, with strong margin and EPS expansion. Key franchises in oncology, hematology, neurology, and immunology drove performance, while diagnostics faced China headwinds. Guidance remains unchanged, with continued pipeline momentum and disciplined capital allocation.
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Significant clinical advances were reported across the hematology portfolio, including strong sales growth, robust efficacy and safety data for key therapies in DLBCL and hemophilia, and the advancement of next-generation bispecifics and gene therapies. Regulatory filings and pivotal phase III trials are ongoing, with new product launches and label extensions expected to drive future growth.
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Ambitious growth targets include doubling patient access to novel diagnostics, launching 75 new assays by 2030, and maintaining mid to high single-digit sales growth. Key innovations such as the SBX/Exelios sequencing platform, Cobas Mass Spec, and digital health solutions are set to drive future performance.
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Q1 2025 saw 6% group sales growth, led by pharma (+8%) and robust new product launches, while diagnostics remained flat due to China pricing reforms. Major U.S. investments, pipeline progress, and strong performance in oncology, hematology, and ophthalmology support a positive outlook, though currency headwinds and market dynamics in China and the U.S. present challenges.
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The neurology franchise expects sustained double-digit growth, with Ocrevus and Elevidys maintaining strong sales guidance. Trontinemab shows rapid amyloid clearance and favorable safety in Alzheimer's, advancing to phase III, while prasinezumab in Parkinson's shows promising trends despite missing its primary endpoint. Robust diagnostic advances and a strong pipeline support continued leadership.
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SBX nanopore sequencing technology is positioned to disrupt the $6B NGS market with high accuracy, speed, and flexibility, supporting both research and clinical applications. The open, modular platform targets a 2026 launch, aims for broad adoption, and is designed for scalability and cost efficiency.
Fiscal Year 2024
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Group sales rose 7% year-over-year, with base business up 9% and strong growth in both Pharma and Diagnostics. Core operating profit increased 14%, core EPS up 12% (excluding tax effects), and free cash flow surged 34%. 2025 guidance targets mid-single digit sales growth and high single digit core EPS growth.
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The event showcased a strategic pivot to AI-driven drug discovery, highlighting Lab-in-the-Loop integration, proprietary multimodal models, and autonomous agents. Significant R&D investment supports these efforts, which are now embedded across the pipeline and therapeutic areas.
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Key neurology assets are advancing, with Trontinumab showing rapid amyloid clearance, robust biomarker effects, and low ARIA rates in Alzheimer's trials. Diagnostic innovations like Elecsys blood tests support early, reliable detection. Phase III planning will focus on safety, efficacy, and patient-friendly regimens.
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Group sales rose 6% at constant exchange rates, driven by strong base business growth in both pharma and diagnostics, while COVID-19 effects faded. Key launches and regulatory approvals boosted performance, and guidance was raised for mid-single-digit sales growth, despite currency headwinds and LOE impacts.
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Management outlined a focused strategy to deliver 20 transformative medicines and 75 novel diagnostics by 2030, with strong growth expected from the on-market portfolio, pipeline, and recent acquisitions. R&D Excellence and operational efficiency are driving productivity, while upcoming late-stage readouts and launches are set to sustain momentum.
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Revised summary: The update detailed progress on the CBRM franchise, with strong early data for CT-388 and CT-996 in obesity, showing robust weight loss and manageable safety. Both move to phase 2, focusing on differentiation via biased agonist design, oral delivery, and combos. Risks are managed through a fail-fast approach and careful trial design.
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Group sales grew 5% at constant exchange rates (8% excluding COVID-19), with strong momentum in both pharma and diagnostics. Operating profit and core EPS rose 11% and 9% respectively, driven by cost control and key product launches. Guidance for mid-single-digit sales growth and high single-digit core EPS growth is confirmed for 2024.
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Vabysmo continues rapid global growth, supported by strong clinical and real-world data, with the pre-filled syringe launch expected to further accelerate adoption. Susvimo's relaunch and expanding indications position it as a future blockbuster, while the pipeline advances with innovative therapies and delivery platforms.
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Hematology sales grew 12% in Q1, led by Hemlibra and Polivy. STARGLO phase III data showed glofitamab GEMOX doubled median overall survival in relapsed/refractory DLBCL. Hemlibra maintains strong efficacy, safety, and patient satisfaction, with new administration options and an auto-injector in development.