Roche (ROG) investor relations material

Oncology and Hematology Performance and Strategy

• Oncology and hematology generated CHF 5.9 billion in Q1 sales, representing 40% of total sales and 8% year-over-year growth, driven by breast, lung, malignant heme, and hemophilia segments.

• Market leadership maintained in HER2 breast cancer, lung cancer (Tecentriq, Alecensa), non-Hodgkin lymphoma, CLL (Venclexta), and hemophilia (Hemlibra).

• Six positive phase III readouts and three new molecular entities with phase III indications since 2024, with over 70% being first-in-class or best-in-class assets.

• Pipeline rejuvenation includes six new molecular entities via business development and four platform research deals.

• Portfolio spans small molecules, bispecifics, multispecifics, ADCs, and cell therapies, with a focus on patient tolerability and accessibility.

RAS and KRAS Innovation

• RAS mutations are present in one in four stage IV cancer patients, especially in lung, colorectal, and pancreatic cancers.

• Divarasib, a G12C inhibitor, shows 5–20x potency and 10–20x selectivity over competitors, with median PFS of 15 months in second-line NSCLC.

• Divarasib received FDA Breakthrough Designation and is being evaluated in the KRASCENDO-1 phase III trial, with data expected year-end.

• Combination strategies and adaptive dosing are being systematically incorporated into ongoing trials to optimize efficacy and tolerability.

• Pan-RAS and pan-KRAS inhibitors are in development, with a focus on combinability and diverse mechanisms to address tumor biology and resistance.

Breast Cancer Franchise and Pipeline

• Strong legacy in HER2-positive breast cancer, expanding into HR-positive with Itovebi (PI3K inhibitor) and giredestrant (oral SERD).

• ZN-1041, a brain-penetrant HER2 TKI, is being developed for patients with brain metastases, with promising combinability and tolerability data.

• Giredestrant demonstrated highest preclinical potency among oral SERDs, full ER antagonism, and strong combinability with CDK4/6 inhibitors.

• LidERA trial showed 30% reduction in recurrence or death risk in adjuvant ER-positive breast cancer; PDUFA date set for November 30.

• Multiple ongoing and new trials for giredestrant, including phase IIIb studies for upfront and switch strategies, and novERA for AI-intolerant patients.