Daiichi Sankyo Company (4568) Status Update summary

Strategic vision and growth objectives

• Aims to become a global top 10 oncology company by 2030, focusing on innovation, sustainable growth, and rapid patient access to new treatments.

• Five-year plan (FY2021–FY2025) targets leadership in oncology, with a shift to further growth and new product launches.

• By 2030, plans to have five marketed ADCs in over 30 indications, reaching up to 700,000 patients globally.

• 2025 is positioned as a pivotal year with multiple clinical trial readouts and launches expected to drive significant growth.

Product portfolio and clinical catalysts

• Enhertu has become the standard of care in multiple indications, with 2024 revenue projected to exceed $3.7 billion and further growth expected from new approvals in HER2-low and ultra-low breast cancer.

• Datopotamab deruxtecan (Dato-DXd/DATROWAY®) recently approved in Japan and the U.S. for HR-positive, HER2-negative metastatic breast cancer, with a PDUFA date in July for EGFR-mutant non-small cell lung cancer and positive CHMP opinion in Europe.

• Nine new indications across HER2 and Datroway are targeted for launch in 2025 and 2026, potentially tripling the eligible patient pool.

• DESTINY-Breast06 approval moves Enhertu to chemo-naive HR+/HER2 low and ultralow mBC, expanding eligible patients by ~18,000 in major markets.

Commercial performance and market expansion

• Global net sales for Q3 FY2024 reached JPY 143.1 billion, with U.S. revenue up 39.6% year-over-year and Europe up 52.9%.

• Enhertu is commercialized in over 60 countries, achieving nearly 40% year-over-year growth and number one market share in its first four indications.

• U.S. and European divisions are investing in customer-facing teams and infrastructure to support growth and maximize market penetration.

• Over 50 national reimbursement successes for Enhertu in Europe, with record time to reimbursement for key indications.