Daiichi Sankyo Company (4568) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Financial Performance and Outlook

• FY2024 revenue forecast is JPY 1.83 trillion, a 14.3% increase year-over-year, with core operating profit projected at JPY 260 billion, up 33.2% from the previous year.

• Revenue growth is driven by strong performance in North America and Europe, strategic alliances, and milestone payments, especially from ENHERTU and DATROWAY.

• Annual product sales for ENHERTU are expected to exceed JPY 500 billion in FY2024.

• R&D expenses are forecasted at JPY 460 billion, reflecting increased investment in pipeline development.

• Capital investment of approximately JPY 600 billion is planned to expand ADC supply capacity globally.

ADC Portfolio, Pipeline, and Innovation

• Seven ADCs are based on the DXd platform, with ENHERTU and DATROWAY leading in late-stage and launched indications.

• ENHERTU has five approved indications, is launched in over 60 countries, and won the 2024 Prix Galien USA for Best Biotechnology Product.

• DESTINY-Breast06 trial showed significant PFS benefit for ENHERTU in HER2-low/ultralow breast cancer; regulatory submissions are under review in Japan, US, and EU.

• DATROWAY is approved in Japan for HR+/HER2- BC 2L+; US and EU submissions are under review, with a new BLA for EGFRm NSCLC submitted in Nov 2024.

• Strategic collaborations with AstraZeneca and Merck are expanding clinical development, technology platforms, and digital pathology innovation.

Clinical Development and Regulatory Milestones

• Multiple pivotal trials are ongoing for Dato-DXd, including AVANZAR and TROPION-Breast01, with regulatory submissions underway.

• Subcutaneous formulation of ENHERTU is in development to reduce patient treatment burden.

• HER3-DXd and R-DXd are advancing in collaboration with Merck, with key decisions expected by October 2025.

• Over 15 clinical studies and 9 major congress data presentations for Merck collaboration assets.

• Demand for 5DXd ADCs is expected to reach over 50 million vials annually, 1.5 times higher than initial forecasts.