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.

• Profit attributable to owners is projected at JPY 225 billion, a 12.1% increase year-on-year.

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

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

• Shareholder returns will be enhanced through dividend increases, flexible share buybacks, and a policy targeting ROE >16% and DOE >8% by FY2025.

ADC pipeline and innovation

• Seven DXd ADCs are in development, with ENHERTU and DATROWAY as key late-stage and launched assets.

• ENHERTU is approved in five indications, launched in over 60 countries, and forecasted to exceed JPY 500 billion in FY2024 sales.

• Datroway (Dato-DXd) was recently approved in Japan for breast cancer; US and EU submissions are under review, with a new BLA for EGFRm NSCLC submitted in Nov 2024.

• DS-9606, a PBD ADC, showed promising phase one data in multiple cancers.

• ENHERTU and Datroway have received prestigious industry awards for innovation, including the 2024 Prix Galien USA for Best Biotechnology Product.

Clinical development and regulatory progress

• DESTINY-Breast06 study showed significant PFS benefit for ENHERTU in HER2-low and ultra-low breast cancer; regulatory submissions are under review in Japan, US, and EU, with a US decision expected by February.

• Datroway is prioritized for EGFR-mutated NSCLC, with new clinical studies planned for biomarker-positive patients.

• Strategic collaborations with AstraZeneca and Merck have expanded clinical development, combination therapy opportunities, and resulted in over 15 clinical studies and 9 major congress data presentations.

• Multiple pivotal trials are ongoing for both ENHERTU and Datroway in various cancer types.

• ENHERTU and Datroway's value has been driven by global launches and significant milestone payments.