Strong Revenue Growth
Consolidated revenue of JPY 1,533.5 billion in FY2025 Q3, up JPY 165.9 billion or 12.1% year‑on‑year.
Core Operating Profit Increase
Core operating profit rose to JPY 249.2 billion, an increase of JPY 20.2 billion or 8.8% year‑on‑year (actual increase excluding FX was JPY 13.8 billion).
ENHERTU: Material Global Growth and Regulatory Momentum
ENHERTU global Q3 sales of JPY 506.8 billion (up JPY 102.4 billion YoY). New U.S. first‑line HER2+ breast cancer promotion launched; multiple regulatory filings ongoing (Japan, China, EU) and Project Orbis reviews. NCCN guideline upgrades (including Category 1 listings for certain indications) and DESTINY‑Breast03 final OS results (median OS 56.4 months vs 42.7 months for comparator; 5‑year survival 48.1% vs 36.9%) supporting sustained adoption.
DATROWAY: Rapid Uptake and Forecast Upgrade
DATROWAY Q3 global sales JPY 31.6 billion (83.8% of October forecast); cumulative prescriptions >3,000 (≈1.5x prior quarter). Full‑year sales forecast increased to JPY 47 billion (+JPY 9.2 billion vs October) driven by stronger‑than‑expected uptake, particularly in U.S. lung cancer indication.
Partnership Milestones and Non‑organic Revenue
Recorded JPY 20.9 billion revenue from contract upfront payments and development milestones (AstraZeneca and Merck) in Q3, including milestone for DESTINY‑Breast09 approval in the U.S. and an upfront from Merck for R‑DXd.
Favorable Patent Ruling
U.S. Court of Appeals for the Federal Circuit affirmed USPTO decision invalidating Seagen's U.S. patent related to Daiichi Sankyo's ADC, reversing prior District Court damages/royalties order—legally favorable outcome.
R&D Progress and New Trial Initiations
Ongoing and new trials: DESTINY‑Lung06, DESTINY‑Ovarian01 randomized phase, DESTINY‑Endometrial‑02; DATROWAY Phase III activity (including TROPION‑Lung17 initiation) and multiple regulatory submissions (e.g., TB02 filings accepted in EU/China). DS‑3610 STING‑agonist ADC entered first‑in‑human trial. Several key readouts and regulatory decisions expected in next fiscal year.
Domestic Recognition for EZHARMIA
EZHARMIA received the Prime Minister's award recognizing its contribution to cancer therapy; product approved in Japan (ATL and PTCL) and acknowledged societally.