Revenue Growth
Consolidated revenue for Q3 FY2025 was JPY 1,533.5 billion, up JPY 165.9 billion year‑on‑year (+12.1%). Management maintained the FY2025 consolidated earnings forecast (no change from October).
Core Operating Profit Increase
Core operating profit rose to JPY 249.2 billion, an increase of JPY 20.2 billion year‑on‑year (+8.8%). Excluding FX effects, the actual increase in core operating profit was JPY 13.8 billion.
Profit Attributable to Owners Increased
Profit attributable to owners of the company was JPY 217.4 billion, up JPY 8.8 billion year‑on‑year (+4.2%).
ENHERTU Strong Sales and Guideline Momentum
Global ENHERTU sales for Q3 FY2025 were JPY 506.8 billion, up JPY 102.4 billion year‑on‑year (≈+25% vs prior year). New patient share remains #1 across major countries for existing indications. Multiple NCCN guideline upgrades/additions (including Category 1 adjuvant HER2‑positive high recurrence and upgrades for HER2‑positive esophageal/gastric cancers) support further uptake and label expansion.
DATROWAY Acceleration and Upgraded Full‑Year Forecast
Q3 global DATROWAY sales reached JPY 31.6 billion (83.8% of October forecast). Rapid uptake in U.S. lung cancer indication and expanded prescriptions (over 3,000 cumulative patients, ~1.5x vs end of prior quarter). Full‑year DATROWAY forecast increased to JPY 47.0 billion (+JPY 9.2 billion vs October).
Clinical and Regulatory Progress
Multiple regulatory and trial milestones: U.S. first‑line HER2‑positive breast cancer approval for ENHERTU (DB09) and U.S. promotion started; DESTINY‑Breast03 final OS analysis shows median OS 56.4 vs 42.7 months (5‑year survival 48.1% vs 36.9%); new trials initiated (DESTINY‑Lung06, DESTINY‑Ovarian01 randomized phase, DESTINY‑Endometrial‑02). Several ENHERTU indication filings under review globally (Project Orbis).
Partnership Milestones and Milestone Income
Contract upfront payments and development milestones (AstraZeneca, Merck) contributed JPY 20.9 billion to revenue in the quarter (including milestone for DESTINY‑Breast09 approval and Merck upfront for R‑DXd).
Favorable Legal Outcome
U.S. Court of Appeals for the Federal Circuit affirmed PTO decision invalidating Seagen's U.S. patent, reversing prior judgment requiring damages/royalties — a materially favorable IP/legal outcome.
R&D Pipeline Advancement and Recognition
First‑in‑human trial started for DS‑3610 (STING agonist ADC). EZHARMIA (in‑house) received the Prime Minister's award for medical R&D contributions. Several late‑stage readouts expected in the coming fiscal periods (e.g., DESTINY‑Lung04, TROPION‑Lung07/08, AVANZAR).