Contents of this document
- Plan to begin a FIH trial of DS1025 in solid tumors in the first half of FY2026
- Plan to begin the Phase 3 TROPION-Urothelial04 trial of Datroway® in combination with rilvegostomig in the second half of FY2026
- Policy of identifying multiple Next BGTs by FY2030
- Enhertu® global product sales2,192 Hundreds of millions of yenYear on year against the same period last year+41.2%
- Datroway® global product sales206 Hundreds of millions of yenYear on year against the same period last year+289.9%
- Cumulative number of patients treated with Datroway®7,000 people, approx.Year on year against the same period last yearApproximately 1.4x the previous quarter
- Percentage of metastatic breast cancer patients for whom treatment options can be offered90 Over %
- Datroway® confirmed ORR in TNBC62.5 %
- Confirmed ORR for chemotherapy29.3 %
- ORR for the TROPION-Urothelial04 combination therapy68.2 %
- 12-month PFS rate for the TROPION-Urothelial04 combination therapy73.5 %
- Japan BusinessRevenue1,200 Hundreds of millions of yen (YoY -3.9%)
- Daiichi Sankyo HealthcareRevenue226 Hundreds of millions of yen
- Oncology BusinessRevenue1,974 Hundreds of millions of yen
- American RegentRevenue422 Hundreds of millions of yen
- EU Specialty BusinessRevenue747 Hundreds of millions of yen
- ASCA (Asia and Latin America) BusinessRevenue687 Hundreds of millions of yen
| Item | Details |
|---|---|
| Document type | Presentation materials for financial results |
| Fiscal Period Covered | FY2026 First Quarter |
| Net Sales | 5,747 Hundreds of millions of yen (YoY +21.1%) |
| Operating profit | 851 Hundreds of millions of yen (YoY -12.0%) |
| Ordinary income | 913 Hundreds of millions of yen |
| Net income | 686 Hundreds of millions of yen (YoY -19.7%) |
| Selling, general and administrative expenses | 2,260 Hundreds of millions of yen |
| Results for the three months of the current quarter | Revenue 5,747 Hundreds of millions of yen (YoY +21.1%) / Operating profit 851 Hundreds of millions of yen (YoY -12.0%) / Profit before tax 913 Hundreds of millions of yen / Profit for the year attributable to owners of the parent 686 Hundreds of millions of yen (YoY -19.7%) / Quarterly EPS ¥37.72 (YoY -18.1%) |
| Full-year earnings forecast | Revenue 23,400 Hundreds of millions of yen / Cost of sales 5,500 Hundreds of millions of yen / Selling, general and administrative expenses 9,300 Hundreds of millions of yen / Research and development costs 5,000 Hundreds of millions of yen / Core operating profit 3,600 Hundreds of millions of yen / Operating profit 3,200 Hundreds of millions of yen / Profit before tax 3,340 Hundreds of millions of yen / Profit for the year attributable to owners of the parent 2,510 Hundreds of millions of yen / EPS ¥137.94 |
| Progress against full-year forecast | Enhertu® global product sales 25.4% / Datroway® global product sales 18.5% |
| Segment results | Segment Japan Business / Revenue 1,200 Hundreds of millions of yen (YoY -3.9%), Segment Daiichi Sankyo Healthcare / Revenue 226 Hundreds of millions of yen, Segment Oncology Business / Revenue 1,974 Hundreds of millions of yen, Segment American Regent / Revenue 422 Hundreds of millions of yen, Segment EU Specialty Business / Revenue 747 Hundreds of millions of yen, Segment ASCA (Asia and Latin America) Business / Revenue 687 Hundreds of millions of yen |
| Breakdown of Factors Affecting the Change | Revenue Japan Business Unit and other 7 / Oncology Business Unit 478 / American Regent Unit 110 / EU Specialty Business Unit 22 / ASCA Business Unit 47 / Upfront and milestone payments 152 / Foreign Exchange Effects 419 / Operating profit Revenue 1,001 / Cost of sales 385 / Selling, general and administrative expenses 459 / Research and development costs 95 / Non-core income and expenses 179 |
| Key KPIs | Indicator name Enhertu® global product sales / Value 2,192 Hundreds of millions of yen / Year on year against the same period last year +41.2%, Indicator name Datroway® global product sales / Value 206 Hundreds of millions of yen / Year on year against the same period last year +289.9%, Indicator name Cumulative number of patients treated with Datroway® / Value 7,000 people, approx. / Year on year against the same period last year Approximately 1.4x the previous quarter, Indicator name Percentage of metastatic breast cancer patients for whom treatment options can be offered / Value 90 Over % / Year on year against the same period last year Not disclosed, Indicator name Datroway® confirmed ORR in TNBC / Value 62.5 % / Year on year against the same period last year Not disclosed, Indicator name Confirmed ORR for chemotherapy / Value 29.3 % / Year on year against the same period last year Not disclosed, Indicator name ORR for the TROPION-Urothelial04 combination therapy / Value 68.2 % / Year on year against the same period last year Not disclosed, Indicator name 12-month PFS rate for the TROPION-Urothelial04 combination therapy / Value 73.5 % / Year on year against the same period last year Not disclosed |
| Assumptions Underlying the Business Outlook | USD/JPY from the second quarter onward ¥155 / EUR/JPY from the second quarter onward ¥180 |
| Medium-term management plan targets | Fifth medium-term management plan Revenue ¥1.6 trillion / Oncology revenue ¥600 billion or more / Core operating profit margin before R&D expenses 40% / ROE 16% or higher / DOE 8% or higher / FY2025 actual Revenue ¥2.123 trillion / Oncology revenue ¥954 billion / Core operating profit margin before R&D expenses 40.1% / ROE 16.9% / DOE 8.7% |
| Financial targets | ROE Target 16% or higher / Actual results 16.9% / DOE Target 8% or higher / Actual results 8.7% |
| Market Size / Share | Percentage of metastatic breast cancer patients for whom treatment options can be offered At least 90% / Datroway® patient share in the US EGFR-mutated NSCLC 3L+ market 1st place |
| New initiatives | Plan to begin a FIH trial of DS1025 in solid tumors in the first half of FY2026, Plan to begin the Phase 3 TROPION-Urothelial04 trial of Datroway® in combination with rilvegostomig in the second half of FY2026, Policy of identifying multiple Next BGTs by FY2030 |
Items this document does not state (13)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Revenue increased in the first quarter, driven by sales growth for Enhertu® and Datroway® and foreign exchange effects. Operating profit declined due to higher cost of sales and profit-sharing expenses accompanying revenue growth, increased R&D investment, and costs related to the reorganization of the EU Specialty Business Unit. The full-year revenue forecast was revised upward due to the revised assumed exchange rates from the second quarter onward and US Enhertu® product sales exceeding expectations. The operating profit forecast was revised upward due to the reversal of the provision for compensation related to the cancellation of investment in the Odawara Plant.