Contents of this document
- Beginning in-house sales of Xeplion and Xeplion TRI in Japan
- Providing information to medical institutions following the additional approval of Wegovy for the MASH indication
- Establishing a new Vaccine and Adjuvant Business Development Office
- Commercializing proprietary TLR7 adjuvant technology and promoting collaboration with vaccine developers
- Expanding direct-to-consumer advertising for Orgovyx
- Orgovyx U.S. sales (dollar basis)323 USD millionYear on year against the same period last year143%
- Gemtesa U.S. sales (dollar basis)189 USD millionYear on year against the same period last year129%
- Orgovyx first-quarter target achievement rate102 %
- Gemtesa first-quarter target achievement rate116 %
- Percentage of patients achieving at least a 50% improvement in total symptom score with nuvisertib combination therapy53% (12 weeks), 60% (24 weeks)
- Percentage of patients achieving at least a 25% improvement in spleen volume with nuvisertib combination therapy73% (12 weeks), 100% (24 weeks)
- SMP-3124 disease control rate48.2 %
| Item | Details |
|---|---|
| Document type | Financial results presentation |
| Fiscal Period Covered | First quarter of the fiscal year ending March 2027 |
| Net Sales | ¥1,295 100 million (YoY +19.9%) |
| Operating profit | ¥182 100 million (YoY -10.8%) |
| Ordinary income | not disclosed (profit before tax for the quarter is presented under IFRS) |
| Net income | ¥170 100 million (YoY +51.7%) |
| Gross Profit Margin | Rate Not disclosed / Year-on-year change (points) Declined (figure not disclosed) |
| Operating profit margin | Rate Not disclosed / Year-on-year change (points) Declined (figure not disclosed) |
| Selling, general and administrative expenses | ¥390 100 million |
| Results for the three months of the current quarter | For the first quarter of FY2026, revenue was ¥129.5 billion, operating profit was ¥18.2 billion, profit before tax for the quarter was ¥18.3 billion, and profit for the quarter attributable to owners of the parent was ¥17.0 billion. |
| Full-year earnings forecast | Revenue ¥5,400 100 million / Cost of sales ¥2,450 100 million / Gross profit ¥2,950 100 million / Selling, general and administrative expenses ¥1,550 100 million / Research and development costs ¥510 100 million / Core operating profit ¥910 100 million / Operating profit ¥900 100 million / Income before taxes ¥835 100 million / Profit for the period attributable to owners of the parent ¥770 100 million |
| Progress against full-year forecast | Revenue 24 % / Cost of sales 25.1 % / Gross profit 23.1 % / Selling, general and administrative expenses 25.1 % / Research and development costs 22.4 % / Core operating profit 19.9 % / Operating profit 20.2 % / Income before taxes 21.9 % / Profit for the period attributable to owners of the parent 22.1 % |
| Self-assessment against the plan | Orgovyx achieved 102% of its first-quarter target and Gemtesa achieved 116%. The FY2026 development events for enzomenib are progressing as planned. |
| Segment results | Japan Revenue ¥222 100 million (YoY +4.6%) / Gross profit ¥97 100 million (YoY -7.6%) / United States Revenue ¥943 100 million (YoY +34.9%) / Gross profit ¥570 100 million (YoY +34.4%) / Other Revenue ¥130 100 million (YoY -22.6%) / Gross profit ¥13 100 million (YoY -88.2%) |
| Breakdown of Factors Affecting the Change | Revenue United States ¥244 100 million / Japan ¥10 100 million / Other ¥-39 100 million / Cost of sales Japan ¥17 100 million / United States ¥98 100 million / Other ¥58 100 million / Gross profit Japan ¥-8 100 million / United States ¥146 100 million / Other ¥-96 100 million / Cost Selling, general and administrative expenses ¥36 100 million / Research and development costs ¥33 100 million / Financial income and expenses ¥86 100 million |
| Key KPIs | Indicator name Orgovyx U.S. sales (dollar basis) / Value 323 USD million / Year on year against the same period last year 143%, Indicator name Gemtesa U.S. sales (dollar basis) / Value 189 USD million / Year on year against the same period last year 129%, Indicator name Orgovyx first-quarter target achievement rate / Value 102 % / Year on year against the same period last year Not disclosed, Indicator name Gemtesa first-quarter target achievement rate / Value 116 % / Year on year against the same period last year Not disclosed, Indicator name Percentage of patients achieving at least a 50% improvement in total symptom score with nuvisertib combination therapy / Value 53% (12 weeks), 60% (24 weeks) / Year on year against the same period last year Not disclosed, Indicator name Percentage of patients achieving at least a 25% improvement in spleen volume with nuvisertib combination therapy / Value 73% (12 weeks), 100% (24 weeks) / Year on year against the same period last year Not disclosed, Indicator name SMP-3124 disease control rate / Value 48.2 % / Year on year against the same period last year Not disclosed |
| Unit price and quantity metrics | For Orgovyx and Gemtesa, volumes were broadly in line with expectations, while the payer mix had a positive impact on pricing. Orgovyx volumes are presented as the number of bottles. For Gemtesa, trends in total prescriptions and new prescriptions are presented. |
| Assumptions Underlying the Business Outlook | Exchange rate FY2026 forecast: US$1 = ¥155.00 |
| Market Size / Share | Adjuvant market 2024 ¥570 billion / 2030 forecast ¥735 billion / Gemtesa Reached approximately the same level as competing products based on prescription volume (market share figure not disclosed) |
| New initiatives | Beginning in-house sales of Xeplion and Xeplion TRI in Japan, Providing information to medical institutions following the additional approval of Wegovy for the MASH indication, Establishing a new Vaccine and Adjuvant Business Development Office, Commercializing proprietary TLR7 adjuvant technology and promoting collaboration with vaccine developers, Expanding direct-to-consumer advertising for Orgovyx |
Items this document does not state (11)
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 because growth in the U.S. exceeded the decline in the Asia business. The gross profit margin declined due to changes in the product mix associated with the transfer of part of the interest in the Asia business. R&D expenses increased as clinical trials in oncology were accelerated and efforts in the neuropsychiatry field were advanced. Operating profit declined due to these and other increases in expenses.