Nippon Shinyaku Co.,Ltd.
4516・Prime Market・Pharmaceuticals
Pharmaceuticals Business
Core business with global expansion centered on rare and intractable diseases
| Period | Current | Previous | Change |
|---|---|---|---|
| Revenue (Pharmaceuticals Business) | ¥148,484 million | ¥138,654 million | ↑ |
| Segment profit | ¥33,343 million | ¥33,542 million | ↓ |
| Segment assets | ¥211,763 million | ¥175,655 million | ↑ |
| Depreciation and amortization | ¥6,396 million | ¥5,808 million | ↑ |
| Capital expenditures | ¥5,437 million | ¥30,864 million | ↓ |
| Revenue growth rate (year-on-year) | +7.1% | — | ↑ |
Business Details
Manufactures and sells urology treatments, hematologic cancer treatments, treatments for intractable/rare diseases, and gynecological treatments. Revenue composition for FY2026 (ending March 2026): product sales ¥90,062 million, Industrial Property Rights Revenue (Royalty) ¥49,457 million, joint promotion income ¥8,964 million. Major customers include Johnson & Johnson (¥56,413 million), Suzuken (¥21,587 million), Alfresa (¥16,176 million), and Mediceo (¥12,958 million). In the US, NS Pharma, Inc. handles sales and clinical development.
Recent Overview
Revenue increased on new recognition of Erleada and rapid growth of Fintepla, but segment profit declined slightly
Pharmaceuticals Business revenue for FY2026 (ending March 2026) was ¥148,484 million (+7.1% year-on-year). Growth was driven by Uptravi (+17.5%) and Fintepla (+92.5%), with Erleada newly recognized as product sales of ¥5,961 million from October 2025. Meanwhile, Viltepso saw a revenue decline of -4.1% in the US. Segment profit was ¥33,343 million, a slight decrease from the prior year's ¥33,542 million. As a subsequent event, on May 7, 2026, Capricor Therapeutics filed a lawsuit seeking termination of the sales agreement, among other claims.
Key Products
Growth Drivers
- Expansion of Uptravi sales in Japan and overseas along with increased overseas royalty income (+17.5% in FY2026 (ending March 2026), forecast of ¥19,200 million in FY2027 (ending March 2027))
- Rapid growth of Fintepla (+92.5% in FY2026 (ending March 2026)), expanding revenue contribution in the rare disease area
- Substantial revenue contribution from full-year recognition of Erleada (forecast of ¥14,400 million in FY2027 (ending March 2027))
- Entry into the DMD cardiomyopathy area through the new launch of Deramiocel (US) (forecast of ¥11,400 million in FY2027 (ending March 2027); PDUFA date: August 22, 2026)
- Continued expansion of Industrial Property Rights Revenue (Royalty) (forecast of ¥53,000 million in FY2027 (ending March 2027))
- New entry into the blastic plasmacytoid dendritic cell neoplasm area through the March 2026 launch of NS-401 (Tagraxofusp)
- Expansion of indications through the application to expand GA101 (Obinutuzumab) to idiopathic nephrotic syndrome (May 2026)
Risks
- Downward pressure on revenue of existing products due to annual drug price revisions and policies promoting the use of generic drugs
- Erosion of the mid- to long-term revenue base due to patent cliff risk for Uptravi
- Business continuity risk from the lawsuit filed by Capricor Therapeutics on May 7, 2026, seeking termination of the sales agreement for Deramiocel (CAP-1002), among other claims
- Approval delay risk from the FDA's Complete Response Letter (CRL) for RGX-121 (Mucopolysaccharidosis Type II) received in February 2026, and the ongoing response to the appeal
- Development delay risk from the FDA clinical hold on RGX-111 (Mucopolysaccharidosis Type I) in January 2026
- Decline in Viltepso US sales (-4.1%) and intensifying competitive environment
- Profit pressure from increased R&D expenses (¥36,713 million in FY2026 (ending March 2026), forecast of ¥40,500 million in FY2027 (ending March 2027))
- Increased cost burden from higher selling, general and administrative expenses (¥43,565 million in FY2026 (ending March 2026), +14.6% year-on-year)
Last updated: June 23, 2026