KAKEN PHARMACEUTICAL CO., LTD.
4521・Prime Market・Pharmaceuticals
Pharmaceutical Business
The core segment of Kaken Pharmaceutical, responsible for the manufacture and sale of pharmaceuticals, medical devices, and agricultural chemicals
| Period | Current | Previous | Change |
|---|---|---|---|
| Revenue (Pharmaceutical Business segment) | ¥74,328 million | ¥91,553 million | ↓ |
| Segment profit (loss) | ¥(2,277) million | ¥19,659 million | ↓ |
| Overseas revenue | ¥12,840 million | ¥26,609 million | ↓ |
| Segment assets | ¥106,225 million | ¥103,175 million | ↑ |
| Increase in property, plant and equipment and intangible assets | ¥6,239 million | ¥20,225 million | ↓ |
| R&D expenses (consolidated, company-wide) | ¥20,585 million | ¥18,725 million | ↑ |
| Goodwill amortization | ¥268 million | ¥79 million | ↑ |
| Goodwill balance at period end | ¥5,399 million | ¥5,459 million | ↓ |
Business Details
The Pharmaceutical Business segment's main business is the manufacture and sale of pharmaceuticals, medical devices, and agricultural chemicals. Domestically, it operates primarily in the dermatology and orthopedics fields, while overseas it also generates revenue through licensing agreements and intellectual property transfers. The constituent companies are Kaken Pharmaceutical Co., Ltd., Kaken Pharma Co., Ltd., Aasumu Co., Ltd., KAKEN INVESTMENTS INC., and Aadi Bioscience. In FY2026 (ending March 2026), the segment recorded a substantial decline in revenue due to the reversal effect of the prior year's large one-time licensing agreement payment, resulting in a segment loss.
Recent Overview
Revenue fell 18.8% and the segment shifted to a loss due to the reversal effect of the prior year's large licensing one-time payment; R&D expenses continued to increase
In FY2026 (ending March 2026), Pharmaceutical Business segment revenue was ¥74,328 million (down 18.8% year on year), with a segment loss of ¥2,277 million (compared to a profit of ¥19,659 million in the prior year). The main cause was the reversal effect of the one-time payments recorded in the prior year from the 'NM26' intellectual property transfer and the 'STAT6 inhibitor' licensing agreement, with overseas revenue at ¥12,840 million (down 51.7% year on year). Domestically, while 'Ecroc' saw increased sales and 'Ecterly' began sales, the AG replacement of 'Clenafin' progressed. R&D expenses were ¥20,585 million (up 9.9% year on year), continuing strategic investment. The provisional accounting treatment related to the business combination with Aadi Bioscience was finalized, and goodwill was revised to ¥4,648 million (after finalization).
Key Products
Growth Drivers
- Concretization of the new product pipeline through planned manufacturing and marketing approval applications for KP-001 (refractory vascular malformations) and KAR (head lice infestation) during the first half of FY2026 (the fiscal year ending March 2027)
- Acquisition of sales rights in the Asia region and future milestone income through the strategic licensing and joint development agreement for 'NM81' concluded with Numab
- Expansion of the product lineup through newly introduced products such as 'Ecterly' (hereditary angioedema), 'Silk-Elastin Wound Sheet', 'gMSC1', and 'Nabenivart'
- Continued increase in domestic sales of 'Ecroc' and expansion of overseas operations through the launch of sales in South Korea
- Acceleration of European expansion of 'Jublia (Clenafin)' (manufacturing and marketing approval obtained in Germany, the second country following Italy)
- Promotion of the growth strategy for the natural substance agricultural chemical 'Polyoxin' and increased revenue in agricultural chemicals driven by the herbicide 'Metamifop' and others
- Revenue and profit growth expected in FY2027 (ending March 2027) due to receipt of one-time payments upon milestone achievement, among other factors (revenue of ¥89,900 million, operating profit of ¥7,900 million)
Risks
- Structural and ongoing decline in domestic revenue due to the progressing replacement of the onychomycosis treatment 'Clenafin' by its authorized generic (AG)
- Profit pressure from the continued high level of R&D expenses (¥20,585 million in FY2026, ending March 2026) and one-time contract payments associated with multiple licensing agreements
- Continued headwinds to the domestic pharmaceutical business from healthcare cost containment measures such as fundamental drug pricing system reforms and the introduction of a selective medical care system for long-listed products
- Risk of significant fluctuation in overseas revenue: due to a revenue structure dependent on large one-time licensing agreement payments, results vary substantially depending on whether contracts are concluded (overseas revenue declined 51.7% in FY2026, ending March 2026)
- Risk of impairment of goodwill, sales rights (¥12,201 million), and in-process R&D (¥5,495 million) related to acquired assets including Aadi Bioscience (FYARRO)
- Risk of clinical trial failure in the development pipeline: potential impairment of R&D investment if approval applications and launches for KP-001, KAR, and others are delayed or do not materialize
Last updated: June 25, 2026