Long, Costly R&D and Uncertainty Around Commercializing New Products
First written in FY2016. 2 of 6 entries say "Restated". Latest entry: FY2025-H1.
JCR Pharmaceuticals moved to the "Worse" side of this theme in 2020, the same year as the typical company in this theme.
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
22 other companies' latest entry also says "Materialised".
- FY2025-H1MaterialisedAnnual report
「In light of the failure to demonstrate the expected efficacy in the Phase 1/2 clinical trial, the Company decided to discontinue this development program.」
The risk associated with long-term, high-cost R&D and the uncertainty of new product commercialization materialized when development of JR-031HIE was discontinued after it failed to demonstrate the expected efficacy. - FY2023-Q2MaterialisedAnnual report
「The Company plans to resubmit the application using the results of the global Phase 3 clinical trial currently underway.」
The disclosure describes the uncertainty surrounding obtaining approval before a new product can be commercialized, including the rejection of JR-141's application in Brazil and plans to resubmit after the global Phase 3 clinical trial. - FY2020ReframedAnnual report
「Pharmaceuticals can be launched only after approval following rigorous reviews by the relevant authorities of their efficacy and safety. Accordingly, if during R&D it becomes apparent that a pipeline product may not meet the approval standards for efficacy or safety, and development must be discontinued or delayed, there is a risk that recovering R&D costs and securing expected revenue will become difficult or be delayed.」
Reorganized the risks associated with long-term, high-cost R&D to include, in addition to the previously disclosed risks of development discontinuation and extensions to the development period, failure to meet approval standards for efficacy and safety and the impact on milestone revenue. - FY2019RestatedAnnual report
「The Group conducts R&D in the fields of pharmaceuticals and regenerative medicine products, but R&D in these fields requires substantial time and funding. If circumstances arise that require the discontinuation of development or an extension of the development period before products currently under development are commercialized, the Group's financial results and financial position may be affected.」
Reconfirms the risks associated with R&D requiring a long period and substantial funding, and the impact of development discontinuation or extensions to the development period. - FY2018RestatedAnnual report
「The Group conducts R&D in the fields of pharmaceuticals and regenerative medicine products, but R&D in these fields requires substantial time and funding. If circumstances arise that require the discontinuation of development or an extension of the development period before products currently under development are commercialized, the Group's financial results and financial position may be affected.」
Reconfirms the risks associated with R&D requiring a long period and substantial funding, and the impact of development discontinuation or extensions to the development period. - FY2016First statedAnnual report
「The Company conducts R&D in the fields of pharmaceuticals and advanced medical technologies, but R&D in these fields requires substantial time and funding. If circumstances arise that require the discontinuation of development or an extension of the development period before products currently under development are commercialized, the Company's financial results and financial position may be affected.」
Discloses the risk that the discontinuation of development or an extension of the development period may affect financial results and financial position.