Prolonged Development, Failure and Approval Uncertainty in New Drug Development
First written in FY2024. 2 of 3 entries say "Restated". Latest entry: FY2025.
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
28 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「Pharmaceutical development generally takes a long time from the start of research to approval and requires substantial research and development investment, while the probability of successful commercialization is significantly lower than in other industries.」
Prolonged development timelines, substantial investment, a low probability of successful commercialization, and uncertainty over approval in regulatory reviews continued to be identified as major risks. - FY2025-H1RestatedAnnual report
「During the interim accounting period, there were no significant changes in the occurrence of the major risks that management recognizes could materially affect the company’s financial position, financial performance, and cash flows, or in the matters described as “Business Risks” in the annual securities report for the previous fiscal year.」
The company explains that there have been no material changes in the major risks or in the business and other risks described in the previous fiscal year. - FY2024First statedAnnual report
「The development of pharmaceuticals and related products requires many years and substantial research expenses, and research and development programs do not necessarily succeed.」
The company cites the possibility of development being extended or discontinued due to efficacy or safety issues, approval not being obtained due to regulatory changes, and investments not being recovered.