Risks Related to Regulations, Political Conditions and the Business Environment in Overseas Markets
First written in FY2016. 5 of 10 entries say "Worsened", first in FY2022-Q1. Latest entry: 2026-04-28.
Otsuka Holdings moved to the "Worse" side of this theme in 2024, 3 years after the typical company in this theme (2021).
The whole theme swung hardest in 2025: 47 of 94 companies on the "Worse" side.
15 other companies' latest entry also says "Mitigated".
- 2026-04-28MitigatedEarnings
「Although there are concerns about transportation delays and higher costs for certain products and raw materials due to the situation in the Middle East, the impact on the Group’s overall results is currently limited because of inventory securing and alternative sourcing.」
The company recognizes transportation and cost risks arising from the situation in the Middle East, while considering the impact on results limited through inventory securing and alternative sourcing. - FY2025WorsenedAnnual report
「In 2025, the second year of the Fourth Medium-Term Management Plan, social conditions became even more uncertain due to heightened geopolitical risks associated with the situations in Russia and Ukraine and the Middle East, as well as U.S. tariff policies, and the Group's business activities were also affected to some extent.」
In addition to the situations in Russia and Ukraine and the Middle East, the disclosure explicitly identifies U.S. tariff policies, broadening the scope of geopolitical and business-environment risks associated with overseas expansion. - FY2024WorsenedAnnual report
「In particular, rapid changes in the international situation and the outbreak of armed conflicts may give rise to risks such as business restrictions in the relevant regions, supply-chain disruptions and delivery delays. In addition, unstable foreign-exchange markets and sharp market fluctuations could have a material impact on the Group's operating results and financial position.」
In addition to the existing risks related to regulations, political conditions and business environments in various countries, the disclosure explicitly identifies armed conflict, economic security regulations, logistics restrictions and sharp foreign-exchange movements, broadening the scope of geopolitical risks. - FY2023WorsenedAnnual report
「During the period of the Third Medium-Term Management Plan, which ended in fiscal 2023, social conditions became increasingly uncertain due to the impact of the COVID-19 pandemic and heightened geopolitical risks associated with the situations in Russia and Ukraine and the Middle East, and the Group's business activities were also affected to some extent.」
The disclosure explicitly adds the situation in the Middle East to the existing situation involving Russia and Ukraine, noting that geopolitical risks and uncertainty in the social environment have increased. - FY2022RestatedAnnual report
「Some clinical trials have been affected, and the company has halted the start-up of trial sites and patient enrollment in both countries. It is responding by transferring activities to other regions to minimize delays in ongoing clinical trials.」
While the suspension of clinical-trial site start-ups and patient enrollment due to the situation in Ukraine and Russia continues, the company is responding by transferring activities to other regions and taking other measures. - FY2022-Q3RestatedAnnual report
「Some clinical trials have been affected, and the company has halted the start-up of trial sites and patient enrollment in both countries. It is responding by transferring activities to other regions to minimize delays in ongoing clinical trials.」
While the suspension of clinical-trial site start-ups and patient enrollment due to the situation in Ukraine and Russia continues, the company continues to take steps to limit delays by transferring activities to other regions. - FY2022-Q2WorsenedAnnual report
「Some clinical trials have been affected, and the company has halted the start-up of trial sites and patient enrollment in both countries. It is responding by transferring activities to other regions to minimize delays in ongoing clinical trials.」
The situation involving Ukraine and Russia has had a concrete impact on research and development, including the suspension of trial-site start-up and patient enrollment in both countries. The company is responding by transferring activities to alternative regions, while also anticipating impacts on raw material prices, the supply chain and foreign exchange rates if the situation is prolonged or worsens. - FY2022-Q1WorsenedAnnual report
「Although there were some supply chain disruptions and impacts on clinical trials, the overall impact was limited.」
The situation involving Ukraine and Russia has newly caused supply chain disruptions and impacts on clinical trials. The company has no operating sites in either country and states that the overall impact is limited as of the present time. - FY2017RestatedAnnual report
「In conducting global business activities, if the Group cannot completely avoid risks such as the legal regulations, economic conditions, political instability and uncertainty in the business environment of each country, this could have a material impact on the Group's operating results and financial condition.」
The company continues to identify risks related to regulations, economic conditions, political conditions and the business environment in each country in connection with research and development, manufacturing and sales in the United States, Europe, Asia and other regions. - FY2016First statedAnnual report
「In conducting global business activities, if the Group cannot completely avoid risks such as the legal regulations, economic conditions, political instability and uncertainty in the business environment of each country, this could have a material impact on the Group's operating results and financial condition.」
The company has newly and formally disclosed country-specific risks associated with research and development, manufacturing and sales in the United States, Europe, Asia and other regions.