Prolonged Pharmaceutical Development and Uncertainty over Approval
First written in FY2017. 1 of 2 entries say "Materialised", first in 2026-03-31. Latest entry: 2026-03-31.
GNI Group moved to the "Worse" side of this theme in 2026, 6 years after the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
22 other companies' latest entry also says "Materialised".
- 2026-03-31MaterialisedRevision to earnings forecast
「Because the timing of regulatory approvals and other permissions has a significant impact on the launch of new drugs in the pharmaceutical business and the revenue contribution from new businesses in the medtech business, including private-label operations in the United States and exports to selected Asian countries where demand is expected, none of these contributions has been included in the forecast from a conservative standpoint.」
The prolonged development timelines and approval uncertainty for pharmaceuticals were reflected in the non-disclosure of profit items and the exclusion of revenue contributions from new drugs and new businesses from the earnings forecast. - FY2017First statedAnnual report
「しかしながら、医薬品の開発には多額の開発コストと長期の開発期間を要し、さらに製造承認は、当該国政府機関の許可に基づくため、その承認時期は不確定要素を含むものであります。そのため、当社グループが希望しているとおりに医薬品の生産及び販売が行われる保証はなく、当社グループの経営計画はこれらの進捗状況の影響を受けることになります。」
医薬品開発には多額のコストと長期の期間を要し、承認時期も不確定で、計画どおりの生産・販売が保証されないリスクを説明している。