Risks Related to New Contact Lens Product Development and Changes in Laws and Regulations
First written in FY2016. 1 of 3 entries say "Materialised", first in FY2017. Latest entry: FY2018.
1 other company's latest entry also says "Restated".
- FY2018RestatedAnnual report
「The Group is also focusing on activities to provide high-quality, high-value-added products, but these activities do not necessarily lead to the development of new products. In addition, if newly developed products do not meet market needs and fail to achieve the level of revenue or profit anticipated by the Group, the Group's performance may be affected. Furthermore, laws and regulations in the medical industry have undergone frequent changes in recent years, and depending on the details of future amendments, the Group's performance may be affected.」
The Group continues to face uncertainty in new product development, the risk that products may not meet market needs, and the potential impact of amendments to medical-related laws and regulations. - FY2017MaterialisedAnnual report
「Revenue was ¥17,080,799 thousand, down 3.9% from the previous fiscal year, due in part to delays in obtaining regulatory approvals for new contact lens products, which pushed back their launch dates.」
For new product development and regulatory approval risks, delays in obtaining approvals and the resulting postponement of product launches were cited as actual factors behind the revenue decline. - FY2016First statedAnnual report
「The contact lens business operated by the Group falls under the category of highly controlled medical devices, and research and development of new materials and products is essential for companies to continue growing in the medical device market. The Group is also focusing on activities to provide high-quality, high-value-added products, but these activities do not necessarily lead to the development of new products. In addition, laws and regulations in the medical industry have undergone frequent changes in recent years, and depending on the details of future amendments, the Group's performance may be affected.」
The disclosure indicates that new materials and product development are necessary for highly controlled medical devices, and that unsuccessful development or amendments to medical-related laws and regulations could affect performance.