Lengthy Drug Development and Uncertainty Over Commercial Success

「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」

「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」

「We are working to improve efficiency by focusing on selected areas, including by adopting a process for evaluating development from multiple perspectives. However, these inherent R&D-related risks cannot be completely eliminated.」

「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」

「In the pharmaceutical industry, measures to optimize medical costs, including pharmaceutical-system reforms and the further strengthening of policies to promote the use of generic drugs, continue to advance. As companies are required to further strengthen their management, the earnings environment is becoming increasingly challenging due to factors including higher R&D expenses and greater development risks.」

「There were no new major risks during the three months ended 30 June, and no material changes to the business and other risks described in the annual securities report for the previous fiscal year.」

「During the first three quarters of the current fiscal year, there were no new occurrences of the major risks that management recognises could materially affect the filing company's financial position, operating results or cash flows among the matters relating to business conditions, financial conditions and other matters described in the quarterly report, and no material changes to the "Business and Other Risks" described in the annual securities report for the previous fiscal year.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses and increased development risks.」

「Pharmaceutical development requires substantial investment of management resources and a long period of time. However, if it is found or anticipated that efficacy or safety will not reach the level required for approval by the regulatory authorities, development may be discontinued or additional studies may be conducted. In such cases, invested capital may be difficult to recover, and the launch of the product may be delayed. The Company seeks to improve efficiency through selection and concentration, including by adopting a process for evaluating development from multiple perspectives, but these inherent research and development risks cannot be completely eliminated.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「Pharmaceutical development requires substantial investment of management resources and a long period of time. However, if it is found or anticipated that efficacy or safety will not reach the level required for approval by the regulatory authorities, development may be discontinued or additional studies may be conducted. In such cases, invested capital may be difficult to recover, and the launch of the product may be delayed.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including drug pricing system reforms and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「The development of prescription drugs requires substantial technical, financial and human resources and a long period of time. Nevertheless, a product may fail to achieve commercial success.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have continued to be promoted, including fundamental reform of the drug pricing system and strengthened measures to encourage the use of generic drugs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have been promoted, including annual drug price revisions and fundamental reforms aimed at improving the quality of healthcare, in order to curb steadily rising social security costs. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, based on the government's "Basic Policy for Fundamental Reform of the Drug Pricing System" published in December 2016, the main details of the reform were compiled in December 2017. Policies for fundamental reforms, including annual drug price revisions and improvements in the quality of healthcare, were presented, and measures to contain healthcare costs were promoted. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「In the pharmaceutical industry, measures to contain healthcare costs have been promoted under the government's basic policy for fundamental reform of the drug pricing system published in December 2016, including a policy of revising drug prices annually. As companies were required to further strengthen management, the earnings environment became increasingly challenging, with higher research and development expenses, increased development risks and intensifying competition.」

「The development of prescription drugs requires substantial technical, financial and human resources and a long period of time. Nevertheless, a product may fail to achieve commercial success.」

「In the pharmaceutical industry, the environment surrounding healthcare continued to change rapidly, including ongoing discussions by the Council on Economic and Fiscal Policy regarding annual revisions to drug prices. As companies were required to further strengthen management in order to respond appropriately to changes in the market environment, the business environment remained challenging, with many issues to address, including higher research and development expenses, increased development risks and intensifying competition.」

「During the cumulative second quarter of the current fiscal year, there were no occurrences of matters concerning the business situation, accounting situation or other matters described in the quarterly report that could have a material impact on investors’ decisions, and no material changes to the “Business and Other Risks” described in the annual securities report for the previous fiscal year.」

「In the pharmaceutical industry, the Ministry of Health, Labour and Welfare formulated a comprehensive strategy to strengthen the pharmaceutical industry, and the environment surrounding healthcare changed rapidly. As companies were required to further strengthen management in order to respond appropriately to changes in the market environment, the business environment remained challenging, with many issues to address, including higher research and development expenses, increased development risks and intensifying competition.」

「The development of prescription drugs requires substantial technical, financial and human resources and a long period of time. Nevertheless, a product may fail to achieve commercial success.」