MANI,INC.

If the global fluidization of labor markets leads to the outflow of talent from key positions or insufficient development of highly specialized researchers and engineers, this could result in a temporary decline in organizational capability and business execution capacity, potentially affecting operating results. As countermeasures, the Company has established work systems that allow for diverse working styles, as well as tiered training systems and educational programs to strengthen specialization.

There is a risk that demand may decrease and profitability may decline due to price competition from the rise of low-cost products in emerging countries or patients avoiding medical treatment due to economic conditions. In addition, there is a risk that unexpected changes in laws and regulations, political instability, war, terrorism, natural disasters, or other force majeure events in countries where subsidiaries are established could disrupt product supply and destabilize the continuity of transactions. As countermeasures, the Company has enhanced its overseas network through the establishment of RHQs and regional sales bases, and has established a system for continuously monitoring laws, regulations, and political conditions in each country.

If the Company fails to comply with domestic pharmaceutical and medical device-related laws such as the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, it may be required to revoke licenses, recall products, or discontinue manufacturing and sales, which could have a material impact on business activities. Overseas as well, insufficient response to revisions of local relevant laws and regulations poses a risk of affecting financial position and operating results. As countermeasures, the Company strives to comply with relevant laws and regulations and conform to standards in the countries of manufacture and sale, and has established a quality management system that is continuously improved.

If large-scale product recalls occur due to unexpected defects or suspected defects during manufacturing, this could result in recall costs, regulatory responses, decreased sales, and claims for damages, potentially leading to a decline in the Group's credibility and impairment of corporate value. As countermeasures, the Company has established a strict quality control and quality assurance system based on the Ministerial Ordinance on Standards for Quality Management Systems for Medical Devices, the Ministerial Ordinance on Organizational Standards, the Ministerial Ordinance on Good Vigilance Practice (GVP), and ISO standards, and conducts quality monitoring not only during the manufacturing stage but also after sale.

If unexpected problems regarding efficacy or safety are discovered or arise during the new product development and launch process, the Company may be unable to launch new products at the expected time, or development costs may increase. As countermeasures, the Company promotes the development of new products and new technologies through proactive research and development activities, and seeks to improve the efficiency of development themes and enhance project management sophistication through strengthened collaboration between development and marketing.

If a large-scale disaster occurs, product supply may be temporarily disrupted, destabilizing the continuity of transactions, which could affect financial position and operating results. As countermeasures, the Company conducts disaster prevention drills assuming earthquakes and fires, and performs regular equipment inspections, while also having prepared BCPs at domestic locations and MHC to establish a system for rapid and effective recovery in the event of an emergency.

If business activities are affected by cyberattacks such as unauthorized external access or intrusion by computer viruses, this could affect financial position and operating results. As countermeasures, the Company has established an Information Security Committee and an information security risk management department, formulated rules and regulations related to information security, and put in place a system capable of responding promptly in the event of an incident.

Failure to respond to medium- to long-term impacts on social infrastructure from climate change and abnormal weather, changes in climate change-related policies, changes in financial markets and social norms, and rapid transition to a low-carbon society could affect financial position and operating results. While the Company's products are mostly small in size and their environmental burden in terms of power consumption and transportation is assumed to be minor, the Sustainability Committee and other bodies deliberate on risk response policies across the entire company to minimize the impact of risks that materialize.

The Group, which conducts business globally, engages in foreign currency-denominated transactions, and may be affected in its financial position and operating results by fluctuations in exchange rates. As countermeasures, the Company quantitatively assesses the impact on business performance through exchange rate sensitivity analysis and other means, and has established basic policies and procedures for risk hedging, as well as a system for making prompt decisions when risks materialize.

In some countries, there is a trend toward preferential treatment of domestically produced goods, which may require the Group to take local countermeasures such as local assembly production. Such changes in the regulatory environment involve additional cost burdens and changes to the business model, posing a risk to profitability. As countermeasures, the Company continuously monitors changes in laws and regulations in each country and strives to gain a multifaceted understanding of market trends through RHQs and local sales bases.