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Business risks

Among the matters related to the Group's business status, accounting status, etc., the major risks that management recognizes as having the potential to have a significant impact on the financial position, Results of Operations, and Cash Flows status of the consolidated companies are as follows. These risks were discussed by the "Risk Committee," a subcommittee (specialist committee) of the Sustainability Committee established as an advisory body to the Board of Directors, and resolved by the Board of Directors. The Group conducts its business activities while recognizing the possibility that these risks may occur. Matters relating to the future in this document have been judged as of the end of this consolidated fiscal year.

(1) Regarding the industry environment

① About national medical policy

In Japan, each prefecture is required to estimate medical needs and the required number of hospital beds for each medical function, and to formulate a "regional medical plan" that contains measures to realize a medical care system that suits the local situation.We are promoting differentiation and collaboration among four medical functions: highly acute, acute, recovery, and chronic.

The Group strives to collect detailed information on changes in medical policies and external environment in the region and the management status of medical institutions, strengthens proposal capabilities by promoting solution businesses, and improves distribution efficiency by taking advantage of economies of scale. We are planning to work on measures to contribute to regional medical care, but by promoting functional differentiation and consolidation at medical institutions, there is a possibility that the number of medical institutions to be sold will decrease due to the consolidation of medical equipment purchased by each medical institution. In addition, it may further intensify competition in the medical equipment sales industry, which may affect the sales amount and profits of the Group.

② Revision of reimbursement prices for medical supplies

Reimbursement prices are the prices that medical institutions can claim for materials (specified insured medical materials) as medical fees from insurance institutions (part of which is paid by the patient) under the public health insurance system. Reimbursement prices are revised in conjunction with the revision of medical fees, which takes place every two years in principle. The sales price to medical institutions and the purchase price from suppliers of specified insured medical materials are based on the reimbursement price, but are not fixed. Furthermore, the revised reimbursement prices differ depending on each medical material. Therefore, it is difficult to calculate in advance the impact of reimbursement price revisions on sales amounts and revenues.

In the Group, the sales of specified insurance medical materials subject to such reimbursement prices account for about one-third of the total, and the revision of the reimbursement price is the sales price and gross profit margin of the Group. If it acts on a downward trend, it may affect the sales amount and profits of the Group.

(2) Management strategy and issues to be addressed

① About M & A

As a medium- to long-term management strategy, the Group will expand its corporate scale through M & A with companies closely linked to each region in order to maintain growth in response to the changing industry environment and meet diversifying medical field needs. I am aiming for. We intend to achieve stable growth and increase corporate value by reducing costs and improving operational efficiency by taking advantage of economies of scale.

However, the medical device sales industry is dominated by small and medium-sized companies, most of which are unlisted. Therefore, there is no market price that can be used as a basis for valuing a company's value. We recognize that financial details are often insufficient in terms of precision and transparency. When determining the acquisition price and merger ratio, the Group conducts preliminary investigations and comprehensively considers factors such as the company's financial situation, progress in business plans, and future prospects. We also consider the results of an independent third-party valuation firm's corporate value assessment, depending on the company's size. We negotiate and discuss transactions as carefully as possible. However, there is no guarantee that the underlying business plan can be achieved. If we are unable to achieve the projected revenues, we may need to record an impairment loss on goodwill, which could have an adverse effect on the Group's revenues. Furthermore, while we intend to conduct preliminary investigations with the utmost care and accuracy, there is a possibility that off-balance-sheet liabilities or compliance issues may arise after an acquisition or merger, which could have an adverse effect on the Group's revenues.

We also recognize that each company subject to M & A has its own corporate culture and employees. The Group intends to respect the corporate culture and employees of each company that is closely related to the region and work hand in hand as a group, but the fusion of corporate culture and personnel exchanges cannot be carried out smoothly, and human resources will flow out. In some cases, or if the core systems and business procedures cannot be thoroughly integrated, it may not be possible to achieve the expected effects such as operational efficiency and synergistic effects through M & A, which will affect the sales amount and profits of the Group. May affect.

② About new business

In order to meet the diversifying needs of medical settings, the Group intends to further contribute to regional medical care by implementing measures to enhance its corporate value, such as strengthening its proposal capabilities by promoting solutions businesses and improving logistics efficiency by leveraging economies of scale. When the Group undertakes a new business, a business plan is formulated after thorough prior consideration and approved by the Board of Directors. However, the development of a new business often requires upfront investment, and it is expected to take a considerable amount of time for the business to generate stable revenue, which could temporarily reduce the Group's profit margins. Furthermore, if the business is unable to develop according to the initial business plan due to changes in the medical industry environment, the Group may be unable to recoup its investment, which could affect the Group's revenue.

③ Regarding efficient management structure

The Group is working to strengthen its efficient management structure and internal control by introducing a core system that links and integrates operations such as purchasing, sales, billing, and payment to group operating companies. While collecting information and opinions from the sales sites and management departments that operate the system, we will continue to work on strengthening and further improving the functions of the system to build a system environment with higher added value. However, while a large amount of capital investment is required to build a system environment, if there is a discrepancy between the operation of medical sites and diversifying needs, the maturity of new operations will proceed as expected. If this is not the case, operating productivity and operational efficiency may decline, which may result in unrecoverable investment and may affect the Group's sales and profits.

(3) Legal regulations related to our group's business

The Group is subject to the following legal regulations in carrying out its business.

Therefore, as a medical company, our Group has adopted the basic stance of corporate activities as "When faced with a situation where we must choose between justice and profit, we will choose justice without hesitation." We have formulated compliance guidelines and implemented an in-house e-learning training system to thoroughly inform all officers and employees of the code of conduct and strive to reduce the risk of violations of legal regulations. In addition, we are working to build a system for complying with laws and regulations by conducting internal audits by our Internal Audit Department, which is independent from other business execution divisions, verifying and evaluating the appropriateness and effectiveness of the internal control system and encouraging its improvement. However, even if we take these measures, we may not be able to avoid the risk of violations of legal regulations, including personal misconduct by officers and employees. In the event of a violation of legal regulations, depending on the nature of the violation, we may be subject to legal sanctions such as the revocation of licenses and permits, other administrative measures, and fines, as well as the possibility of being suspended from transactions with business partners, the possibility of an impact on sales activities due to a decline in trust in our Group, the possibility of compensation for damages suffered by victims, and the possibility of incurring large expenses for improving and strengthening our internal control system, which may affect the sales and profits of our Group.

① About permits, etc.

Medical device sales, lending, repair, manufacturing and sales, and sales of pharmaceuticals and regenerative medicine products are subject to regulations under the Pharmaceuticals and Medical Devices Act. Therefore, it is subject to regulations by various business laws such as the Poisonous and Deleterious Substances Control Law, the Nursing Care Insurance Law, and the Construction Business Law. The main licenses, etc. obtained based on various business laws including the Pharmaceuticals and Medical Devices Act are as follows.

subject Name of Law Contents of legal regulations
Highly managed medical equipment, etc.
Sales / lending business
Pharmaceuticals
Medical Device Law
Pursuant to Article 39, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We have permission.
Highly controlled medical equipment for animals, etc.
Sales / lending business
Pharmaceuticals
Medical Device Law
Pursuant to Article 39, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We have permission.
Medical equipment repair business Pharmaceuticals
Medical Device Law
Pursuant to the provisions of Article 40-2, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We have permission.
Type 2
Medical device manufacturing and sales business
Pharmaceuticals
Medical Device Law
Pursuant to the provisions of Article 23-2, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We have permission.
Pharmaceutical sales business Pharmaceuticals
Medical Device Law
Pursuant to Article 24, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We are licensed for wholesale sales.
Product sales business such as regenerative medicine Pharmaceuticals
Medical Device Law
Pursuant to the provisions of Article 40-5, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We have permission.
Veterinary drug sales business Pharmaceuticals
Medical Device Law
Pursuant to Article 24, Paragraph 1 of the Pharmaceuticals and Medical Devices Act
We are licensed for wholesale sales.
Poisonous and deleterious substance sales business Poisonous and
Deleterious Substances Control Law
Pursuant to Article 4, Paragraph 1 of the Poisonous and Deleterious Substances Control Law
We are registered as a general retailer.
Welfare equipment sales business Long-Term Care Insurance Law Pursuant to the provisions of Article 70, Paragraph 1 and Article 115-2, Paragraph 1 of the Nursing Care Insurance Act
We are designated as a designated specific welfare equipment sales business operator and a designated specific care prevention welfare equipment sales business operator.
Welfare equipment rental business Long-Term Care Insurance Law Pursuant to the provisions of Article 70, Paragraph 1 and Article 115-2, Paragraph 1 of the Nursing Care Insurance Act
We are designated as a designated welfare equipment rental business operator and a designated care prevention welfare equipment rental business operator.
General construction industry Construction Business Act Pursuant to Article 3, Paragraph 1 of the Construction Business Law
We are licensed for general construction work.

② About antitrust law and antitrust law

Our group's customers include public medical institutions such as national and public hospitals, and because transactions involve bidding, we must comply with anti-bribery laws and the Antimonopoly Act, which prohibits bid rigging. In addition, our group handles a large number of medical devices from American manufacturers, so we must pay attention not only to domestic anti-bribery laws but also to foreign laws such as the U.S. Foreign Corrupt Practices Act (FCPA).

③ About the prize labeling law and the fair competition rules for the medical equipment industry

The Premiums and Representations Act establishes special premium regulations that apply to industries such as the medical device industry, including the medical device sales industry, and our group does not use premiums as a means of unfairly inducing medical institutions, etc. to trade in medical devices. It is prohibited to provide goods or services necessary for the use of medical devices or other prizes beyond what is deemed appropriate in light of normal business practices. Regarding premium regulations, in addition to the regulations of the Act, we must also comply with the Medical Device Industry Fair Competition Code established by the Medical Device Industry Fair Trade Council, a self-regulatory organization for the industry to which our group belongs.

④ About the Personal Information Protection Law

In addition to the personal information of employees, the Group may handle personal information held by medical institutions and personal information of individual sales destinations of medical equipment and long-term care welfare equipment. When handling personal information, it is necessary to establish a management system for proper acquisition and leakage prevention based on the Personal Information Protection Law.

(4) Regarding large-scale natural disasters and emerging infectious diseases

① About large-scale natural disasters

Our group has bases in various regions, including the Tokyo metropolitan area, and conducts business activities over a wide area. In preparation for natural disasters such as earthquakes, fires, typhoons, floods, and snow damage, we have formulated a business continuity plan (BCP), and as a member of the medical industry, we are working to establish a stable supply system to ensure the continuity of medical infrastructure. In preparation for disasters, we have a seismically isolated logistics center in Kanagawa Prefecture and a large-scale logistics center with a warehouse area of over 19,000 m2 in Gunma Prefecture, and are working to expand our backup system to maintain product supply. However, our group's business scope is wide, and in light of the increasing scale of disasters due to recent climate change, it is difficult to avoid all risks in the event of a disaster. If the scale of the disaster were to far exceed expectations and damage was caused to the Group's headquarters, business locations, warehouse facilities, etc., resulting in damage to products, soiling or damage, making it difficult for employees to work, making deliveries difficult due to the disruption of distribution routes, or making sales and purchasing difficult due to damage to customers and suppliers, this could disrupt ordinary business operations and affect the Group's sales and profits.

② About emerging infectious diseases

The Group conducts its business activities in close daily contact with medical institutions such as hospitals and clinics. As medical professionals, the Group has formulated an emerging infectious disease BCP manual that includes infection prevention measures similar to those of medical institutions, and strives to implement safety measures for employees, customers and business partners. However, if a large-scale emerging infectious disease such as a new strain of influenza or COVID-19 occurs and the scale and speed of infection spread far exceeds expectations, it may disrupt ordinary business operations, such as temporary business suspension, delays in purchasing, inventory backlog, and delays in collection of accounts receivable, which may affect the sales and profits of the Group.

(5) About our group's products

① About the expiration date management of the products we handle

Some of the products handled by the Group, including medical devices and pharmaceuticals, have expiration dates set by the manufacturer. Aiming to deliver safer, higher-quality products to medical and nursing care facilities, the Group is working to improve and strengthen its expiration date management system by conducting regular physical inventory checks and other thorough operational verifications, as well as utilizing IT systems. However, in the unlikely event that expired products are distributed due to human error or system problems within the Group and serious health damage occurs, this could have an impact on sales activities due to the revocation of licenses and permits related to the medical device sales business, a decline in trust in the Group, and other factors. In addition, there is a risk that large expenses may be incurred for compensation to patients and medical institutions, and for improving and strengthening the expiration date management system, which could have an impact on the Group's sales and profits.

② About private brand products

Our group sells private brand products that prioritize the needs of medical institutions, and as these are medical-related products, we strive to ensure reliable quality. Having shifted from a dealer to a manufacturer, we strive to select and supply products responsibly. However, if an unforeseen defect or malfunction occurs in a private brand product, in addition to the significant costs of product recalls and compensation for damages, a loss of trust in our group could have an impact on our group's sales and profits.

③ About innovation of medical technology

Medical technology is advancing day by day, and the medical devices used are also changing, for example, with the development of minimally invasive medicine in the treatment of heart disease. As a general dealer of medical equipment, the Group handles medical equipment in almost all areas without being biased to a specific area, but future innovations in medical technology will reduce the use of the medical equipment we handle. In some cases, it may affect the sales amount and profits of the Group.

(6) Bad debt risk

The Group strives to prevent and minimize bad debts by thoroughly managing credit by assessing and judging each client's current situation, future prospects, management, industry circumstances, etc. and setting credit limits for each client in accordance with credit management regulations. However, if an unexpected bad debt risk becomes apparent due to a client's worsening business performance, etc., and it becomes necessary to record losses and reserves, this could affect the Group's profits.

(7) Regarding fluctuations in performance

The Group's customers include public medical institutions such as national and public hospitals, and as such medical institutions tend to concentrate capital investment in December and March, which is the end of the fiscal year, the Group's sales are higher in the second and third quarters of each year than in other periods, and profits tend to increase accordingly during these periods. In reaction to this, sales through the fourth quarter tend to be lower than in other periods, and profits tend to decrease accordingly during these periods. In addition, when a medical institution builds a new facility, relocates, or expands, a large amount of medical equipment is purchased in a lump sum, which can temporarily increase sales. Therefore, the Group's quarterly Results of Operations are not linked to full-year Results of Operations, and it is difficult to predict full-year Results of Operations based solely on quarterly or half-year Results of Operations.

The sales and operating profit or operating loss for each quarter from the ended June 2023 to the fiscal year ending June 2025 are as follows: