Financial Results Briefing for Third Quarter of Fiscal Year Ending December 31, 2024 (January 1, 2024 to September 30, 2024)
November 8, 2024
Yumi Nakagawa
Executive Officer, General Manager, CFO Unit
Kobayashi Pharmaceutical Co., Ltd.
Introduction | 2/29 |
Statement Regarding Our Benikoji (Red Yeast Rice)-related Products
We deeply apologize again for the significant concerns and distress felt by our customers, business partners, and all those associated with us, in connection with our benikoji-related products.
We extend our prayers for the souls of those who have tragically passed away, and offer our sincere condolences to their families. We express our hopes for the swift recovery of all those currently hospitalized or undergoing treatment.
Recent developments | 3/29 |
Date | Outline |
August 19 | Began providing compensation to customers who have suffered health problems as |
a result of taking our Beni-kojiCholeste-Helpand other products. | |
September 17 | Released “Notice regarding Formulation of Measures to Prevent Recurrence.” |
The Ministry of Health, Labour and Welfare made an announcement on investigation | |
September 18 | into the causes, confirming that puberulic acid causes renal disorders while |
compounds Y and Z do not cause renal disorders. | |
October 8 | Released “Notice regarding Partial Decline of Remuneration.” |
October 10 | Osaka City announced that it was “reasonable to determine that this was a food |
poisoning incident.” | |
Number of Cases Related to Beni-kojiCholeste-Helpand Other Products | 4/29 |
As of November 3, 2024
No actual intake*2 | 272 | ||
Under confirmation of actual intake | 0 | ||
Subject to detailed investigation*3 | 125 | ||
Number of death- | |||
Investigation ongoing*4 | 10 | ||
related inquiries*1 | |||
(Breakdown) | Investigation completed | 43 | |
Other*5 | 72 | ||
(Total) | 397 | ||
Hospitalization*6 | 523 (329 ) | ||
Hospital visit (including hospitalization for medical tests)*6 | 2,069 (1,555 ) | ||
Total number of persons who received medical examinations | 2,592 (1,884 ) | ||
(hospitalization + hospital visit)*6 | |||
Number of health consultations | Approx. 11,200 | ||
Number of all consultations received (including inquiries other than | Approx. 150,000 | ||
health consultations) | |||
*1 Including 5 cases that were announced before the change in the way the number was shown
*2 Number of cases where it was confirmed that Beni- koji Choleste-Helpor other products were not actually taken
*3 Number of cases subject to confirmation procedures
*4 Number of cases currently under detailed investigation
*5 Number of cases where it is difficult to conduct an investigation because consent for detailed investigation cannot be obtained or for other reasons
*6 The figures in parentheses indicate the number of cases of renal-related diseases only.
(“Hospitalization,” “hospital visit,” “total number of persons who received medical examinations,” “number of health consultations,” and “number of all consultations received” are total numbers.)
Progress of Compensation for Health Damage (for hospitalization and hospital visit) | |||
(as of October 31, 2024) | 5/29 | ||
| Status of compensation eligibility assessment | * The figures are total numbers. |
Inquiries | Application | ||
documents sent | |||
Approx. 1,150 | |||
[From April 25] | |||
Provisional payment of the | |||
actual amount of medical | |||
expenses | |||
Approx. 700
[From August 19]
Main compensation
(Medical expenses, damages for
mental suffering, etc.)
Applications accepted
Approx. 650
Assessment
Determined
Approx. 250
Before and during
assessment
Approx. 400
Approx. 450
Progress of Measures to Prevent Recurrence | 6/29 | |||||
1. Awareness Raising and Structural Enhancement regarding Quality and Safety | ||||||
Item | Description and progress | |||||
• Establish an education and training system for all executives and employees regarding | ||||||
quality and safety. | ||||||
(1) Raising awareness: “Quality and Safety First” | → Conducted food hygiene training for Executive Officers. | |||||
Educational contents for all executives and employees are currently being compiled. | ||||||
A new educational program will start in January 2025. | ||||||
(2) Structural enhancement (i): Quality assurance system | ||||||
• Position the Reliability Assurance Headquarters as a responsible department independent | ||||||
A. Clarification of responsible departments | of Businesses. | |||||
→ Under consideration to start under a new organizational structure from January 2025 | ||||||
B. Improving quality control system | • Clarify roles and responsibilities of the quality control department and the audit department. | |||||
→ Under consideration to start under a new organizational structure from January 2025 | ||||||
• Establish a new department to be specialized in dealing with laws and regulations related to | ||||||
C. Establishment of a specialized department | development and manufacturing. | |||||
→ Under consideration to start under a new organizational structure from January 2025 | ||||||
Progress of Measures to Prevent Recurrence | 7/29 |
1. Awareness Raising and Structural Enhancement regarding Quality and Safety
Item
Description and progress
(3) Structural enhancement (ii): Management system
• Conduct regular audits (including third-party audits) of each plant. | ||
A. Enhancement of the governance structure of | → Details are explained on the next page. | |
plants | • Establish a new “Plant Manufacturing Promotion Department (tentative name)” to be responsible for | |
identifying and examining issues at each plant. | ||
→ Under consideration to start under a new organizational structure from January 2025 | ||
• Organize laws and regulations, various guidelines, and rules for each product category. | ||
→ As a first step, discussions are being held on design quality and product quality standards in the food | ||
category. | ||
To be deployed to other categories under the new organizational structure starting in January 2025. | ||
B. Development of related rules | • Disseminate the quality assurance policy throughout the company. | |
→ All executives and employees started chanting the policy together during morning meetings every week. | ||
• To enable all manufacturing departments to share the same vision in promoting quality enhancement | ||
activities, establish the “Manufacturing Quality Action Policy” as a concrete code of conduct for the | ||
quality assurance policy. | ||
→ Establish a highly viable policy in the new organizational structure starting in January 2025. | ||
Audit Status of Each Plant (Self-inspection) | 8/29 |
In addition to the self-inspection of “all products to be orally taken (supplements, pharmaceutical products, etc.)” reported at the Financial Results Briefing for 2Q of Fiscal Year Ending December 2024 on August 8, inspection was also conducted on “products that come in contact with the skin.”
- Is there any risk of contamination by foreign substances or bacteria or of production of unknown substances such as mycotoxins?
- Are the hygiene standards of the plants properly set and operated?
(Implementation of GMP standards and equivalent standards, education on hygiene control, etc.) - Are procedures established and are operations performed in such a way that manufacturing records are kept?
(Status of establishment of written procedures, records, etc.) - Is manufacturing performed in accordance with the contents of written procedures?
No serious risks were identified from the production lines of the products that come into contact with the skin.
Audit Status of Each Plant (audit by a third-party organization) | 9/29 | ||||||||
Time: | October 2024 | ||||||||
Target plants: Four plants in Japan (Toyama Kobayashi, Aloe Pharmaceutical, Plax, Sendai Kobayashi) | |||||||||
Target lines: Production lines of products that are taken orally or come into contact with the skin | |||||||||
(excluding pharmaceutical products) | |||||||||
Check items: Hygiene control (including insect and rat prevention), risk assessment, education, | |||||||||
facility/equipment management (maintenance), etc. | |||||||||
Kiribai Kobayashi | Toyama Kobayashi Pharmaceutical | Kobayashi Pharmaceutical Plax | Sendai Kobayashi Pharmaceutical | ||||||
GMP, QMS | |||||||||
Pharmaceutical | GMP, GMP for health foods | (ITOYOUJI, containers, etc.) | |||||||
(Pharmaceutical products, medical devices, | |||||||||
ISO9001/ISO13485 | (Pharmaceutical products, supplements, | ||||||||
consumable supplies, etc.) | |||||||||
(Body warmers) | |||||||||
consumable supplies, etc.) | |||||||||
Ehime Kobayashi | Osaka Plant: Closed |
(Red yeast rice incubation | |
Pharmaceutical | |
process) | |
(Hygiene products, etc.) | |
Aloe Pharmaceutical | |||||
Meitan Hompo: Production suspended (under | GMP | ||||
(Pharmaceutical products, etc.) | |||||
inspection) | |||||
(Red yeast rice incubation process, supplements) | |||||
Audit Status of Each Plant (audit by a third-party organization) | 10/29 |
There were no findings that would immediately lead to the occurrence of serious quality defects. However, several professional and objective views were pointed out that could not be found in self- inspections, especially those related to hygiene management. (Details on the next page)
Based on the results of self-inspections and third-party audits, we will continue to make improvements to achieve an even higher level of quality control.