Dependence on Partners and the Risks of Contract Termination and Policy Changes
First written in FY2016. 11 of 17 entries say "Restated". Latest entry: FY2026.
Kidswell Bio moved to the "Worse" side of this theme in 2020, 3 years before the typical company in this theme (2023).
The whole theme swung hardest in 2020: 8 of 42 companies on the "Worse" side.
4 other companies' latest entry also says "Worsened".
- FY2026WorsenedAnnual report
「If coordination of the manufacturing plan with the CDMO does not progress, excess inventory may arise and have a material impact on the group's operating results and cash flow.」
Regarding the contract-dependence risk associated with changes in partners' sales policies and downward revisions to demand forecasts, the company specified the potential for excess inventory and an impact on cash flow if it cannot coordinate the manufacturing plan with the CDMO. - FY2023-Q3RestatedAnnual report
「During the cumulative third-quarter period, there were no new business risks and no material changes in the business risks described in the annual securities report for the preceding fiscal year.」
The company disclosed that there had been no material changes regarding the risks of dependence on partners and changes to or termination of partnerships. - FY2022ReframedAnnual report
「The company decided that it would be best to transfer this business to ㈱メトセラ, which has experience and expertise in R&D in the same cardiac disease field, with that company taking the lead in development. Accordingly, on 4 April 2022, it resolved to transfer and completed the transfer of shares in ㈱日本再生医療, its subsidiary responsible for developing JRM-001. Going forward, the company will remain involved in development by supporting development activities.」
Regarding dependence on partners and affiliates, the development structure changed from ㈱日本再生医療, the company's subsidiary, to ㈱メトセラ as the lead developer, with the company remaining involved as a supporter. - FY2021-Q1MaterialisedAnnual report
「Regarding development in China of the adalimumab biosimilar (development code: GBS-005) in the biosimilars business, Changchun Changsheng Bio-technology Co., Ltd., our partner for joint commercialization, was liquidated after being sanctioned in July 2018 over a scandal involving its rabies vaccine manufacturing business. Accordingly, we formally terminated the partnership with the company under the joint commercialization agreement.」
Following misconduct and liquidation at a partner, the company formally terminated the joint commercialization agreement, reconfirming that the risk of dependence on the partner and contract termination had materialized in actual business development. - FY2020RestatedAnnual report
「The company has entered into business partnerships, joint research agreements, licensing agreements and other arrangements with partner companies in each business and conducts development activities collaboratively. However, if the relevant contract is terminated for any reason, including interruption or discontinuation due to factors beyond the company's control, such as changes in the business environment or management policies of the respective companies, this may have a material impact on the company's business strategy and business plans.」
The company continues to disclose the risk of dependence on changes in partners' business environments and policies and on contract termination. - FY2020-Q3WorsenedAnnual report
「The company's biosimilars under development are sold by partner companies. If, for any reason, a partner company encounters difficulties in sales, the resulting decline in sales of the relevant drug may reduce the company's earnings and have a material impact on its business plans and operating results.」
Regarding the risk of dependence on partners, the company explicitly identifies the risk that sales difficulties at partner companies responsible for selling products under development may affect sales and earnings, thereby specifying the scope of the risk. - FY2019RestatedAnnual report
「If the relevant contract is terminated for any reason, including interruption or discontinuation due to factors beyond the company's control, such as changes in the business environment or management policies of the respective companies, this may have a material impact on the company's business strategy and business plans.」
The company continues to disclose the risk of dependence on changes in partners' business environments and policies and on contract termination. - FY2019-Q2MaterialisedAnnual report
「Regarding the partnership with Changchun Changsheng Bio-technology Co., Ltd. for the joint commercialization of the adalimumab biosimilar in China, we announced our policy of terminating the partnership after violations of laws and regulations were discovered in the company's core rabies vaccine manufacturing business.」
Following a violation of laws and regulations by a partner, the company decided to terminate the joint commercialization partnership, and the risk of dependence on the partner and contract termination materialized in actual business development. - FY2019-Q1RestatedAnnual report
「During the cumulative first-quarter period, there were no new business or other risks and no material changes to the business or other risks described in the annual securities report for the previous fiscal year.」
The company disclosed that there had been no material changes regarding the risk of dependence on changes in partners' policies, contract terminations and other factors. - FY2018RestatedAnnual report
「If partnerships cannot be established as planned, if a partnership changes, or if a partnership is terminated, this may have a significant impact on the company's business plans.」
The company continues to disclose the risk associated with its development policy of primarily relying on external partnerships, including the risk that partnerships may not be established, may change or may be terminated. - FY2018-Q3RestatedAnnual report
「During the nine months ended September, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no material changes regarding the risk of dependence on changes in partners' policies, contract terminations and other factors. - FY2018-Q2RestatedAnnual report
「During the six months ended June, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the prior fiscal year.」
The company disclosed that there had been no material changes regarding the risk of dependence on changes in partners' policies, contract terminations and other factors. - FY2017RestatedAnnual report
「At each stage of R&D, the company builds broad partnerships with pharmaceutical companies and others that conduct development and sales, enabling it to use the specialized external technical capabilities of these partners while avoiding increases in fixed costs and advancing R&D strategically and flexibly. However, if partnerships cannot be established as planned, if a partnership changes, or if a partnership is terminated, this may have a significant impact on the company's business plans.」
The company continues to disclose the risk associated with its development policy of primarily relying on external partnerships, including the risk that partnerships may not be established, may change or may be terminated. - FY2017-Q3RestatedAnnual report
「As a basic policy for reducing R&D risk, the company does not conduct every stage of R&D in-house but advances development through business partnerships with external parties. Consequently, external factors, such as changes in the policies of business partners, may delay R&D progress and significantly affect the company's earnings.」
The company continues to explicitly identify its development policy of primarily relying on external partnerships and the associated risk of dependence on changes in partners' policies and other factors. - FY2017-Q2RestatedAnnual report
「As a basic policy for reducing R&D risk, the company does not conduct every stage of R&D in-house but advances development through business partnerships with external parties. Consequently, external factors, such as changes in the policies of business partners, may delay R&D progress and significantly affect the company's earnings.」
The company continues to explicitly identify its policy of primarily relying on external partnerships and the associated risk of dependence on partners' policy changes, contracts and other matters. - FY2017-Q1RestatedAnnual report
「As a basic policy for reducing R&D risk, the company does not conduct every stage of R&D in-house but advances development through business partnerships with external parties. Consequently, external factors, such as changes in the policies of business partners, may delay R&D progress and significantly affect the company's earnings.」
The company continues to explicitly identify the risk that changes in the policies of external partners and other factors may affect R&D and earnings. - FY2016First statedAnnual report
「Changes in the policies of business partners and other factors may delay R&D progress and cause the company's earnings to be significantly affected by external factors.」
Because the company depends on pharmaceutical companies and others for development, clinical trials, sales and out-licensing, changes in a counterparty's policies or termination of a contract may affect its business plans.