Medium-Term Management Policy to Develop Regenerative Medicine Contract Services into a Core Business

「高付加価値な「治験製品製造フェーズ」へ複数案件が移行し、増収に寄与。」

「At the same time, several projects moved into high-value-added phases through the company's distinctive offering of end-to-end support through commercial production. Specifically, projects with Actuarise Inc., VC Cell Therapy Co., Ltd., Metcela Inc. and AlliedCel Inc. are progressing steadily, advancing the shift toward a robust business portfolio that is not dependent on any specific customer.」

「Several important projects are progressing steadily. Actuarise Inc. completed dosing of subjects in a domestic Phase II clinical trial. The company entered into a capital and business alliance with VC Cell Therapy Co., Ltd. to commercialize regenerative medicine products using iPS cells and began contract work. It also entered into an agreement with Metcela Inc. concerning the manufacture of investigational products for a regenerative medicine product targeting functional single-ventricle disease. In addition, in October 2025, it entered into a contract for commissioned and contracted services concerning the "induced regulatory T cells" being developed by AlliedCel Inc., on the premise that the company would undertake manufacturing of the product after its launch.」

「The company steadily recognized revenue from contracts with general customers, meaning customers other than the parent company, TEIJIN LIMITED. Actuarise Inc., the commissioning party, began a domestic Phase II clinical trial for the product as a regenerative medicine product and completed dosing of the subjects. The company also entered into a capital and business alliance with VC Cell Therapy Co., Ltd. to commercialize regenerative medicine products using iPS cells and began contract work. In addition, it entered into a contract to manufacture investigational products for a regenerative medicine product being developed by Metcela Inc. for functional single-ventricle disease.」

「Revenue from the regenerative medicine contract services business for the six-month accounting period was ¥309.510 million, down 34.1% year on year. Revenue from general customer contracts, meaning contracts with parties other than the parent company, expanded as the development stages of contracted projects progressed. However, the substantial decrease in milestone payments and contract revenue from TEIJIN LIMITED resulted in an overall year-on-year decline in revenue. In addition, for the regenerative medicine cell products of contracting customers, the company was able to provide CDMO and CRO services in a timely and seamless manner, including the transplantation of the first patient in a domestic Phase II clinical trial.」

「Revenue from the regenerative medicine contract services (CDMO) business for the fiscal year was ¥865.533 million, up 106.4% year on year. Contract work from new customers, existing customers and the parent company, TEIJIN LIMITED, each increased steadily. The signing of a license agreement with TEIJIN LIMITED on 19 April 2023 for the regenerative medicine contract services business and the recognition of ¥170 million, representing part of the milestone consideration under the agreement, were also major factors behind the increase.」

「Revenue from the regenerative medicine contract services (CDMO and CRO) business for the cumulative third quarter was ¥635.384 million, up 142.4% year on year. Projects accepted in the previous fiscal year and newly accepted and launched projects each progressed steadily, making a significant contribution to the increase in revenue. In addition, the signing of a license agreement with TEIJIN LIMITED on 19 April 2023 for the regenerative medicine contract services business and the recognition of ¥170 million, representing part of the milestone consideration received in connection with the agreement, were also major factors behind the increase.」

「Revenue from the regenerative medicine contract services business for the cumulative second quarter was ¥469.756 million, up 151.1% year on year. Contract work from new customers, existing customers and the parent company, TEIJIN LIMITED, each increased steadily. In particular, revenue increased substantially following the signing of a license agreement with TEIJIN LIMITED on 19 April 2023 for the regenerative medicine contract services business and the recognition of ¥170 million, representing part of the milestone consideration received in connection with the agreement.」

「In particular, on 19 April 2023, we executed a licence agreement with TEIJIN LIMITED relating to the regenerative medicine contract business. Revenue increased substantially because we recorded part of the milestone consideration received in connection with the execution of this agreement, amounting to ¥170.000 million.」

「Revenue from the regenerative medicine contract business for the nine months ended in the third quarter was ¥262.151 million, down 15.2% year on year. Although contracts from parent company TEIJIN LIMITED increased, acquisition of new projects was delayed by the impact of COVID-19 and other factors, resulting in lower revenue than in the same period of the previous year. We aim to expand the regenerative medicine contract business again by increasing new contracts from third parties and advancing contracts from TEIJIN LIMITED.」

「Revenue from the regenerative medicine contract business for the six months ended in the second quarter was ¥187.095 million, up 8.3% year on year. Contracts from parent company TEIJIN LIMITED increased, resulting in higher revenue than in the same period of the previous year. We aim to expand the regenerative medicine contract business again by further increasing new contracts from third parties and advancing contracts from TEIJIN LIMITED.」

「Revenue from the regenerative medicine contract business for the three months ended in the first quarter was ¥68.300 million, down 33.0% year on year. Although contracts from parent company TEIJIN LIMITED increased, overall revenue declined from the same period of the previous year because an upfront contractual payment had been recorded in the previous fiscal year. We aim to expand the regenerative medicine contract business again by increasing new contracts from TEIJIN LIMITED and third parties.」

「Revenue from the regenerative medicine contract business for the fiscal year was ¥391.208 million, down 45.8% from the previous fiscal year. In March 2021, our parent company and largest shareholder changed from FUJIFILM Corporation to TEIJIN LIMITED. Following this change, we held repeated discussions with FUJIFILM regarding the handling of commissioned development work from FUJIFILM, agreed not to continue it and decided to discontinue the transactions. This resulted in a substantial decline in revenue for the fiscal year, but we aim to expand the regenerative medicine contract business again by increasing new contracts from TEIJIN LIMITED and third parties.」

「Revenue from the regenerative medicine contract business for the nine months ended in the third quarter was ¥309.081 million, up 0.1% year on year, remaining almost unchanged from the same period of the previous year. From February to March 2021, TEIJIN LIMITED conducted a tender offer for our common shares. As a result, in March 2021, our parent company and largest shareholder changed from FUJIFILM Corporation to TEIJIN LIMITED. Following this change, we held repeated discussions with FUJIFILM regarding the handling of commissioned development work from FUJIFILM, agreed not to continue it and decided to discontinue the transactions. We plan to complete the transfer of work within the current fiscal year. Accordingly, we are preparing to allocate the personnel capacity and space arising in the regenerative medicine contract business to new contracts from TEIJIN LIMITED and third parties, and expect revenue from these contracts to be added from the next fiscal year.」

「Revenue from the regenerative medicine contract business for the six months ended in the second quarter was ¥172.795 million, down 18.8% year on year. Clinical trials and other activities partially resumed at companies and academic institutions where development had been delayed by the impact of COVID-19, allowing contracted work to progress on several projects. However, revenue declined overall from the same period of the previous year because some projects were delayed or their schedules changed.」

「Revenue from the regenerative medicine contract business for the three months ended in the first quarter was ¥101.886 million, up 38.2% year on year. As clinical trials and other development activities partially resumed at companies and academic institutions where development had been delayed by the impact of COVID-19, contracted work progressed on several projects. In addition, we received upfront contractual payments from existing customers, resulting in higher revenue than in the same period of the previous year.」

「Revenue from the regenerative medicine contract business for the nine months ended in the third quarter was ¥308.898 million, down 33.9% year on year. In the first half, clinical trials and technology transfers from overseas were delayed at client companies and academic institutions heavily affected by the spread of COVID-19, resulting in a substantial decline in our revenue. From the third quarter onward, companies and academia showed clear signs of resuming development such as clinical trials, and contracts for the next development stage were executed for several projects, establishing an outlook for revenue generation in the fourth quarter. We will continue discussions on contracts with customers, promote contracted work under contracts already executed and seek to generate revenue.」

「Revenue from the regenerative medicine contract business for the six months ended in the second quarter was ¥212.847 million, down 29.8% year on year. Development continued to stagnate at medical institutions and companies heavily affected by the spread of COVID-19, with clinical trials and technology transfers overseas remaining delayed, resulting in a substantial decline in revenue from the same period of the previous year. However, customers have recently shown clear signs of resuming development, and discussions are progressing on executing contracts for the next development stage.」

「Revenue from the regenerative medicine contract business for the three months ended in the first quarter was ¥73.724 million, down 40.6% year on year. At medical institutions and client companies heavily affected by COVID-19, development not only stagnated, but clinical trial starts and technology transfers overseas were also delayed, resulting in a substantial decline in revenue from the same period of the previous year. Taking the impact of COVID-19 into account, we will continue discussions with customers to review the timing of resumption and the scope of contracted work, both for projects contracted independently by us and for projects from regenerative medicine ventures invested in by FUJIFILM. We aim to secure revenue for the current fiscal year by concentrating on projects that can be implemented during the pandemic.」

「In March 2020, we obtained marketing approval for Nepic, an autologous cultured corneal epithelium developed under commission from NIDEC CORPORATION, an ophthalmic medical device manufacturer, and it became covered by public health insurance from 1 June of the same year. Nepic was also the first regenerative medicine product to emerge from our regenerative medicine contract business.」

「Revenue from the regenerative medicine contract business for the nine months ended in the third quarter was ¥466.985 million, down 1.4% year on year, as the start and execution of work took longer than expected.」

「Revenue from the regenerative medicine contract business for the six months ended in the second quarter was ¥303.325 million, up 1.9% year on year. Revenue increased only slightly because the start and execution of projects took longer than expected and, in some cases, the timing of revenue recognition was later than planned.」

「Revenue from the regenerative medicine contract business for the three months ended in the first quarter was ¥124.185 million, up 40.5% year on year. Revenue increased from the same period of the previous year due to milestone income and other items accompanying progress on contracted projects.」

「Revenue from the regenerative medicine contract business for the fiscal year was ¥835.601 million, up 6.4% year on year. The number of contracted customers increased amid growing corporate initiatives in regenerative medicine. Revenue growth was supported by milestone income accompanying progress on contracted projects and the acquisition of new projects for development consulting and development and manufacturing contracts for regenerative medicine products.」

「Revenue from the regenerative medicine contract business for the nine months ended in the third quarter was ¥473.520 million, up 15.3% year on year. The number of contracted customers increased amid growing corporate initiatives in regenerative medicine, while revenue was supported by the receipt of milestones upon achievement of progress in contracted research themes and growth in new orders for development consulting and development and manufacturing contracts for regenerative medicine products. However, execution is behind the target revenue because finalising detailed specifications and executing contracts have taken longer than expected, among other reasons.」

「Revenue from the regenerative medicine contract business for the six months ended in the second quarter was ¥297.651 million, up 21.3% year on year. This was supported by the receipt of milestones upon achievement of progress in contracted research themes and growth in new orders from companies and academia for development consulting and development and manufacturing contracts for regenerative medicine products.」

「Although the number of development and manufacturing contract projects for regenerative medicine products increased as a result of customer development activities targeting companies and academia, revenue declined from the same period of the previous year because contract renewals and agreement on the scope of work with some customers took time, and the receipt of consideration such as milestone payments was delayed.」

「Revenue from the regenerative medicine contract business was ¥785.076 million, down 19.6% year on year including patent transfer income and up 16.0% excluding patent transfer income. Excluding patent transfer income, the increase from the previous fiscal year was attributable to an increase in contracts from companies and academia, including regenerative medicine ventures, amid growing demand for the business.」

「From the first quarter accounting period, we reviewed the classification of reportable segments from the perspective of future business development and changed the presentation method to provide a more appropriate presentation of management information. Under our medium-term management policy of developing the “regenerative medicine contract business,” which had previously been included in the “regenerative medicine products business,” into a core operation, we have separated it as an independent business and changed the method of presentation to report it as a segment.」

「Under our medium-term management policy of developing the “regenerative medicine contract business,” which had previously been included in the “regenerative medicine products business,” into a core operation, we have separated it as an independent business and changed the method of presentation to report it as a segment.」

「Under our medium-term management policy of developing the “regenerative medicine contract business,” which had previously been included in the “regenerative medicine products business,” into a core operation, we have separated it as an independent business and changed the method of presentation to report it as a segment.」