Contents of this document
- Launch of domestic sales of ReHeart® and commencement of transplants in September-October
- Joint development of cardiac muscle organoids with Asahi Intecc
- Completion of a pilot plant using a subsidy for the regenerative medicine CDMO business
- Research and development of large-scale cell culture technology
- Joint research with Stanford University on cardiac muscle sheets for overseas markets
- Negotiations on partnerships with overseas medical institutions and companies
| Item | Details |
|---|---|
| Document type | Presentation materials for financial results |
| Fiscal Period Covered | First quarter of the fiscal year ending March 2027 |
| Net Sales | ¥1 million |
| Operating profit | ¥-333 million (operating loss) |
| Ordinary income | ¥-321 million (ordinary loss) |
| Net income | -317 Millions of yen (quarterly net loss attributable to owners of the parent) |
| Selling, general and administrative expenses | {"value":334,"unit":"Millions of yen","売上高販管費率":"Not disclosed"} |
| Results for the three months of the current quarter | Revenue of ¥1 million, operating loss of ¥333 million, ordinary loss of ¥321 million, and quarterly net loss attributable to owners of the parent of ¥317 million |
| Full-year earnings forecast | Net Sales ¥540 million / Operating loss ¥-1,030 million / Ordinary loss ¥-580 million / Net loss attributable to owners of the parent ¥-570 million |
| Segment results | CDMO business: Sales decline stated. Segment revenue and profit figures are Not disclosed |
| Breakdown of Factors Affecting the Change | Net Sales CDMO business sales decline (¥83 million decrease) / Cost of sales Same as above (¥54 million decrease) / Selling, general and administrative expenses +¥107 million / Total research and development expenditure −¥24 million / Income from joint research and development +¥128 million / Net research and development expenses +¥103 million / Other SG&A expenses +¥3 million / Non-operating income +¥9 million / Non-Operating Expenses -¥5 million |
| Assumptions Underlying the Business Outlook | ReHeart® reimbursement price ¥53,200,000 / Planned transplants in September-October 2026 2 cases / Post-marketing data collection within 3 years At least 75 cases |
| Market Size / Share | Annual number of eligible patients in Japan with acute myocardial infarction and related conditions 30,000 cases/year / Potential demand 3,000 cases/year (assuming 10% of eligible patients) |
| New initiatives | Launch of domestic sales of ReHeart® and commencement of transplants in September-October, Joint development of cardiac muscle organoids with Asahi Intecc, Completion of a pilot plant using a subsidy for the regenerative medicine CDMO business, Research and development of large-scale cell culture technology, Joint research with Stanford University on cardiac muscle sheets for overseas markets, Negotiations on partnerships with overseas medical institutions and companies |
Items this document does not state (17)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.In the first quarter, lower sales in the CDMO business reduced revenue, while the increase in net research and development expenses widened the operating loss. The upward revision to the full-year forecast reflects the inclusion of ReHeart®'s reimbursement price and cost of sales in the forecasts following approval of its reimbursement price, lower research and development expenses associated with ReHeart®'s approval, the end of a joint research agreement, and the expected receipt of a subsidy for the regenerative medicine CDMO business.