Contents of this document
- Increase in Selling, General and Administrative Expenses¥-65 million
- Increase in R&D expenses¥-315 million
- Increase in financial revenue¥52 million
- Increase in financial expenses¥-552 million
- Increase in derivative valuation losses¥-527 million
- Increase in stock acquisition rights issuance costs¥-56 million
- Launch of the REVIVE-ARDS global Phase 3 trial for HLCM051 as an ARDS treatment
- Development of a 500-liter bioreactor facility in Kobe and establishment of a CDMO business using a subsidy from the Ministry of Economy, Trade and Industry
- Signing of a supply agreement with JENECELL for HLSI071 conditioned media
- Signing of a basic agreement on HLSI071 transactions with Alfresa
- Full-scale operation of a cell-processing manufacturing facility for HLSI071 conditioned media
- Plans to establish a data collection system linking a medical-specialty LLM with electronic medical records for the acute phase of ischemic stroke
- Patients in Japan and the US (3 indications)More than 1.5 million/year
- Annual manufacturing capacity40,000 People/year
- 3D culture capacity500 L
- REVIVE-ARDS trial patient count550 Example
- Number of cases in the MATRICS-1 trial156 people
- JENECELL initial order value¥144 million equivalent
- Estimated global ARDS patient populationMore than 1.1 million
- Estimated ARDS patient population in Japan28,000 People/year
- Estimated number of ARDS patients eligible for treatment in the US20,000 People/year
- Annual US ARDS sales potential¥4,750 100 million
| Item | Details |
|---|---|
| Document type | Financial results presentation |
| Fiscal Period Covered | First quarter of the fiscal year ending December 2026 |
| Net Sales | ¥8 million (YoY -78.9%) |
| Operating profit | ¥-1,130 million |
| Net income | ¥-3,457 million |
| Selling, general and administrative expenses | Selling, general and administrative expenses increased by ¥65 million year on year. Total amount and SG&A-to-revenue ratio: Not disclosed |
| Breakdown of Factors Affecting the Change | Factors Increase in Selling, General and Administrative Expenses / Amount ¥-65 million, Factors Increase in R&D expenses / Amount ¥-315 million, Factors Increase in financial revenue / Amount ¥52 million, Factors Increase in financial expenses / Amount ¥-552 million, Factors Increase in derivative valuation losses / Amount ¥-527 million, Factors Increase in stock acquisition rights issuance costs / Amount ¥-56 million |
| Key KPIs | Indicator name Patients in Japan and the US (3 indications) / Value More than 1.5 million/year / Year on year against the same period last year Not disclosed, Indicator name Annual manufacturing capacity / Value 40,000 People/year / Year on year against the same period last year Not disclosed, Indicator name 3D culture capacity / Value 500 L / Year on year against the same period last year Not disclosed, Indicator name REVIVE-ARDS trial patient count / Value 550 Example / Year on year against the same period last year Not disclosed, Indicator name Number of cases in the MATRICS-1 trial / Value 156 people / Year on year against the same period last year Not disclosed, Indicator name JENECELL initial order value / Value ¥144 million equivalent / Year on year against the same period last year Not disclosed |
| Unit price and quantity metrics | For the US ARDS market, the materials show the relationship between drug prices of approximately ¥11.25 million, ¥22.5 million and ¥37.5 million, among others, and total treated patients from the fifth year onward of 21,000, 20,000 and 13,000, respectively. |
| Number of employees | Number of Employees 72 People (employees only) / Change during the period 15 People (employees only) / Hiring plan Not disclosed |
| Orders received and order backlog | Orders received 144 Equivalent to ¥ millions (JENECELL's initial order) / Order backlog Not disclosed |
| Market Size / Share | Market Estimated global ARDS patient population / Value More than 1.1 million, Market Estimated ARDS patient population in Japan / Value 28,000 People/year, Market Estimated number of ARDS patients eligible for treatment in the US / Value 20,000 People/year, Market Annual US ARDS sales potential / Value ¥4,750 100 million |
| New initiatives | Launch of the REVIVE-ARDS global Phase 3 trial for HLCM051 as an ARDS treatment, Development of a 500-liter bioreactor facility in Kobe and establishment of a CDMO business using a subsidy from the Ministry of Economy, Trade and Industry, Signing of a supply agreement with JENECELL for HLSI071 conditioned media, Signing of a basic agreement on HLSI071 transactions with Alfresa, Full-scale operation of a cell-processing manufacturing facility for HLSI071 conditioned media, Plans to establish a data collection system linking a medical-specialty LLM with electronic medical records for the acute phase of ischemic stroke |
Items this document does not state (18)
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.Selling, general and administrative expenses increased by ¥65 million, while research and development expenses increased by ¥315 million. In addition, although financial income increased by ¥52 million, financial expenses increased by ¥552 million, primarily due to a ¥527 million increase in derivative valuation losses.