Contents of this document
- Increase in revenue forecast¥71 millionFactorsIncrease in the supply volume of HGF active pharmaceutical ingredient to クラリス社
- Increase in cost of sales forecast¥29 million
- Reduction in SG&A expense forecast¥-606 millionFactorsDecrease in R&D expenses
- Reduction in research and development expense forecast¥-588 millionFactorsDelay in trials related to HGF manufacturing development and streamlining of trial items
- Improvement in operating loss¥648 million
- Improvement in ordinary loss¥686 million
- Improvement in net loss¥686 million
- Establishment of a Quality Assurance Department and a Corporate Strategy Office
- Supply of HGF active pharmaceutical ingredient to クラリス・バイオセラピューティクス社 and development in the ophthalmology field
- Development and establishment of manufacturing capabilities for the Phase III trial for the acute phase of spinal cord injury and in-house approval acquisition
- Target number of subjects in the Phase III trial for the acute phase of spinal cord injury25 cases
- Target number of subjects in the Phase II ALS trial48 cases
- Number of patients in Japan with acute spinal cord injury5,000 People/year
- Number of ALS patients in Japan9,800 people
- Number of employees11 People
- HGF protein formulation for the acute phase of spinal cord injuryJapan: up to ¥10 billion; overseas: up to ¥50 billion
- HGF protein formulation for ALSJapan: up to ¥20 billion; overseas: up to ¥100 billion
| Item | Details |
|---|---|
| Document type | Presentation materials on financial results |
| Fiscal Period Covered | Third quarter of the fiscal year ending September 2021 |
| Net Sales | ¥117 million |
| Operating profit | ¥-304 million (operating loss) |
| Ordinary income | ¥-245 million (ordinary loss) |
| Net income | ¥-246 million (net loss) |
| Selling, general and administrative expenses | ¥422 million |
| Full-year earnings forecast | Net Sales ¥277 million / Cost of sales ¥73 million / Selling, General and Administrative Expenses ¥592 million / Research and development costs ¥409 million / Operating loss ¥-388 million / Ordinary loss ¥-328 million / Net loss for the period ¥-330 million |
| Breakdown of Factors Affecting the Change | Item Increase in revenue forecast / Amount ¥71 million / Factors Increase in the supply volume of HGF active pharmaceutical ingredient to クラリス社, Item Increase in cost of sales forecast / Amount ¥29 million, Item Reduction in SG&A expense forecast / Amount ¥-606 million / Factors Decrease in R&D expenses, Item Reduction in research and development expense forecast / Amount ¥-588 million / Factors Delay in trials related to HGF manufacturing development and streamlining of trial items, Item Improvement in operating loss / Amount ¥648 million, Item Improvement in ordinary loss / Amount ¥686 million, Item Improvement in net loss / Amount ¥686 million |
| Key KPIs | Indicator name Target number of subjects in the Phase III trial for the acute phase of spinal cord injury / Value 25 cases / Year on year against the same period last year Not disclosed, Indicator name Target number of subjects in the Phase II ALS trial / Value 48 cases / Year on year against the same period last year Not disclosed, Indicator name Number of patients in Japan with acute spinal cord injury / Value 5,000 People/year / Year on year against the same period last year Not disclosed, Indicator name Number of ALS patients in Japan / Value 9,800 people / Year on year against the same period last year Not disclosed, Indicator name Number of employees / Value 11 People / Year on year against the same period last year Not disclosed |
| Number of employees | Number of Employees 11 People / Reference date End of July 2021 / Changes during the period and hiring plan Not disclosed |
| Financial targets | Equity ratio Actual results 97.6 % |
| Market Size / Share | Subject HGF protein formulation for the acute phase of spinal cord injury / Market Size Japan: up to ¥10 billion; overseas: up to ¥50 billion, Subject HGF protein formulation for ALS / Market Size Japan: up to ¥20 billion; overseas: up to ¥100 billion |
| New initiatives | Establishment of a Quality Assurance Department and a Corporate Strategy Office, Supply of HGF active pharmaceutical ingredient to クラリス・バイオセラピューティクス社 and development in the ophthalmology field, Development and establishment of manufacturing capabilities for the Phase III trial for the acute phase of spinal cord injury and in-house approval acquisition |
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.The revenue forecast was raised due to an increase in the supply volume of HGF active pharmaceutical ingredient to クラリス社. Research and development expenses also decreased because trials related to HGF manufacturing development were delayed and the number of trial items was streamlined. The company states that this will not affect the approval application schedule for the acute phase of spinal cord injury.