Items stated in the management plan
Annual update| Item | Details |
|---|---|
| Plan name | Business Plan and Growth Potential |
| Plan period | Fiscal year ending March 2027 and beyond |
| Progress against the plan | Annual update |
| Total investment plan | Amount 25.4 Hundreds of millions of yen / Period Covered Fiscal year ending March 2027 and beyond |
| Investment amount by sector | Field Cardiac muscle cell sheet (dilated cardiomyopathy (DCM)) / Amount 4.3 Hundreds of millions of yen, Field Cardiac muscle cell sheet (overseas and ischemic cardiomyopathy (ICM)) / Amount 3.6 Hundreds of millions of yen, Field Catheter-based treatments (acute myocardial infarction (AMI) and chronic total occlusion (CTO)) / Amount 14.5 Hundreds of millions of yen, Field Capital Expenditure / Amount 3.0 Hundreds of millions of yen |
| Non-financial targets | Indicator name Number of cases subject to post-marketing verification of efficacy and further safety / Target value At least 75 cases / Timing Within 7 years of obtaining conditional and time-limited approval |
| Key initiatives | A major first step toward profitability, Accelerate the development of products that will serve as the next growth drivers, Establish large-scale cell-culture technology |
| Size of the Target Market | Japan Number of heart failure patients 1,300,000 people / NYHA class II 455,000 people / NYHA class III 325,000 people / Source Miller LW. (2011). Left Ventricular Assist Devices Are Underutilized. Circulation, 123, 1552–1558. / United States Number of heart failure patients 6,000,000 people / NYHA class II 2,100,000 people / NYHA class III 1,500,000 people / Source Savarese G, Lund L.H. (2017). Global Public Health Burden of Heart Failure. Card Fail Rev., 3(1), 7–11. / Worldwide Number of heart failure patients 26,000,000 people / NYHA class II 9,100,000 people / NYHA class III 6,500,000 people / Source Not disclosed |
| Risks identified | Uncertainty in research and development, Dependence on a small organization and a limited number of personnel driving the business, The drug pricing system and policies to contain medical costs |
Items this document does not state (16)
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.To establish the manufacturing and sales infrastructure needed to deliver the cardiac muscle cell sheet to patients as soon as possible following approval, while expanding the subsequent pipeline and product portfolio by applying the established cell-culture technologies and platform across additional areas.