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Management planning4894Cuorips Inc.Pharmaceuticals

Business Plan and Growth Potential

Following the acquisition in March 2026 of conditional and time-limited marketing approval for the cardiac muscle cell sheet "ReHeart," the plan was updated to advance preparations for domestic sales and overseas expansion. In addition, catheter-based treatments, the YS series, and large-scale cell culture and CDMO were identified as the next growth areas to pursue.

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Items stated in the management plan

Annual update
Business Plan and Growth PotentialPlan period Fiscal year ending March 2027 and beyond
Total investment planAmount 25.4 Hundreds of millions of yen / Period Covered Fiscal year ending March 2027 and beyond
Investment amount by sectorField 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
Key initiatives
01A major first step toward profitability
02Accelerate the development of products that will serve as the next growth drivers
03Establish large-scale cell-culture technology
Non-financial targetsIndicator 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
Size of the Target MarketJapan 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 by the company
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 stated in the management plan
ItemDetails
Plan nameBusiness Plan and Growth Potential
Plan periodFiscal year ending March 2027 and beyond
Progress against the planAnnual update
Total investment planAmount 25.4 Hundreds of millions of yen / Period Covered Fiscal year ending March 2027 and beyond
Investment amount by sectorField 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 targetsIndicator 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 initiativesA 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 MarketJapan 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 identifiedUncertainty 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)
Sales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceSegment targetPlan assumptionsResults under the previous planReason for revision or withdrawalDate of board resolutionPublication date

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.

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Business Plan and Growth Potential | Cuorips Inc. (4894) timely disclosure | Komori