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How definitive the wording is.Items stated in the management plan
Annual updateInvestment amount by sectorField Build infrastructure for the CDMO business / Amount Not disclosed / Related disclosure Utilizing a subsidy of approximately ¥7 billion
Key initiatives
01A business strategy to scale globally from Japan
02Focus on ARDS (significant efficacy)
03Make the domestic Japanese regulatory application for ARDS approval the top priority
04Conduct a Phase 3 trial aimed at obtaining approval in the United States, the largest market
05Establish a commercial manufacturing system at Minaris
06Establish a sales and marketing organization
07Expand partnerships
08Pursue commercialization of culture supernatant
09Build infrastructure for the CDMO business
Plan assumptionsThe estimated number of ARDS patients worldwide exceeds 1.1 million, comprising 670,000 in China, 262,000 in the United States, 133,000 in Europe, and 28,000 in Japan, For moderate to severe ARDS in the United States, the number of eligible patients is estimated at approximately 100,000, with access-adjusted demand in a stable state estimated at approximately 20,000 patients annually, The optimal unit price for HLCM051 in the United States is assumed to be approximately ¥30 million (USD 200,000)
Non-financial targetsIndicator name Manufacturing capacity through three-dimensional culture / Target value Capacity to supply treatments for 40,000 people annually / Timing Scheduled for completion by the end of 2027, Indicator name HLCR011 (iPS cell-derived RPE cells) / Target value Commercial launch / Timing FY2028 launch target
Size of the Target MarketSubject Global ARDS market / Scale More than 1.1 million estimated patients worldwide: 670,000 in China, 262,000 in the United States, 133,000 in Europe, and 28,000 in Japan / Source Company estimates for Japan; Diamond et al. for the United States; CORDIS for Europe; song-et-al-2014 for China, Subject ARDS in the United States / Scale 150,000 patients with moderate to severe disease, approximately 100,000 eligible patients, and annual access-adjusted demand of approximately 20,000 patients / Source Analysis conducted by Dedham Group under commission from the company, Subject Revenue potential of HLCM051 in the United States / Scale Annual sales potential of ¥475 billion / Source Analysis conducted by Dedham Group under commission from the company
Reason for revision or withdrawal
ARDS has demonstrated significant efficacy, offers the highest probability of success in the development process, and has been clearly agreed upon with regulatory authorities. For acute ischemic stroke, the company will reconsider its development policy in light of the status of discussions with regulatory authorities and the company's available resources.
| Item | Details |
|---|---|
| Plan name | Business Plan and Growth Potential |
| Progress against the plan | Annual update |
| Investment amount by sector | Field Build infrastructure for the CDMO business / Amount Not disclosed / Related disclosure Utilizing a subsidy of approximately ¥7 billion |
| Non-financial targets | Indicator name Manufacturing capacity through three-dimensional culture / Target value Capacity to supply treatments for 40,000 people annually / Timing Scheduled for completion by the end of 2027, Indicator name HLCR011 (iPS cell-derived RPE cells) / Target value Commercial launch / Timing FY2028 launch target |
| Plan assumptions | The estimated number of ARDS patients worldwide exceeds 1.1 million, comprising 670,000 in China, 262,000 in the United States, 133,000 in Europe, and 28,000 in Japan, For moderate to severe ARDS in the United States, the number of eligible patients is estimated at approximately 100,000, with access-adjusted demand in a stable state estimated at approximately 20,000 patients annually, The optimal unit price for HLCM051 in the United States is assumed to be approximately ¥30 million (USD 200,000) |
| Key initiatives | A business strategy to scale globally from Japan, Focus on ARDS (significant efficacy), Make the domestic Japanese regulatory application for ARDS approval the top priority, Conduct a Phase 3 trial aimed at obtaining approval in the United States, the largest market, Establish a commercial manufacturing system at Minaris, Establish a sales and marketing organization, Expand partnerships, Pursue commercialization of culture supernatant, Build infrastructure for the CDMO business |
| Reason for revision or withdrawal | ARDS has demonstrated significant efficacy, offers the highest probability of success in the development process, and has been clearly agreed upon with regulatory authorities. For acute ischemic stroke, the company will reconsider its development policy in light of the status of discussions with regulatory authorities and the company's available resources. |
| Size of the Target Market | Subject Global ARDS market / Scale More than 1.1 million estimated patients worldwide: 670,000 in China, 262,000 in the United States, 133,000 in Europe, and 28,000 in Japan / Source Company estimates for Japan; Diamond et al. for the United States; CORDIS for Europe; song-et-al-2014 for China, Subject ARDS in the United States / Scale 150,000 patients with moderate to severe disease, approximately 100,000 eligible patients, and annual access-adjusted demand of approximately 20,000 patients / Source Analysis conducted by Dedham Group under commission from the company, Subject Revenue potential of HLCM051 in the United States / Scale Annual sales potential of ¥475 billion / Source Analysis conducted by Dedham Group under commission from the company |
| Publication date | 23 March 2026 |
Items this document does not state (16)
Plan periodSales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSelf-assessment of PBR and share priceTotal investment planSegment targetResults under the previous planRisks identifiedDate of board resolution
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.ARDS has demonstrated "significant efficacy," offers the highest probability of success in the development process, and has been clearly agreed upon with regulatory authorities. For acute ischemic stroke, the company stated that it would reconsider its development policy in light of the status of discussions with regulatory authorities and the company's available resources.
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