Worth reading
46Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Mixed performance
Direction inferred from the company’s description.Scale
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Displayed only when the document provides numerical figures.Wording
Avoiding a definitive answer
How definitive the wording is.Items stated in the management plan
Annual updateWhat happened to the previous planNew drug approval and launch in 2027 → After obtaining approval to initiate the Phase 3 clinical trial, which is currently under application, the company will take into account the details of that approval and other factors before announcing a more specific target again.-99.9%Calculated from the two disclosed figures
Total investment plan¥4.5–5.0 billion (projected cost of the CBP501 Phase 3 clinical trial)
Investment amount by sectorField CBP501 Phase 3 clinical trial / Amount ¥4.5–5.0 billion / Timing Not disclosed, Field Basic research expenses and SG&A expenses / Amount ¥100–150 million per quarter / Timing Next steps
Statements about the use of capital
Self-assessment of PBR and share priceThe company cited the probability of success, the time value of money, concerns over funding required to continue development, and the difficulty of valuation as general discount factors. It explained that current market valuation has been affected by awareness of the value of its pipeline and development progress. No PBR figure was provided.PBR is a measure of how many times the share price is the book value per share.
Key initiatives
01Current status of the application and preparations to initiate the Phase 3 trial in Europe
02Early initiation of preclinical trials
03Continued creation of new drug candidates
04Further development progress and disclosure of results
05Careful investor relations
06Securing funding and structures to maintain development funding and continuity
Plan assumptionsEstimated peak market size in the US at $900 million, Estimated peak market size in Europe, including the UK, at €550–900 million, More than 47,000 third-line pancreatic cancer patients annually in the US, 60,000–100,000 third-line pancreatic cancer patients annually in Europe, The proportion of patients selecting drug treatment is 20%–70%, Approximately 80% of patients continue visiting for treatment, CBP501's peak market share is 60%, Treatment duration is at least 4 months, Monthly drug costs in the US are approximately $20,000, Monthly drug costs in Europe are €9,000–10,000, Under the target scenario, post-launch end-user sales increase from $400 million in Y1 to $750 million in Y6, The target royalty rate for a partnership at the final stage of development is 40%–80%
Non-financial targetsIndicator name CBP501 Phase 3 clinical trial in Europe / Target value Start / Timing Short term, Indicator name CBP501 development / Target value Accelerate development and submit a new drug application / Timing Medium term, Indicator name CBT005 preclinical trial / Target value Initiate at an early stage / Timing Not disclosed
Size of the Target MarketThe US market is estimated to reach a peak of $900 million. Sources include The International Agency for Research on Cancer (IARC) GLOBOCAN2018, Anticancer Research, Oncologist, Cancer Res Clin Oncol, Cancer Med, J Clin Oncol, Therapeutics and Clinical Risk Management, materials from the General Meeting of the Central Social Insurance Medical Council of the Ministry of Health, Labour and Welfare, and the American Society of Health-System Pharmacists (ASHP). The European market, including the UK, is estimated to reach a peak of €550–900 million. Sources include ECIS (European Cancer Information System) Globocan 2022 data and other clinical and drug-pricing materials.
Risks identified by the company
Uncertainty in drug development, including substantial costs, the time required, and the probability of success
Uncertainty regarding future revenue
Uncertainty regarding future legal and regulatory requirements, healthcare insurance systems, and other factors
Potential competition
Securing Development Funding
Clinical trial data
Continued expansion of the development pipeline
Intellectual Property Rights
Financial position
An increase in the number of shares outstanding due to the exercise or conversion of potentially dilutive securities
Material events or similar matters related to the going concern assumption
Reason for revision or withdrawal
Given that approval to initiate the Phase 3 clinical trial in Europe has still not been obtained, the company judged that, after taking into account the time required to conduct the trial and submit an application for new drug approval, it would be difficult to achieve the previous development target of obtaining new drug approval and launching the product in 2027.
| Item | Details |
|---|---|
| Plan name | Presentation on Business Plans and Growth Potential |
| Progress against the plan | Annual update |
| Self-assessment of PBR and share price | The company cited the probability of success, the time value of money, concerns over funding required to continue development, and the difficulty of valuation as general discount factors. It explained that current market valuation has been affected by awareness of the value of its pipeline and development progress. No PBR figure was provided. |
| Total investment plan | ¥4.5–5.0 billion (projected cost of the CBP501 Phase 3 clinical trial) |
| Investment amount by sector | Field CBP501 Phase 3 clinical trial / Amount ¥4.5–5.0 billion / Timing Not disclosed, Field Basic research expenses and SG&A expenses / Amount ¥100–150 million per quarter / Timing Next steps |
| Non-financial targets | Indicator name CBP501 Phase 3 clinical trial in Europe / Target value Start / Timing Short term, Indicator name CBP501 development / Target value Accelerate development and submit a new drug application / Timing Medium term, Indicator name CBT005 preclinical trial / Target value Initiate at an early stage / Timing Not disclosed |
| Plan assumptions | Estimated peak market size in the US at $900 million, Estimated peak market size in Europe, including the UK, at €550–900 million, More than 47,000 third-line pancreatic cancer patients annually in the US, 60,000–100,000 third-line pancreatic cancer patients annually in Europe, The proportion of patients selecting drug treatment is 20%–70%, Approximately 80% of patients continue visiting for treatment, CBP501's peak market share is 60%, Treatment duration is at least 4 months, Monthly drug costs in the US are approximately $20,000, Monthly drug costs in Europe are €9,000–10,000, Under the target scenario, post-launch end-user sales increase from $400 million in Y1 to $750 million in Y6, The target royalty rate for a partnership at the final stage of development is 40%–80% |
| Key initiatives | Current status of the application and preparations to initiate the Phase 3 trial in Europe, Early initiation of preclinical trials, Continued creation of new drug candidates, Further development progress and disclosure of results, Careful investor relations, Securing funding and structures to maintain development funding and continuity |
| Results under the previous plan | New drug approval and launch in 2027 → After obtaining approval to initiate the Phase 3 clinical trial, which is currently under application, the company will take into account the details of that approval and other factors before announcing a more specific target again. |
| Reason for revision or withdrawal | Given that approval to initiate the Phase 3 clinical trial in Europe has still not been obtained, the company judged that, after taking into account the time required to conduct the trial and submit an application for new drug approval, it would be difficult to achieve the previous development target of obtaining new drug approval and launching the product in 2027. |
| Size of the Target Market | The US market is estimated to reach a peak of $900 million. Sources include The International Agency for Research on Cancer (IARC) GLOBOCAN2018, Anticancer Research, Oncologist, Cancer Res Clin Oncol, Cancer Med, J Clin Oncol, Therapeutics and Clinical Risk Management, materials from the General Meeting of the Central Social Insurance Medical Council of the Ministry of Health, Labour and Welfare, and the American Society of Health-System Pharmacists (ASHP). The European market, including the UK, is estimated to reach a peak of €550–900 million. Sources include ECIS (European Cancer Information System) Globocan 2022 data and other clinical and drug-pricing materials. |
| Risks identified | Uncertainty in drug development, including substantial costs, the time required, and the probability of success, Uncertainty regarding future revenue, Uncertainty regarding future legal and regulatory requirements, healthcare insurance systems, and other factors, Potential competition, Securing Development Funding, Clinical trial data, Continued expansion of the development pipeline, Intellectual Property Rights, Financial position, An increase in the number of shares outstanding due to the exercise or conversion of potentially dilutive securities, Material events or similar matters related to the going concern assumption |
| Date of board resolution | 24 October 2025 |
| Publication date | 12 August 2026 |
Items this document does not state (11)
Plan periodSales TargetOperating profit targetOperating profit margin targetNet income targetROE targetROIC targetPayout ratio / DOE policyTreasury share acquisition policyCost of capitalSegment target
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 materials were updated around the time of the full-year results announcement in August. The company explained that the previous target was changed because approval to initiate the Phase 3 clinical trial in Europe had not been obtained and, after taking into account the time required to conduct the trial and submit an application for new drug approval, it judged that obtaining approval and launching the product in 2027 would be difficult.
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