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Results presentation4884Kringle Pharma,Inc.Pharmaceuticals

Full-Year Earnings Presentation Materials for the Fiscal Year Ending September 2026

For the fiscal year ended September 2026, revenue increased substantially due to the supply of drug substance and technology access fees from Claris, as well as a contract upfront payment from Maruishi Pharmaceutical. Operating loss, ordinary loss and net loss decreased from the previous year. For the fiscal year ending September 2027, the company presented an earnings forecast calling for a substantial increase in losses due to higher research and development expenses.

Worth reading
40Recurring
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
370
¥ million (year-on-year increase in revenue)
Wording
Avoiding a definitive answer
How definitive the wording is.

Contents of this document

Results presentationFull year ended September 20267 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
Net Sales¥442 million+513.9%
Operating profit¥-813 million +10.6%operating loss
Ordinary income¥-810 million +11.4%ordinary loss
Net income¥-813 million +11.2%net loss
Selling, general and administrative expenses¥1,185 million
Full-year earnings forecast
Fiscal year ending September 2027
Net Sales
¥127 million
Cost of sales
¥0 million
Selling, General and Administrative Expenses
¥1,901 million
Research and Development Expenses
¥1,498 million
Operating loss
¥-1,773 million
Ordinary loss
¥-1,773 million
Net loss for the period
¥-1,775 million
What the company explained in this material
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
  • Drug substance supply and technology access fee income from ClarisListed as a reason for the increase in revenue
  • Contract upfront payment income from Maruishi PharmaceuticalListed as a reason for the increase in revenue
  • Decline in R&D expenditure64
  • Timing shift in expenses for developing a commercial formulation for vocal fold scarsListed as a reason for the decrease in expenses
Assumptions Underlying the Business OutlookThe assumptions used by the company in preparing its forecast.
Revenue from new partnerships and other arrangements may arise, but because this is uncertain at present, it has not been included in the revenue forecast for the fiscal year ending September 2027
New initiatives
  • Start of an additional Phase III trial in acute spinal cord injury
  • Establishment of a US subsidiary and US IND clearance
  • Exclusive marketing license agreement with Maruishi Pharmaceutical for a treatment for vocal fold scars
  • Advancement of preparations for a US Phase III trial in acute spinal cord injury
  • Preparation for establishing a manufacturing system for recombinant human HGF drug substance using a new manufacturing process
  • Funding through a private placement and stock acquisition rights
Key KPIsA metric the company considers important as a management benchmark.
  • Number of employees19 People
  • Improvement of 15 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group)41 %
  • Improvement of 10 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group)55 %
  • Durability of the CSB-001 effect (eyes with an improvement of 15 or more letters)58 %
  • Durability of the CSB-001 effect (eyes with an improvement of 10 or more letters)83 %
Financial targets
Actual results
Equity ratio57.1%
Market Size / Share
  • Acute Spinal Cord InjuryApproximately ¥12.0 billion
    RegionJapan
  • Acute Spinal Cord InjuryApproximately ¥60 billion
    RegionWorldwide
  • Vocal Fold ScarringApproximately ¥5.0 billion
    RegionJapan
  • Vocal Fold ScarringApproximately ¥30 billion
    RegionWorldwide
  • ALSApproximately ¥20.0 billion
    RegionJapan
  • ALSApproximately ¥100 billion
    RegionWorldwide
Number of employees
Number of Employees19 People
Contents of this document
ItemDetails
Document typeResults presentation
Fiscal Period CoveredFull year ended September 2026
Net Sales¥442 million (YoY +513.9%)
Operating profit¥-813 million (operating loss) (YoY +10.6%)
Ordinary income¥-810 million (ordinary loss) (YoY +11.4%)
Net income¥-813 million (net loss) (YoY +11.2%)
Selling, general and administrative expenses¥1,185 million
Full-year earnings forecastFiscal year ending September 2027 Net Sales ¥127 million / Cost of sales ¥0 million / Selling, General and Administrative Expenses ¥1,901 million / Research and Development Expenses ¥1,498 million / Operating loss ¥-1,773 million / Ordinary loss ¥-1,773 million / Net loss for the period ¥-1,775 million
Breakdown of Factors Affecting the ChangeFactors Drug substance supply and technology access fee income from Claris / Amount Listed as a reason for the increase in revenue, Factors Contract upfront payment income from Maruishi Pharmaceutical / Amount Listed as a reason for the increase in revenue, Factors Decline in R&D expenditure / Amount 64, Factors Timing shift in expenses for developing a commercial formulation for vocal fold scars / Amount Listed as a reason for the decrease in expenses
Key KPIsIndicator name Number of employees / Value 19 People / Year on year against the same period last year Not disclosed, Indicator name Improvement of 15 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group) / Value 41 % / Year on year against the same period last year Not disclosed, Indicator name Improvement of 10 or more letters in visual acuity in LSCD (at week 20, CSB-001 treatment group) / Value 55 % / Year on year against the same period last year Not disclosed, Indicator name Durability of the CSB-001 effect (eyes with an improvement of 15 or more letters) / Value 58 % / Year on year against the same period last year Not disclosed, Indicator name Durability of the CSB-001 effect (eyes with an improvement of 10 or more letters) / Value 83 % / Year on year against the same period last year Not disclosed
Number of employeesNumber of Employees 19 People / Change during the period Not disclosed / Hiring plan Not disclosed
Assumptions Underlying the Business OutlookRevenue from new partnerships and other arrangements may arise, but because this is uncertain at present, it has not been included in the revenue forecast for the fiscal year ending September 2027
Financial targetsTarget Not disclosed / Actual results Equity ratio 57.1%
Market Size / ShareSubject Acute Spinal Cord Injury / Region Japan / Market Size Approximately ¥12.0 billion, Subject Acute Spinal Cord Injury / Region Worldwide / Market Size Approximately ¥60 billion, Subject Vocal Fold Scarring / Region Japan / Market Size Approximately ¥5.0 billion, Subject Vocal Fold Scarring / Region Worldwide / Market Size Approximately ¥30 billion, Subject ALS / Region Japan / Market Size Approximately ¥20.0 billion, Subject ALS / Region Worldwide / Market Size Approximately ¥100 billion
New initiativesStart of an additional Phase III trial in acute spinal cord injury, Establishment of a US subsidiary and US IND clearance, Exclusive marketing license agreement with Maruishi Pharmaceutical for a treatment for vocal fold scars, Advancement of preparations for a US Phase III trial in acute spinal cord injury, Preparation for establishing a manufacturing system for recombinant human HGF drug substance using a new manufacturing process, Funding through a private placement and stock acquisition rights
Items this document does not state (16)
Gross Profit MarginOperating profit marginResults for the three months of the current quarterProgress against full-year forecastSelf-assessment against the planSegment resultsUnit price and quantity metricsNumber of stores and locationsRisk amount incorporated into the outlookMedium-term management plan targetsAnnual DividendPayout ratioAcquisition of treasury sharesCapital expendituresOrders received and order backlogKey points of the Q&A

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 increase in revenue for the fiscal year ended September 2026 was attributable to drug substance supply and technology access fee income from Claris, as well as contract upfront payment income from Maruishi Pharmaceutical. The reduction in losses was due to higher revenue, lower research and development expenses and other factors. The increase in losses forecast for the fiscal year ending September 2027 is due to higher research and development expenses for an additional domestic Phase III trial in acute spinal cord injury, preparations for a Phase III trial in the United States, and preparations for manufacturing a commercial formulation for vocal fold scars.

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Full-Year Earnings Presentation Materials for the Fiscal Year Ending September 2026 | Kringle Pharma,Inc. (4884) timely disclosure | Komori