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Presentation materials on financial results4593HEALIOS K.K.Pharmaceuticals

Financial Results Briefing Materials for the Second Quarter of the Fiscal Year Ending December 2026

Cumulative results for the second quarter of FY2026 December saw the operating loss widen due to higher research and development expenses and SG&A expenses, while the net loss narrowed from the same period of the previous year due in part to lower financial expenses. The commercial manufacturing site for the ARDS treatment product was also changed from overseas facilities to Minaris's Yokohama site, and manufacturing process validation is under way in preparation for the marketing approval application.

Worth reading
43Recurring
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
-830
¥ millions (year-on-year change in operating income)
Wording
Avoiding a definitive answer
How definitive the wording is.

Contents of this document

Presentation materials on financial resultsSecond quarter of the fiscal year ending December 20268 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
Net Sales¥15 million
Operating profit¥-2,404 million
Net income¥-2,266 million
What the company explained in this material
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
  • Increase in Selling, General and Administrative Expenses¥-177 million
  • Increase in R&D expenses¥-667 million
  • Increase in financial revenue¥611 million
  • Decrease in financial expenses¥2,645 million
New initiatives
  • Change the commercial manufacturing site for the ARDS treatment product from overseas facilities to Minaris's Yokohama site
  • Install a 500-liter bioreactor at Kobe KCIC and establish a CDMO business
  • Begin product shipments under the culture supernatant supply agreement with JENECELL
  • Hire 24 new employees, primarily for manufacturing, quality and supply chain functions
  • Plan to establish a data collection system linking a healthcare-specific LLM with electronic medical records for the acute phase of ischemic stroke
Key KPIsA metric the company considers important as a management benchmark.
  • Maximum number of cases in the REVIVE-ARDS trial550 Example
  • Estimated number of ARDS patients eligible for treatment in the United States20,000 People/year
  • Number of cases in the MATRICS-1 trial156 People
  • Annual supply capacity of the Kobe CDMO40,000 People/year
Unit price and quantity metricsThese figures show sales broken down by price and volume.
  • ARDS drug pricing in the United States
    Value
    1,125, 2,250, 3,750, 3,000
  • Number of ARDS patients treated in the United States
    Value
    21,000, 20,000, 13,000
Market Size / Share
  • Estimated number of ARDS patients worldwide1,100,000 Over people
  • Estimated number of ARDS patients eligible for treatment in the United States20,000 People/year
  • ARDS revenue potential in the United States4,750 Hundred millions of yen
Orders received and order backlog
¥144 million initial orders
Number of employees
Number of Employees82 People
Change during the period24 People
Change unitPeople
Capital expenditures
Approximately ¥7 billion (subsidy)
Contents of this document
ItemDetails
Document typePresentation materials on financial results
Fiscal Period CoveredSecond quarter of the fiscal year ending December 2026
Net Sales¥15 million
Operating profit¥-2,404 million
Net income¥-2,266 million
Breakdown of Factors Affecting the ChangeFactors Increase in Selling, General and Administrative Expenses / Amount ¥-177 million, Factors Increase in R&D expenses / Amount ¥-667 million, Factors Increase in financial revenue / Amount ¥611 million, Factors Decrease in financial expenses / Amount ¥2,645 million
Key KPIsIndicator name Maximum number of cases in the REVIVE-ARDS trial / Value 550 Example / Year on year against the same period last year Not disclosed, Indicator name Estimated number of ARDS patients eligible for treatment in the United States / Value 20,000 People/year / Year on year against the same period last year Not disclosed, Indicator name Number of cases in the MATRICS-1 trial / Value 156 People / Year on year against the same period last year Not disclosed, Indicator name Annual supply capacity of the Kobe CDMO / Value 40,000 People/year / Year on year against the same period last year Not disclosed
Unit price and quantity metricsIndicator name ARDS drug pricing in the United States / Value 1,125, 2,250, 3,750, 3,000, Indicator name Number of ARDS patients treated in the United States / Value 21,000, 20,000, 13,000
Number of employeesNumber of Employees 82 People / Change during the period 24 People / Change unit People
Capital expendituresApproximately ¥7 billion (subsidy)
Orders received and order backlogAmount ¥144 million (initial orders)
Market Size / ShareMarket Estimated number of ARDS patients worldwide / Value 1,100,000 Over people, Market Estimated number of ARDS patients eligible for treatment in the United States / Value 20,000 People/year, Market ARDS revenue potential in the United States / Value 4,750 Hundred millions of yen
New initiativesChange the commercial manufacturing site for the ARDS treatment product from overseas facilities to Minaris's Yokohama site, Install a 500-liter bioreactor at Kobe KCIC and establish a CDMO business, Begin product shipments under the culture supernatant supply agreement with JENECELL, Hire 24 new employees, primarily for manufacturing, quality and supply chain functions, Plan to establish a data collection system linking a healthcare-specific LLM with electronic medical records for the acute phase of ischemic stroke
Items this document does not state (18)
Ordinary incomeGross Profit MarginOperating profit marginSelling, general and administrative expensesResults for the three months of the current quarterFull-year earnings forecastProgress against full-year forecastSelf-assessment against the planSegment resultsNumber of stores and locationsAssumptions Underlying the Business OutlookRisk amount incorporated into the outlookMedium-term management plan targetsFinancial targetsAnnual DividendPayout ratioAcquisition of treasury sharesKey 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.

Operating income deteriorated due to increases of ¥177 million in SG&A expenses and ¥667 million in research and development expenses. Net income benefited from a ¥611 million increase in financial income and a ¥2,645 million decrease in financial expenses. The commercial manufacturing site was changed to ensure a stable supply and product quality after approval.

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Financial Results Briefing Materials for the Second Quarter of the Fiscal Year Ending December 2026 | HEALIOS K.K. (4593) timely disclosure | Komori