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Financial results presentation4593HEALIOS K.K.Pharmaceuticals

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

In the first quarter of FY2026 December, revenue declined from ¥38 million in the same period of the previous year to ¥8 million, while the operating loss widened to ¥1,130 million and the net loss widened to ¥3,457 million. Meanwhile, business development progressed, including the launch of the global Phase 3 trial of the ARDS treatment and the signing of a supply agreement for conditioned media.

Worth reading
39Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Deterioration
Direction inferred from the company’s description.
Scale
-386
¥ millions (year-on-year change in operating income)
Wording
Avoiding a definitive answer
How definitive the wording is.

Contents of this document

Financial results presentationFirst quarter of the fiscal year ending December 20267 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
Net Sales¥8 million-78.9%
Operating profit¥-1,130 million
Net income¥-3,457 million
Selling, general and administrative expensesSelling, general and administrative expenses increased by ¥65 million year on year. Total amount and SG&A-to-revenue ratio: Not disclosed
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¥-65 million
  • Increase in R&D expenses¥-315 million
  • Increase in financial revenue¥52 million
  • Increase in financial expenses¥-552 million
  • Increase in derivative valuation losses¥-527 million
  • Increase in stock acquisition rights issuance costs¥-56 million
New initiatives
  • Launch of the REVIVE-ARDS global Phase 3 trial for HLCM051 as an ARDS treatment
  • Development of a 500-liter bioreactor facility in Kobe and establishment of a CDMO business using a subsidy from the Ministry of Economy, Trade and Industry
  • Signing of a supply agreement with JENECELL for HLSI071 conditioned media
  • Signing of a basic agreement on HLSI071 transactions with Alfresa
  • Full-scale operation of a cell-processing manufacturing facility for HLSI071 conditioned media
  • Plans to establish a data collection system linking a medical-specialty LLM with electronic medical records for the acute phase of ischemic stroke
Key KPIsA metric the company considers important as a management benchmark.
  • Patients in Japan and the US (3 indications)More than 1.5 million/year
  • Annual manufacturing capacity40,000 People/year
  • 3D culture capacity500 L
  • REVIVE-ARDS trial patient count550 Example
  • Number of cases in the MATRICS-1 trial156 people
  • JENECELL initial order value¥144 million equivalent
Unit price and quantity metricsThese figures show sales broken down by price and volume.
For the US ARDS market, the materials show the relationship between drug prices of approximately ¥11.25 million, ¥22.5 million and ¥37.5 million, among others, and total treated patients from the fifth year onward of 21,000, 20,000 and 13,000, respectively.
Market Size / Share
  • Estimated global ARDS patient populationMore than 1.1 million
  • Estimated ARDS patient population in Japan28,000 People/year
  • Estimated number of ARDS patients eligible for treatment in the US20,000 People/year
  • Annual US ARDS sales potential¥4,750 100 million
Orders received and order backlog
Orders received144 Equivalent to ¥ millions JENECELL's initial order
Number of employees
Number of Employees72 People employees only
Change during the period15 People employees only
Contents of this document
ItemDetails
Document typeFinancial results presentation
Fiscal Period CoveredFirst quarter of the fiscal year ending December 2026
Net Sales¥8 million (YoY -78.9%)
Operating profit¥-1,130 million
Net income¥-3,457 million
Selling, general and administrative expensesSelling, general and administrative expenses increased by ¥65 million year on year. Total amount and SG&A-to-revenue ratio: Not disclosed
Breakdown of Factors Affecting the ChangeFactors Increase in Selling, General and Administrative Expenses / Amount ¥-65 million, Factors Increase in R&D expenses / Amount ¥-315 million, Factors Increase in financial revenue / Amount ¥52 million, Factors Increase in financial expenses / Amount ¥-552 million, Factors Increase in derivative valuation losses / Amount ¥-527 million, Factors Increase in stock acquisition rights issuance costs / Amount ¥-56 million
Key KPIsIndicator name Patients in Japan and the US (3 indications) / Value More than 1.5 million/year / Year on year against the same period last year Not disclosed, Indicator name Annual manufacturing capacity / Value 40,000 People/year / Year on year against the same period last year Not disclosed, Indicator name 3D culture capacity / Value 500 L / Year on year against the same period last year Not disclosed, Indicator name REVIVE-ARDS trial patient count / Value 550 Example / 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 JENECELL initial order value / Value ¥144 million equivalent / Year on year against the same period last year Not disclosed
Unit price and quantity metricsFor the US ARDS market, the materials show the relationship between drug prices of approximately ¥11.25 million, ¥22.5 million and ¥37.5 million, among others, and total treated patients from the fifth year onward of 21,000, 20,000 and 13,000, respectively.
Number of employeesNumber of Employees 72 People (employees only) / Change during the period 15 People (employees only) / Hiring plan Not disclosed
Orders received and order backlogOrders received 144 Equivalent to ¥ millions (JENECELL's initial order) / Order backlog Not disclosed
Market Size / ShareMarket Estimated global ARDS patient population / Value More than 1.1 million, Market Estimated ARDS patient population in Japan / Value 28,000 People/year, Market Estimated number of ARDS patients eligible for treatment in the US / Value 20,000 People/year, Market Annual US ARDS sales potential / Value ¥4,750 100 million
New initiativesLaunch of the REVIVE-ARDS global Phase 3 trial for HLCM051 as an ARDS treatment, Development of a 500-liter bioreactor facility in Kobe and establishment of a CDMO business using a subsidy from the Ministry of Economy, Trade and Industry, Signing of a supply agreement with JENECELL for HLSI071 conditioned media, Signing of a basic agreement on HLSI071 transactions with Alfresa, Full-scale operation of a cell-processing manufacturing facility for HLSI071 conditioned media, Plans to establish a data collection system linking a medical-specialty LLM with electronic medical records for the acute phase of ischemic stroke
Items this document does not state (18)
Ordinary incomeGross Profit MarginOperating profit marginResults 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 sharesCapital expendituresKey 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.

Selling, general and administrative expenses increased by ¥65 million, while research and development expenses increased by ¥315 million. In addition, although financial income increased by ¥52 million, financial expenses increased by ¥552 million, primarily due to a ¥527 million increase in derivative valuation losses.

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