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Earnings presentation2160GNI Group Ltd.Pharmaceuticals

Overview of Gyre Therapeutics, our subsidiary’s, first-quarter financial results and business highlights for fiscal 2026

In Q1 FY2026, revenue exceeded the prior-year period, while higher acquisition-related expenses, stock-based compensation, and clinical and commercialization preparation costs for F351 caused operating income and net income to turn negative. The full-year FY2026 revenue forecast was maintained at $100.5–111.0 million, and progress was reported on the priority review designation for F351 in China and the completion of the acquisition of Cullgen, among other matters.

Worth reading
42Recurring
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
-11.7
US$ million (year-on-year change in operating income)
Wording
Conditional
How definitive the wording is.

Contents of this document

Earnings presentationFY2026 First Quarter4 items taken from the company’s own explanation
Financial Results Figures (The key points of this material are explained below)
Net Sales22.5 USD million
Operating profit-9.4 USD million
Net income-9.9 USD million
Selling, general and administrative expensesSelling and marketing expenses 14.1, general and administrative expenses 7.3
Results for the three months of the current quarterRevenue of $22.5 million, an operating loss of $9.4 million, a net loss of $9.9 million, and cash and cash equivalents and other balances of $79.2 million for the three months of the quarter. Selling and marketing expenses were $14.1 million, research and development expenses were $6.7 million, and general and administrative expenses were $7.3 million.
Full-year earnings forecast
Revenue$100.5–111.0 million
What the company explained in this material
Breakdown of Factors Affecting the ChangeReasons cited by the Company for the change in the figures.
  • Advisory fees related to the acquisition of Cullgen$2.5 million
  • Increase in Gyre's stock-based compensation expense$2.1 million
  • Promotional activities and initial preparations for the commercialization of F351$2.9 million
  • Increase in R&D expenses$3.6 million
  • Phase 3c clinical trial of F351 in China and other activities$2.0 million
  • Materials, utilities and other expenses$0.5 million
  • Preclinical activities in preparation for the US IND filing for F351$1.1 million
Assumptions Underlying the Business OutlookThe assumptions used by the company in preparing its forecast.
Exchange rateUS$1 = ¥159
New initiatives
  • Completion of the acquisition of Cullgen Inc.
  • Acquisition of TPD degrader and DAC technologies
  • Filing of the F351 NDA in China and priority review designation
  • Preparations for the US IND filing for F351
  • Initiation of a Phase 2/3 adaptive-design trial for RILI
Key KPIsA metric the company considers important as a management benchmark.
  • Number of enrolled subjects in the Phase 3 clinical trial for pneumoconiosis272 People
  • Number of enrolled cases in the Phase 2/3 RILI trial1 Example
Contents of this document
ItemDetails
Document typeEarnings presentation
Fiscal Period CoveredFY2026 First Quarter
Net Sales22.5 USD million
Operating profit-9.4 USD million
Net income-9.9 USD million
Selling, general and administrative expensesSelling and marketing expenses 14.1, general and administrative expenses 7.3
Results for the three months of the current quarterRevenue of $22.5 million, an operating loss of $9.4 million, a net loss of $9.9 million, and cash and cash equivalents and other balances of $79.2 million for the three months of the quarter. Selling and marketing expenses were $14.1 million, research and development expenses were $6.7 million, and general and administrative expenses were $7.3 million.
Full-year earnings forecastRevenue $100.5–111.0 million
Breakdown of Factors Affecting the ChangeFactors Advisory fees related to the acquisition of Cullgen / Amount $2.5 million, Factors Increase in Gyre's stock-based compensation expense / Amount $2.1 million, Factors Promotional activities and initial preparations for the commercialization of F351 / Amount $2.9 million, Factors Increase in R&D expenses / Amount $3.6 million, Factors Phase 3c clinical trial of F351 in China and other activities / Amount $2.0 million, Factors Materials, utilities and other expenses / Amount $0.5 million, Factors Preclinical activities in preparation for the US IND filing for F351 / Amount $1.1 million
Key KPIsIndicator name Number of enrolled subjects in the Phase 3 clinical trial for pneumoconiosis / Value 272 People / Year on year against the same period last year Not disclosed, Indicator name Number of enrolled cases in the Phase 2/3 RILI trial / Value 1 Example / Year on year against the same period last year Not disclosed
Assumptions Underlying the Business OutlookExchange rate US$1 = ¥159
New initiativesCompletion of the acquisition of Cullgen Inc., Acquisition of TPD degrader and DAC technologies, Filing of the F351 NDA in China and priority review designation, Preparations for the US IND filing for F351, Initiation of a Phase 2/3 adaptive-design trial for RILI
Items this document does not state (19)
Ordinary incomeGross Profit MarginOperating profit marginProgress against full-year forecastSelf-assessment against the planSegment resultsUnit price and quantity metricsNumber of stores and locationsNumber of employeesRisk amount incorporated into the outlookMedium-term management plan targetsFinancial targetsAnnual DividendPayout ratioAcquisition of treasury sharesCapital expendituresOrders received and order backlogMarket Size / ShareKey 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 shift to an operating loss was due to a $12.1 million increase in total operating expenses. The main components were $2.5 million in advisory fees related to the acquisition of Cullgen, a $2.1 million increase in Gyre's stock-based compensation expense, $2.9 million for promotional activities and initial preparations for the commercialization of F351, and a $3.6 million increase in research and development expenses. The increase in research and development expenses was attributable to the Phase 3c clinical trial of F351 in China and other activities, materials and utilities, and preclinical activities in preparation for the US IND filing for F351.

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Overview of Gyre Therapeutics, our subsidiary’s, first-quarter financial results and business highlights for fiscal 2026 | GNI Group Ltd. (2160) timely disclosure | Komori