Contents of this document
- 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
- 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
- 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
| Item | Details |
|---|---|
| Document type | Earnings presentation |
| Fiscal Period Covered | FY2026 First Quarter |
| Net Sales | 22.5 USD million |
| Operating profit | -9.4 USD million |
| Net income | -9.9 USD million |
| Selling, general and administrative expenses | Selling and marketing expenses 14.1, general and administrative expenses 7.3 |
| Results for the three months of the current quarter | Revenue 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 |
| Breakdown of Factors Affecting the Change | Factors 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 KPIs | Indicator 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 Outlook | Exchange rate US$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 |
Items this document does not state (19)
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.