Gyre Therapeutics | 8-K: FY2026 Q1 Revenue Misses Estimate at USD 22.52 M

Revenue: As of FY2026 Q1, the actual value is USD 22.52 M, missing the estimate of USD 31.61 M.

EPS: As of FY2026 Q1, the actual value is USD -0.1.

EBIT: As of FY2026 Q1, the actual value is USD -9.355 M.

Segment Revenue

Gyre Therapeutics, Inc. reported total revenues of $22.5 million for the first quarter of 2026, marking a 2% increase from $22.1 million for the same period in 2025 . This growth was primarily driven by a $0.5 million rise in Contiva™ sales and a $0.7 million increase in Etorel™ sales, partially offset by a $0.7 million decrease in ETUARY™ sales and a $0.1 million decrease in other product sales . ETUARY™ sales: $21.0 million for the quarter ended March 31, 2026, representing an approximately 3% year-over-year decline from $21.7 million in the prior year period . Etorel™ sales: $0.7 million for the quarter ended March 31, 2026 . Contiva™ sales: $0.8 million for the quarter ended March 31, 2026, compared to $0.3 million for the same period in 2025 .

Operational Metrics

• Cost of Revenues: Cost of revenues increased by 37% to $1.2 million for the three months ended March 31, 2026, from $0.9 million for the same period in 2025 . This increase was mainly due to a $0.3 million rise in early production costs for Etorel™ and a $0.2 million increase in stock-based compensation expense, partly offset by a $0.2 million decrease in ETUARY™ cost of sales .
• Selling and Marketing Expense: This expense rose by 30% to $14.1 million for the three months ended March 31, 2026, from $10.8 million in the prior year period . The increase was primarily attributed to a $2.9 million increase in promotion expenses for Etorel™ and Contiva™, early-stage preparation activities for F351 commercial launch, and a $1.0 million increase in stock-based compensation expense, partially offset by a $0.5 million decrease in staff costs .
• Research and Development Expense: This expense increased by 118% to $6.7 million for the three months ended March 31, 2026, from $3.1 million for the same period in 2025 . The rise was mainly due to a $2.0 million increase in clinical research expenses related to F351 in the PRC and a $1.1 million increase in Gyre Therapeutics, Inc.’s pre-clinical activities for future investigational new drug (IND) filings in the United States .
• General and Administrative Expense: This expense increased by 46% to $7.3 million for the three months ended March 31, 2026, from $5.0 million in the prior year period . This was primarily driven by a $0.8 million increase in stock-based compensation costs and a $0.9 million increase in staff costs .
• Transaction Costs: Gyre Therapeutics, Inc. incurred $2.5 million in transaction costs for the three months ended March 31, 2026, related to the acquisition of Cullgen .
• Loss from Operations: The company reported a loss from operations of - $9.4 million for the three months ended March 31, 2026, compared to an income from operations of $2.3 million for the same period in 2025, representing an $11.7 million decrease .
• Net Loss: The net loss for the three months ended March 31, 2026, was - $9.9 million, compared to a net income of $3.7 million for the same period in 2025, a $13.6 million decrease .
• Non-GAAP Adjusted Net Loss: The non-GAAP adjusted net loss was - $4.2 million for the three months ended March 31, 2026, compared to a non-GAAP adjusted net income of $2.9 million for the same period in 2025 .

Cash Position

As of March 31, 2026, Gyre Therapeutics, Inc. held $37.5 million in cash and cash equivalents, $12.3 million in short-term bank deposits, and $29.4 million in long-term certificates of deposit, totaling $79.2 million . This represents an increase of $3.3 million, or 4%, from $75.9 million as of December 31, 2025, primarily due to higher customer collections and reduced tax payments .

Unique Metrics

• Acquisition of Cullgen: Gyre Therapeutics, Inc. completed the acquisition of Cullgen in an approximately $300 million all-stock transaction in May 2026, expanding its pipeline into inflammatory diseases and cancers .
• F351 NDA Submission: The New Drug Application (NDA) for F351 (hydronidone) for CHB-associated liver fibrosis was submitted to China’s CDE in March 2026 and is currently under completeness review for acceptance .
• ETUARY™ Phase ²⁄₃ Trial: The first patient was enrolled in a Phase ²⁄₃ trial evaluating ETUARY™ for radiation-induced lung injury, including immune-related pneumonitis, in April 2026 .

Outlook / Guidance

Gyre Therapeutics, Inc. affirmed its full year 2026 revenue guidance of $100.5 million to $111.0 million . The final patient in the Phase 3 trial of pirfenidone for pneumoconiosis is expected to complete the study in the third quarter of 2026 . The company plans to file an Investigational New Drug (IND) application for F351 in the U.S. by the end of 2026, with a Phase 2 clinical trial planned if the IND becomes effective .