Gyre Therapeutics (GYRE) Q4 2025 earnings summary

Executive summary

• Full-year 2025 revenue rose 10% year-over-year to $116.6 million, within revised guidance.

• 2026 revenue guidance set at $100.5–$111.0 million, reflecting a transition year with regulatory focus.

• Agreement to acquire Cullgen for $300 million to expand into targeted protein degradation; closing expected Q2 2026.

• Completed enrollment in 52-week Phase 3 pirfenidone trial for pneumoconiosis; NDA for Hydronidone in China planned for H1 2026.

• U.S. IND application for Hydronidone in MASH-associated liver fibrosis anticipated in 2026.

Financial highlights

• Q4 2025 revenue was $37.2 million, up 33.3% year-over-year, driven by new product launches and increased ETUARYⓇ sales.

• Full-year 2025 revenue reached $116.6 million, up 10.2% from 2024, with growth from ContivaⓇ and EtorelⓇ launches.

• Q4 2025 net loss was $1.4 million versus $0.6 million net income in Q4 2024; full-year 2025 net income was $9.9 million, down from $17.9 million in 2024.

• Non-GAAP adjusted net income for 2025 was $18.9 million, up from $16.9 million in 2024.

• Cash, cash equivalents, and deposits totaled $75.9 million as of December 31, 2025.

Outlook and guidance

• 2026 revenue expected to decline 4.8%–13.8% year-over-year, reflecting a transition period prioritizing regulatory activities.

• Promotional activities for ContivaⓇ and EtorelⓇ to be moderated due to market uncertainties.

• Guidance assumes constant FX rates and no major economic disruptions.