Press release
Gyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business Update
Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively Full-year revenue guidance revised to
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"Net income of $5.9 million and $11.2 million for the three and nine months ended September 30, 2025, respectively Full-year revenue guidance revised to $115-118 million (from $118 - $128 million previously) due to delayed Etorel® (Nintedanib) rollout and government procurement-related uncertainty Q3 2025 vs Q3 2024 Highlights Quarterly revenue of $30.6 million, up 20% year-over-year, driven by ETUARY® growth and contributions from sales of Etorel® and Contiva®.GAAP net income doubled to $5.9 million and adjusted net income rose to $8.8 million, reflecting commercial execution and disciplined cost control.Operating income increased 64% to $6.9 million, as operating expenses grew at a slower pace than revenue.Basic EPS improved to $0.04, compared to $0.01 year-over-year. Nine-Month 2025 Highlights Revenue of $79.4 million, moderately above the prior-year period, supported by steady Q3 growth of Etorel® and Contiva®, after earlier supply chain and distribution delays related to new product launches.Basic EPS down from $0.14 to $0.08, reflecting higher operating expenses related to the dual product launches in the first half of 2025, partially offset by the strong Q3 profit recovery.$80.3 million in cash, cash equivalents, and short and long-term deposits, up 57% year-to-date, as of Sept 30, 2025. Business Update Hydronidone New Drug Application (NDA) progressing in China, with Priority Review discussions ongoing and targeted submission following completion of regulatory interactions.Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients, 18 sites). Plan to initiate an adaptive Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications (RILI/immune-related pneumonitis) in Q4 2025.U.S. MASH IND anticipated timeline adjusted to 2026 to allow for (i) the incorporation of the complete Phase 2 and 3 CHB-associated liver fibrosis clinical data from China; and (ii) planning and expected initiation of a hepatic impairment study under the existing U.S. IND to further inform safety, dose optimization, and regulatory discussions. SAN DIEGO, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today anno...