Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Financial Performance - Full-year 2025 revenue increased by 10.2% year-over-year to $116.6 million, driven by sales growth in new products [11][10] - Fourth quarter 2025 revenue was $37.2 million, representing a 33.3% increase compared to $27.9 million in the same period of 2024 [10] - The company expects 2026 revenue guidance of $100.5 million to $111.0 million, indicating a decline of approximately 4.8% to 13.8% compared to 2025 [15][16] Product Development and Pipeline - The company completed patient enrollment in a 52-week Phase 3 trial for pirfenidone in pneumoconiosis, involving 272 patients across 18 sites [2][9] - An agreement was reached to acquire Cullgen, enhancing the company's capabilities in targeted protein degradation and expanding its pipeline [6][2] - The company plans to submit a New Drug Application (NDA) for Hydronidone in the first half of 2026, following alignment with China's Center for Drug Evaluation [2][4] Sales and Marketing - Sales of ETUARY (pirfenidone) reached $106.1 million for the full year 2025, slightly up from $105.0 million in 2024 [4] - The launch of new products, Etorel and Contiva, contributed $4.6 million and $5.5 million in sales, respectively, for the full year 2025 [4][11] - Selling and marketing expenses for the fourth quarter of 2025 were $23.8 million, a 40.8% increase from $16.9 million in the same period of 2024, primarily due to expanded commercial activities [10] Research and Development - Research and development expenses for the full year 2025 were $13.7 million, up from $12.0 million in 2024, driven by increased clinical trial costs [14][12] - The company anticipates conducting a hepatic impairment study under its active U.S. IND application to inform dose selection for Hydronidone [9][2] - The company is also preparing for an adaptive Phase 2/3 trial in China for pirfenidone targeting radiation-induced lung injury [9][2] Corporate Updates - As of December 31, 2025, the company had cash and cash equivalents totaling $75.9 million [7] - The acquisition of Cullgen is expected to close in the second quarter of 2026, creating a fully integrated biopharmaceutical company with capabilities in both the U.S. and China [6][2] - The company has aligned with China's CDE on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval [2][4]