Financial Performance - Net income for Q1 2025 was $3.7 million, down from $9.9 million in Q1 2024, primarily due to lower revenue and unfavorable changes in fair value of warrant liabilities [19]. - Q1 2025 revenue was $22.1 million, a decrease of $5.1 million compared to $27.2 million in Q1 2024, attributed to a decline in ETUARY® sales and weaker economic conditions in China [14]. - Revenues for Q1 2025 were $22,058 million, a decrease of 18.5% compared to $27,172 million in Q1 2024 [27]. - Net income for Q1 2025 was $3,734 million, down 62.5% from $9,935 million in Q1 2024 [27]. - The company reported a non-GAAP adjusted net income of $2,887 million for Q1 2025, compared to $8,204 million in Q1 2024, reflecting a decline of 64.8% [32]. - Basic net income per share attributable to common stockholders was $0.03 for Q1 2025, down from $0.09 in Q1 2024 [27]. Sales and Revenue Guidance - ETUARY® (pirfenidone) generated $21.7 million in sales during Q1 2025, maintaining its position as the market leader for idiopathic pulmonary fibrosis (IPF) in China [4]. - Gyre Therapeutics reaffirmed its full-year 2025 revenue guidance of $118 to $128 million, compared to $105.8 million in 2024 [14]. Research and Development - The company completed data collection for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B-associated liver fibrosis, with topline results expected in Q2 2025 [5]. - Research and development expenses increased to $3.1 million in Q1 2025, up from $2.2 million in Q1 2024, driven by clinical research costs [16]. - Gyre received NMPA approval to initiate a clinical trial of pirfenidone for radiation-induced lung injury, marking its entry into oncology supportive care [8]. Commercialization Efforts - Commercialization of avatrombopag was initiated in March 2025, targeting thrombocytopenia in adults with chronic liver disease [7]. - Nintedanib is on track for commercialization in May 2025, expanding treatment options for pulmonary fibrosis [6]. Financial Position - As of March 31, 2025, Gyre held $51.3 million in cash and cash equivalents, sufficient to fund operations for the next 12 months [13]. - Cash and cash equivalents increased to $15,045 million as of March 31, 2025, up from $11,813 million at the end of 2024 [30]. - Total assets rose to $129,790 million as of March 31, 2025, compared to $125,406 million at the end of 2024 [30]. - Total liabilities decreased to $25,488 million as of March 31, 2025, down from $27,004 million at the end of 2024 [30]. - The company’s accumulated deficit improved to $(70,755) million as of March 31, 2025, from $(73,453) million at the end of 2024 [30]. Operating Expenses - Operating expenses totaled $19,785 million in Q1 2025, slightly up from $19,101 million in Q1 2024, with significant increases in research and development expenses from $2,182 million to $3,095 million [27]. - The weighted average shares used in calculating diluted net income per share were 101,970,672 for Q1 2025, compared to 102,594,197 for Q1 2024 [27].
Gyre Therapeutics(GYRE) - 2025 Q1 - Quarterly Results