Etorel® (nintedanib ethanesulfonate soft capsules)
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Gyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business Update
Globenewswire· 2025-11-07 11:00
Core Insights - Gyre Therapeutics reported a net income of $5.9 million for Q3 2025 and $11.2 million for the nine months ended September 30, 2025, reflecting improved commercial execution and cost control [1][7][15] - The company revised its full-year revenue guidance to $115-118 million, down from $118-128 million, due to delays in the rollout of Etorel® and uncertainties in government procurement [1][18] Financial Performance - Q3 2025 revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY®, Etorel®, and Contiva® sales [7][16] - For the nine months ended September 30, 2025, total revenue was $79.4 million, slightly above the $77.9 million reported for the same period in 2024 [15][16] - Basic EPS improved to $0.04 for Q3 2025, compared to $0.01 in Q3 2024, while for the nine months, it decreased from $0.14 to $0.08 due to higher operating expenses [7][15] Product Sales - ETUARY® generated $27.7 million in sales for Q3 2025, up from $25.3 million in Q3 2024, while Etorel® and Contiva® contributed $1.5 million and $1.2 million, respectively, in their first full quarter of sales [8][16] - The company faced initial supply chain and distribution challenges for Etorel®, which moderated its launch uptake, but demand is starting to improve [17] Pipeline Development - Gyre is advancing its pipeline with a focus on Hydronidone, which is progressing towards NDA submission in China, and plans to file a U.S. IND for MASH-associated liver fibrosis in 2026 [5][14] - The company completed patient enrollment in a 52-week Phase 3 trial of pirfenidone for pneumoconiosis, with plans to initiate an adaptive Phase 2/3 trial for oncology-related pulmonary complications in Q4 2025 [5][14] Cash Position - As of September 30, 2025, Gyre held $80.3 million in cash and cash equivalents, reflecting a 57% increase year-to-date [7][12]