0001193125-26-106251
SEC filingGyre Therapeutics, Inc. (GYRE) reported strong revenue growth of 10.2% to $116.6 million for FY 2025 ended December 31, 2025, driven by $106.1 million from flagship ETUARY® (pirfenidone) for IPF, plus initial contributions from new launches Etorel® ($4.6 million) and Contiva® ($5.5 million), offsetting a decline in generic sales. Despite revenue expansion, net income fell 44.8% to $9.9 million and income from operations dropped 28.9% to $11.5 million, reflecting 17.3% higher operating expenses at $105.1 million, primarily from 13.3% increased selling/marketing ($65.2 million) and 29.1% higher G&A ($20.8 million), including elevated stock-based compensation. Gross margin remained robust at 95.4%. Cash position strengthened significantly to $37.1 million from $11.8 million prior year, with net cash increase of $25.3 million supported by $24.4 million financing inflows from equity offerings and option exercises. Balance sheet shows total assets of $166.1 million, stockholders' equity $106.0 million. Forward-looking, NDA submission for Hydronidone in CHB liver fibrosis targeted H1 2026; U.S. Phase 2 MASH trial planned post-IND 2026. Merger with Cullgen announced March 2026 to expand pipeline.
Gyre Therapeutics delivered FY 2025 revenue of $116.6 million, up 10.2% YoY from $105.8 million, primarily from ETUARY® ($106.1 million, +1.0%) and new product launches Etorel® ($4.6 million) and Contiva® ($5.5 million). Gross profit rose 11.1% to $111.2 million (95.4% margin vs. 96.3% prior year). Operating income declined 28.9% to $11.5 million due to 17.3% higher opex ($105.1 million), driven by selling/marketing (+13.3% to $65.2 million) and G&A (+29.1% to $20.8 million). Net income from operations fell 44.8% to $9.9 million; net income attributable to common stockholders $5.0 million. Cash grew to $37.1 million (+$25.3 million net increase), bolstered by $24.4 million financing. Total assets $166.1 million; equity $106.0 million.
Revenue growth stemmed from diversified portfolio: ETUARY® contributed 91% ($106.1 million, stable YoY amid competition), Etorel® (nintedanib, IPF/SSc-ILD/PF-ILD) generated $4.6 million post-June 2025 launch, Contiva® (avatrombopag, TP/ITP) $5.5 million post-March 2025 launch. Generic sales declined $0.4 million. PRC-focused sales via distributors (100%); no U.S. revenue yet. Strategic marketing realignment boosted ETUARY® in Q3; new products offset generics drop. Etorel® selected for National Centralized Drug Procurement (Nov 2025), impact pending.
Gross margin dipped slightly to 95.4% from 96.3%, pressured by 39.4% higher COGS ($5.4 million) from depreciation (+$0.8 million), new product costs (+$0.6 million), stock comp (+$0.5 million). Operating margin contracted to 9.9% from 15.3% on opex leverage loss. Selling/marketing up 13.3% (conferences +$2.5 million, staff +$2.6 million, stock comp +$2.3 million); R&D +13.9% (trials +$1.0 million); G&A +29.1% (stock comp +$3.3 million). Interest income +12.9% ($1.7 million); warrant fair value gain narrowed to -$2.7 million. Tax provision -14.4% to $4.6 million.
Operating cash flow swung to +$1.0 million from -$3.6 million, aided by collections (+$10.8 million AR improvement), lower raw materials/taxes. Investing outflow -$0.5 million (certificates of deposit net -$0.1 million, capex -$1.2 million). Financing +$24.4 million (public offering $23.0 million, options $2.4 million). Cash & equivalents $37.1 million; short-term deposits $15.4 million; long-term CDs $23.5 million. Current assets $102.4 million; total assets $166.1 million (PPE $23.6 million). Liabilities $23.9 million (low debt); equity $142.3 million (Gyre $106.0 million). Working capital strong at $84.1 million.
NDA submission for Hydronidone (CHB liver fibrosis) H1 2026 post-Phase 3 success (52.85% fibrosis regression, p=0.0002). U.S. IND filing 2026 for Phase 2 MASH trial. Phase 3 ETUARY® PD enrollment complete; RILI Phase 2/3 H1 2026. F573 Phase 2 completion 2026; F230 Phase 1 ongoing; F528 IND Q1 2027. Cullgen merger (March 2026) to expand pipeline, pending approvals. Risks: PRC procurement pricing, competition, regulatory delays, BIOSECURE Act supply chain impacts.