Gyre Therapeutics, Inc. reported a net income of $9.9 million for the fiscal year ending December 31, 2025, a decrease from the $17.9 million reported in the previous fiscal year. Revenue increased to $116.6 million, up from $105.8 million in 2024, driven by sales of ETUARY®, Etorel®, and Contiva®. The company's core product, ETUARY®, continued to be a significant revenue generator, supplemented by the introduction of Etorel® and Contiva® to the market. Despite the revenue growth, net income attributable to common stockholders decreased from $12.1 million in 2024 to $5.0 million in 2025.
The increase in revenue was offset by higher operating expenses, which rose to $105.1 million in 2025 from $89.6 million in 2024. Selling and marketing expenses increased due to expanded promotional campaigns and higher staff costs, while research and development expenses also saw an uptick due to ongoing clinical trials and preclinical research. The company's cost of revenue also increased, primarily due to higher plant depreciation and increased costs associated with Contiva® and Etorel®. These factors contributed to a decrease in income from operations, which fell from $16.2 million in 2024 to $11.5 million in 2025.
Strategic developments for Gyre Therapeutics included a Merger Agreement with Cullgen Inc., aimed at creating a tax-free reorganization. The merger is subject to customary closing conditions, including stockholder approval and regulatory filings. In addition, Gyre Pharmaceuticals increased its capital contribution in Gyre Pharmaceuticals by $1.28 million in exchange for 9,184,910 additional shares of Gyre Pharmaceuticals. As a result, Gyre Therapeutics' indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7%.
Key operational developments included the ongoing clinical trials for Hydronidone, F573, and F230, as well as the commercial launch of Etorel® and Contiva® in the PRC. Sales of ETUARY® reached $106.1 million in 2025, while Etorel® and Contiva® generated $4.6 million and $5.5 million in sales, respectively. The company is also pursuing potential label expansion for ETUARY® into additional indications, including pneumoconiosis and radiation-induced lung injury. As of December 31, 2025, Gyre Therapeutics had 618 employees in the PRC and 7 full-time employees in the United States.
Looking ahead, Gyre Therapeutics expects to submit an NDA seeking conditional approval for Hydronidone in the first half of 2026, subject to regulatory and technical preparations. The company also intends to file a U.S. IND for Hydronidone in 2026 and initiate a Phase 2 clinical trial for MASH-associated liver fibrosis, pending regulatory feedback. The company believes its existing cash and investments, along with cash flows from operations, will be sufficient to fund its planned operating expenses and capital expenditure requirements for at least the next 12 months.
About GYRE THERAPEUTICS, INC.
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