Gyre Therapeutics, Inc. reported a net income of $17.9 million for the year ended December 31, 2024, a significant improvement from the $85.5 million net loss in 2023. This turnaround is largely attributed to increased profitability in its majority-owned subsidiary, Gyre Pharmaceuticals, located in China. Revenue for 2024 totaled $105.8 million, a decrease of $7.7 million (6.8%) compared to 2023, primarily due to decreased sales volumes of ETUARY (pirfenidone) and generic drugs resulting from economic fluctuations in China. The gross profit margin remained high at 96.3% in 2024, compared to 95.9% in 2023.
Significant changes in operating expenses contributed to the improved profitability. Selling and marketing expenses decreased by $3.6 million (6.0%), primarily due to reduced sales activities and payroll costs. Research and development expenses also decreased by $1.8 million (12.7%), mainly due to projects advancing to later stages. Conversely, general and administrative expenses increased by $1.4 million (9.9%), largely due to increased professional fees and personnel costs associated with being a public company. The company also recorded no acquired in-process research and development expenses in 2024, compared to $83.1 million in 2023, reflecting the completion of a significant asset acquisition.
Strategic developments included the acquisition of commercial rights to nintedanib in May 2024, expanding Gyre Pharmaceuticals' pulmonary fibrosis portfolio. The company also advanced its lead product candidate, F351 (hydronidone), completing a Phase 2 trial in China and preparing a U.S. Investigational New Drug (IND) application for a Phase 2 trial in 2025. Other key operational developments included the initiation of a Phase 2 trial for F573 in China and the NMPA approval of an IND for F230. Gyre Pharmaceuticals also received NMPA approval for avatrombopag maleate tablets for the treatment of thrombocytopenia associated with chronic liver disease and chronic idiopathic thrombocytopenia, planning to commence commercialization in 2025. The company paused two Phase 3 trials for pirfenidone in China to prioritize other product candidates.
As of December 31, 2024, Gyre Therapeutics had five full-time employees in the United States and 574 in China. The company's cash and cash equivalents totaled $11.8 million, and it anticipates that its existing cash resources, cash flows from operations, and access to capital markets will be sufficient to fund operations for at least the next 12 months. The company's outlook includes the anticipated release of topline results from the Phase 3 trial of F351 in the second quarter of 2025, which is considered a critical milestone for its clinical development and commercial strategy. The company also plans to submit a U.S. IND application for F351 in the first half of 2025 and to commercially launch nintedanib and avatrombopag in 2025. The company does not anticipate paying cash dividends in the foreseeable future. The company also notes several risk factors, including competition, regulatory uncertainties, and reliance on third-party manufacturers and distributors.
About GYRE THERAPEUTICS, INC.
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