Gyre Therapeutics Inc (GYRE) Announces Full Year 2023 Financial Outcomes and Business Progress
Revenue: Increased to $113.5 million in 2023, up from $102.3 million in 2022.
Net Loss: Reported a net loss of $85.5 million in 2023, compared to a net income of $4.3 million in 2022.
Cash Position: Cash and cash equivalents stood at $33.5 million as of December 31, 2023.
ETUARY Sales: Sales of ETUARY (Pirfenidone) grew by 13%, reaching $112.1 million in 2023.
Clinical Trials: Phase 3 clinical trial for F351 in CHB-associated liver fibrosis completed enrollment; Phase 2a NASH trial in the U.S. planned for 2025.
Leadership: Dr. Han Ying appointed as CEO; Rodney L. Nussbaum joined Board of Directors and Audit Committee.
Business Combination: Completed business combination with GNI Group Ltd., acquiring controlling interest in Beijing Continent Pharmaceuticals Co., Ltd.
Gyre Therapeutics Inc (NASDAQ:GYRE), a biopharmaceutical company specializing in the development of anti-fibrotic therapeutics, released its 8-K filing on March 26, 2024, detailing the financial results for the full year ended December 31, 2023, and providing a business update. The company is headquartered in San Diego, CA, and focuses on F351 (Hydronidone) for the treatment of NASH-associated liver fibrosis in the U.S. Gyre also advances a diverse pipeline in China through its controlling interest in Beijing Continent Pharmaceuticals Co., Ltd.
Strategic Developments and Financial Performance
The year 2023 marked a pivotal period for Gyre with significant corporate developments, including the appointment of Dr. Han Ying as CEO and the completion of a business combination with GNI Group Ltd. This strategic move resulted in Gyre acquiring a controlling interest in Beijing Continent Pharmaceuticals Co., Ltd., expanding its liver fibrosis portfolio with the acquisition of F351.
Despite the absence of analyst estimates, Gyre's financial achievements were underscored by a 13% increase in ETUARY sales, contributing to the total revenue of $113.5 million for 2023. However, the company reported a substantial net loss of $85.5 million, a stark contrast to the net income of $4.3 million in the previous year. This loss was attributed to increased operating expenses, including acquired in-process research and development costs, and changes in the fair value of warrant liability.
Research and Development Highlights
In the realm of clinical development, Gyre reported progress with F351, a structural analogue of the approved anti-fibrotic drug Pirfenidone. The Phase 3 trial for CHB-associated liver fibrosis in China completed enrollment, with topline data expected by early 2025. Additionally, the company is preparing for a Phase 2a clinical trial in the U.S. for NASH-associated liver fibrosis, slated for 2025.
Other notable R&D activities include the ongoing Phase 2 trial for F573, a caspase inhibitor for liver injury/failure, and preclinical studies for F528 and F230, targeting COPD and pulmonary arterial hypertension, respectively.
Financial Statements Analysis
The balance sheet as of December 31, 2023, showed a healthy cash position of $33.5 million, an increase from the prior year's $25.2 million. The income statement reflected the revenue growth, with a notable rise in ETUARY sales. However, the cost of revenues, selling and marketing expenses, and R&D expenses collectively contributed to the operating loss of $67.2 million.
Adjusted net income, a non-GAAP financial measure, was presented as $25.4 million, which excludes certain expenses such as acquired in-process research and development and stock-based compensation, providing a different perspective on the company's financial health.
Gyre's financial tables indicated a comprehensive view of its operations, including the consolidated statements of operations and balance sheets, highlighting the changes in revenues, expenses, and equity.
Overall, Gyre Therapeutics Inc (NASDAQ:GYRE) experienced a transformative year with strategic advancements and clinical progress. While the company faced financial challenges with a significant net loss, the growth in product sales and promising clinical developments provide a foundation for potential future success. Investors and stakeholders will be watching closely as Gyre continues to navigate the biotechnology landscape with its innovative pipeline and commercial endeavors.
Explore the complete 8-K earnings release (here) from Gyre Therapeutics Inc for further details.
This article first appeared on GuruFocus.
