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Net Income of $3.7 million; reaffirms Full-Year Revenue Guidance of $118–$128 million
SAN DIEGO, May 09, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced financial results for the first quarter ended March 31, 2025 and provided a business update.
“This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “The successful launch of avatrombopag and our growing commercial footprint with hepatology and hematology specialists provide a strong foundation for our future growth. In addition, the recent NMPA approval to initiate a clinical trial of pirfenidone in radiation-induced lung injury, including with or without immune-related pneumonitis, supports our ability to enter the oncology supportive care space with a novel, lung-protective therapy. We plan to initiate an adaptive Phase 2/3 trial in the second half of 2025 to advance this program through development.”
First Quarter 2025 Business Highlights and Upcoming Milestones
Commercial Portfolio Expansion
ETUARY® (pirfenidone): Delivered $21.7 million in Q1 sales. While sales declined year-over-year due to relatively high sales in the first quarter of 2024, ETUARY remains the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC.
Nintedanib: Gyre remains on track to commercially launch nintedanib in May 2025, targeting multiple forms of fibrosing interstitial lung disease (“ILD”), including IPF, systemic sclerosis-associated ILD, and progressive fibrosing ILD. This is expected to expand Gyre’s share of the pulmonary fibrosis treatment landscape and support second-half 2025 revenue growth.
Avatrombopag: Commercialization of avatrombopag was initiated in March 2025, expanding Gyre’s footprint in hepatology and hematology. Approved for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, the launch aligns with Gyre’s strategy to deepen clinical engagement with liver disease specialists and diversify the market of available products.
Indication Expansion: Oncology Supportive Care
Pirfenidone New Indication: In March 2025, Gyre received NMPA approval to initiate a clinical trial of pirfenidone for RILI, including cases complicated by CIP. This development positions pirfenidone for potential entry into oncology supportive care, with plans to begin an adaptive Phase 2/3 trial in the second half of 2025 across top oncology centers in China.
Pipeline Development Updates
F573:
F230:
F528:
Corporate Updates
Financial Results
Cash Position
As of March 31, 2025, Gyre Therapeutics held $15.0 million in cash and cash equivalents, $14.8 million in short-term bank deposits, and $21.4 million in long-term certificates of deposit, totaling $51.3 million.
Gyre believes that its existing cash resources, combined with anticipated cash flow from commercial operations, will be sufficient to fund its operating and capital requirements for the next 12 months.
Financial Results for the Three Months Ended March 31, 2025
Gyre anticipates revenue growth over the remainder of the year, driven by the planned commercial launch of Nintedanib in May 2025 and the continued expansion of avatrombopag. Based on current performance and market outlook, the company is reaffirming its full-year 2025 revenue guidance of $118 to $128 million1, compared to $105.8 million in 2024.
[1] 2025 revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.
Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
About F351 (Hydronidone)
F351 is a structural analogue of the approved anti-fibrotic IPF drug pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to report topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including topline results of the Phase 3 trial of Hydronidone in CHB-associated liver fibrosis, timing of initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, initiation of Gyre Pharmaceuticals’ clinical trial evaluating pirfenidone capsules in oncology-related pulmonary complications, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors:
Stephen Jasper
| Gyre Therapeutics, Inc. | ||||||||
| Condensed Consolidated Statements of Operations | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | 22,058 | $ | 27,172 | ||||
| Operating expenses: | ||||||||
| Cost of revenues | 894 | 979 | ||||||
| Selling and marketing | 10,841 | 12,542 | ||||||
| Research and development | 3,095 | 2,182 | ||||||
| General and administrative | 4,955 | 3,398 | ||||||
| Total operating expenses | 19,785 | 19,101 | ||||||
| Income from operations | 2,273 | 8,071 | ||||||
| Other income, net: | ||||||||
| Other income, net | 107 | 122 | ||||||
| Change in fair value of warrant liability | 2,255 | 4,288 | ||||||
| Income before income taxes | 4,635 | 12,481 | ||||||
| Provision for income taxes | (901 | ) | (2,546 | ) | ||||
| Net income | 3,734 | 9,935 | ||||||
| Net income attributable to noncontrolling interest | 1,036 | 2,403 | ||||||
| Net income attributable to common stockholders | $ | 2,698 | $ | 7,532 | ||||
| Net income per share attributable to common stockholders: | ||||||||
| Basic | $ | 0.03 | $ | 0.09 | ||||
| Diluted | $ | 0.00 | $ | 0.03 | ||||
| Weighted average shares used in calculating net income per share attributable to common stockholders: | ||||||||
| Basic | 86,420,530 | 83,265,879 | ||||||
| Diluted | 101,970,672 | 102,594,197 | ||||||
| Gyre Therapeutics, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,045 | $ | 11,813 | ||||
| Short-term bank deposits | 14,846 | 14,858 | ||||||
| Notes receivable | 2,138 | 4,373 | ||||||
| Accounts receivables, net | 20,150 | 19,589 | ||||||
| Other receivables from GNI | 230 | 230 | ||||||
| Inventories, net | 7,878 | 6,337 | ||||||
| Receivable from GCBP | — | 4,961 | ||||||
| Prepaid assets and other current assets | 8,161 | 2,625 | ||||||
| Total current assets | 68,448 | 64,786 | ||||||
| Property and equipment, net | 23,518 | 23,880 | ||||||
| Intangible assets, net | 5,083 | 273 | ||||||
| Deferred tax assets | 5,818 | 5,619 | ||||||
| Long-term certificates of deposit | 21,367 | 24,568 | ||||||
| Other assets, noncurrent | 5,556 | 6,280 | ||||||
| Total assets | $ | 129,790 | $ | 125,406 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 122 | $ | 108 | ||||
| Contract liabilities | 28 | 61 | ||||||
| Due to related parties | 228 | 227 | ||||||
| Accrued expenses and other current liabilities | 17,239 | 10,615 | ||||||
| Income tax payable | 569 | 2,831 | ||||||
| Operating lease liabilities, current | 805 | 713 | ||||||
| CVR derivative liability | — | 4,961 | ||||||
| Total current liabilities | 18,991 | 19,516 | ||||||
| Operating lease liabilities, noncurrent | 780 | 885 | ||||||
| Deferred government grants | 905 | 928 | ||||||
| Warrant liability, noncurrent | 3,413 | 5,668 | ||||||
| Other noncurrent liabilities | 1,399 | 7 | ||||||
| Total liabilities | 25,488 | 27,004 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par value, 400,000,000 shares authorized; 87,636,209 shares and 86,307,544 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 87 | 86 | ||||||
| Additional paid-in capital | 138,179 | 136,185 | ||||||
| Statutory reserve | 3,098 | 3,098 | ||||||
| Accumulated deficit | (70,755 | ) | (73,453 | ) | ||||
| Accumulated other comprehensive loss | (2,486 | ) | (2,597 | ) | ||||
| Total Gyre stockholders’ equity | 68,123 | 63,319 | ||||||
| Noncontrolling interest | 36,179 | 35,083 | ||||||
| Total equity | 104,302 | 98,402 | ||||||
| Total liabilities and stockholders' equity | $ | 129,790 | $ | 125,406 | ||||
| Gyre Therapeutics, Inc. | |||||||
| Reconciliation of GAAP to Non-GAAP Financial Measures | |||||||
| (In thousands) | |||||||
| (Unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| Net income | $ | 3,734 | $ | 9,935 | |||
| Gain from change in fair value of warrant liability (1) | (2,255 | ) | (4,288 | ) | |||
| Stock-based compensation | 507 | 11 | |||||
| Provision for income taxes | 901 | 2,546 | |||||
| Non-GAAP adjusted net income | $ | 2,887 | $ | 8,204 | |||
(1) Reflects adjustments for fair value of warrant liability based on the Black-Scholes option pricing model.
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