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Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

(Positive)
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Gyre Therapeutics (Nasdaq: GYRE) reported full-year 2025 revenue of $116.6 million, up 10.2% year-over-year, and ending cash and deposits of $75.9 million. The company provided 2026 revenue guidance of $100.5M–$111.0M and announced an agreement to acquire Cullgen for approximately $300 million. Gyre expects to submit an NDA for Hydronidone for conditional approval in China in H1 2026 and completed enrollment in a 52-week Phase 3 pirfenidone trial (272 patients).

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Positive

  • Revenue +10.2% YoY to $116.6 million
  • ETUARY sales $106.1M for full-year 2025
  • Completed Phase 3 pirfenidone enrollment: 272 patients
  • Agreement to acquire Cullgen valued at ~$300M

Negative

  • Full-year 2026 revenue guidance down to $100.5M–$111.0M (decline ~13.8%–4.8%)
  • Selling and marketing expense increased to $65.2M (+$7.7M YoY)
  • Income from operations decreased to $11.5M (down $4.7M YoY)
  • Net income declined to $9.9M (down $8.0M YoY)

News Market Reaction – GYRE

-6.30%
4 alerts
-6.30% Session close to close
-4.0% Trough Tracked
$802.46M Market Cap
0.9x Rel. Volume

In the Mar 12 session, GYRE declined 6.30%, reflecting a notable negative market reaction. Argus tracked a trough of -4.0% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.3% in the session following this news. A negative reaction despite operational pr...
Analysis

The stock moved -6.3% in the session following this news. A negative reaction despite operational progress would fit a history where earnings often met with selling pressure, including a -30.21% move on Mar 17, 2025 even as profitability improved. The market could focus on the 2026 revenue guide of $100.5–$111.0M, which is below 2025’s $116.6M, and on increased operating expenses. While the Cullgen deal and Hydronidone path add strategic depth, integration, regulatory timelines, and reduced near-term growth could amplify downside sentiment.

Key Figures

FY 2025 revenue: $116.6 million 2026 revenue guidance: $100.5–$111.0 million ETUARY 2025 sales: $106.1 million +5 more
8 metrics
FY 2025 revenue $116.6 million Full year 2025; up 10.2% year-over-year
2026 revenue guidance $100.5–$111.0 million Full year 2026; guided 4.8–13.8% below 2025
ETUARY 2025 sales $106.1 million Full year 2025 product sales
Contiva 2025 sales $5.5 million Full year 2025 following March 2025 launch
Etorel 2025 sales $4.6 million Full year 2025 following June 2025 launch
Cash & deposits $75.9 million As of December 31, 2025
FY 2025 net income $9.9 million Full year ended December 31, 2025
Cullgen acquisition value $300 million All-stock transaction value announced March 2026

Previous Earnings Reports

5 past events · Latest: Nov 07 (Neutral)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Nov 07 Q3 2025 earnings Neutral -1.8% Q3 revenue growth with guidance cut amid rollout and procurement uncertainty.
Aug 11 Q2 2025 earnings Positive +6.9% Revenue and net income growth, Hydronidone progress, and reaffirmed 2025 guidance.
May 09 Q1 2025 earnings Positive +0.5% Profitable quarter, product launches and reaffirmed full-year 2025 revenue outlook.
Mar 17 FY 2024 earnings Positive -30.2% Return to profitability and growth guidance but sharp selloff followed results.
Nov 13 Q3 2024 earnings Negative -9.6% Year-over-year declines in revenue and net income despite pipeline advancement.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases have often coincided with weak to negative price reactions despite generally constructive operational updates, with one notably sharp selloff in March 2025.

Recent Company History

Over the past year, Gyre’s earnings updates have traced its shift from reliance on ETUARY® toward a broader China-focused fibrosis franchise and new launches. Events on Mar 17, 2025 and Aug 11, 2025 featured positive net income and growth plans but mixed share reactions, including a -30.21% drop after 2024 results. Subsequent quarters added Hydronidone Phase 3 progress and launches of Contiva® and Etorel®, while guidance was trimmed in Q3 2025. Today’s full-year 2025 results and 2026 guidance extend that trajectory with moderated near-term growth.

Key Terms

New Drug Application (NDA), Investigational New Drug (IND), Phase 3, Phase 2, +4 more
8 terms
New Drug Application (NDA) regulatory
"NDA submission for conditional approval expected in the first half of 2026"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
Investigational New Drug (IND) regulatory
"Hydronidone U.S. Investigational New Drug (IND) application for MASH-associated liver fibrosis"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
Phase 3 medical
"Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial"
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
Phase 2 medical
"initiate a Phase 2 clinical trial"
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.
double-blind medical
"The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"randomized, double-blind, placebo-controlled trial enrolled 272 patients"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
non-GAAP financial
"This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP."
Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.
View in glossary
warrant liability financial
"decrease in change in fair value of warrant liability of $4.5 million"
Warrant liability is the financial obligation a company records when it grants warrants—special options giving the holder the right to buy company shares at a set price in the future. It matters to investors because changes in this liability can affect a company's reported earnings and overall financial health, similar to how a pending contract can influence a company's future value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range

Full year 2026 revenue guidance of $100.5 to $111.0 million

Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026

Alignment with China’s Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026

Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial
(272 patients across 18 sites)

Hydronidone U.S. Investigational New Drug (IND) application for MASH-associated liver fibrosis anticipated in 2026

SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

“2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China’s CDE,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. “Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States.”

Fourth Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio

  • ETUARY® (pirfenidone): Generated $106.1 million in sales of ETUARY® for the full year ended December 31, 2025, compared to $105.0 million for the same period in 2024.
  • Etorel® (nintedanib ethanesulfonate soft capsules): Launched in June 2025 and generated $4.6 million in sales for the full year ended December 31, 2025.
  • Contiva® (avatrombopag maleate tablets): Launched in March 2025 and generated $5.5 million in sales for the full year ended December 31, 2025.

Pipeline Development Updates

Hydronidone:

  • In November 2025, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) presented positive Phase 3 trial results evaluating Hydronidone for the treatment of liver fibrosis in chronic hepatitis B (CHB)-associated liver fibrosis at The Liver Meeting® 2025, the annual meeting of the American Association of the Study of Liver Diseases. The abstract was selected as a Poster of Distinction.
  • Following the Phase 3 trial results, Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE. Based on the discussions, the CDE indicated that the existing Phase 3 clinical data support a conditional approval filing and potential priority review eligibility, subject to formal acceptance and approval. The Company plans to submit an NDA for conditional approval in the first half of 2026.
  • In the United States, Gyre Therapeutics plans to conduct a hepatic impairment study under its active U.S. IND application to inform dose selection and enrollment criteria in patients with reduced hepatic function, supporting the Company's broader U.S. development strategy.
  • Gyre Therapeutics remains on track to submit an IND application in 2026 with the U.S. Food & Drug Administration for Hydronidone in MASH-associated liver fibrosis, and, subject to IND clearance, initiate a Phase 2 clinical trial.

Pirfenidone:

  • In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in its 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of PD. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China and is designed to assess the efficacy and safety of 52 weeks of pirfenidone treatment in patients with this chronic occupational lung disease characterized by progressive pulmonary fibrosis. The final patient is expected to complete the trial in the third quarter of 2026.
  • Following approval in March 2025 from China’s National Medical Products Association’s (NMPA) for a clinical trial evaluating pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the first half of 2026 in China. This trial will evaluate pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.

Corporate Updates:

  • In March 2026, Gyre announced an agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader antibody conjugate therapies, in an all-stock transaction valued at approximately $300 million. Following the closing of the acquisition, expected in the second quarter of 2026, the new combined entity is expected to be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas, including inflammatory diseases, cancers, and pain.

Financial Results

Cash Position

As of December 31, 2025, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $75.9 million.

Financial Results for the Three Months Ended December 31, 2025

  • Revenues: Revenues for the three months ended December 31, 2025 were $37.2 million, compared to $27.9 million for the same period in 2024, representing an increase of $9.3 million, or 33.3% year-over-year. The growth was driven by $1.5 million in Etorel® sales and $2.5 million in Contiva® sales, as well as a $5.5 million increase in ETUARY® sales, partially offset by a $0.2 million decrease in generic drug revenue. The increase in ETUARY® sales reflects strengthened commercial execution and the reallocation of marketing resources during the second half of 2025.
  • Cost of Revenues: For the three months ended December 31, 2025, cost of revenues was $1.7 million, compared to $1.2 million for the same period in 2024. The $0.5 million increase was primarily driven by a $0.4 million increase in stock-based compensation expense, and a $0.1 million increase in cost of sales of Etorel® and Contiva®.
  • Selling and Marketing Expense: Selling and marketing expense for the three months ended December 31, 2025 was $23.8 million, compared to $16.9 million for the same period in 2024, representing an increase of $6.9 million, or 40.8% year-over-year. The increase was primarily attributable to expanded commercial activities, including a $2.9 million increase in personnel costs driven by higher sales headcount and commissions, a $2.2 million increase in stock-based compensation expense, a $1.7 million increase in conference and promotional activities, and a $0.1 million increase in travel and other expenses.
  • Research and Development Expense: For the three months ended December 31, 2025, research and development expense was $4.8 million, compared to $3.7 million for the same period in 2024. The $1.1 million increase was primarily driven by a $0.6 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, a $0.3 million increase in pre-clinical research costs, a $0.2 million increase in clinical trial costs and a $0.3 million increase in staff costs which included $0.2 million in stock-based compensation expenses, partially offset by a $0.3 million decrease in materials and utilities expenses.
  • General and Administrative Expense: For the three months ended December 31, 2025, general and administrative expense was $6.7 million, compared to $5.5 million for the same period in 2024. The $1.2 million increase was primarily driven by a $1.2 million increase in stock-based compensation expense and a $0.8 million increase in functional and administrative department's personnel expense, partially offset by a $0.6 million decrease in professional service expense, a $0.1 million decrease in depreciation and amortization expense and a $0.1 million decrease in miscellaneous expense.
  • Income from Operations: For the three months ended December 31, 2025, income from operations was $0.1 million, compared to $0.7 million income from operations for the same period in 2024. The $0.6 million decrease in income from operations was driven primarily by a $9.9 million increase in total operating expenses, partially offset by a $9.3 million increase in revenue.
  • Net (Loss) Income: For the three months ended December 31, 2025, net loss was $1.4 million, compared to $0.6 million net income for the same period in 2024. The $2.0 million decrease was driven primarily by an increase in income tax expense of $1.1 million, an increase in operating expenses of $9.9 million and a decrease in other income of $0.3 million, partially offset by an increase in revenue of $9.3 million.
  • Non-GAAP Adjusted Net Income: For the three months ended December 31, 2025, non-GAAP adjusted net income was $4.3 million, compared to $1.1 million for the same period in 2024. The $3.2 million increase was primarily driven by an increase in revenue of $9.3 million partially offset by the increase in operating expenses of $5.8 million and an decrease in other income of $0.3 million.

Financial Results for the Full Year Ended December 31, 2025

  • Revenues: Revenues for the full year ended December 31, 2025 were $116.6 million, compared to $105.8 million for the same period in 2024, representing an increase of $10.8 million, or 10.2% year-over-year. The growth was driven by $5.5 million in Contiva® sales and $4.6 million in Etorel® sales, along with a $1.1 million increase in ETUARY® sales, partially offset by a $0.4 million decline in generic drug revenue.

    Sales of Contiva® and Etorel®, which commenced commercialization in March 2025 and June 2025, respectively, were primarily driven by the targeted allocation of commercial and marketing resources to support their respective launches during the first half of 2025. The increase in ETUARY® sales reflects a strategic realignment of marketing efforts in the third quarter of 2025 to optimize product mix and address evolving market dynamics.
  • Cost of Revenues: For the full year ended December 31, 2025, cost of revenues was $5.4 million, compared to $3.9 million for the same period in 2024. The $1.5 million increase was primarily driven by a $0.8 million increase in ETUARY®'s cost, due to higher plant, property and equipment depreciation from a plant renovation completed in the second half of 2024, a $0.6 million increase in the cost of Contiva® and Etorel®, in line with the corresponding increase in their sales, and a $0.5 million increase in stock-based compensation expense. These factors were partially offset by a $0.4 million decrease in costs related to generic drugs due to the decrease in sales.
  • Selling and Marketing Expense: For the full year ended December 31, 2025, selling and marketing expense was $65.2 million, compared to $57.5 million for the same period in 2024. This $7.7 million increase was primarily driven by a $2.5 million increase in conference expenses and promotional expenses, attributable to the launch of additional promotional campaigns in the current year—particularly for the Company’s new products, a $2.6 million increase in staff costs, which was driven by expanded headcount and higher sales commissions, consistent with the corresponding growth in revenue, a $2.3 million increase in stock-based compensation expense and a $0.3 million increase in traveling and other expense.
  • Research and Development Expense: For the full year ended December 31, 2025, research and development expense was $13.7 million, compared to $12.0 million for the same period in 2024. The $1.7 million increase was attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone, PD and RILI, a $0.4 million increase in staff costs, which included $0.2 million in stock-based compensation expense, a $0.5 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, and a $0.4 million increase in pre-clinical research expenses. These expense increases were partially offset by a $0.6 million decrease in materials and utilities expenses.
  • General and Administrative Expense: For the full year ended December 31, 2025, general and administrative expense was $20.8 million, compared to $16.1 million for the same period in 2024. This $4.7 million increase was primarily driven by a $3.3 million increase in stock-based compensation expense, a $1.3 million increase in functional and administrative department's personnel expense, and a $0.9 million increase in miscellaneous expense. These cost increases were partially offset by a $0.8 million decrease in professional service expenses.
  • Income from Operations: For the full year ended December 31, 2025, income from operations was $11.5 million, compared to $16.2 million in income for the same period in 2024. The $4.7 million decrease in income from operations was driven primarily by a $15.5 million increase in total operating expenses, partially offset by a $10.8 million increase in revenue.
  • Net Income: For the full year ended December 31, 2025, net income was $9.9 million, compared to $17.9 million net income for the same period in 2024. This $8.0 million decrease was driven primarily by the increase in operating expenses of $15.5 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $10.8 million, an increase in other income of $0.4 million, and a decrease in income tax expense of $0.8 million.
  • Non-GAAP Adjusted Net Income: For the full year ended December 31, 2025, non-GAAP adjusted net income was $18.9 million, compared to $16.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $10.8 million and an increase in other income of $0.4 million partially offset by an increase in operating expenses of $9.2 million.

Full Year 2026 Financial Guidance

For the full year 2026, the Company expects to generate revenues of $100.5 million to $111.0 million, representing a decline of approximately 13.8% to 4.8% compared to 2025.

The Company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone.

In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the Company expects to moderate promotional activities for Contiva® and Etorel®.

Please note the following regarding the total revenue guidance:

  • Guidance assumes a constant foreign currency exchange rate.
  • Guidance assumes 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 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 Hydronidone

Hydronidone is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing Tumor Growth Transforming (TGF)-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in hepatic stellate cells.

The drug has completed Phase 3 clinical evaluation in China for chronic hepatitis B (CHB)-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.

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 China in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in China. Hydronidone received Breakthrough Therapy designation by the NMPA CDE in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH) and acute/acute-on-chronic liver failure (ALF/ACLF). As of December 31, 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for 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, the anticipated timing of the submission of Gyre Therapeutics’ U.S. IND application for Hydronidone for the treatment of MASH-associated liver fibrosis, plans to conduct a hepatic impairment study of Hydronidone in U.S. subjects under Gyre Therapeutics’ active IND application, timing for the initiation of Gyre Pharmaceuticals’ Phase 2/3 trial in China for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA and timing for potential commercial approval for Hydronidone for the treatment of CHB-associated liver fibrosis, expectations regarding conducting a confirmatory trial for Hydronidone in China, trial design of Gyre’s Phase 3 clinical trial evaluating pirfenidone for the treatment of pneumoconiosis, interactions with regulators, the structure, timing and completion of the proposed acquisition of Cullgen, the anticipated timing of closing of the acquisition of Cullgen, the future operations of the combined entity, the nature, strategy and focus of the combined Gyre and Cullgen entity, the development and commercial potential and potential benefits of any product candidates of the combined Gyre and Cullgen entity, Gyre’s ability to meet its expected revenue guidance 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; supply chain and distribution delays and challenges. 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 subsequent 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:
David Zhang
Gyre Therapeutics
david.zhang@gyretx.com

  
Gyre Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
 
  
  Three Months Ended
December 31,
(Unaudited)
  Year Ended December 31, 
  2025  2024  2025  2024 
Revenues $37,195  $27,872  $116,588  $105,757 
Operating expenses:            
Cost of revenues  1,743   1,177   5,416   3,884 
Selling and marketing  23,816   16,856   65,179   57,511 
Research and development  4,815   3,712   13,698   12,024 
General and administrative  6,701   5,464   20,804   16,109 
Loss (Gain) on disposal of assets, net  2   (2)  4   66 
Total operating expenses  37,077   27,207   105,101   89,594 
Income from operations  118   665   11,487   16,163 
Other income (expenses):            
Interest income, net  509   346   1,747   1,547 
Other expense, net  (956)  (433)  (1,505)  (1,659)
Change in fair value of warrant liability  263   194   2,707   7,167 
(Loss) Income before income taxes  (66)  772   14,436   23,218 
Provision for income taxes  (1,300)  (203)  (4,556)  (5,320)
Net (loss) income  (1,366)  569   9,880   17,898 
Net income attributable to noncontrolling interest  357   668   4,853   5,813 
Net (loss) income attributable to common stockholders $(1,723) $(99) $5,027  $12,085 
Net (loss) income per share attributable to common stockholders:            
Basic $(0.02) $(0.00) $0.06  $0.14 
Diluted $(0.02) $(0.00) $0.02  $0.05 
Weighted average shares used in calculating net income per share attributable to common stockholders:            
Basic  91,156,159   85,952,413   89,344,622   85,094,948 
Diluted  91,156,159   85,952,413   103,180,037   102,293,526 


  
Gyre Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
 
  
  December 31, 2025  December 31, 2024 
Assets      
Current assets:      
Cash and cash equivalents $37,070  $11,813 
Short-term bank deposits  15,355   14,858 
Notes receivable  5,638   4,373 
Accounts receivable, net  31,078   19,589 
Other receivables from GNI  230   230 
Inventories  10,171   6,337 
Prepaid assets  1,338   1,189 
Receivable from GCBP     4,961 
Other current assets  1,489   1,436 
Total current assets:  102,369   64,786 
Property and equipment, net  23,599   23,880 
Intangible assets, net  4,727   273 
Right-of-use assets  1,131   1,818 
Land use rights, net  1,425   1,432 
Deferred tax assets  6,873   5,619 
Long-term certificates of deposit  23,516   24,568 
Other assets, noncurrent  2,492   3,030 
Total assets $166,132  $125,406 
Liabilities, convertible preferred stock, and equity      
Current liabilities:      
Accounts payable $124  $108 
Contract liabilities  14   61 
Due to related parties  227   227 
Accrued expenses and other current liabilities  14,345   10,615 
Income tax payable  2,940   2,831 
Operating lease liabilities, current  636   713 
CVR derivative liability     4,961 
Total current liabilities:  18,286   19,516 
Operating lease liabilities, noncurrent  303   885 
Deferred government grants  852   928 
Warrant liability, noncurrent  2,961   5,668 
Other noncurrent liabilities  1,448   7 
Total liabilities $23,850  $27,004 
Commitments and Contingencies      
Stockholders’ equity:      
Common stock, $0.001 par value, 400,000,000 shares authorized; 91,314,007 shares and 86,307,544 shares issued and outstanding at December 31, 2025 and 2024, respectively  91   86 
Additional paid-in capital  172,047   136,185 
Statutory reserve  3,098   3,098 
Accumulated deficit  (68,426)  (73,453)
Accumulated other comprehensive loss  (779)  (2,597)
Total Gyre stockholders’ equity  106,031   63,319 
Noncontrolling interest  36,251   35,083 
Total equity  142,282   98,402 
Total liabilities and stockholders' equity $166,132  $125,406 


  
Gyre Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands)
(unaudited)
 
  
 Three Months Ended
December 31,
  Years Ended December 31, 
 2025  2024  2025  2024 
Net (loss) income$(1,366) $569  $9,880  $17,898 
Gain from change in fair value of warrants(1) (263)  (194)  (2,707)  (7,167)
Stock-based compensation 4,597   567   7,157   831 
Provision for income taxes 1,300   203   4,556   5,320 
Non-GAAP adjusted net income$4,268  $1,145  $18,886  $16,882 

(1)   Reflects adjustments for fair value of warrants based on the Black-Scholes option pricing model.


FAQ

What did GYRE report for full-year 2025 revenue and growth?

Gyre reported $116.6 million in revenue for full-year 2025, a 10.2% increase year-over-year. According to Gyre, growth was driven by ETUARY sales and launches of Contiva and Etorel, partially offset by lower generic drug revenue.

What is GYRE's revenue guidance for 2026 and what does it imply?

Gyre expects $100.5M–$111.0M in 2026 revenue, implying a decline versus 2025. According to Gyre, 2026 will be a transition year prioritizing regulatory work and moderating promotional activity amid procurement program uncertainties.

What are the key details of GYRE's agreement to acquire Cullgen (GYRE)?

Gyre announced an all-stock agreement to acquire Cullgen valued at approximately $300 million. According to Gyre, the deal adds targeted protein degradation capabilities and U.S.-based discovery, creating an integrated U.S.-China biopharma platform.

What is the regulatory status of Hydronidone for GYRE (GYRE)?

Gyre plans to submit an NDA in H1 2026 seeking conditional approval in China, following CDE alignment on filings. According to Gyre, CDE discussions indicated Phase 3 data may support conditional approval and possible priority review eligibility.

When will GYRE's pirfenidone Phase 3 trial complete and how large is it?

Gyre completed enrollment of 272 patients in a 52-week Phase 3 pirfenidone trial across 18 sites; final patient completion is expected in Q3 2026. According to Gyre, the trial assesses efficacy and safety in pneumoconiosis over 52 weeks.