Product Development and Commercialization - Gyre Pharmaceuticals successfully advanced pirfenidone to commercialization in the PRC for the treatment of idiopathic pulmonary fibrosis (IPF) and is conducting an additional Phase 3 trial for pneumoconiosis, with patient enrollment completed in Q3 2025 [125]. - The company received approval for a clinical trial application for pirfenidone to treat radiation-induced lung injury, with an adaptive Phase 2/3 trial expected to initiate in Q4 2025 [125]. - Gyre Pharmaceuticals launched Etorel® in the PRC in Q2 2025, targeting systemic sclerosis-associated interstitial lung disease and progressive fibrosing interstitial lung disease, aiming to enhance market penetration and brand recognition [126]. - Contiva® was commercialized in the PRC in March 2025 for treating thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, expanding the company's product offerings [127]. - Hydronidone, a lead candidate for liver fibrosis, completed a pivotal Phase 3 trial with 248 patients, achieving a statistically significant ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002) [129]. - The company plans to file a New Drug Application with the NMPA for Hydronidone and is preparing to submit a U.S. IND for a Phase 2 trial in 2026 for metabolic dysfunction-associated steatohepatitis-related liver fibrosis [130]. - Gyre Pharmaceuticals is currently enrolling patients in a Phase 2 trial for F573, a caspase inhibitor for acute liver failure, and has initiated a Phase 1 trial for F230, a selective endothelin receptor agonist for pulmonary arterial hypertension [131]. Financial Performance - For the three months ended September 30, 2025, the company reported revenues of $30.6 million, a 20% increase from $25.5 million in the same period of 2024, driven by sales growth in ETUARY®, Contiva®, and Etorel® [160]. - The net income for the three months ended September 30, 2025, was $5.9 million, representing a 108% increase compared to $2.9 million in the same period of 2024 [159]. - The accumulated deficit as of September 30, 2025, was $66.7 million, an improvement from $73.5 million as of December 31, 2024 [144]. - Revenues for the nine months ended September 30, 2025, were $79.4 million, a 2% increase from $77.9 million in 2024, driven by new product sales of Contiva® and Etorel® [171]. - Net income attributable to common stockholders decreased by $5.4 million, or 45%, to $6.8 million for the nine months ended September 30, 2025 [170]. - Cash provided by operating activities was $6.6 million for the nine months ended September 30, 2025, compared to cash used of $0.9 million in 2024 [186]. - Cash provided by financing activities was $24.1 million for the nine months ended September 30, 2025, primarily from the issuance of common stock [191]. - As of September 30, 2025, the company had cash and cash equivalents of $40.4 million, with an accumulated deficit of $66.7 million [181]. Expenses and Commitments - Selling and marketing expenses increased by $1.6 million, or 12%, for the three months ended September 30, 2025, primarily due to higher payroll and promotional expenses [162]. - Research and development expenses decreased by $0.4 million, or 15%, for the three months ended September 30, 2025, mainly due to reduced clinical trial costs [164]. - The cost of revenues for the three months ended September 30, 2025, was $1.6 million, a 70% increase from $1.0 million in the same period of 2024 [161]. - Other income for the three months ended September 30, 2025, was $0.7 million, compared to an expense of $0.1 million in the same period of 2024, primarily due to increased government grants [167]. - The provision for income taxes increased to $1.7 million for the three months ended September 30, 2025, from $1.1 million in the same period of 2024, reflecting higher profits [168]. - Cost of revenues increased by $1.0 million, or 36%, to $3.7 million for the nine months ended September 30, 2025, primarily due to higher costs associated with Etorel® and Contiva® [173]. - Selling and marketing expenses rose by $0.7 million, or 2%, totaling $41.4 million for the nine months ended September 30, 2025, mainly due to increased conference expenses [174]. - Research and development expenses increased by $0.6 million, or 7%, to $8.9 million, primarily due to a $1.0 million rise in clinical trial costs [175]. - General and administrative expenses surged by $3.5 million, or 32%, to $14.1 million, driven by increased personnel and stock compensation costs [176]. - The company has committed to allocate $37.6 million toward future research and development activities, including the Hydronidone program [196]. - Commitments related to the purchase of property and equipment were $4.6 million as of September 30, 2025, expected to be incurred within one year [197]. - The company is committed to annual payments for the Etorel® IP Rights transferor over eight years following the commencement of commercial sales [198]. Corporate Developments - On October 30, 2023, Catalyst Biosciences acquired an indirect controlling interest in Gyre Pharmaceuticals, increasing its indirect interest from 56.0% to 65.2% [132][133]. - A private placement agreement was entered into on October 27, 2023, with GNI USA for $5.0 million, involving the purchase of Series X Convertible Preferred Stock and warrants [140]. - BJC increased its capital contribution in Gyre Pharmaceuticals by $1.28 million in Q3 2025, raising the company's indirect interest from 65.2% to 69.7% [142]. Regulatory and Reporting Status - There have been no significant changes to critical accounting policies and estimates compared to the previous Annual Report [199]. - The company qualifies as a "smaller reporting company" and can take advantage of scaled disclosures as long as certain market value and revenue thresholds are met [200]. - As of June 30, 2025, the company remains a smaller reporting company and continues to qualify as an "accelerated filer" under the Sarbanes-Oxley Act [201]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company [203].

Core Insights - Gyre Therapeutics, Inc. reported quarterly earnings of $0.06 per share, exceeding the Zacks Consensus Estimate of $0.05 per share, and showing an increase from $0.02 per share a year ago, resulting in an earnings surprise of +20.00% [1] - The company posted revenues of $30.56 million for the quarter ended September 2025, which fell short of the Zacks Consensus Estimate by 8.89%, but represented an increase from $25.49 million year-over-year [2] - Gyre Therapeutics shares have declined approximately 39.3% year-to-date, contrasting with the S&P 500's gain of 14.3% [3] Earnings Outlook - The future performance of Gyre Therapeutics' stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is $0.06, with projected revenues of $38.74 million, and for the current fiscal year, the estimate is $0.13 on revenues of $121.1 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Gyre Therapeutics belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The correlation between near-term stock movements and earnings estimate revisions suggests that tracking these revisions can provide insights into stock performance [5]

Core Insights - Gyre Therapeutics reported a net income of $5.9 million for Q3 2025 and $11.2 million for the nine months ended September 30, 2025, reflecting improved commercial execution and cost control [1][7][15] - The company revised its full-year revenue guidance to $115-118 million, down from $118-128 million, due to delays in the rollout of Etorel® and uncertainties in government procurement [1][18] Financial Performance - Q3 2025 revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY®, Etorel®, and Contiva® sales [7][16] - For the nine months ended September 30, 2025, total revenue was $79.4 million, slightly above the $77.9 million reported for the same period in 2024 [15][16] - Basic EPS improved to $0.04 for Q3 2025, compared to $0.01 in Q3 2024, while for the nine months, it decreased from $0.14 to $0.08 due to higher operating expenses [7][15] Product Sales - ETUARY® generated $27.7 million in sales for Q3 2025, up from $25.3 million in Q3 2024, while Etorel® and Contiva® contributed $1.5 million and $1.2 million, respectively, in their first full quarter of sales [8][16] - The company faced initial supply chain and distribution challenges for Etorel®, which moderated its launch uptake, but demand is starting to improve [17] Pipeline Development - Gyre is advancing its pipeline with a focus on Hydronidone, which is progressing towards NDA submission in China, and plans to file a U.S. IND for MASH-associated liver fibrosis in 2026 [5][14] - The company completed patient enrollment in a 52-week Phase 3 trial of pirfenidone for pneumoconiosis, with plans to initiate an adaptive Phase 2/3 trial for oncology-related pulmonary complications in Q4 2025 [5][14] Cash Position - As of September 30, 2025, Gyre held $80.3 million in cash and cash equivalents, reflecting a 57% increase year-to-date [7][12]

Financial Performance - Net income for Q3 2025 was $5.9 million, doubling from $2.9 million in Q3 2024[20] - Quarterly revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY® and contributions from Etorel® and Contiva®[4] - Basic EPS improved to $0.04 in Q3 2025, compared to $0.01 in Q3 2024[4] - Operating income increased 64% to $6.9 million, with operating expenses growing at a slower pace than revenue[4] - Net income for the nine months ended September 30, 2025, was $11.2 million, a decrease from $17.3 million in 2024, primarily due to a $5.6 million increase in operating expenses[6] - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $14.6 million, down from $15.7 million in 2024, mainly due to a $3.3 million increase in operating expenses[6] - Non-GAAP adjusted net income for the first nine months of 2025 was $14,618 million, compared to $15,737 million in the same period of 2024, indicating a decrease of 7.1%[39] Revenue and Sales - Sales of ETUARY® for Q3 2025 were $27.7 million, compared to $25.3 million in Q3 2024[7] - Etorel® generated $1.5 million in sales during its first full quarter of launch[7] - Contiva® sales amounted to $1.2 million for Q3 2025[8] - Revenues for the nine months ended September 30, 2025, were $79.4 million, compared to $77.9 million in 2024, reflecting a $1.5 million increase[34] - Gyre Pharmaceuticals' flagship product, ETUARY®, achieved net sales of $105.8 million in 2024, maintaining a prominent market share[28] Expenses and Costs - For the nine months ended September 30, 2025, research and development expenses increased to $8.9 million from $8.3 million in 2024, primarily due to a $1.0 million rise in clinical trial costs[6] - General and administrative expenses rose to $14.1 million for the nine months ended September 30, 2025, compared to $10.6 million in 2024, driven by a $2.8 million increase in personnel and stock compensation costs[6] - Income from operations decreased to $11.4 million for the nine months ended September 30, 2025, down from $15.5 million in 2024, attributed to a $5.6 million increase in total operating expenses[6] - Stock-based compensation expenses increased to $1,147 million in Q3 2025 from $237 million in Q3 2024, reflecting a rise of 384%[39] Cash and Assets - Cash and cash equivalents totaled $80.3 million as of September 30, 2025, up 57% year-to-date[15] - Cash and cash equivalents increased significantly to $40.4 million as of September 30, 2025, from $11.8 million at the end of 2024[36] - Total assets grew to $159.4 million as of September 30, 2025, compared to $125.4 million at the end of 2024[36] Corporate Developments - The company completed patient enrollment in a 52-week Phase 3 trial for pirfenidone, involving 272 patients across 18 sites[4] - Gyre Therapeutics increased its indirect majority interest in Gyre Pharmaceuticals from 65.2% to 69.7% in Q3 2025 through additional capital contributions[28] Tax and Liabilities - Provision for income taxes for Q3 2025 was $1,693 million, up from $1,074 million in Q3 2024, marking an increase of 57.7%[39] - The loss from the change in fair value of warrant liability was $23 million in Q3 2025, a decrease from a gain of $228 million in Q3 2024[39]

Core Insights - Gyre Therapeutics has completed patient enrollment in a 52-week Phase 3 clinical trial for Pirfenidone capsules aimed at treating pneumoconiosis, a chronic lung disease [1][2] Industry Overview - Pneumoconiosis is the most common and severe occupational disease in China, affecting over 450,000 patients with thousands of new cases annually, caused by long-term inhalation of mineral dusts [3][4] - There is currently no approved therapy in China specifically targeting the fibrotic mechanisms of pneumoconiosis, highlighting a significant unmet medical need [3][4] Clinical Trial Details - The Phase 3 trial involves 272 patients across 18 clinical research centers in China, designed to assess the efficacy and safety of Pirfenidone over a 52-week period [2][5] - The trial compares Pirfenidone at a dosage of 1,800 mg/day with a placebo [5] Drug Information - Pirfenidone, originally approved in China in 2011 for idiopathic pulmonary fibrosis, functions by inhibiting TGF-β signaling and fibroblast proliferation [6] - Gyre is expanding the use of Pirfenidone beyond idiopathic pulmonary fibrosis to include treatment for pneumoconiosis and oncology-related pulmonary complications [6] Trial Objectives and Endpoints - The primary endpoint of the trial is the change in forced vital capacity (FVC) % predicted at Week 52, with key secondary endpoints including changes in lung diffusing capacity, 6-minute walk distance, and rates of acute exacerbations [9]

Core Insights - Gyre Therapeutics announced positive results from its Phase 3 clinical trial of Hydronidone, an anti-fibrotic agent for liver fibrosis in chronic hepatitis B, to be presented at The Liver Meeting® 2025 [1][2] Company Overview - Gyre Therapeutics is a biopharmaceutical company based in San Diego, CA, focused on developing and commercializing Hydronidone for liver fibrosis, including MASH, in the United States [2] - The company leverages its experience in mechanistic studies and clinical trials related to CHB-induced liver fibrosis [2] - Gyre is also advancing a broad pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions of ETUARY and development programs for F573, F528, and F230 [2] Clinical Trial Details - The Phase 3 trial results of Hydronidone will be presented by Prof. Lungen Lu, M.D., at The Liver Meeting® 2025 on November 7, 2025 [2] - The presentation is categorized under the Hepatitis B session and has been selected as a Poster of Distinction [2]

Summary of Gyre Therapeutics FY Conference Call Company Overview - **Company Name**: Gyre Therapeutics (NasdaqCM: GYRE) - **Industry**: Pharmaceutical, specifically focused on fibrosis-first therapies - **Foundation Year**: 2002 - **Headquarters**: China with global ambitions - **Employee Count**: Approximately 600, with 400 in commercial activities [2][3] Core Business and Market Position - **Primary Focus**: Treatment of pulmonary fibrosis, particularly through the drug pirfenidone, branded as ETUARY® in China - **Market Share**: - 50% market share in the idiopathic pulmonary fibrosis (IPF) market - Over 90% market share in the pirfenidone space in China [3] - **Patient Reach**: Treated over 150,000 patients in the last decade, with coverage across 3,000 hospitals and pharmacies [4] Financial Performance - **EBITDA**: Positive since 2017, with a compounded annual growth rate of 32% [4] - **Revenue Trends**: Experienced a small dip in revenue last year due to economic conditions but anticipates continued growth [4] Product Pipeline and Development - **Lead Drug**: Hydronidone (F351), designed to tackle fibrosis with improved potency and safety profile compared to pirfenidone [5] - **Recent Clinical Results**: - Phase 3 results for chronic hepatitis B (CHB) showed statistically significant fibrosis regression with a treatment delta of approximately 23% [9] - Safety profile demonstrated a 4.88% rate of serious adverse events compared to 6.45% for placebo [10] - **Future Plans**: - Filing for Investigational New Drug (IND) status in the U.S. for advanced liver fibrosis (MASH) [10][12] - Expanding into additional indications such as radiation-induced lung injury (RALI), pneumoconiosis, and diabetic kidney disease (DKD) [6][7] Strategic Moves - **Acquisitions**: - Acquired generic rights for nintedanib, expanding treatment offerings [8] - Acquired rights to Contiva (Evotrauma PEG) to enter the hepatology space [8] - **Market Potential**: - Targeting a CHB market in China with approximately 5 million patients, including 2.6 million with unmet needs [11] - MASH market in the U.S. estimated at 650,000 patients, significantly larger than the CHB market [12] Competitive Advantages - **Integrated Platform**: - Two GMP-certified manufacturing facilities ready to scale production [5][16] - End-to-end control from discovery to commercialization, allowing for cost efficiency and rapid scaling [16] - **Market Strategy**: - Focus on China for faster patient enrollment and cost efficiency, with plans to expand globally [14] - Strong commercial execution in China to maintain market leadership [15] Conclusion - **Growth Narrative**: Gyre Therapeutics presents a story of sustainable growth with a diversified pipeline and strategic market positioning, offering potential upside for investors [17]

Company Overview - Gyre Therapeutics is pioneering fibrosis treatment with a track record of success, evidenced by the approval of pirfenidone in China in 2011[7] - The company has treated over 150,000 IPF patients with pirfenidone[7] - Gyre has maintained an approximately 50% IPF market share in China, with over 90% share in pirfenidone in 2024[7] - Gyre's revenue grew at approximately 32% CAGR since 2017, with 2023 revenue at $113.5 million and 2024 revenue at $105.8 million[7] Hydronidone Clinical Trial Results and Regulatory Pathway - In a Phase 3 trial for CHB-associated liver fibrosis, Hydronidone showed a statistically significant ≥1-stage fibrosis regression at Week 52: 52.85% vs Placebo: 29.84% (P = 0.0002)[14] - Hydronidone also achieved a key secondary endpoint with ≥1-grade inflammation improvement without fibrosis progression at Week 52: 49.57% vs Placebo: 34.82% (P = 0.0246)[14] - Serious Adverse Events in the Hydronidone group were 4.88% (6/123) compared to 6.45% (8/124) in the Placebo group[16] - The company expects to file a New Drug Application (NDA) to NMPA in Q3 2025 for Hydronidone, seeking accelerated approval[16] Market Opportunity and Expansion - In China, the total HBV infected population is estimated at 60-70 million, with 2.6 million diagnosed compensated F2-F4 fibrosis patients as the initial target for Hydronidone[21] - The MASH fibrosis market in the U S is approximately 7 2 times larger than the CHB fibrosis market[25]

Company Overview - Gyre Therapeutics is a biopharmaceutical company based in San Diego, CA, focused on developing and commercializing Hydronidone for liver fibrosis, including MASH, in the United States [3] - The company leverages its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis [3] - In China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions of ETUARY and development programs for F573, F528, and F230 [3] Upcoming Events - Management will present at the H.C. Wainwright 27 Annual Global Investment Conference on September 10, 2025, at 12:30 p.m. ET [1] - A live webcast of the presentation will be available on Gyre's website, with a replay accessible after the live session [2]

Core Insights - Gyre Therapeutics has appointed Dr. Dan Weng to its Board of Directors, effective August 18, 2025, which is seen as a pivotal moment for the company [1][4]. Company Overview - Gyre Therapeutics is a commercial-stage biopharmaceutical company focused on fibrosis-first therapies for chronic diseases across various organ systems [1]. - The company’s flagship product, ETUARY (Pirfenidone capsule), was the first approved treatment for idiopathic pulmonary fibrosis (IPF) in the People's Republic of China (PRC) in 2011, achieving net sales of $105.0 million in 2024 [4]. - Gyre's pipeline includes Hydronidone, which has shown statistically significant fibrosis regression in a Phase 3 clinical trial for chronic hepatitis B (CHB)-associated liver fibrosis and is expected to file for New Drug Application (NDA) in Q3 2025 [4]. Leadership and Experience - Dr. Weng has nearly four decades of experience in managing global clinical trials and has held executive positions in various international contract research organizations (CROs) [2][4]. - His previous roles include President and CEO of Medelis, Inc., and Chairman and CEO of EPS International Holding Co., where he oversaw significant growth and corporate strategy [2]. Strategic Focus - Gyre Therapeutics aims to expand its commercial reach and advance its multinational pipeline, leveraging Dr. Weng's strategic insight and regulatory experience [4]. - The company is also developing treatments for various conditions, including Parkinson's disease (PD), diabetic kidney disease (DKD), radiation-induced lung injury (RILI), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH), and acute liver failure/acute-on-chronic liver failure (ALF/ACLF) [4][5].