Catalyst Biosciences, Inc.(CBIO) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update Leadership Transition Gyre Therapeutics appointed Ping Zhang as interim CEO, with Dr. Han Ying transitioning to Senior VP of Science for R&D - Ping Zhang (Executive Chairman) was appointed interim CEO, responsible for daily operations and global strategic expansion[1][3] - Dr. Han Ying resigned as CEO, transitioning to Senior Vice President of Science, responsible for research and discovery activities to support the company's fibrosis pipeline[1][3] Q2 2025 & Year-to-Date Highlights Q2 and H1 2025 highlights include net income growth, reaffirmed guidance, positive Hydronidone Phase III results, and successful new product launches Financial Highlights | Metric | Q2 2025 | H1 2025 | | :--- | :--- | :--- | | Net Income | $1.6 million | $5.3 million | | Revenue | $26.8 million | $48.8 million | | GAAP Basic EPS | $0.00 | $0.04 | - Reaffirmed full-year 2025 revenue guidance of $118-$128 million[1] - Hydronidone (F351) showed statistically significant fibrosis reversal after 52 weeks of treatment in a Phase III clinical trial for CHB-related liver fibrosis[4] - Etorel (nintedanib ethanesulfonate soft capsules) successfully launched in China for SSc-ILD and PF-ILD[4] - First subject dosed in Phase I clinical trial of F230 for PAH[4] CEO Outlook & Strategic Priorities Interim CEO Ping Zhang outlined strategic priorities for commercial expansion, fibrosis pipeline advancement, and Hydronidone's NDA submission - Plan to initiate a Phase II trial for Hydronidone in MASH-related liver fibrosis in the US in H2 2025[5] - Expect to initiate a Phase II/III trial for pirfenidone in tumor-related lung complications in H2 2025[5] - Plan to submit a New Drug Application (NDA) for Hydronidone to the NMPA in Q3 2025[5] Business Highlights & Upcoming Milestones Commercial Portfolio Expansion Q2 2025 commercial portfolio expanded with successful Etorel and Contiva launches, offsetting a slight ETUARY® sales decline Product Sales | Product | Q2 2025 Sales (million USD) | Q2 2024 Sales (million USD) | Change (million USD) | | :--- | :--- | :--- | :--- | | ETUARY® (pirfenidone) | $23.5 | $25.1 | ↓ $1.6 | | Etorel (nintedanib ethanesulfonate) | $1.6 | N/A | New Launch | | Contiva (avatrombopag maleate) | $1.5 | N/A | New Launch | - Etorel launched in China in June 2025 for SSc-ILD and PF-ILD[6] - Contiva began commercialization in China in March 2025 for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenia[7] Pipeline Development Updates The company's pipeline advanced with positive Hydronidone Phase III results, planned US MASH trials, and new clinical stages for ETUARY® and F230 Hydronidone - In May 2025, Hydronidone achieved positive results in a pivotal Phase III clinical trial for chronic hepatitis B (CHB)-related liver fibrosis, showing statistically significant fibrosis reversal after 52 weeks[8] - Hydronidone also met key secondary endpoints at 52 weeks, demonstrating inflammation improvement without fibrosis progression[8] - Plan to submit a New Drug Application (NDA) to the NMPA in Q3 2025[8] - Internal review is ongoing to determine if a new IND is required for the US Phase II trial in MASH-related liver fibrosis, expected to start in H2 2025[9] ETUARY® (Pirfenidone) - Plan to initiate an adaptive Phase II/III trial for pirfenidone in radiation-induced lung injury (RILI) in China in H2 2025[10] F573 - F573, a caspase inhibitor for acute/acute-on-chronic liver failure (ALF/ACLF), is expected to complete its Phase II clinical trial by end of 2026[11] F230 - In June 2025, the first subject was successfully dosed in China for the Phase I clinical trial of F230, a novel endothelin A receptor agonist, for pulmonary arterial hypertension (PAH)[12] F528 - F528, a novel anti-inflammatory agent, is undergoing preclinical studies for COPD, with an IND application planned for 2026[13] Corporate Updates Corporate Updates Gyre Therapeutics completed leadership transition, appointed interim CEO, raised $23 million, and increased Gyre Pharmaceuticals ownership - In August 2025, Ping Zhang was appointed interim CEO, and Dr. Han Ying transitioned to a scientific leadership role[14] - In May 2025, completed an underwritten public offering, raising approximately $23 million in gross proceeds[14] - In Q3 2025, the company's indirect ownership in Gyre Pharmaceuticals increased from 65.2% to 69.7%[14] Financial Results Cash Position As of June 30, 2025, cash and equivalents totaled $75.9 million, primarily from $21.3 million net proceeds of a May public offering Cash and Equivalents | Asset Category | Amount (million USD) | | :--- | :--- | | Cash and Cash Equivalents | $36.5 | | Short-Term Bank Deposits | $17.9 | | Long-Term Time Deposits | $21.5 | | Total | $75.9 | - The increase in cash and cash equivalents primarily includes approximately $21.3 million in net proceeds from an underwritten public offering in May 2025[15] Financial Results for the Three Months Ended June 30, 2025 Q2 2025 revenue grew from new product launches, but increased operating expenses led to a decline in operating and net income Condensed Consolidated Statements of Operations (Q2) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | YOY Change (million USD) | YOY Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $26.8 | $25.2 | ↑ $1.6 | ↑ 6.3% | | Cost of Revenue | $1.2 | $0.8 | ↑ $0.4 | ↑ 50.0% | | Selling and Marketing Expenses | $15.2 | $14.4 | ↑ $0.8 | ↑ 5.6% | | Research and Development Expenses | $3.4 | $3.3 | ↑ $0.1 | ↑ 3.0% | | General and Administrative Expenses | $4.8 | $3.4 | ↑ $1.4 | ↑ 41.2% | | Operating Income | $2.2 | $3.2 | ↓ $1.0 | ↓ 31.3% | | Net Income | $1.6 | $4.5 | ↓ $2.9 | ↓ 64.4% | | Non-GAAP Adjusted Net Income | $2.9 | $3.1 | ↓ $0.2 | ↓ 6.5% | - Revenue growth was primarily driven by Etorel launch ($1.6 million) and Contiva sales ($1.5 million), partially offset by a decrease in ETUARY® sales ($1.5 million)[16] - The decline in operating income was primarily due to a $2.6 million increase in total operating expenses, partially offset by a $1.6 million increase in revenue[16] Financial Results for the Six Months Ended June 30, 2025 H1 2025 revenue declined due to lower ETUARY® sales and increased operating expenses, leading to a significant drop in operating and net income Condensed Consolidated Statements of Operations (H1) | Metric | H1 2025 (million USD) | H1 2024 (million USD) | YOY Change (million USD) | YOY Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $48.8 | $52.4 | ↓ $3.6 | ↓ 6.9% | | Cost of Revenue | $2.0 | $1.7 | ↑ $0.3 | ↑ 17.6% | | Selling and Marketing Expenses | $26.0 | $26.9 | ↓ $0.9 | ↓ 3.3% | | Research and Development Expenses | $6.5 | $5.5 | ↑ $1.0 | ↑ 18.2% | | General and Administrative Expenses | $9.8 | $6.8 | ↑ $3.0 | ↑ 44.1% | | Operating Income | $4.4 | $11.3 | ↓ $6.9 | ↓ 61.1% | | Net Income | $5.3 | $14.5 | ↓ $9.2 | ↓ 63.4% | | Non-GAAP Adjusted Net Income | $5.8 | $11.3 | ↓ $5.5 | ↓ 48.7% | - Revenue decline was primarily due to a $6.8 million decrease in ETUARY® sales, partially offset by new product sales growth from Contiva ($1.8 million) and Etorel ($1.6 million)[17] - The decrease in ETUARY® sales was mainly attributed to the non-recurrence of a one-time rural marketing campaign in H1 2024, a weak economic environment in China, and increased competition in the IPF treatment market[17] - The decline in operating income was primarily due to a $3.6 million decrease in revenue and a $3.3 million increase in total operating expenses[23] Full Year 2025 Financial Guidance The company reaffirmed its full-year 2025 revenue guidance of $118-$128 million, projecting growth driven by new product commercialization and ETUARY® sales 2025 Financial Outlook | Metric | FY 2025 Guidance | | :--- | :--- | | Total Revenue | $118 - $128 million | | YOY Growth | 11.3% - 20.8% | | Driving Factors | Commercialization of Etorel and Contiva, and ETUARY® sales | - Revenue guidance assumes constant exchange rates and no significant economic disruptions or recession[21] Use of Non-GAAP Financial Measures Gyre Therapeutics uses non-GAAP adjusted net income, excluding specific items, to provide a clearer assessment of core operating performance - Adjusted net income excludes changes in fair value of warrant liabilities, share-based compensation expenses, and income tax provision[22] - Management believes adjusted net income provides investors with additional useful information for evaluating the company's performance and valuation[22] About the Company About Gyre Pharmaceuticals Gyre Pharmaceuticals focuses on organ fibrosis drug R&D, manufacturing, and commercialization, with flagship ETUARY® and a diverse pipeline - ETUARY® (pirfenidone capsules) was China's first approved IPF treatment in 2011, with $105 million in net sales in 2024[24] - Hydronidone showed statistically significant fibrosis reversal in a Phase III clinical trial for CHB-related liver fibrosis and is expected to have its NDA submitted in Q3 2025[24] - Gyre Therapeutics acquired a 65.2% indirect majority stake in Gyre Pharmaceuticals in October 2023, increasing to 69.7% in Q3 2025[24] About Gyre Therapeutics Gyre Therapeutics, based in San Diego, focuses on Hydronidone development for US MASH, and advances ETUARY® and other pipeline programs in China - Gyre Therapeutics, headquartered in San Diego, USA, primarily focuses on the development and commercialization of Hydronidone for liver fibrosis (including MASH) in the US[25] - Through indirect control of Gyre Pharmaceuticals, the company advances ETUARY®'s therapeutic indication expansion and development programs such as F573, F528, and F230 in China[25] Forward-Looking Statements Forward-Looking Statements This press release contains forward-looking statements, subject to risks and uncertainties, where actual results may differ materially from expectations - Forward-looking statements cover expectations regarding R&D efforts, clinical trial timelines, regulatory filings and approvals, product sales, and financial condition[26] - Actual results may differ materially due to risks and uncertainties such as the ability to execute clinical development strategies, timing of regulatory approvals, competition, economic conditions, and sufficiency of capital resources[26] Financial Statements Condensed Consolidated Statements of Operations The condensed consolidated statements of operations detail Q2 and H1 2025 revenue, expenses, and net income, reflecting profitability and cost structure Condensed Consolidated Statements of Operations | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | 26,771 | 25,225 | 48,829 | 52,397 | | Total Operating Expenses | 24,600 | 22,031 | 44,385 | 41,132 | | Operating Income | 2,171 | 3,194 | 4,444 | 11,265 | | Net Income | 1,576 | 4,538 | 5,310 | 14,473 | | Net Income Attributable to Common Stockholders | 442 | 3,528 | 3,140 | 11,060 | | Basic Earnings Per Share | 0.00 | 0.04 | 0.04 | 0.13 | | Diluted Earnings Per Share | 0.00 | 0.01 | 0.01 | 0.04 | Condensed Consolidated Balance Sheets The condensed consolidated balance sheets present assets, liabilities, and equity as of June 30, 2025, and December 31, 2024, showing asset growth and capital structure Condensed Consolidated Balance Sheets | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and Cash Equivalents | 36,491 | 11,813 | | Short-Term Bank Deposits | 17,874 | 14,858 | | Total Current Assets | 91,285 | 64,786 | | Total Assets | 152,646 | 125,406 | | Liabilities and Stockholders' Equity | | | | Total Current Liabilities | 16,920 | 19,516 | | Total Liabilities | 23,203 | 27,004 | | Equity Attributable to Gyre Stockholders | 92,026 | 63,319 | | Non-Controlling Interests | 37,417 | 35,083 | | Total Equity | 129,443 | 98,402 | | Total Liabilities and Stockholders' Equity | 152,646 | 125,406 | Reconciliation of GAAP to Non-GAAP Financial Measures This reconciliation table details the calculation from GAAP to non-GAAP adjusted net income, excluding specific items for clearer core operating performance GAAP to Non-GAAP Reconciliation | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Income | 1,576 | 4,538 | 5,310 | 14,473 | | Loss (gain) from change in fair value of warrant liabilities | (212) | (2,913) | (2,467) | (7,201) | | Share-based compensation expenses | 906 | 16 | 1,413 | 27 | | Income tax provision | 662 | 1,497 | 1,563 | 4,043 | | Non-GAAP Adjusted Net Income | 2,932 | 3,138 | 5,819 | 11,342 |