Catalyst Biosciences, Inc.(CBIO) - 2025 Q1 - Quarterly Results

Business Highlights and Upcoming Milestones Gyre Therapeutics advanced commercial and clinical strategies in Q1 2025, launching avatrombopag, preparing nintedanib, and progressing pipeline milestones - ETUARY® (pirfenidone) sales were $21.7 million in Q1 2025, remaining the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC despite a year-over-year decline[4] - Commercialization of avatrombopag in China began in March 2025, targeting liver disease specialists, with nintedanib on track for a May 2025 launch to expand IPF treatment options[5][6][7] - China's NMPA granted IND approval for a new pirfenidone indication to treat radiation-induced lung injury (RILI), marking the company's entry into oncology supportive care, with an adaptive Phase 2/3 trial planned for the second half of 2025[3][5][8] - Database lock was achieved for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (CHB)-associated liver fibrosis, with topline results expected in Q2 2025[5] Pipeline Development Status | Candidate | Indication | Stage / Next Milestone | | :--- | :--- | :--- | | F573 | Acute/Acute on-Chronic Liver Failure (ALF/ACLF) | Phase 2 trial completion expected by end of 2026 | | F230 | Pulmonary Arterial Hypertension (PAH) | Phase 1 trial expected to begin in Q2 2025 | | F528 | Chronic Obstructive Pulmonary Disease (COPD) | IND application planned for 2026 | - Ping Zhang was appointed as Executive Chairman of the Board of Directors in March 2025[12] Financial Results Gyre's Q1 2025 financial results showed decreased revenues and net income due to strategic marketing shifts, with the company reaffirming its full-year revenue guidance Q1 2025 Key Financial Metrics | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | | :--- | :--- | :--- | | Revenues | $22.1 million | $27.2 million | | Income from Operations | $2.3 million | $8.1 million | | Net Income | $3.7 million | $9.9 million | | GAAP Basic EPS | $0.03 | $0.09 | | Non-GAAP Adjusted Net Income | $2.9 million | $8.2 million | - The $5.1 million year-over-year revenue decrease was primarily due to a $5.2 million decline in ETUARY® sales, resulting from a deliberate reallocation of marketing resources to support new product launches[14] - The company reaffirmed its full-year 2025 revenue guidance of $118 to $128 million, anticipating growth driven by the launch of Nintedanib and expansion of avatrombopag[1][14] - As of March 31, 2025, the company held $51.3 million in cash, cash equivalents, and short/long-term deposits, deemed sufficient to fund operations for the next 12 months[5][13] Q1 2025 Operating Expense Changes (YoY) | Expense Category | Q1 2025 (in millions) | Q1 2024 (in millions) | Change Driver | | :--- | :--- | :--- | :--- | | Cost of Revenues | $0.9M | $1.0M | Decreased in line with sales decline | | Selling & Marketing | $10.8M | $12.5M | Decreased due to lower commission costs from reduced sales | | Research & Development | $3.1M | $2.2M | Increased due to higher clinical research expenses for F351 | | General & Administrative | $5.0M | $3.4M | Increased due to higher personnel/stock costs and annual meeting expenses | Financial Statements The unaudited condensed consolidated financial statements detail Gyre's Q1 2025 performance, showing revenue and net income declines, balance sheet changes, and GAAP to Non-GAAP reconciliation Condensed Consolidated Statements of Operations For Q1 2025, Gyre reported revenues of $22.1 million and net income attributable to common stockholders of $2.7 million, both decreasing year-over-year Statement of Operations Summary (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues | $22,058 | $27,172 | | Total operating expenses | $19,785 | $19,101 | | Income from operations | $2,273 | $8,071 | | Net income | $3,734 | $9,935 | | Net income attributable to common stockholders | $2,698 | $7,532 | | Basic EPS | $0.03 | $0.09 | Condensed Consolidated Balance Sheets As of March 31, 2025, Gyre's balance sheet showed total assets of $129.8 million, total liabilities of $25.5 million, and total stockholders' equity of $104.3 million, with increased cash and cash equivalents Balance Sheet Summary (in thousands) | Line Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,045 | $11,813 | | Total current assets | $68,448 | $64,786 | | Total assets | $129,790 | $125,406 | | Total current liabilities | $18,991 | $19,516 | | Total liabilities | $25,488 | $27,004 | | Total stockholders' equity | $104,302 | $98,402 | Reconciliation of GAAP to Non-GAAP Financial Measures The company reconciled Q1 2025 GAAP net income of $3.7 million to a non-GAAP adjusted net income of $2.9 million, primarily by excluding a $2.3 million gain from warrant liability and adding $0.5 million in stock-based compensation GAAP to Non-GAAP Reconciliation (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net income (GAAP) | $3,734 | $9,935 | | Adjustments: | | | | Gain from change in fair value of warrant liability | $(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 | Company and Product Overview Gyre Therapeutics is a biopharmaceutical company focused on organ fibrosis, developing F351 for MASH-associated fibrosis in the U.S. and commercializing ETUARY® (pirfenidone) in the PRC while advancing a diverse pipeline - F351 (Hydronidone), a structural analogue of pirfenidone, inhibits key pathways in liver fibrosis and is being evaluated in a Phase 3 trial for CHB-associated liver fibrosis in the PRC, with topline data expected in Q2 2025[18][20] - Gyre Pharmaceuticals' flagship product, ETUARY® (pirfenidone), was the first approved IPF treatment in the PRC and generated $105.8 million in net sales in 2024[20] - Gyre Therapeutics' primary focus in the U.S. is the development and commercialization of F351 for MASH-associated fibrosis[21] Forward-Looking Statements This section contains a standard "safe harbor" provision, cautioning that forward-looking statements regarding clinical trials, regulatory approvals, commercial launches, and financial performance are subject to significant risks and uncertainties - The press release contains forward-looking statements concerning R&D efforts, clinical trial timing, commercial launches, and financial position, which are subject to substantial risks and uncertainties[23] - Actual results could differ materially from expectations due to various risks, including the ability to execute clinical strategies, unpredictable trial outcomes, regulatory hurdles, competition, and economic conditions[23]