FibroGen(US:FGEN)2025-08-11 20:10PART I—FINANCIAL INFORMATION Financial Statements Unaudited financial statements show discontinued China operations, reduced net loss for continuing operations, and substantial doubt about going concern without the pending sale Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $23,367 | $50,482 | | Total current assets | $162,322 | $196,509 | | Total assets | $178,055 | $214,525 | | Liabilities & Deficit | | | | Total current liabilities | $155,895 | $133,306 | | Senior secured term loan facilities, non-current | $0 | $73,092 | | Total liabilities | $359,085 | $398,160 | | Total stockholders' deficit | ($222,997) | ($225,602) | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,348 | $998 | $4,088 | $26,363 | | Research and development | $5,865 | $32,360 | $15,040 | $68,848 | | Selling, general and administrative | $7,057 | $14,906 | $15,164 | $31,622 | | Loss from continuing operations | ($13,683) | ($47,095) | ($30,449) | ($96,141) | | Income from discontinued operations, net of tax | $6,080 | $31,551 | $27,485 | $47,664 | | Net loss | ($7,603) | ($15,544) | ($2,964) | ($48,477) | | Net loss per share - basic and diluted | ($1.88) | ($3.89) | ($0.73) | ($12.19) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $15,401 | ($99,157) | | Net cash provided by (used in) investing activities | ($29) | $123,515 | | Net cash used in financing activities | ($97) | ($133) | | Net increase in cash and cash equivalents | $17,663 | $27,026 | - The company has determined there is substantial doubt about its ability to continue as a going concern within 12 months, as it may not have sufficient liquidity for U.S. operations or be able to comply with its debt covenant without completing the sale of FibroGen International or raising additional capital39 - On February 20, 2025, FibroGen agreed to sell all its roxadustat assets in China (FibroGen International) to AstraZeneca, with this transaction treated as a discontinued operation and related assets and liabilities classified as 'held for sale'313647 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses strategic focus on FG-3246 and roxadustat, noting reduced operating expenses and critical dependence on the China business sale for liquidity - The company's strategic focus is on developing FG-3246, a first-in-class ADC for metastatic castration-resistant prostate cancer (mCRPC), with a Phase 2 study anticipated to start in Q3 2025137 - FibroGen had a positive Type-C meeting with the FDA in July 2025 and reached alignment on key elements for a proposed Phase 3 study of roxadustat for anemia associated with lower-risk myelodysplastic syndromes (MDS)139156 Operating Costs and Expenses Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Cost of goods sold | $337 | $21,483 | ($21,146) | (98)% | | Research and development | $15,040 | $68,848 | ($53,808) | (78)% | | Selling, general and administrative | $15,164 | $31,622 | ($16,458) | (52)% | | Total operating costs and expenses | $31,060 | $121,953 | ($90,893) | (75)% | - The significant decrease in operating expenses for H1 2025 compared to H1 2024 was primarily driven by lower employee-related costs from a reduction in force, termination of pamrevlumab programs, and a one-time $21.1 million cost of goods sold in 2024 related to the AstraZeneca U.S./RoW agreement termination141151206 - The company's liquidity is critically dependent on the sale of its China operations, as without completing the sale or raising additional capital, FibroGen will not have sufficient funds for U.S. operations for the next 12 months and will violate its debt covenant, raising substantial doubt about its ability to continue as a going concern238414 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, FibroGen is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company defined in Rule 12b-2 of the Exchange Act, FibroGen is not required to provide the information for this item244 Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025246 - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls247 PART II—OTHER INFORMATION Legal Proceedings The company is involved in various legal actions, with no material accruals as of June 30, 2025, due to unestimable outcomes - The company did not have any material accruals for active legal actions as of June 30, 2025, because the outcomes could not be predicted or reasonably estimated250 Risk Factors The company faces significant risks including dependence on lead products, drug development uncertainties, reliance on collaborators, and critical going concern issues tied to the China operations sale - The company is substantially dependent on the success of its lead products, roxadustat and FG-3246, and failure in these programs would materially harm the business255260 - A critical risk is the company's ability to continue as a going concern; failure to complete the sale of FibroGen International, access cash from China, or raise new capital would lead to insufficient liquidity for U.S. operations and a breach of debt covenants379414 - The company faces significant risks related to its operations in China, including regulatory changes, geopolitical tensions, intellectual property protection challenges, and restrictions on cash repatriation, pending the sale of these operations259380 - FibroGen relies heavily on third-party collaborations with partners like Astellas, and termination of these agreements or failure by partners to perform would adversely affect the development and commercialization of roxadustat254306309 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None478 Defaults Upon Senior Securities Not applicable - Not applicable479 Mine Safety Disclosures Not applicable - Not applicable480 Other Information There were no Rule 10b5-1 trading arrangements to report for the period - None481 Exhibits This section lists exhibits filed with the Form 10-Q, including corporate amendments, financing agreements, officer certifications, and XBRL data