FibroGen(FGEN) - 2024 Q1 - Quarterly Results

Executive Summary & Business Update FibroGen reported a strong start to 2024, highlighted by compelling Phase 1 data for FG-3246 and robust growth of its roxadustat business in China - CEO Thane Wettig highlighted a strong start to 2024, driven by compelling Phase 1 data for FG-3246 and continued robust growth of roxadustat in China[3] - The company reaffirms its cash runway into 2026, supported by a cash, cash equivalents, investments, and accounts receivable balance of $214.7 million[3][6][12] - First quarter net revenue grew 55% year-over-year, driven by roxadustat performance in China and a one-time drug product revenue recognition from the termination of the US/RoW AstraZeneca agreement[6][12] Key Milestones and Pipeline Developments FibroGen outlined key upcoming milestones, including topline data for two pamrevlumab Phase 3 studies in pancreatic cancer and an approval decision for roxadustat in China Pamrevlumab Topline data from two late-stage pamrevlumab trials in pancreatic cancer are expected in mid-2024 and Q3 2024 - Topline data from the PanCAN Precision Promise Phase 2/3 study in metastatic pancreatic cancer is anticipated in mid-2024[6][7] - Topline data from the LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer is expected in Q3 2024[6][7] - Pamrevlumab has received Orphan Drug Designation and Fast Track designation from the U.S. FDA for the treatment of LAPC[14] Roxadustat Roxadustat sales in China showed robust growth, with an approval decision for chemotherapy-induced anemia (CIA) expected in H2 2024 - An approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China is expected in the second half of 2024[4] - If approved for CIA, FibroGen is set to receive a $10 million milestone payment from AstraZeneca[4] - Roxadustat volume in China grew 39% year-over-year in the first quarter[6][12] Oncology Pipeline Compelling Phase 1 data for FG-3246 in mCRPC led to a planned Phase 2 study in H2 2024, alongside IND submissions for FG-3165 and FG-3175 - Phase 1 data for FG-3246 in mCRPC showed a median radiographic progression-free survival (rPFS) of 8.7 months and a 36% rate of PSA reduction (≥ 50%)[12] - A Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC is anticipated to start in the second half of 2024[7] - An IND was submitted for FG-3165 (Galectin-9 targeting mAb) in April 2024, and an IND filing for FG-3175 (anti-CCR8 mAb) is expected in 2025[7][12] Financial Performance FibroGen reported total revenues of $55.9 million for Q1 2024, a 55% increase year-over-year, with net loss significantly narrowed to $32.9 million Q1 2024 Financial Highlights Total revenue increased 55% year-over-year to $55.9 million, with net loss significantly reduced to $32.9 million or $0.33 per share Q1 2024 vs Q1 2023 Key Financials | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $55.9M | $36.2M | +55% | | Net Loss | ($32.9M) | ($76.7M) | +57% | | Net Loss per Share | ($0.33) | ($0.81) | +59% | Roxadustat China Sales Performance (Q1 2024 vs Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | FibroGen Net Product Revenue (U.S. GAAP) | $30.5M | $24.2M | +26% | | Total Roxadustat Net Sales in China (incl. JDE) | $79.4M | $64.1M | +24% | - The company reaffirms its full-year 2024 net product revenue guidance under U.S. GAAP to range between $120 million to $135 million[12] - Cash, cash equivalents, investments, and accounts receivable totaled $214.7 million at March 31, 2024, supporting operations into 2026[12] Condensed Consolidated Statements of Operations Total revenue increased to $55.9 million in Q1 2024, driven by product and one-time drug product revenue, resulting in a reduced net loss of $32.9 million Condensed Consolidated Statements of Operations | (In thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total revenue | $55,902 | $36,161 | | Product revenue, net | $30,538 | $24,161 | | Drug product revenue, net | $24,486 | $2,109 | | Total operating costs and expenses | $86,965 | $112,252 | | Research and development | $38,392 | $74,486 | | Selling, general and administrative | $22,820 | $34,275 | | Loss from operations | ($31,063) | ($76,091) | | Net loss | ($32,933) | ($76,705) | | Net loss per share - basic and diluted | ($0.33) | ($0.81) | Condensed Consolidated Balance Sheets Total assets decreased to $365.9 million as of March 31, 2024, with total liabilities also decreasing to $552.0 million Condensed Consolidated Balance Sheet Highlights | (In thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $105,734 | $113,688 | | Short-term investments | $71,865 | $121,898 | | Total current assets | $278,167 | $331,559 | | Total assets | $365,868 | $423,529 | | Liabilities and Stockholders' Deficit | | | | Total current liabilities | $196,733 | $217,668 | | Total liabilities | $552,023 | $585,728 | | Total stockholders' deficit | ($207,635) | ($183,679) | Corporate Information FibroGen appointed Deyaa Adib, MD as Chief Medical Officer and provided details for its Q1 2024 conference call and webcast - Appointed Deyaa Adib, MD as the new Chief Medical Officer[9] - The company is focused on accelerating the development of novel therapies in cancer biology, with key assets including pamrevlumab, roxadustat, and FG-3246[17]