FibroGen(US:FGEN)2023-05-07 16:00Financial Performance - Revenue for Q1 2023 was $36.2 million, a decrease of 40.5% compared to $60.8 million in Q1 2022[142]. - Net loss for Q1 2023 was $76.7 million, or $0.81 per share, compared to a net loss of $63.2 million, or $0.68 per share in Q1 2022[143]. - Total revenue for the three months ended March 31, 2023, was $36.2 million, a decrease of $24.7 million or 41% compared to the same period in 2022[179][184]. - License revenue decreased by $16.6 million or 73% to $6 million for the three months ended March 31, 2023, primarily due to the absence of revenue from Astellas[185]. - Total development and other revenue decreased by $7.9 million, or 67%, for Q1 2023 compared to Q1 2022, with total development revenue at $3.7 million[189]. - Product revenue increased by $5.3 million or 28% to $24.2 million for the three months ended March 31, 2023[179]. - Net product revenue from the AstraZeneca China Agreement was $24.2 million for the three months ended March 31, 2023, compared to $18.9 million in the same period in 2022[177]. Cash and Investments - Cash and cash equivalents totaled $188.6 million as of March 31, 2023, an increase from $155.7 million at the end of 2022[142]. - Total cash, cash equivalents, and investments decreased by $69.1 million from December 31, 2022, primarily due to cash used in operations[144]. - Net cash used in operating activities was $(101.6) million for the three months ended March 31, 2023, compared to $(8.5) million for the same period in 2022[231][233]. - Net cash provided by investing activities was $103.5 million for the three months ended March 31, 2023, primarily from $104.8 million of proceeds from maturities of investments[235]. - Net cash provided by financing activities was $31.5 million for the three months ended March 31, 2023, primarily from $30.8 million net proceeds received under the ATM Program[239]. - The company believes its existing cash and investments will meet anticipated cash requirements for at least the next 12 months, but may need additional capital thereafter[241]. Research and Development - Upcoming topline data expected for pamrevlumab in IPF from ZEPHYRUS-1 in mid-2023 and ZEPHYRUS-2 in mid-2024[150]. - Phase 3 trial for pamrevlumab in LAPC completed enrollment of 284 patients, with topline data expected in the first half of 2024[151]. - Roxadustat achieved over 50% increase in sales volume in Q1 2023 compared to Q1 2022, holding approximately 35% market share in China[157]. - Roxadustat did not meet its primary efficacy endpoint in the Phase 3 MATTERHORN trial, with 47.5% of patients achieving red blood cell transfusion independence compared to 33.3% in the placebo group (p=0.217)[158]. - The Phase 3 trial for roxadustat in chemotherapy-induced anemia has enrolled 159 subjects, with topline data expected in Q2 2023[159]. Expenses - Total operating costs and expenses decreased by $11.6 million, or 9%, for Q1 2023, totaling $112.3 million compared to $123.8 million in Q1 2022[207]. - Research and development expenses decreased by $14.5 million, or 16%, for Q1 2023, totaling $74.5 million compared to $89.0 million in Q1 2022[207]. - Selling, general and administrative (SG&A) expenses increased by $3.7 million, or 12%, for the three months ended March 31, 2023, compared to the same period a year ago[215]. - Interest expense increased significantly to $(2,372) thousand for the three months ended March 31, 2023, compared to $(97) thousand in the same period a year ago, representing a 2,345% increase[215]. - Interest income and other income improved by $1.4 million, or 422%, for the three months ended March 31, 2023, compared to the same period a year ago[220]. Agreements and Obligations - A financing agreement was entered into on April 29, 2023, providing for a $75 million initial term loan and up to $75 million in delayed draw term loans contingent on clinical milestones[160]. - An exclusive option agreement to acquire Fortis Therapeutics was established, with an upfront payment of $5 million and a potential acquisition cost of $80 million, plus up to $200 million in contingent payments[162][165]. - Total cash consideration received through March 31, 2023, from collaboration agreements amounted to $1.3 billion, with potential additional payments of $1.2 billion[178]. - The company had a total of $98.9 million of cash and cash equivalents held outside of the U.S. in foreign subsidiaries, including $77.6 million in China[227]. - The company has outstanding non-cancelable purchase obligations totaling $51.9 million, with $28.9 million expected to be paid within the next 12 months[243]. - Future milestone payments for research and preclinical stage development programs could total approximately $697.9 million, contingent on achieving specific milestones[245]. Market and Operational Risks - Roxadustat product sales in China began generating revenue in Q3 2019, but the company anticipates continued losses for the foreseeable future[240]. - The company is subject to risks related to the development and commercialization of novel therapeutics, which may lead to unforeseen expenses and complications[240]. - There were no material changes to the company's exposure to market risks during the three months ended March 31, 2023[249]. - There have been no material changes in critical accounting policies or estimates during the three months ended March 31, 2023[248]. - The company did not have any off-balance sheet arrangements during the three months ended March 31, 2023[246].