FibroGen(FGEN) - 2024 Q2 - Quarterly Report

Revenue Performance - Revenue for the three months ended June 30, 2024, was $50.6 million, a 14.5$44.3 million in the same period of 2023[123]. - Roxadustat commercial sales in China contributed $49.6 million for the three months ended June 30, 2024, compared to$23.9 million in the same period of 2023, representing a 74.1% increase[124]. - Net product revenue for Q2 2024 was $49.6 million, a 108$23.9 million in Q2 2023[160]. - Total revenue for the six months ended June 30, 2024, was $106.5 million, up 32$80.5 million in the same period last year[163]. - Sales to Falikang generated net revenue of $46.0 million for Q2 2024, a 124$20.5 million in Q2 2023[169]. - Total product revenue, net increased by $25.8 million, or 108$25.5 million, or 124%, for the three months ended June 30, 2024, and by $31.2 million, or 75$48.5 million, a significant reduction from a net loss of $164.4 million for the same period in 2023[128]. - Operating costs and expenses for the three months ended June 30, 2024, were$61.6 million, down from $132.4 million in the same period of 2023, reflecting a decrease of 53.5$24.6 million one-time charge in the prior year and lower clinical trial expenses by $17.7 million for the three months ended June 30, 2024[126]. - Total operating costs and expenses decreased by$70.8 million, or 53%, for the three months ended June 30, 2024, and by $96.1 million, or 39$8.9 million, or 29%, for the three months ended June 30, 2024, and decreased by $20.4 million, or 31$61.4 million, or 64%, for the three months ended June 30, 2024, and by $97.5 million, or 57$140.7 million as of June 30, 2024, a decrease of $101.0 million from December 31, 2023[128]. - Net cash used in operating activities was$99.2 million for the six months ended June 30, 2024, compared to $212.2 million for the same period in 2023[203]. - Total net cash provided by investing activities was$123.5 million for the six months ended June 30, 2024, compared to $89.2 million for the same period in 2023[204]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[208]. - The company expects to need substantial additional funding to support ongoing operations and research and development efforts[209]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca have generated a total of$790.1 million in consideration through June 30, 2024[152]. - The AstraZeneca U.S./RoW Agreement generated $439 million in milestone and upfront payments before its termination in February 2024[155]. - Future milestone payments under license agreements could total approximately$697.9 million, contingent upon achieving specific developmental and regulatory milestones[213]. Clinical Trials and Pipeline - Pamrevlumab did not meet the primary endpoint of overall survival in the PanCAN's Precision Promise trial, with a median overall survival of 17.3 months compared to 17.9 months in the control arm[143]. - The Phase 3 LAPIS trial for pamrevlumab included 284 patients, randomized 1:1 to receive either pamrevlumab or placebo[144]. - The preclinical pipeline includes FG-3165 and FG-3175, both targeted antibodies for immuno-oncology, with FG-3165 receiving FDA clearance for investigational new drug application[144][145]. - FibroGen made four quarterly payments totaling $5.4 million to Fortis for development obligations related to FG-3246[147]. - If the option to acquire Fortis is exercised, FibroGen will pay$80 million, with potential contingent payments of up to $200 million for regulatory approvals[147].