FibroGen(FGEN)2023-08-06 16:00Financial Performance - Revenue for Q2 2023 was $44.3 million, a 48.8% increase from $29.8 million in Q2 2022[152]. - Net loss for Q2 2023 was $87.7 million, compared to a net loss of $72.6 million in Q2 2022, resulting in a net loss per share of $0.90[156]. - Total revenue for the three months ended June 30, 2023, increased by $14.5 million, or 49%, compared to the same period in 2022, while total revenue for the six months decreased by $10.2 million, or 11%[210]. - License revenue for the three months ended June 30, 2023, was $1.0 million, a decrease of 69% compared to $3.2 million in the same period of 2022[211]. - Development and other revenue decreased by $0.3 million, or 5%, for the three months ended June 30, 2023, and decreased by $8.2 million, or 47%, for the six months ended June 30, 2023[214]. - Product revenue, net for the three months ended June 30, 2023, was $23.9 million, an increase of 3% compared to $23.3 million in the same period of 2022[204]. - Drug product revenue, net for the three months ended June 30, 2023, was $14.3 million, a 6% increase compared to $1.1 million in the same period of 2022[208]. - Other revenue for the three months ended June 30, 2023, was $1.0 million, a 274% increase compared to $0.3 million in the same period of 2022[214]. - Total product revenue, net increased by $0.6 million, or 3% for the three months ended June 30, 2023, and increased by $5.9 million, or 14% for the six months ended June 30, 2023, compared to the same periods a year ago[219]. Operating Costs - Operating costs for Q2 2023 were $132.4 million, up from $108.0 million in Q2 2022, primarily due to increased product revenue and clinical trial expenses[154]. - Total operating costs and expenses increased by $24.3 million, or 23% for the three months ended June 30, 2023, and increased by $12.8 million, or 6% for the six months ended June 30, 2023, respectively[236]. - Research and development expenses increased by $24.5 million, or 35% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Selling, general and administrative expenses increased by $923,000, or 3% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Cost of goods sold decreased by $1.1 million, or 16% for the three months ended June 30, 2023, and decreased by $1.8 million, or 17% for the six months ended June 30, 2023, respectively[237]. - Cost of goods sold associated with roxadustat commercial sales in China was $3.6 million for Q2 2023, a decrease of $1.3 million, or 26% year-over-year[238]. Cash and Investments - Cash and cash equivalents totaled $152.6 million as of June 30, 2023, a decrease of $3.1 million from $155.7 million at the end of 2022[158]. - Total cash, cash equivalents, and investments decreased by $81.3 million from December 31, 2022, primarily due to cash used in operations[158]. - As of June 30, 2023, the company had short-term investments of $183.1 million, down from $266.3 million as of December 31, 2022[262]. - Net cash used in operating activities was $212.2 million for the six months ended June 30, 2023, compared to $41.5 million for the same period in 2022[265][267]. - Net cash provided by investing activities was $89.2 million for the six months ended June 30, 2023, primarily from $192.9 million of proceeds from maturities of investments[268]. - Net cash provided by financing activities was $123.0 million for the six months ended June 30, 2023, mainly from $71.3 million net proceeds from senior secured term loan facilities[271]. Clinical Development - Roxadustat generated $23.9 million in net product revenue from commercial sales in China during Q2 2023[154]. - Pamrevlumab is in Phase 3 clinical development for locally advanced unresectable pancreatic cancer, with topline data expected in Q1 2024[162]. - The Phase 3 trial for pamrevlumab in ambulatory Duchenne muscular dystrophy (DMD) completed enrollment of 73 patients, with topline data expected in August 2023[164]. - The Phase 3 trial for pamrevlumab in idiopathic pulmonary fibrosis did not meet its primary endpoint, with a mean decline in FVC of 260 ml compared to 330 ml in the placebo group[167]. - In a Phase 3 study for chemotherapy-induced anemia, Roxadustat demonstrated non-inferiority to recombinant erythropoietin alfa on the primary endpoint of hemoglobin change[171]. - FG-3246 showed a PSA50 response rate of 45% and an objective partial response rate of 19% in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[177]. - The company is developing a PET biomarker for FG-3246 in collaboration with UCSF, with a Phase 2 trial anticipated to start in the second half of 2024[178]. Financing and Agreements - A financing agreement was established for a $75 million senior secured term loan to support ongoing operations[183]. - An exclusive option agreement was signed to acquire Fortis Therapeutics, with a potential payment of $80 million upon acquisition and up to $200 million in contingent payments[187]. - The company recognized $1 million in upfront payments under the Eluminex Agreement during Q2 2023, with additional milestone payments recognized[190]. - Total cash consideration received through June 30, 2023, from collaboration agreements amounted to $1,306.3 million, with potential cash consideration of $1,237.0 million, totaling $2,543.3 million[203]. - Future milestone payments under license agreements could total approximately $697.9 million, contingent on achieving specific developmental milestones[280]. Future Outlook - The company anticipates needing substantial additional funding for ongoing operations and research and development efforts[274][275]. - The company expects future development services to continue through 2024, with co-development services in China expected to continue through 2028[206]. - The company anticipates fluctuations in revenue generated from collaboration agreements due to the uncertain timing and amount of payments and sales[209]. - The liquidity position of FibroGen Beijing is influenced by various factors, including potential future cash distributions and debt obligations[263]. - The company has not made any debt repayments or distributions from FibroGen Beijing to entities outside of China to date[263].