FibroGen(FGEN)2022-05-08 16:00Revenue Performance - Revenue for the three months ended March 31, 2022, was $60.8 million, a 58% increase from $38.4 million in the same period in 2021[125]. - In Q1 2022, total revenue increased by $22.4 million, or 58%, to $60.8 million compared to $38.4 million in Q1 2021[171]. - License revenue for Q1 2022 was $22.6 million, a 100% increase from $0 in Q1 2021, primarily due to a $25.0 million regulatory milestone from Astellas for EVRENZO® approval in Russia[177]. - Product revenue, net, rose by $3.5 million, or 23%, to $18.9 million in Q1 2022 from $15.4 million in Q1 2021[171]. - Development and other revenue decreased by $2.8 million, or 19%, to $11.8 million in Q1 2022 compared to $14.6 million in Q1 2021[179]. - Drug product revenue for Q1 2022 was $7.6 million, down 10% from $8.5 million in Q1 2021[171]. - FibroGen recognized net product revenue of $18.9 million from its collaboration with AstraZeneca in China for Q1 2022, compared to $15.4 million in Q1 2021[166]. - Total product revenue, net increased by $3.5 million, or 23%, for the three months ended March 31, 2022, compared to the same period a year ago, reaching $18.9 million[182]. - Direct sales revenue, net decreased by $2.3 million, or 46%, for the three months ended March 31, 2022, compared to the same period a year ago, totaling $2.7 million[183]. - Sales to Falikang revenue, net increased by $5.8 million, or 56%, for the three months ended March 31, 2022, compared to the same period a year ago, amounting to $16.2 million[185]. Expenses and Losses - Net loss for the three months ended March 31, 2022, was $63.2 million, or $0.68 per share, compared to a net loss of $71.8 million, or $0.78 per share, in the prior year[129]. - Operating costs and expenses for the three months ended March 31, 2022, increased by $14.9 million compared to the same period in 2021, primarily due to higher drug development and clinical trial expenses[128]. - Research and development expenses increased by $14.3 million, or 19%, for the three months ended March 31, 2022, totaling $89.0 million[198]. - Total operating costs and expenses increased by $15.0 million, or 14%, for the three months ended March 31, 2022, totaling $123.8 million[191]. - Cost of goods sold increased by $0.8 million, or 25%, for the three months ended March 31, 2022, compared to the same period a year ago, reaching $4.2 million[192]. - SG&A expenses remained relatively flat for the three months ended March 31, 2022, compared to the same period a year ago, totaling $30.6 million[200]. Cash Flow and Financial Position - Cash and cash equivalents, investments, and accounts receivable totaled $565.4 million as of March 31, 2022, a decrease of $25.0 million from December 31, 2021[130]. - Cash and cash equivalents as of March 31, 2022, were $185.9 million, with short-term investments of $242.2 million and long-term investments of $93.5 million[211]. - Net cash used in operating activities was $8.5 million for the three months ended March 31, 2022, compared to $45.0 million for the same period in 2021[216]. - Net cash provided by investing activities was $25.9 million for the three months ended March 31, 2022, primarily from $76.1 million of proceeds from maturities of investments[222]. - Net increase in cash and cash equivalents was $14.7 million for the three months ended March 31, 2022, compared to a decrease of $244.9 million for the same period in 2021[218]. - As of March 31, 2022, $96.9 million of operating lease liabilities were reported, with $15.3 million expected to be paid within the next 12 months[229]. - The company anticipates needing substantial additional funding for ongoing operations and research and development efforts[226]. - Cash flows from the joint venture with AstraZeneca are intended to remain onshore in China for future expansion or debt obligations[212]. Clinical Trials and Development - The company is conducting two Phase 3 studies of pamrevlumab for idiopathic pulmonary fibrosis, with topline data expected in mid-2023[146]. - Enrollment for the Phase 2/3 trial of roxadustat in myelodysplastic syndromes is ongoing, with topline data expected in the first half of 2023[138]. - The company expects topline overall survival data from the Phase 3 trial of pamrevlumab for locally advanced unresectable pancreatic cancer in the first half of 2024[148]. - The company has completed enrollment of the Phase 3 trial for pamrevlumab in Duchenne muscular dystrophy, with topline data expected in the first half of 2023[150]. - The company expects to complete enrollment of its Phase 3 clinical trial, LELANTOS-2, with approximately 70 ambulatory DMD patients by Q2 2022[151]. Future Revenue and Collaborations - Total cash consideration received through March 31, 2022, from collaboration agreements with Astellas and AstraZeneca amounted to $1.3 billion, with potential future payments of $1.3 billion[169]. - The company anticipates fluctuations in revenue due to the uncertain timing and amount of collaboration payments and product sales[175]. - Future revenues will continue to be generated from collaboration agreements, including license fees, milestone payments, and royalties on drug product sales[175]. - Future milestone payments for research and pre-clinical stage development programs could total approximately $704.1 million under license agreements with HiFiBiO and others, contingent on achieving specific milestones[231]. Market Risks and Accounting Policies - The effective tax rate for the three months ended March 31, 2022, remained at (0.2)%[207]. - The company reported no material changes to its exposure to market risks during the three months ended March 31, 2022[237]. - There were no material changes in critical accounting policies, estimates, and judgments during the three months ended March 31, 2022, compared to the previous year[236]. - The company had no relationships with unconsolidated organizations or financial partnerships for off-balance sheet arrangements during the three months ended March 31, 2022[232].