FibroGen(US:FGEN)2021-11-08 16:00Financial Performance - Revenue for the three months ended September 30, 2021, was $155.973 million, a significant increase from $44.032 million in the same period of 2020, representing a growth of 253%[169] - Net income for the three months ended September 30, 2021, was $49.798 million, compared to a net income of $33.004 million for the same period in 2020, reflecting a year-over-year increase of 51%[169] - License revenue for Q3 2021 was $116.4 million, a 100% increase compared to the previous year[211] - Total revenue for Q3 2021 increased by $111.9 million, or 254%, compared to the same period last year[216] - Development and other revenue for Q3 2021 was $26.1 million, a 26% increase from $20.7 million in Q3 2020[211] - Product revenue for Q3 2021 was $13.4 million, a decrease of 41% compared to the previous year[211] - Total product revenue, net for the nine months ended September 30, 2021, was $42.2 million, a 3% decrease from $43.3 million in the same period in 2020[225] Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2021, were $104.999 million, up from $11.702 million in the same period of 2020, indicating a substantial increase due to higher sales and marketing expenses[173] - Total operating costs and expenses increased by $93.3 million, or 797%, for the three months ended September 30, 2021, and by $126.9 million, or 52%, for the nine months ended September 30, 2021, compared to the same periods a year ago[233] - Research and development expenses increased by $17.4 million, or 30%, for the three months ended September 30, 2021, and by $98.3 million, or 56%, for the nine months ended September 30, 2021, compared to the same periods a year ago[240][242] - SG&A expenses increased by $74.8 million, or 153%, for the three months ended September 30, 2021, and by $25.0 million, or 39%, for the nine months ended September 30, 2021, compared to the same periods a year ago[244][245] Cash and Investments - Cash and cash equivalents totaled $274.527 million as of September 30, 2021, down from $678.393 million at the end of 2020, a decrease of $403.866 million[169] - As of September 30, 2021, the company had cash and cash equivalents of $274.5 million, with short-term and long-term investments totaling $211.9 million and $142.6 million, respectively[259] - The company reported a net cash used in operating activities of $27.3 million for the nine months ended September 30, 2021, primarily due to a net loss of $155.9 million adjusted for non-operating cash items[263] - For the nine months ended September 30, 2021, net cash used in investing activities was $376.4 million, mainly from purchases of available-for-sale securities totaling $397.9 million[269] Product Development and Regulatory Updates - The FDA issued a complete response letter regarding Roxadustat's NDA for CKD anemia, indicating that it could not be approved in its current form[181] - The company is conducting a Phase 2/3 trial for Roxadustat in anemia associated with myelodysplastic syndromes, with topline data expected between the second half of 2022 and the first half of 2023[182] - Pamrevlumab has received multiple designations from the FDA, including Rare Pediatric Disease designation and Fast Track designation for the treatment of Duchenne muscular dystrophy[187] - The company expects topline overall survival data from the Phase 3 clinical program for pamrevlumab in pancreatic cancer in the first half of 2024[189] - The company expects topline data from the LELANTOS-1 Phase 3 trial in the first half of 2023[191] - The LELANTOS-2 trial is enrolling approximately 70 ambulatory DMD patients, with a treatment period of 52 weeks[192] Collaboration and Licensing Agreements - The company recognized $120.0 million in milestone payments from Astellas due to the approval of EVRENZO® in Europe[199] - Total cash consideration received from collaboration agreements with Astellas and AstraZeneca through September 30, 2021, was $1.28 billion[209] - Total potential cash payments from collaboration agreements amount to $2.54 billion, including upfront and milestone payments[209] - Future milestone payments under license agreements could total approximately $359.1 million, contingent upon achieving specific developmental and regulatory milestones[278] - The company has an exclusive license agreement with Eluminex, which includes an $8.0 million upfront payment and potential future payments of up to $100.0 million[195] Market Position and Sales - Roxadustat had a 33% value share in the erythropoiesis stimulating agents and HIF-PH inhibitors market in China as of October 2021[179] - Falikang became fully operational in January 2021, and it is the primary customer for roxadustat sales in China[282] - Revenue from roxadustat sales is recognized when control is transferred to Falikang, based on estimated transaction price per unit and actual quantity delivered[284] - Direct sales to pharmaceutical distributors in provinces not covered by Falikang also contribute to revenue, with revenue recognized upon transfer of control[289] Financial Risks and Future Outlook - The company anticipates continued losses despite revenue growth from roxadustat product sales in China, and is implementing cost reduction efforts following a Complete Response Letter (CRL) for roxadustat in the U.S.[260] - The company expects substantial additional funding will be needed to support ongoing operations and research and development efforts[260] - The company is subject to risks related to the development and commercialization of novel therapeutics, which may lead to unforeseen expenses and complications[260] - The company has not identified any material changes to its exposure to market risks as of September 30, 2021[295]