FibroGen(FGEN)

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FibroGen(FGEN) - 2022 Q2 - Quarterly Report
2022-08-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) Delaware 77-0357827 (State or Other Jurisdiction of ...
FibroGen(FGEN) - 2022 Q1 - Earnings Call Transcript
2022-05-10 03:25
FibroGen, Inc. (NASDAQ:FGEN) Q1 2022 Earnings Conference Call May 9, 2022 5:00 PM ET Company Participants Michael Tung – Corporate Strategy/Investor Relations Enrique Conterno – Chief Executive Officer Mark Eisner – Chief Medical Officer Juan Graham – Chief Financial Officer Thane Wettig – Chief Commercial Officer Chris Chung – Senior Vice President of China Operations Conference Call Participants Michael Yee – Jefferies Andy Hsieh – William Blair Yaron Werber – Cowen Annabel Samimy – Stifel Operator Ladies ...
FibroGen(FGEN) - 2022 Q1 - Quarterly Report
2022-05-08 16:00
Revenue 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].
FibroGen (FGEN) Investor Presentation - Slideshow
2022-03-12 15:55
FibroGen, Inc. Corporate Presentation March 2022 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identified b ...
FibroGen(FGEN) - 2021 Q4 - Earnings Call Presentation
2022-03-04 21:13
FibroGen Reports Fourth Quarter and Full Year 2021 Financial Results February 28, 2022 Forward-Looking Statements This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking stat ...
FibroGen(FGEN) - 2021 Q4 - Earnings Call Transcript
2022-03-01 03:57
FibroGen, Inc. (NASDAQ:FGEN) Q4 2021 Earnings Conference Call February 28, 2022 5:00 PM ET Company Participants Michael Tung - VP, Corporate Strategy and IR Enrique Conterno - CEO Juan Graham - CFO Mark Eisner - CMO John Hunter - CSO Thane Wettig - CCO Chris Chung - SVP, China Operations Conference Call Participants Annabel Samimy - Stifel Michael Yee - Jefferies Alex Ramsey - William Blair Operator Good day, and thank you for standing by and welcome to the FibroGen Fourth Quarter 2021 Financial Results Con ...
FibroGen(FGEN) - 2021 Q4 - Annual Report
2022-02-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | |--------------------------------- ...
FibroGen (FGEN) Investor Presentation
2021-11-23 18:21
FibroGen, Inc. Corporate Presentation November 2021 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identifie ...
FibroGen(FGEN) - 2021 Q3 - Earnings Call Presentation
2021-11-10 05:44
FibroGen Reports Third Quarter 2021 Financial Results November 9, 2021 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can gen ...
FibroGen(FGEN) - 2021 Q3 - Earnings Call Transcript
2021-11-10 04:43
FibroGen, Inc. (NASDAQ:FGEN) Q3 2021 Earnings Conference Call November 9, 2021 5:00 PM ET Company Participants Michael Tung - VP, Corporate Strategy and IR Enrique Conterno - CEO Juan Graham - CFO Mark Eisner - CMO John Hunter - CSO Conference Call Participants Annabel Samimy - Stifel Edwin Zhang - H.C. Wainwright Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Paul Choi - Goldman Sachs Andy Hsieh - William Blair Operator Hello. Thank you for standing by. Welcome to the FibroGen Third Quarter 2021 Fin ...