FibroGen(FGEN)

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FibroGen(FGEN) - 2020 Q3 - Quarterly Report
2020-11-05 21:13
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 September 30, 2020 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 - Slideshow
2020-09-18 17:39
FibroGen, Inc. Corporate Presentation September 2020 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 identifi ...
FibroGen(FGEN) - 2020 Q2 - Earnings Call Transcript
2020-08-07 05:47
FibroGen, Inc. (NASDAQ:FGEN) Q2 2020 Earnings Conference Call August 6, 2020 5:00 PM ET Company Participants Michael Tung – Vice President-Corporate Strategy and Investor Relations Enrique Conterno – Chief Executive Officer Pat Cotroneo – Chief Financial Officer Chris Chung – Senior Vice President-China Operations Thane Wettig – Chief Commercial Officer Peony Yu – Chief Medical Officer Conference Call Participants Geoffrey Porges – SVB Leerink Michael Yee – Jefferies Joel Beatty – Citi Jason Gerberry – Bank ...
FibroGen(FGEN) - 2020 Q2 - Quarterly Report
2020-08-06 20:16
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, 2020 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) - 2020 Q1 - Earnings Call Transcript
2020-05-09 20:05
FibroGen, Inc. (NASDAQ:FGEN) Q1 2020 Earnings Conference Call May 7, 2020 5:00 PM ET Corporate Participants Mike Tung - Investor Relations Enrique Conterno - Chief Executive Officer Peony Yu - Chief Medical Officer Chris Chung - Senior Vice President, China Operations Elias Kouchakji - Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance Pat Cotroneo - Chief Financial Officer Conference Call Participants Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Jason Gerberry - Bank of ...
FibroGen(FGEN) - 2020 Q1 - Quarterly Report
2020-05-07 20:12
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 March 31, 2020 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) - 2019 Q4 - Earnings Call Transcript
2020-03-03 00:38
FibroGen, Inc. (NASDAQ:FGEN) Q4 2019 Earnings Conference Call March 2, 2020 5:00 PM ET Company Participants Mike Tung - Investor Relations Enrique Conterno - Chief Executive Officer Peony Yu - Chief Medical Officer Chris Chung - Senior Vice President, China Operations Elias Kouchakji - Senior Vice President, Clinical Development, Drug Safety and Pharmacovigilance Pat Cotroneo - Chief Financial Officer Conference Call Participants Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Andy Hsieh - William Bla ...
FibroGen(FGEN) - 2019 Q4 - Annual Report
2020-03-02 21:18
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, 2019 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 in ...
FibroGen (FGEN) Investor Presentation - Slideshow
2020-01-24 16:35
FibroGen, Inc. Corporate Presentation January 2020 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 statements can generally be identified b ...
FibroGen(FGEN) - 2019 Q3 - Quarterly Report
2019-11-12 13:23
Financial Performance - Revenue for the three months ended September 30, 2019, was $33.2 million, an increase from $29.0 million in the same period last year, while revenue for the nine months ended September 30, 2019, was $248.6 million, up from $104.9 million year-over-year [129]. - The company reported a net loss of $49.4 million for the three months ended September 30, 2019, compared to a net loss of $42.6 million for the same period last year, while for the nine months ended September 30, 2019, net income was $21.2 million, a significant improvement from a net loss of $107.4 million in the prior year [133]. - Total revenue for the three months ended September 30, 2019, increased by $4.1 million, or 14%, compared to the same period in 2018, and for the nine months, it increased by $143.7 million, or 137% [222]. - License revenue for the three months ended September 30, 2019, was $11.9 million, a 100% increase, and for the nine months, it was $162.5 million, an increase of 1,035% compared to the same periods in 2018 [223]. - Development revenue for the three months ended September 30, 2019, decreased by $8.4 million, or 29%, and for the nine months, it decreased by $5.1 million, or 6% compared to the same periods in 2018 [228]. Cash and Investments - Cash and cash equivalents, investments, and accounts receivable totaled $658.9 million as of September 30, 2019, a decrease of $82.0 million from December 31, 2018, primarily due to cash used in operations [134]. - As of September 30, 2019, the company had cash and cash equivalents of $196.6 million and short-term investments of $432.0 million [259]. - The company expects its existing cash, cash equivalents, and investments to meet anticipated cash requirements for at least the next 12 months [261]. - Net cash used in operating activities was $33.7 million for the nine months ended September 30, 2019, primarily due to a net income of $21.2 million adjusted for non-cash items of $61.9 million [264]. - Net cash provided by investing activities was $145.1 million for the nine months ended September 30, 2019, consisting of proceeds from maturities of investments of $305.0 million [268]. Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2019, increased by $14.2 million compared to the same period last year, primarily due to higher outside service expenses and legal expenses [130]. - Total operating costs and expenses for the three months ended September 30, 2019, increased by $14.2 million, or 20%, and for the nine months, it increased by $26.0 million, or 12% compared to the same periods in 2018 [235]. - Selling, general and administrative (SG&A) expenses increased by $20.5 million, or 133%, for the three months ended September 30, 2019, compared to the same period a year ago, driven by increases in outside service expenses and facility-related expenses [244]. - SG&A expenses for the nine months ended September 30, 2019, increased by $38.8 million, or 84%, compared to the same period a year ago [248]. - Research and development expenses decreased by $6.5 million, or 11%, for the three months ended September 30, 2019, compared to the same period a year ago, primarily due to decreases in drug development expenses and clinical trial costs [240]. Product Development and Approvals - Roxadustat received marketing authorization in China for the treatment of anemia caused by chronic kidney disease (CKD) in non-dialysis patients in August 2019, and was approved in Japan for dialysis patients in September 2019 [135]. - The company plans to submit the U.S. NDA for roxadustat in the fourth quarter of 2019 and the MAA in Europe in the first quarter of 2020 [136]. - The company is conducting a Phase 2 clinical trial of roxadustat for chemotherapy-induced anemia, enrolling up to 100 patients [189]. - The ongoing Phase 3 trial for pamrevlumab in idiopathic pulmonary fibrosis (IPF) aims to enroll approximately 565 patients [192]. - The company plans to share results from the Phase 2 trial of pamrevlumab for Duchenne muscular dystrophy (DMD) with the FDA in Q4 2023 [194]. Clinical Trial Results - Roxadustat demonstrated a mean change in hemoglobin of 1.85 g/dL in non-dialysis patients compared to 0.13 g/dL in the placebo group, with a p-value of <0.001, indicating statistical significance [137]. - In a subgroup of dialysis patients with inflammation, the mean change in hemoglobin was 1.29 g/dL for roxadustat compared to 0.96 g/dL for epoetin alfa, with a p-value of <0.0001 [138]. - Roxadustat-treated patients had a lower one-year decline in estimated glomerular filtration rate (eGFR) of -2.8 mL/min/1.73m² compared to -4.4 mL/min/1.73m² in placebo-treated patients, with a treatment difference of 1.6 mL/min/1.73m² (p<0.0001) [143]. - In the ANDES trial, roxadustat showed a mean hemoglobin change of 2.00 g/dL compared to 0.16 g/dL for placebo (p<0.0001) [156]. - In the HIMALAYAS trial, the mean hemoglobin change for roxadustat was 2.57 g/dL versus 2.36 g/dL for epoetin alfa, achieving superiority (p=0.0005) [162]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca include total consideration that could reach $2.5 billion, with $917.6 million from Astellas and $1.6 billion from AstraZeneca [200][207]. - Astellas is responsible for 100% of commercialization costs in its territories, while AstraZeneca will pay for all commercialization costs in the U.S. and RoW [209]. - License revenue recognized under collaboration agreements with Astellas included a regulatory milestone of $12.5 million related to NDA approval in Japan during the third quarter of 2019 [224]. - License revenue recognized under collaboration agreements with AstraZeneca included a regulatory milestone of $50.0 million related to the planned NDA submission in the U.S. [226]. - Development revenue recognized under collaboration agreements with Astellas for the nine months ended September 30, 2019, increased by $9.2 million, or 56% due to regulatory milestones [230]. Market and Regulatory Environment - The overall safety profile of roxadustat was comparable to placebo, with common adverse events including nausea, hypertension, and hyperkalemia [161]. - The company recorded a cumulative-effect adjustment of approximately $50.3 million in right-of-use assets and approximately $62.0 million in lease liabilities upon the adoption of ASC 842 [283]. - The company did not have any relationships with unconsolidated organizations or financial partnerships for off-balance sheet arrangements during the three and nine months ended September 30, 2019 [273]. - There has been no material change in the company's exposure to market risks as disclosed in the Annual Report for the year ended December 31, 2018 [292].