FibroGen(FGEN)

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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) - 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].
FibroGen(FGEN) - 2019 Q2 - Quarterly Report
2019-08-08 20:21
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, 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 ...
FibroGen(FGEN) - 2019 Q1 - Quarterly Report
2019-05-09 20:21
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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | |-----------------------------------------------------------------------------------------------------------|-------------------------------| ...
FibroGen(FGEN) - 2018 Q4 - Annual Report
2019-02-27 22:02
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, 2018 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 ...