FGEN FibroGen Inc

41.12
-0.5  -1%
Previous Close 41.62
Open 41.61
52 Week Low 22.65
52 Week High 51.56
Market Cap $3,715,401,548
Shares 90,355,096
Float 78,917,183
Enterprise Value $3,245,963,678
Volume 823,268
Av. Daily Volume 684,430
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Upcoming Catalysts

Drug Stage Catalyst Date
Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Roxadustat
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Roxadustat
Chemotherapy-induced anemia (CIA)
Phase 2
Phase 2
Phase 2 trial initiation announced September 26, 2019.
Pamrevlumab
Duchenne muscular dystrophy
Phase 3
Phase 3
Phase 3 commencement of enrollment announced August 10, 2020.
Pamrevlumab (LAPIS)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 initiation of dosing announced October 23, 2019.
Pamrevlumab (FG-3019) - ZEPHYRUS
Idiopathic pulmonary fibrosis
Phase 3
Phase 3
Phase 3 trial initiation announced July 22, 2019. Second Phase 3 trial to be initiated later in 2020.
Pamrevlumab
COVID-19
Phase 2
Phase 2
Phase 2 commencement of enrolment announced June 23, 2020.
Pamrevlumab - Borea
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 commencement of enrolment in Italy trial announced June 8, 2020.

Latest News

  1. SAN FRANCISCO, Sept. 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Percy Carter, MBA, PhD, to the newly-created position of Chief Scientific Officer, where he will lead FibroGen's research efforts, leveraging more than 20 years of global biopharmaceutical leadership and experience.

    "Great science and innovation are the backbone of FibroGen and what enable us to develop transformational medicines for patients. With Percy's leadership, we will continue our legacy of biological breakthroughs and advancing first-in-class therapeutics," said Enrique Conterno, Chief Executive Officer, FibroGen. "Percy's expertise and experience make him the ideal person to lead FibroGen's scientific agenda. I look forward…

    SAN FRANCISCO, Sept. 08, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Percy Carter, MBA, PhD, to the newly-created position of Chief Scientific Officer, where he will lead FibroGen's research efforts, leveraging more than 20 years of global biopharmaceutical leadership and experience.

    "Great science and innovation are the backbone of FibroGen and what enable us to develop transformational medicines for patients. With Percy's leadership, we will continue our legacy of biological breakthroughs and advancing first-in-class therapeutics," said Enrique Conterno, Chief Executive Officer, FibroGen. "Percy's expertise and experience make him the ideal person to lead FibroGen's scientific agenda. I look forward to his leadership impact on advancing our unique position in both hypoxia-inducible factor and connective tissue growth factor biology to expand our pipeline of novel drug candidates."

    Dr. Carter most recently served as Global Head of Discovery Sciences at Janssen (Pharmaceutical Companies of Johnson & Johnson) where he led a global organization of over 700 employees comprising several key functions, including: Computational Sciences; Discovery Chemistry; Drug Metabolism & Pharmacokinetics; Lead Discovery; and Core Business Services. Percy worked in collaboration with therapeutic area discovery scientists and other stakeholders to define and operationalize innovative strategies for the successful identification and optimization of novel small molecule, peptide, and RNA-based drug candidates.

    Prior to his role with Janssen, Percy was Senior Vice President and Head of Discovery for Bristol-Myers Squibb (BMS). For almost two decades at BMS, he held roles of increasing responsibility in drug discovery, covering all therapeutic areas, drug platforms and stages of discovery. Percy began his career as a Senior Research Scientist in Chemical and Physical Sciences at DuPont Pharmaceuticals, and joined BMS when the company acquired DuPont Pharmaceuticals in 2001. During his combined time at BMS and DuPont, he collaborated with a wide range of colleagues to help build the immunoscience pipeline. In 2013, after moving into a cross-therapeutic area role, Percy worked on advancing the overall portfolio, driving innovation in supporting technologies, non-traditional modalities, and novel external partnerships.

    Dr. Carter also led the BMS/Syngene R&D collaboration at the BBRC in Bangalore, India for two years across all aspects of discovery.

    Percy is an inventor or co-inventor on more than 28 U.S. patents and has authored or co-authored more than 85 peer-reviewed publications. He received his bachelor's degree in Organic Chemistry from Dartmouth College, his PhD in Chemistry & Chemical Biology from Harvard University, and completed a post-doctoral fellowship at Harvard Medical School and Massachusetts General Hospital. In 2014, he received his MBA from the Massachusetts Institute of Technology.

    "I've been impressed by the innovation at FibroGen. I'm excited to take on this unique opportunity at a company with expansive HIF and CTGF expertise," said Dr. Carter. "I look forward to working with the research organization to advance the next wave of medicines."

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, MD

    Corporate Strategy / Investor Relations

    1.415.978.1434

     

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  2. SAN FRANCISCO, Sept. 01, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare conferences:

    • Citigroup 15th Annual BioPharma Conference on September 9, 2020 at 2:25 PM Eastern Time
    • Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020 at 3:30 PM Eastern Time

    A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at https://fibrogen.gcs-web.com/.  A replay will be available for approximately 30 days.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of…

    SAN FRANCISCO, Sept. 01, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare conferences:

    • Citigroup 15th Annual BioPharma Conference on September 9, 2020 at 2:25 PM Eastern Time
    • Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020 at 3:30 PM Eastern Time

    A live audio webcast will be available on the "Events & Presentations" section of the FibroGen Investor webpage at https://fibrogen.gcs-web.com/.  A replay will be available for approximately 30 days.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.630.0131

    Primary Logo

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  3. SAN FRANCISCO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).

    The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids, for up to 52 weeks. The primary efficacy endpoint is the change in the total score of performance of upper limb (PUL) assessment, from baseline to Week 52, and additional…

    SAN FRANCISCO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).

    The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids, for up to 52 weeks. The primary efficacy endpoint is the change in the total score of performance of upper limb (PUL) assessment, from baseline to Week 52, and additional endpoints include pulmonary and cardiac function tests. Subjects who complete the 52-week study will be eligible for rollover into an open-label extension study with pamrevlumab and systemic corticosteroids.

    "Duchenne muscular dystrophy is a progressive disease associated with muscle deterioration and weakness, often leading to patients becoming wheelchair-bound by the age of 12," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. "In DMD, inhibition of connective tissue growth factor (CTGF) by pamrevlumab could result in decreased fibrosis in muscles leading to increased muscle function. We hope pamrevlumab provides a meaningful treatment for the patients with this debilitating disease." 

    Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Importantly, skeletal muscle from DMD patients shows elevated levels of CTGF, and a major manifestation of DMD is cardiac fibrosis.

    "Initiation of the LELANTOS Phase 3 clinical trial represents a key milestone for FibroGen and for our DMD clinical program, as well as an important development for the patients and families affected by Duchenne," said Enrique Conterno, Chief Executive Officer, FibroGen. "We are grateful for the collaboration of global regulators, investigators, caregivers, and patients in enabling the conduct of this trial."

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 clinical development for coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About Duchenne Muscular Dystrophy

    Duchenne muscular dystrophy is a rare and debilitating neuromuscular disease that affects approximately 1 in every 3,500 newborn boys. The fatal disease is caused by a genetic mutation leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness, muscle loss, fibrosis, and inflammation. Patients with DMD are often wheelchair-bound before the age of 12, and their progressive muscle weakness may lead to serious medical problems relating to respiratory and cardiac muscle.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020, filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.630.0131

    Primary Logo

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  4. - Strong Second Quarter China Roxadustat Net Sales of $15.7 million -
    - Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time -

    SAN FRANCISCO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the second quarter of 2020 and provided an update on the company's recent developments.

    "Despite this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "I am pleased with the progress we are making with roxadustat across a number of fronts; including our engagement with the FDA, the European submission, and our impressive sales in China. Additionally, we recently…

    - Strong Second Quarter China Roxadustat Net Sales of $15.7 million -

    - Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time -

    SAN FRANCISCO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) reported financial results for the second quarter of 2020 and provided an update on the company's recent developments.

    "Despite this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "I am pleased with the progress we are making with roxadustat across a number of fronts; including our engagement with the FDA, the European submission, and our impressive sales in China. Additionally, we recently initiated three new trials with pamrevlumab: our Phase 3 study with DMD and two trials in patients hospitalized with COVID-19."

    Key Events in Recent Months and Other Developments

    Roxadustat

    • U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.
    • Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, accepted by the European Medicines Agency (EMA) for regulatory review in May.
    • Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review.
    • Presented results from the DOLOMITES Phase 3 study at the 57th ERA-EDTA Virtual Congress in which roxadustat demonstrated non-inferiority to darbepoetin alfa in achievement of hemoglobin correction in non-dialysis-dependent patients with CKD.
    • Continued enrollment of Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).

    Pamrevlumab

    • Initiated a randomized, double-blind, placebo-controlled Phase 2 study investigating the efficacy and safety of pamrevlumab in approximately 130 hospitalized patients with acute COVID-19 infection in the U.S.
    • Initiated BOREA, a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19 in Italy.
    • Reopened enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF after pausing for two months to minimize the risk of exposure to COVID-19.
    • Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).

    Upcoming Events

    • Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve.
    • Plan to initiate LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab in approximately 90 patients with non-ambulatory Duchenne muscular dystrophy (DMD).

    Corporate and Financial

    • Total revenue for the second quarter of 2020 was $42.9 million, as compared to $191.6 million for the second quarter of 2019. The current quarter revenue consisted of $15.7 million in net roxadustat sales in China, $19.0 million in development revenue, and $8.2 million in roxadustat API sales to Astellas in Japan.
    • Net loss for the second quarter of 2020 was $85.3 million, or $0.95 net loss per basic and diluted share, compared to a net income of $116.0 million, or $1.34 net income per basic share and $1.26 per diluted share one year ago.
    • At June 30, 2020, FibroGen had $716.0 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
    • Based on our latest forecast, we reiterate our year-end 2020 estimate to be in the range of $720 to $730 million in cash, cash equivalents, restricted time deposits, investments, and receivables.
    • Amended China Agreement with AstraZeneca in July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability for FibroGen.
    • Appointed Thane Wettig to the newly-created position of Chief Commercial Officer.
    • Appointed Aoife Brennan, M.B., B.Ch., President and CEO of Synlogic, Inc. (NASDAQ:SYBX) to board of directors effective August 5, 2020.
    • Appointed Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute to board of directors effective August 5, 2020.

    Conference Call and Webcast Details 

    FibroGen will host a conference call and webcast today, Thursday, August 6, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company's website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen second quarter 2020 financial results conference call, and use passcode 8363719. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 8363719.

    About Roxadustat

    Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan it is approved for the treatment of anemia in CKD patients on dialysis and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia in CKD was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, our financial results, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.



    Condensed Consolidated Balance Sheets

    (In thousands)

     June 30, 2020  December 31, 2019 
     (Unaudited)  (1) 
    Assets       
    Current assets:       
    Cash and cash equivalents$429,269  $126,266  
    Short-term investments 256,317   407,491  
    Accounts receivable, net 26,519   28,455  
    Inventory 8,582   6,887  
    Prepaid expenses and other current assets 6,481   133,391  
    Total current assets 727,168   702,490  
            
    Restricted time deposits 2,072   2,072  
    Long-term investments 229   61,118  
    Property and equipment, net 36,984   42,743  
    Finance lease right-of-use assets 34,368   39,602  
    Other assets 6,862   9,372  
    Total assets$807,683  $857,397  
            
    Liabilities, stockholders' equity and non-controlling interests       
    Current liabilities:       
    Accounts payable$5,015  $6,088  
    Accrued and other liabilities 50,464   83,816  
    Deferred revenue 9,813   490  
    Finance lease liabilities, current 12,279   12,351  
    Total current liabilities 77,571   102,745  
            
    Long-term portion of lease obligations 940   1,141  
    Product development obligations 16,959   16,780  
    Deferred revenue, net of current 138,242   99,449  
    Finance lease liabilities, non-current 31,586   37,610  
    Other long-term liabilities 127,242   64,266  
    Total liabilities 392,540   321,991  
            
    Total stockholders' equity 395,872   516,135  
    Non-controlling interests 19,271   19,271  
    Total equity 415,143   535,406  
    Total liabilities, stockholders' equity and non-controlling interests$807,683  $857,397  
     

    (1) The condensed consolidated balance sheet amounts at December 31, 2019 are derived from audited financial statements.



    Condensed Consolidated Statements of Operations

    (In thousands, except per share data)

     Three Months Ended June 30,  Six Months Ended June 30, 
     2020  2019  2020  2019 
       
     (Unaudited) 
    Revenue:               
    License revenue$  $150,581  $  $150,581 
    Development and other revenue 18,957   40,985   38,402   64,848 
    Product revenue, net 15,693      20,648    
    Drug product revenue 8,238      8,238    
    Total revenue 42,888   191,566   67,288   215,429 
    Operating costs and expenses:               
    Cost of goods sold 3,076      4,047    
    Research and development 61,414   52,008   116,315   102,505 
    Selling, general and administrative 63,535   26,739   113,138   48,948 
    Total operating costs and expenses 128,025   78,747   233,500   151,453 
    Income (loss) from operations (85,137)  112,819   (166,212)  63,976 
    Interest and other, net:               
    Interest expense (651)  (736)  (1,284)  (1,507)
    Interest income and other, net 644   4,125   3,810   8,303 
    Total interest and other, net (7)  3,389   2,526   6,796 
    Income (loss) before income taxes (85,144)  116,208   (163,686)  70,772 
    Provision for (benefit from) income taxes 169   205   (25)  180 
    Net income (loss)$(85,313) $116,003  $(163,661) $70,592 
                    
    Net income (loss) per share               
    Basic$(0.95) $1.34  $(1.84) $0.82 
    Diluted$(0.95) $1.26  $(1.84) $0.77 
                    
    Weighted average number of common shares used to calculate net income (loss) per share:               
    Basic 89,451   86,445   88,835   86,077 
    Diluted 89,451   91,728   88,835   92,069 
                    



    Contact: FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434

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  5. - Appoints Aoife Brennan, M.B., B.Ch., President and CEO of Synlogic Inc. (NASDAQ:SYBX) -
    - Appoints Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute -

    SAN FRANCISCO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Dr. Aoife Brennan and Dr. Ben Cravatt to its Board of Directors effective August 5, 2020. Dr. Brennan is President and CEO of Synlogic Inc. (NASDAQ:SYBX), a clinical stage biotechnology company bringing the transformative potential of synthetic biology to medicine. She joined Synlogic as Chief Medical Officer in 2016 and was promoted to CEO in October 2018. Dr. Cravatt is a Professor and the…

    - Appoints Aoife Brennan, M.B., B.Ch., President and CEO of Synlogic Inc. (NASDAQ:SYBX) -

    - Appoints Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute -

    SAN FRANCISCO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced the appointment of Dr. Aoife Brennan and Dr. Ben Cravatt to its Board of Directors effective August 5, 2020. Dr. Brennan is President and CEO of Synlogic Inc. (NASDAQ:SYBX), a clinical stage biotechnology company bringing the transformative potential of synthetic biology to medicine. She joined Synlogic as Chief Medical Officer in 2016 and was promoted to CEO in October 2018. Dr. Cravatt is a Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute. His research group is interested in developing chemical proteomic technologies that enable protein and drug discovery on a global scale and applying these methods to characterize biochemical pathways that play important roles in human physiology and disease. Professor Cravatt joined the faculty at The Scripps Research Institute in 1997.

    "We are honored to welcome both Aoife and Ben to our Board of Directors at this exciting point in FibroGen's history. Aoife's deep experience in rare diseases and clinical development, and Ben's world-class expertise in biology and chemistry will provide invaluable perspective to our Board." said Enrique Conterno, Chief Executive Officer, FibroGen.

    • "I very much look forward to working with Mr. Conterno and the other Directors to deliver on the unlimited potential of FibroGen and its exciting portfolio of innovative medicines to address major unmet needs in human health and disease." said Dr. Cravatt.
    • "I am excited to join FibroGen's Board as the company moves to accelerate pivotal study development of pamrevlumab in multiple orphan indications, and toward approval and launch of roxadustat for the treatment of anemia associated with CKD worldwide, as well as expanding into additional indications for the treatment of anemia," Dr. Brennan added. "I look forward to working with Enrique and the entire Board of Directors to advance these important products."

    Prior to joining Synlogic, Dr. Brennan served as Vice President and Head of the Rare Disease Innovation Unit at Biogen where her responsibilities included the global marketing approvals of ALPROLIX™, ELOCTATE™ and SPINRAZA™ as well as the advancement of several early-phase programs and external collaborations. She served as a Director of Ra Pharmaceuticals from Sept 2018 through its acquisition in April 2020. Dr. Brennan holds a medical degree from Trinity College Dublin, Ireland and completed residency and fellowship training in general internal medicine and endocrinology. She has completed post-doctoral training in clinical research and metabolism at the Beth Israel Deaconess Medical Center in Boston and is a graduate of the Harvard Medical School Scholars in Clinical Science Program.

    A Professor at Scripps Research for more than twenty years, Dr. Cravatt is an Associate Editor for Journal of the American Chemical Society and is a co-founder of Activx Biosciences, Abide Therapeutics, and Vividion Therapeutics. He serves on the Board of Directors of Vividion, Boundless Bio, and Autobahn Therapeutics. Dr. Cravatt's honors include a Searle Scholar Award, the Eli Lilly Award in Biological Chemistry, a Cope Scholar Award, the ASBMB Merck Award, the RSC Jeremy Knowles Award, the AACR Award for Achievement in Chemistry in Cancer Research, and memberships in the American Academy of Arts and Sciences, National Academy of Inventors, National Academy of Medicine, and National Academy of Sciences. Dr. Cravatt obtained his undergraduate education at Stanford University, receiving a B.S. in the Biological Sciences and a B.A. in History. He then received a Ph.D. from The Scripps Research Institute in 1996.

    "I am delighted to welcome Drs. Brennan and Cravatt to the FibroGen Board of Directors," said Jim Schoeneck, chairman of the FibroGen's Board. "Both will bring fresh perspectives that will help the Board and management advance our clinical development and research agendas to bring potential first-in-class medicines to patients suffering from chronic or life-threatening conditions."

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contact:

    FibroGen, Inc.

    Media Inquiries:

    Sara Iacovino

    1.703.474.4452

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434

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