SEC Filings

Form 10-Q
FIBROGEN INC filed this Form 10-Q on 11/08/2018
Document Outline
Entire Document (5789.9 KB)
Subdocument 1 - 10-Q - 10-Q
Page 1 - UNITED STATES
Page 2 - FIBROGEN, INC.
Page 3 - FIBROGEN, INC.
Page 4 - FIBROGEN, INC.
Page 5 - FIBROGEN, INC.
Page 6 - FIBROGEN, INC.
Page 7 - FIBROGEN, INC.
Page 8 - Investments
Page 9 - Use of Estimates
Page 10 - Statement of Operations
Page 11 - ASU 2016-16
Page 12 - Leases (Topic 842) Leases (Topic 842): Targeted Improvements
Page 13 - AstraZeneca Agreements
Page 14 - Manufacturing rights.
Page 15 - Accounting for the AstraZeneca Agreements
Page 16 - U.S./RoW Agreement:
Page 17 - China Agreement:
Page 18 - Summary of Revenue Recognized Under the Collaboration Agreements
Page 19 - Other Revenues
Page 20 - Cash and Cash Equivalents
Page 21 - Investments
Page 22 - N/A
Page 23 - ITEM 2. MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Page 24 - Financial Highlights
Page 25 - Programs
Page 26 - Pamrevlumab (FG-3019) Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF)
Page 27 - AstraZeneca
Page 28 - Additional Information Related to Collaboration Agreements
Page 29 - License Revenue
Page 30 - Operating Expenses
Page 31 - General and Administrative Expenses
Page 32 - Interest Income and Other, Net
Page 33 - Risk Factors
Page 34 - Investing Activities
Page 35 - Revenue Recognition
Page 36 - Recently Issued and Adopted Accounting Guidance
Page 37 - Financial Instruments-Overall (Subtopic 825-10)
Page 38 - Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instrumen
Page 39 - PART II OTHER INFORMATION
Page 40 - All of our recent revenue has been earned from collaboration partners for our product candidates und
Page 41 - If we are unable to continue to progress our development efforts and achieve milestones under our co
Page 42 - We may be unable to obtain regulatory approval for our product candidates, or such approval may be d
Page 43 - Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that ma
Page 44 - N/A
Page 45 - We do not know whether our ongoing or planned Phase 3 clinical trials in roxadustat or Phase 2 clini
Page 46 - Clinical trials of our product candidates may not uncover all possible adverse effects that patients
Page 47 - If we or third party manufacturers on which we rely cannot manufacture sufficient quantities of our
Page 48 - As an organization, we have not successfully commercialized any drug product and have only completed
Page 49 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 50 - N/A
Page 51 - Our future commercial success depends upon attaining significant market acceptance of our product ca
Page 52 - No or limited reimbursement or insurance coverage of our approved products, if any, by third party p
Page 53 - Conflicts with our collaboration partners could jeopardize our collaboration agreements and our abil
Page 54 - We rely on third parties for the conduct of most of our preclinical and clinical trials for our prod
Page 55 - N/A
Page 56 - Certain of the components of our product candidates are acquired from single-source suppliers and ha
Page 57 - Intellectual property disputes with third parties and competitors may be costly and time consuming,
Page 58 - Our reliance on third parties and agreements with collaboration partners requires us to share our tr
Page 59 - Intellectual property rights do not address all potential threats to any competitive advantage we ma
Page 60 - If our product candidates obtain marketing approval, we will be subject to more extensive healthcare
Page 61 - The impact of recent U.S. healthcare reform, its potential partial or full repeal, and other changes
Page 62 - N/A
Page 63 - We may not be able to conduct, or contract others to conduct, animal testing in the future, which co
Page 64 - Risks Related to Our International Operations
Page 65 - Patients use of traditional Chinese medicine in violation of study protocols in our China studies ma
Page 66 - Our decision to seek approval in China for roxadustat prior to approval in the U.S. or Europe is lar
Page 67 - The Chinese government is implementing a new Two Invoices regulation which could affect the way we s
Page 68 - If our planned business activities in China fall within a restricted category under the China Catalo
Page 69 - Because FibroGen Beijing s funds are held in banks that do not provide insurance, the failure of any
Page 70 - Our foreign operations, particularly those in China, are subject to significant risks involving the
Page 71 - Uncertainties with respect to the China legal system could have a material adverse effect on us.
Page 72 - Our operations in China subject us to various Chinese labor and social insurance laws, and our failu
Page 73 - If we fail to attract and keep senior management and key personnel, in particular our chief executiv
Page 74 - We depend on sophisticated information technology systems to operate our business and a cyber-attack
Page 75 - N/A
Page 76 - We have broad discretion in the use of the net proceeds from our underwritten public offerings of co
Page 77 - We may engage in future acquisitions that could disrupt our business, cause dilution to our stockhol
Page 78 - Changes in our tax provision or exposure to additional tax liabilities could adversely affect our ea
Page 79 - Our amended and restated certificate of incorporation designates the state or federal courts located
Page 80 - ITEM 6. EXHIBITS.
Page 81 - SIGNATURES
Subdocument 2 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 3 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 4 - EX-32.1 - EX-32.1
Page 1 - N/A
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