SEC Filings

Form 10-Q
FIBROGEN INC filed this Form 10-Q on 05/09/2019
Document Outline
Entire Document (5885 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 - FIBROGEN, INC.
Page 9 - Use of Estimates
Page 10 - ASU 2018-02
Page 11 - SEC Disclosure Requirement
Page 12 - Europe Agreement
Page 13 - Summary of Revenue Recognized Under the Collaboration Agreements
Page 14 - Other Revenues
Page 15 - Deferred Revenue
Page 16 - N/A
Page 17 - N/A
Page 18 - N/A
Page 19 - Cash and Cash Equivalents
Page 20 - Property and Equipment
Page 21 - N/A
Page 22 - ITEM 2. MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Page 23 - Financial Highlights
Page 24 - Pooled MACE/MACE+ in Dialysis
Page 25 - Roxadustat for the Treatment of Anemia in Myelodysplastic Syndromes
Page 26 - Duchenne Muscular Dystrophy
Page 27 - AstraZeneca
Page 28 - Additional Information Related to Collaboration Agreements
Page 29 - Operating Expenses
Page 30 - Selling, General and Administrative Expenses
Page 31 - Interest Expense
Page 32 - Operating Capital Requirements
Page 33 - Investing Activities
Page 34 - Leases
Page 35 - Leases (Topic 842) Leases (Topic 842): Targeted Improvements
Page 36 - Fair Value Measurement (Topic 820): Disclosure Framework Changes to the Disclosure Requirements for
Page 37 - PART II OTHER INFORMATION
Page 38 - N/A
Page 39 - All of our recent revenue has been earned from collaboration partners for our product candidates und
Page 40 - If our commercialization efforts for roxadustat in China are unsuccessful, our business, financial c
Page 41 - As a Company, we have no commercialization experience, and the time and resources to develop such ex
Page 42 - Although FibroGen Beijing obtained regulatory approval for roxadustat in China in December 2018, we
Page 43 - Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that ma
Page 44 - We do not know whether our ongoing or planned clinical trials of roxadustat or pamrevlumab will need
Page 45 - Our product candidates may cause or have attributed to them undesirable side effects or have other p
Page 46 - We may fail to enroll a sufficient number of patients in our clinical trials in a timely manner, whi
Page 47 - The FDA and EMA will do their own benefit risk analysis and may reach a different conclusion than we
Page 48 - Even if we are able to obtain regulatory approval of our product candidates, the label we obtain may
Page 49 - If we are unable to establish sales, marketing and distribution capabilities or enter into or mainta
Page 50 - N/A
Page 51 - N/A
Page 52 - Our future commercial success depends upon attaining significant market acceptance of our product ca
Page 53 - Risks Related to Our Reliance on Third Parties
Page 54 - We rely on third parties for the conduct of most of our preclinical and clinical trials for our prod
Page 55 - We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our c
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 - inter partes
Page 59 - We have an extensive worldwide patent portfolio. The cost of maintaining our patent protection is hi
Page 60 - Roxadustat is considered a Class 2 substance on the 2019 World Anti-Doping Agency Prohibited List wh
Page 61 - If our product candidates obtain marketing approval, we will be subject to more extensive healthcare
Page 62 - The impact of recent U.S. healthcare reform, its potential partial or full repeal, and other changes
Page 63 - We may not be able to conduct, or contract others to conduct, animal testing in the future, which co
Page 64 - Our employees may engage in misconduct or other improper activities, including noncompliance with re
Page 65 - The pharmaceutical industry in China is highly regulated and such regulations are subject to change.
Page 66 - In addition to manufacturing, we are responsible for pharmacovigilance, medical affairs, and managem
Page 67 - The market for treatment of anemia in CKD in China is highly competitive.
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 product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 74 - Our headquarters and data storage facilities are located near known earthquake fault zones. The occu
Page 75 - We have broad discretion in the use of the net proceeds from our underwritten public offerings of co
Page 76 - Our principal stockholders and management own a significant percentage of our stock and will be able
Page 77 - Provisions in our charter documents and Delaware law may have anti-takeover effects that could disco
Page 78 - Changes in our tax provision or exposure to additional tax liabilities could adversely affect our ea
Page 79 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 80 - ITEM 6. EXHIBITS.
Page 81 - SIGNATURES
Subdocument 2 - EX-10.26XXXVI - EX-10.26XXXVI
Page 1 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Page 2 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Page 3 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - N/A
XBRL Item - EX-101.INS - XBRL INSTANCE DOCUMENT (What's this?)
XBRL Item - EX-101.SCH - XBRL TAXONOMY EXTENSION SCHEMA (What's this?)
XBRL Item - EX-101.CAL - XBRL TAXONOMY EXTENSION CALCULATION LINKBASE (What's this?)
XBRL Item - EX-101.DEF - XBRL TAXONOMY EXTENSION DEFINITION LINKBASE (What's this?)
XBRL Item - EX-101.LAB - XBRL TAXONOMY EXTENSION LABEL LINKBASE (What's this?)
XBRL Item - EX-101.PRE - XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE (What's this?)
XBRL Viewer