SEC Filings

Form 10-K
FIBROGEN INC filed this Form 10-K on 02/27/2019
Document Outline
Entire Document (11511.7 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - FORWARD-LOOKING STATEMENTS
Page 4 - PART I
Page 5 - Chronic Kidney Disease in Japan.
Page 6 - Roxadustat Phase 3 CKD Anemia Clinical Trials
Page 7 - Incident Dialysis CKD Patients Study (HIMALAYAS) FibroGen
Page 8 - Non-Dialysis CKD Patients (ALPS) Astellas
Page 9 - Stages of CKD and Prevalence in the U.S.
Page 10 - Roxadustat A Novel, Orally Administered Treatment for Anemia
Page 11 - Potential for Reduced Hepcidin Levels and Anemia Correction Without Routine IV Iron Supplementation
Page 12 - Potential Cholesterol Benefits
Page 13 - Potential Reimbursement and Convenience Advantages
Page 14 - Phase 1 and Phase 2 Clinical Trials
Page 15 - Completed Phase 2 Studies
Page 16 - Phase 3 Studies in China
Page 17 - FGCL-4592-808: Mean Change in Hemoglobin over Time in Phase 3 China Non-Dialysis CKD Patients (26 We
Page 18 - FGCL-4592-806: Mean (+/- SE) Change from Baseline in Hemoglobin (Hb)
Page 19 - FGCL-4592-806: Mean (+/- SE) Hemoglobin (Hb) and
Page 20 - Market Opportunity
Page 21 - Current ESA Market Size and Drivers of Market Growth in China
Page 22 - Pricing
Page 23 - ROXADUSTAT FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE IN JAPAN
Page 24 - Phase 3 Study 1517-CL-0312: Open-Label ESA-Conversion Study in Hemodialysis
Page 25 - Limitations of the Current Standard of Care for MDS and Anemia Associated with MDS
Page 26 - Our Solution
Page 27 - PAMREVLUMAB FOR THE TREATMENT OF FIBROSIS AND CANCER
Page 28 - Overview of Fibrosis
Page 29 - Most Biological Factors Implicated in Fibrosis Work Through CTGF
Page 30 - Phase 3 Clinical Development Randomized, Double-Blind, Placebo-Controlled Trial of Pamrevlumab in IP
Page 31 - Study 049 Open-Label Phase 2 Trial of Pamrevlumab in IPF
Page 32 - Changes in Fibrosis in Patients with Mild to Moderate IPF Treated with Pamrevlumab in FGCL-3019-049
Page 33 - Pancreatic Cancer
Page 34 - Study 069 Randomized, Open-Label, Active-Controlled Phase 1/2 Trial of Pamrevlumab in Locally Advanc
Page 35 - Increased Pancreatic Cancer Survival Associated with Increased Plasma Levels of Pamrevlumab
Page 36 - Clinical Development of Pamrevlumab for DMD
Page 37 - Market Opportunity
Page 38 - COLLABORATIONS
Page 39 - N/A
Page 40 - Additional Information Related to Collaboration Agreements
Page 41 - Pamrevlumab
Page 42 - Pancreatic Cancer
Page 43 - Irix Pharmaceuticals, Inc.
Page 44 - GOVERNMENT REGULATION
Page 45 - Phase 1.
Page 46 - Pediatric Exclusivity and Pediatric Use
Page 47 - Prescription Drug Marketing Act
Page 48 - N/A
Page 49 - Pharmaceutical Coverage, Pricing and Reimbursement
Page 50 - Healthcare Reform
Page 51 - Regulation in China
Page 52 - Device Regulation
Page 53 - Regulatory Exclusivity for Approved Products
Page 54 - Foreign Country Data Exclusivity
Page 55 - Roxadustat Patent Portfolio
Page 56 - N/A
Page 57 - Pamrevlumab
Page 58 - University of Miami
Page 59 - Third Party Filings
Page 60 - AVAILABLE INFORMATION
Page 61 - ITEM 1A. RISK FACTORS
Page 62 - All of our recent revenue has been earned from collaboration partners for our product candidates und
Page 63 - Risks Related to the Development and Commercialization of Our Product Candidates
Page 64 - If our commercialization efforts for roxadustat in China are unsuccessful, our business, financial c
Page 65 - As a Company, we have no commercialization experience, and the time and resources to develop such ex
Page 66 - Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that ma
Page 67 - N/A
Page 68 - We do not know whether our ongoing or planned Phase 3 clinical trials in roxadustat or Phase 2 clini
Page 69 - Clinical trials of our product candidates may not uncover all possible adverse effects that patients
Page 70 - If we or third party manufacturers and other service providers on which we rely cannot manufacture s
Page 71 - As an organization, we have not successfully commercialized any drug product. Therefore, we may not
Page 72 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 73 - N/A
Page 74 - Our future commercial success depends upon attaining significant market acceptance of our product ca
Page 75 - No or limited reimbursement or insurance coverage of our approved products, if any, by third party p
Page 76 - Conflicts with our collaboration partners could jeopardize our collaboration agreements and our abil
Page 77 - We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our c
Page 78 - N/A
Page 79 - Certain of the components of our product candidates are acquired from single-source suppliers and ha
Page 80 - Intellectual property disputes with third parties and competitors may be costly and time consuming,
Page 81 - Our reliance on third parties and agreements with collaboration partners requires us to share our tr
Page 82 - Intellectual property rights do not address all potential threats to any competitive advantage we ma
Page 83 - Risks Related to Government Regulation
Page 84 - If our product candidates obtain marketing approval, we will be subject to more extensive healthcare
Page 85 - The impact of recent U.S. healthcare reform, its potential partial or full repeal, and other changes
Page 86 - We may not be able to conduct, or contract others to conduct, animal testing in the future, which co
Page 87 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 88 - The pharmaceutical industry in China is highly regulated and such regulations are subject to change.
Page 89 - Our decision to launch roxadustat in China prior to approval in the U.S. or Europe is largely unprec
Page 90 - The Chinese government is implementing a new Two Invoices regulation which could affect the way we s
Page 91 - FibroGen Beijing would be subject to restrictions on paying dividends or making other payments to us
Page 92 - We may be subject to tax inefficiencies associated with our offshore corporate structure.
Page 93 - We are subject to laws and regulations governing corruption, which will require us to develop, maint
Page 94 - Uncertainties with respect to the China legal system could have a material adverse effect on us.
Page 95 - Recent developments relating to the United Kingdom s referendum vote in favor of leaving the EU coul
Page 96 - If product liability lawsuits are brought against us, we may incur substantial liabilities and may b
Page 97 - Our headquarters and data storage facilities are located near known earthquake fault zones. The occu
Page 98 - We have broad discretion in the use of the net proceeds from our underwritten public offerings of co
Page 99 - Our principal stockholders and management own a significant percentage of our stock and will be able
Page 100 - Provisions in our charter documents and Delaware law may have anti-takeover effects that could disco
Page 101 - Changes in our tax provision or exposure to additional tax liabilities could adversely affect our ea
Page 102 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 103 - PART II
Page 104 - Dividend Policy
Page 105 - ITEM 6. SELECTED FINANCIAL DATA
Page 106 - N/A
Page 107 - ITEM 7. MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Page 108 - Risk Factors
Page 109 - Collaboration Partnerships for Roxadustat
Page 110 - AstraZeneca
Page 111 - Additional Information Related to Collaboration Agreements
Page 112 - RESULTS OF OPERATIONS
Page 113 - License Revenue
Page 114 - Comparison of the years ended December 31, 2018 and 2017
Page 115 - Comparison of the years ended December 31, 2018 and 2017
Page 116 - Comparison of the years ended December 31, 2018 and 2017
Page 117 - Comparison of the years ended December 31, 2017 and 2016
Page 118 - SELECTED QUARTERLY FINANCIAL DATA
Page 119 - Operating Capital Requirements
Page 120 - Investing Activities
Page 121 - Off-Balance Sheet Arrangements
Page 122 - CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Page 123 - Clinical Trial Accruals
Page 124 - Stock-Based Compensation
Page 125 - Recently Issued and Adopted Accounting Guidance
Page 126 - Intra-Entity Transfers of Assets Other Than Inventory
Page 127 - Leases (Topic 842) Leases (Topic 842): Targeted Improvements
Page 128 - ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS
Page 129 - ITEM 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Page 130 - Report of Independent Registered Public Accounting Firm
Page 131 - Definition and Limitations of Internal Control over Financial Reporting
Page 132 - FIBROGEN, INC.
Page 133 - FIBROGEN, INC.
Page 134 - FIBROGEN, INC.
Page 135 - FIBROGEN, INC.
Page 136 - FIBROGEN, INC.
Page 137 - FIBROGEN, INC.
Page 138 - Use of Estimates
Page 139 - Property and Equipment
Page 140 - Research and Development Expenses
Page 141 - General and Administrative Expenses
Page 142 - Recently Issued and Adopted Accounting Guidance
Page 143 - Statement of Operations
Page 144 - ASU 2017-09
Page 145 - Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instrumen
Page 146 - Europe Agreement
Page 147 - Accounting for the Astellas Agreements
Page 148 - Manufacturing rights.
Page 149 - Accounting for the AstraZeneca Agreements
Page 150 - U.S./RoW Agreement:
Page 151 - China Agreement:
Page 152 - N/A
Page 153 - Product Revenue
Page 154 - Cash and Cash Equivalents
Page 155 - Property and Equipment
Page 156 - Accrued Liabilities
Page 157 - Operating Leases
Page 158 - Indemnification Agreements
Page 159 - Voting Right
Page 160 - Common Stock
Page 161 - ESPP
Page 162 - Expected Term.
Page 163 - Warrants
Page 164 - N/A
Page 165 - Uncertain Tax Positions
Page 166 - Geographic Revenues
Page 167 - Schedule II: Valuation and Qualifying Accounts
Page 168 - ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES
Page 169 - PART III
Page 170 - PART IV
Page 171 - N/A
Page 172 - N/A
Page 173 - N/A
Page 174 - N/A
Page 175 - N/A
Page 176 - N/A
Page 177 - N/A
Page 178 - SIGNATURES
Page 179 - POWER OF ATTORNEY
Subdocument 2 - EX-10.9I - EX-10.9I
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Page 11 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Page 12 - [*] = Certain confidential information contained in this document, marked by brackets, has been omit
Subdocument 3 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 4 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 5 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 6 - EX-32.1 - EX-32.1
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