SEC Filings

Form 10-K
BEIGENE, LTD. filed this Form 10-K on 02/28/2019
Document Outline
Entire Document (8602.4 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - BeiGene, Ltd.
Page 3 - Forward Looking Statements and Market Data
Page 4 - N/A
Page 5 - PART I
Page 6 - Our Strategy
Page 7 - Expand Our Product Portfolio and Pipeline Through Collaborations with Other Biopharmaceutical Compan
Page 8 - Our Pipeline and Commercial Products
Page 9 - Market Opportunity and Competition
Page 10 - Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Page 11 - Mantle Cell Lymphoma
Page 12 - Other Lymphomas
Page 13 - Tislelizumab (BGB-A317), an anti-PD-1 Antibody
Page 14 - Summary of Clinical Results
Page 15 - Other Tumor Types
Page 16 - Immune-Related Treatment-Emergent Adverse Events and Deaths
Page 17 - Market Opportunity and Competition
Page 18 - Ovarian Cancer
Page 19 - Clinical Development Plan
Page 20 - BGB-A333, a PD-L1 Inhibitor
Page 21 - REVLIMID
Page 22 - Our Preclinical Programs
Page 23 - Contract Manufacturing Organizations
Page 24 - Celgene China Agreements
Page 25 - Intellectual Property
Page 26 - Lifirafenib
Page 27 - Government Regulation
Page 28 - Phase 2.
Page 29 - Regulation of Combination Products in the United States
Page 30 - Accelerated Approval
Page 31 - Patent Term Restoration and Marketing Exclusivity
Page 32 - Orphan Drugs
Page 33 - Other U.S. Healthcare Laws and Compliance Requirements
Page 34 - European Data Collection
Page 35 - PRC Regulation
Page 36 - Preclinical and Clinical Development
Page 37 - New Policies on Expediting Approval of Imported Oncology Drugs
Page 38 - Trial Exemptions and Acceptance of Foreign Data
Page 39 - Manufacturing and Distribution
Page 40 - Patent-Related Protections
Page 41 - Government price controls
Page 42 - Regulations Relating to Foreign Exchange
Page 43 - Employees
Page 44 - Item 1A. Risk Factors
Page 45 - Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and re
Page 46 - Risks Related to Extensive Government Regulation
Page 47 - We believe that our drug candidates designation in China as Category 1 products should confer certai
Page 48 - The absence of patent-linkage, patent-term extension and data and market exclusivity for NMPA-approv
Page 49 - Our drugs and any future approved drug candidates will be subject to ongoing regulatory obligations
Page 50 - If safety, efficacy, or other issues arise with any medical product that is used in combination with
Page 51 - Reimbursement may not be available for our drug candidates. Even if we are able to commercialize our
Page 52 - Recently enacted and future legislation may increase the difficulty and cost for us to obtain regula
Page 53 - We have limited manufacturing capability and must rely on third-party manufacturers to manufacture o
Page 54 - We have limited experience in marketing third-party drugs and no experience in launching an internal
Page 55 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 56 - We may explore the licensing of commercialization rights or other forms of collaboration worldwide,
Page 57 - The illegal distribution and sale by third parties of counterfeit versions of our drugs or stolen pr
Page 58 - We will need to obtain additional financing to fund our operations, and if we are unable to obtain s
Page 59 - Raising additional capital may cause dilution to our shareholders, restrict our operations or requir
Page 60 - Our business, profitability and liquidity may be adversely affected by deterioration in the credit q
Page 61 - inter partes
Page 62 - We may become involved in lawsuits to protect or enforce our intellectual property, which could be e
Page 63 - If we are sued for infringing intellectual property rights of third parties, such litigation could b
Page 64 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 65 - We may not be successful in obtaining or maintaining necessary rights for our development pipeline t
Page 66 - We expect to rely on third parties to manufacture at least a portion of our clinical and commercial
Page 67 - If third-party manufacturers fail to comply with manufacturing regulations, our financial results an
Page 68 - We have entered into collaborations, such as with Celgene, and may form or seek collaborations or st
Page 69 - If we fail to maintain an effective distribution channel for our products, our business and sales of
Page 70 - We may be restricted from transferring our scientific data abroad.
Page 71 - We have significantly increased the size and capabilities of our organization, and we may experience
Page 72 - If we engage in acquisitions or strategic partnerships, this may increase our capital requirements,
Page 73 - If we fail to comply with the U.S. Foreign Corrupt Practices Act or other anti-bribery and corruptio
Page 74 - Our failure to comply with data protection laws and regulations could lead to government enforcement
Page 75 - If we or parties on whom we rely fail to maintain the necessary licenses for the development, produc
Page 76 - Product liability claims or lawsuits could cause us to incur substantial liabilities.
Page 77 - We manufacture and intend to continue to manufacture ourselves at least a portion of our drug candid
Page 78 - Future operating results could be negatively affected by changes in tax rates, the adoption of new t
Page 79 - There are uncertainties regarding the interpretation and enforcement of PRC laws, rules and regulati
Page 80 - We may rely on dividends and other distributions on equity paid by our PRC subsidiaries to fund any
Page 81 - We may be treated as a resident enterprise for PRC tax purposes under the EIT Law and we may therefo
Page 82 - We and our shareholders face uncertainties with respect to indirect transfers of equity interests in
Page 83 - Our business benefits from certain financial incentives and discretionary policies granted by local
Page 84 - Risks Related to Our American Depositary Shares and Ordinary Shares
Page 85 - We may be subject to securities litigation, which is expensive and could divert management attention
Page 86 - We are a Cayman Islands company. Because judicial precedent regarding the rights of shareholders is
Page 87 - Anti-takeover provisions in our constitutional documents may discourage our acquisition by a third p
Page 88 - Our amended and restated memorandum and articles of association provide that any shareholder bringin
Page 89 - Holders of the ADSs may not receive distributions on our ordinary shares or any value for them if it
Page 90 - If you are a Ten Percent Shareholder, you may be subject to adverse U.S. federal income tax conseque
Page 91 - PART II
Page 92 - Equity Compensation Plan Information
Page 93 - People s Republic of China Taxation
Page 94 - Item 6. Selected Consolidated Financial Data
Page 95 - N/A
Page 96 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 97 - Components of Operating Results
Page 98 - N/A
Page 99 - Selling, General and Administrative Expenses
Page 100 - Results of Operations
Page 101 - Cost of Sales
Page 102 - Selling, General and Administrative Expense
Page 103 - Comparison of the Years Ended December 31, 2017 and 2016
Page 104 - Research and Development Expense
Page 105 - Interest Income (Expense), Net
Page 106 - Use of Funds
Page 107 - Investing Activities
Page 108 - N/A
Page 109 - Contractual Obligations and Commitments
Page 110 - Other Business Agreements
Page 111 - Collaboration Revenue
Page 112 - Royalties:
Page 113 - Awards Granted to Non employees
Page 114 - Income Taxes
Page 115 - Recent Accounting Pronouncements
Page 116 - Currency Convertibility Risk
Page 117 - Changes in Internal Control over Financial Reporting
Page 118 - PART III
Page 119 - PART IV
Page 120 - BEIGENE, LTD.
Page 121 - Report of Independent Registered Public Accounting Firm
Page 122 - Report of Independent Registered Public Accounting Firm
Page 123 - BEIGENE, LTD.
Page 124 - BEIGENE, LTD.
Page 125 - BEIGENE, LTD.
Page 126 - BEIGENE, LTD.
Page 127 - The accompanying notes are an integral part of these consolidated financial statems.
Page 128 - BEIGENE, LTD.
Page 129 - BEIGENE, LTD.
Page 130 - BEIGENE, LTD.
Page 131 - BEIGENE, LTD.
Page 132 - BEIGENE, LTD.
Page 133 - BEIGENE, LTD.
Page 134 - BEIGENE, LTD.
Page 135 - BEIGENE, LTD.
Page 136 - BEIGENE, LTD.
Page 137 - BEIGENE, LTD.
Page 138 - BEIGENE, LTD.
Page 139 - BEIGENE, LTD.
Page 140 - BEIGENE, LTD.
Page 141 - BEIGENE, LTD.
Page 142 - BEIGENE, LTD.
Page 143 - BEIGENE, LTD.
Page 144 - BEIGENE, LTD.
Page 145 - BEIGENE, LTD.
Page 146 - BEIGENE, LTD.
Page 147 - BEIGENE, LTD.
Page 148 - BEIGENE, LTD.
Page 149 - BEIGENE, LTD.
Page 150 - BEIGENE, LTD.
Page 151 - BEIGENE, LTD.
Page 152 - BEIGENE, LTD.
Page 153 - BEIGENE, LTD.
Page 154 - BEIGENE, LTD.
Page 155 - BEIGENE, LTD.
Page 156 - BEIGENE, LTD.
Page 157 - BEIGENE, LTD.
Page 158 - BEIGENE, LTD.
Page 159 - BEIGENE, LTD.
Page 160 - BEIGENE, LTD.
Page 161 - BEIGENE, LTD.
Page 162 - BEIGENE, LTD.
Page 163 - BEIGENE, LTD.
Page 164 - BEIGENE, LTD.
Page 165 - BEIGENE, LTD.
Page 166 - Exhibit Index
Page 167 - N/A
Page 168 - N/A
Page 169 - N/A
Page 170 - SIGNATURES
Page 171 - POWER OF ATTORNEY
Subdocument 2 - EX-21.1 - EXHIBIT 21.1
Page 1 - N/A
Subdocument 3 - EX-23.1 - EXHIBIT 23.1
Page 1 - N/A
Subdocument 4 - EX-31.1 - EXHIBIT 31.1
Page 1 - N/A
Subdocument 5 - EX-31.2 - EXHIBIT 31.2
Page 1 - N/A
Subdocument 6 - EX-32.1 - EXHIBIT 32.1
Page 1 - N/A
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