Eiger Mountains
Form 10-K
EIGER BIOPHARMACEUTICALS, INC. filed this Form 10-K on 03/14/2019
Document Outline
Entire Document (6382.4 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - Eiger BioPharmaceuticals, Inc.
Page 3 - PART I
Page 4 - ITEM 1. Business
Page 5 - Note: All dates represent our current expectations. Actual timing may vary.
Page 6 - LMNA
Page 7 - Journal of the American Medical Association (JAMA)
Page 8 - Business Model and Management Team
Page 9 - Our Product Candidates
Page 10 - The Role of HDV Screening in Identifying Patients Who May Benefit from LNF and/or Lambda
Page 11 - Our Lead HDV Opportunity: LNF
Page 12 - N/A
Page 13 - Phase 3 D-LIVR Study
Page 14 - Lambda Clinical Data
Page 15 - Avexitide for Post-Bariatric Hypoglycemia
Page 16 - Our Next Product Candidate: Avexitide to Treat Post-Bariatric Hypoglycemia
Page 17 - Avexitide SC Injection SAD Study Results
Page 18 - N/A
Page 19 - Avexitide SC Injection MAD Study Glycemic Results
Page 20 - Manufacturing
Page 21 - Lonafarnib (LNF)
Page 22 - Patent Protection of Our Product Candidates
Page 23 - Peginterferon-Lambda (Lambda).
Page 24 - Competition
Page 25 - License and Asset Purchase Agreements
Page 26 - License Agreement with Janssen Pharmaceutica NV
Page 27 - License Agreement with Bristol-Myers Squibb Company
Page 28 - N/A
Page 29 - N/A
Page 30 - N/A
Page 31 - 505(b)(2) NDA Pathway
Page 32 - Advertising and Promotion
Page 33 - Other Healthcare Laws and Compliance Requirements
Page 34 - International Regulation
Page 35 - Research and Development Expenses
Page 36 - N/A
Page 37 - Item 1A. Risk Factors
Page 38 - We have never generated any revenue from product sales and may never be profitable.
Page 39 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 40 - Risks Related to the Development of our Product Candidates
Page 41 - Drug development involves a lengthy and expensive process with an uncertain outcome, and results of
Page 42 - We may find it difficult to enroll patients in our clinical studies given the limited number of pati
Page 43 - Our product candidates may cause undesirable side effects or have other properties that could delay
Page 44 - We rely on third parties to conduct our clinical studies, manufacture our product candidates and per
Page 45 - We rely and expect to continue to rely on third parties to manufacture our clinical product supplies
Page 46 - If the market opportunities for our product candidates are smaller than we believe they are, we may
Page 47 - We face intense competition and rapid technological change and the possibility that our competitors
Page 48 - The commercial success of any of our current or future product candidate will depend upon the degree
Page 49 - We intend to rely on a combination of exclusivity from orphan drug designation as well as patent rig
Page 50 - N/A
Page 51 - We may not have sufficient patent term protections for our products to effectively protect our busin
Page 52 - Third-party claims of intellectual property infringement may prevent or delay our development and co
Page 53 - We may not be successful in meeting our diligence obligations under our existing license agreements
Page 54 - The patent protection and patent prosecution for some of our product candidates is dependent on thir
Page 55 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 56 - Risks Related to our Business Operations
Page 57 - N/A
Page 58 - Failure in our information technology and storage systems or our security measures, including withou
Page 59 - We may not be successful in any efforts to identify, license, discover, develop or commercialize add
Page 60 - We may be subject, directly or indirectly, to foreign, federal and state healthcare fraud and abuse
Page 61 - Our employees, principal investigators, consultants and commercial partners may engage in misconduct
Page 62 - We face potential product liability, and, if successful claims are brought against us, we may incur
Page 63 - We are currently conducting and will continue to conduct clinical trials in foreign countries, which
Page 64 - Risks Related to Celladon s Historical Business Operations
Page 65 - We will incur costs and demands upon management as a result of complying with the laws and regulatio
Page 66 - Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition o
Page 67 - Our net operating loss carryforwards and certain other tax attributes are now subject to limitations
Page 68 - PART II
Page 69 - ITEM 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 70 - Oral Presentation of Phase 2 PREVENT Study of Avexitide in Post-Bariatric Hypoglycemia (PBH) at Upco
Page 71 - Phase 2 LIMT Study
Page 72 - FDA Guidance on HDV Phase 3 Study Design: Primary Endpoint Established
Page 73 - Financial Operations Overview
Page 74 - General and Administrative Expenses
Page 75 - Interest Income
Page 76 - Stock-Based Compensation
Page 77 - Results of Operations
Page 78 - Comparison of the Years Ended December 31, 2017 and 2016
Page 79 - Other income (expense), net
Page 80 - Cash Flows
Page 81 - Cash flows from investing activities
Page 82 - Off-Balance Sheet Arrangements
Page 83 - Report of Independent Registered Public Accounting Firm
Page 84 - Eiger BioPharmaceuticals, Inc.
Page 85 - Eiger BioPharmaceuticals, Inc.
Page 86 - Eiger BioPharmaceuticals, Inc.
Page 87 - Eiger BioPharmaceuticals, Inc.
Page 88 - Eiger BioPharmaceuticals, Inc.
Page 89 - Eiger Biopharmaceuticals, Inc.
Page 90 - Cash and Cash Equivalents
Page 91 - Deferred Financing Costs
Page 92 - Net Loss per Share
Page 93 - Codification Improvements to Leases (Topic 842)
Page 94 - N/A
Page 95 - Property and Equipment, Net
Page 96 - IQVIA General Services Agreement
Page 97 - Progeria Research Foundation (PRF) Collaboration Agreement
Page 98 - Merck License Agreement
Page 99 - EGI Asset Purchase Agreement
Page 100 - Eiccose Purchase Agreement and Related Stanford and Nippon License Agreements
Page 101 - N/A
Page 102 - N/A
Page 103 - Common Stock
Page 104 - N/A
Page 105 - Fair Value of Common Stock
Page 106 - Stock-Based Compensation Expense
Page 107 - Uncertain Tax Positions
Page 108 - Lease Agreement
Page 109 - Other Commitments
Page 110 - ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 111 - PART III
Page 112 - PART IV
Page 113 - N/A
Page 114 - N/A
Page 115 - N/A
Page 116 - SIGNATURES
Subdocument 2 - EX-10.37 - EX-10.37
Page 1 - Exhibit 10.37
Page 2 - 6.Stock Options.
Page 3 - 12.Nondisparagement.
Page 4 - 16.Company Release
Page 5 - 20.Miscellaneous.
Page 6 - I have read, understand and agree fully to the foregoing Agreement:
Page 7 - EXHIBIT A
Page 8 - Eiger BioPharmaceuticals, Inc.
Page 9 - 2.6Government or Third Party
Page 10 - ACCEPTED AND AGREED TO:
Page 11 - EXHIBIT A
Page 12 - EXHIBIT B
Subdocument 3 - EX-10.38 - EX-10.38
Page 1 - Exhibit 10.38
Page 2 - 4.Representations and Warranties.
Page 3 - In Witness Whereof,
Page 4 - EXHIBIT C
Page 5 - Please indicate compliance status since the last Compliance Certificate by circling Yes, No, or N/A
Page 6 - Financial Covenants
Page 7 - Exceptions
Subdocument 4 - EX-21.1 - EX-21.1
Page 1 - N/A
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 6 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 7 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 8 - EX-32.1 - EX-32.1
Page 1 - N/A
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