Eiger Mountains
Form 10-K
EIGER BIOPHARMACEUTICALS, INC. filed this Form 10-K on 03/30/2016
Document Outline
Entire Document (4303.5 KB)
Subdocument 1 - 10-K - FORM 10-K
Page 1 - UNITED STATES
Page 2 - Eiger BioPharmaceuticals, Inc.
Page 3 - PART I
Page 4 - ITEM 1. Business
Page 5 - Pipeline Timeline
Page 6 - N/A
Page 7 - Business Model and Management Team
Page 8 - Hepatitis Delta Overview
Page 9 - Current Therapy for HDV
Page 10 - Eiger s Solution: Lonafarnib for HDV
Page 11 - in vivo
Page 12 - LOWR HDV 1 (LOnafarnib With and without Ritonavir) Phase 2 Study
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - LOWR HDV 2 (LOnafarnib With Ritonavir) Phase 2 Study
Page 17 - LOWR HDV 4 (LOnafarnib With Ritonavir) Phase 2 Trial
Page 18 - Hypoglycemia Associated with Bariatric Surgery Overview
Page 19 - Exendin (9-39) IV Infusion Study Results
Page 20 - Ubenimex for Pulmonary Arterial Hypertension
Page 21 - Preclinical LTB4 Data in PAH
Page 22 - N/A
Page 23 - Eiger s Planned Solution: Ubenimex for PAH
Page 24 - Ubenimex for Lymphedema
Page 25 - Preclinical LTB4 Data in Lymphedema
Page 26 - Eiger s Planned Solution: Ubenimex for Lymphedema
Page 27 - Manufacturing
Page 28 - N/A
Page 29 - Patent Protection of Eiger s Product Candidates
Page 30 - Patent Term
Page 31 - N/A
Page 32 - License and Asset Purchase Agreements
Page 33 - License Agreement with Nippon Kayaku Co., Ltd.
Page 34 - Asset Purchase Agreement with Tracey McLaughlin and Colleen Craig
Page 35 - Exclusive Agreement with the Board of Trustees of the Leland Stanford Junior University PAH
Page 36 - N/A
Page 37 - N/A
Page 38 - N/A
Page 39 - Orphan Drugs
Page 40 - Companion Diagnostics
Page 41 - Other Healthcare Laws and Compliance Requirements
Page 42 - N/A
Page 43 - International Regulation
Page 44 - Research and Development Expenses
Page 45 - N/A
Page 46 - Item 1A. Risk Factors
Page 47 - We have never generated any revenue from product sales and may never be profitable.
Page 48 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 49 - Our business strategy is based upon obtaining orphan drug designation for our product candidates, wh
Page 50 - Drug development involves a lengthy and expensive process with an uncertain outcome, and results of
Page 51 - Clinical studies are costly, time consuming and inherently risky, and we may fail to demonstrate saf
Page 52 - Our product candidates may cause undesirable side effects or have other properties that could delay
Page 53 - We rely on third parties to conduct our clinical studies, manufacture our product candidates and per
Page 54 - We rely and expect to continue to rely on third parties to manufacture our clinical product supplies
Page 55 - N/A
Page 56 - If the market opportunities for our product candidates are smaller than we believe they are, we may
Page 57 - We currently have limited marketing and sales experience. If we are unable to establish sales and ma
Page 58 - Failure to obtain or maintain adequate reimbursement or insurance coverage for new or current produc
Page 59 - N/A
Page 60 - We may not have sufficient patent term protections for our products to effectively protect our busin
Page 61 - Patent laws and rule changes could increase the uncertainties and costs surrounding the prosecution
Page 62 - We may not be successful in meeting our diligence obligations under our existing license agreements
Page 63 - Our product candidates may be subject to generic competition.
Page 64 - The patent protection and patent prosecution for some of our product candidates is dependent on thir
Page 65 - We may be subject to claims that our employees, consultants, or independent contractors have wrongfu
Page 66 - Our future success depends in part on our ability to retain our President and Chief Executive Office
Page 67 - Failure in our information technology and storage systems could significantly disrupt the operation
Page 68 - Healthcare legislative reform measures may have a material adverse effect on our business and result
Page 69 - Our employees, principal investigators, consultants and commercial partners may engage in misconduct
Page 70 - We face potential product liability, and, if successful claims are brought against us, we may incur
Page 71 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 72 - Risks Related to Ownership of our Common Stock
Page 73 - We will incur costs and demands upon management as a result of complying with the laws and regulatio
Page 74 - We are at risk of additional securities class action litigation.
Page 75 - ITEM 1B. Unresolved Staff Comments
Page 76 - PART II
Page 77 - The financial information included in this Selected Financial Data is that of Celladon prior to the
Page 78 - ITEM 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 79 - The financial information included in this Management s Discussion and Analysis of Financial Conditi
Page 80 - Financial Operations Overview
Page 81 - MYDICAR-HFrEF
Page 82 - Other Income (Expense)
Page 83 - Stock-Based Compensation
Page 84 - JOBS Act
Page 85 - General and Administrative Expenses.
Page 86 - Other Expense.
Page 87 - Investing Activities
Page 88 - Contractual Obligations and Commitments
Page 89 - Off-Balance Sheet Arrangements
Page 90 - N/A
Page 91 - ITEM 8. Financial Statements and Supplementary Data
Page 92 - Celladon Corporation
Page 93 - Celladon Corporation
Page 94 - Celladon Corporation
Page 95 - Celladon Corporation
Page 96 - Celladon Corporation
Page 97 - Principles of Consolidation
Page 98 - Property and Equipment
Page 99 - Patent Costs
Page 100 - Recent Accounting Pronouncements
Page 101 - 3. Fair Value Measurements
Page 102 - N/A
Page 103 - 4. Commitments and Contingencies
Page 104 - Amended and Restated License Agreement
Page 105 - Other License Agreements
Page 106 - 5. Long-Term Obligations
Page 107 - 6. Stockholders Equity (Deficit)
Page 108 - 2013 Employee Stock Purchase Plan
Page 109 - Expected term.
Page 110 - N/A
Page 111 - 8. Employee Benefits
Page 112 - 10. Litigation
Page 113 - 12. Selected Quarterly Financial Data (Unaudited)
Page 114 - ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 115 - PART III
Page 116 - James Shaffer.
Page 117 - Thomas Dietz, Ph.D.
Page 118 - Audit Committee and Financial Expert
Page 119 - ITEM 11. Executive Compensation
Page 120 - N/A
Page 121 - Annual Base Salary
Page 122 - Equity-Based Incentive Awards
Page 123 - Agreement with Mr. Cleveland
Page 124 - Agreement with Ms. Reed
Page 125 - 1st Amendments to Employment Agreements
Page 126 - Celladon s Outstanding Equity Awards at Fiscal Year-End
Page 127 - Option Repricings
Page 128 - 401(k) Plan
Page 129 - N/A
Page 130 - 2012 Equity Incentive Plan
Page 131 - N/A
Page 132 - 2015 Director Compensation
Page 133 - ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matt
Page 134 - N/A
Page 135 - ITEM 13. Certain Relationships and Related Party Transactions, and Director Independence
Page 136 - Certain Related-Person Transactions
Page 137 - Celladon Indemnification Agreements
Page 138 - Eiger Subscription Agreement
Page 139 - ITEM 14. Principal Accounting Fees and Services
Page 140 - PART IV
Page 141 - N/A
Page 142 - N/A
Page 143 - N/A
Page 144 - N/A
Page 145 - N/A
Page 146 - SIGNATURES
Page 147 - INDEX TO EXHIBITS
Page 148 - N/A
Page 149 - N/A
Page 150 - N/A
Page 151 - N/A
Page 152 - N/A
Subdocument 2 - EX-21.1 - EX-21.1
Page 1 - Exhibit 21.1
Subdocument 3 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 4 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 5 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 6 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Subdocument 7 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2
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