Eiger Mountains
Form 10-K
EIGER BIOPHARMACEUTICALS, INC. filed this Form 10-K on 03/31/2015
Document Outline
Entire Document (4877.1 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - CELLADON CORPORATION
Page 3 - PART I
Page 4 - N/A
Page 5 - ITEM 1. Business
Page 6 - N/A
Page 7 - N/A
Page 8 - N/A
Page 9 - Strategy
Page 10 - Our Platform
Page 11 - N/A
Page 12 - Our Product Pipeline
Page 13 - Role of SERCA2a in Heart Failure
Page 14 - N/A
Page 15 - in vitro
Page 16 - N/A
Page 17 - MYDICAR Previous Human Experience in HFrEF
Page 18 - CUPID 1, Phase 2a (CELL-001)
Page 19 - N/A
Page 20 - Clinical Events in CELL-001 Phase 2a
Page 21 - N/A
Page 22 - CUPID 1 (CELL-001) Long-term Follow-up
Page 23 - Regulatory Overview and Current and Future Clinical Development of MYDICAR for HFrEF
Page 24 - N/A
Page 25 - MYDICAR for HFrEF
Page 26 - CUPID 3 Trial (CELL-003)
Page 27 - CELL-006 Viral Shedding Trial
Page 28 - Preclinical Studies of MYDICAR in HFrEF
Page 29 - MYDICAR in Arteriovenous Fistula Maturation Failure (SERCA2a-AVF)
Page 30 - MYDICAR LVAD Trial Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Pati
Page 31 - MYDICAR Pulmonary arterial hypertension (PAH)
Page 32 - Sales and Marketing
Page 33 - Our Plans for Scale-Up and Our Approach to Commercial Manufacturing
Page 34 - Companion Diagnostic
Page 35 - Competition
Page 36 - Patent Protection for MYDICAR
Page 37 - International Patent Protection for MYDICAR
Page 38 - Trademarks
Page 39 - Patent Term
Page 40 - Exclusive License Agreement with Dr. Martin J. Kaplitt
Page 41 - Sublicense Agreement and Amended and Restated License Agreement with AmpliPhi
Page 42 - License Agreement with AdVec
Page 43 - Non-Exclusive License Agreement with AskBio
Page 44 - Material Transfer and Exclusivity Agreement with Les Laboratoires Servier
Page 45 - Manufacturing
Page 46 - Development, Manufacturing and Commercial Supply Agreement with Novasep
Page 47 - Government Regulation
Page 48 - N/A
Page 49 - in vitro
Page 50 - U.S. Review and Approval Processes
Page 51 - Fast Track Designation, Accelerated Approval, Priority Review and Breakthrough Therapy Programs
Page 52 - Combination Products
Page 53 - Post-approval Requirements
Page 54 - Coverage and Reimbursement
Page 55 - Additional Regulation
Page 56 - Research and Development Expenses
Page 57 - Item 1A. Risk Factors
Page 58 - We have never generated any revenue from product sales and may never be profitable.
Page 59 - Failure to comply with covenants in our existing loan agreement or satisfy certain conditions of the
Page 60 - Raising additional funds through debt or equity financing could be dilutive and may cause the market
Page 61 - Risks Related to the Discovery and Development of our Product Candidates and Companion Diagnostic
Page 62 - Failure to successfully validate, commercialize and obtain regulatory approval for our companion dia
Page 63 - We may find it difficult to enroll patients in our clinical trials, which could delay or prevent dev
Page 64 - We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and
Page 65 - N/A
Page 66 - Success in early clinical trials may not be indicative of results obtained in later trials.
Page 67 - Our product candidates may cause undesirable side effects or have other properties that could delay
Page 68 - Even if we obtain regulatory approval for a product candidate, our products will remain subject to r
Page 69 - Even if we obtain and maintain approval for MYDICAR from one regulatory authority, we may never obta
Page 70 - Although we have obtained an SPA for a potential Phase 3 pivotal clinical trial of MYDICAR for the t
Page 71 - We and our contract manufacturers are subject to significant regulation with respect to manufacturin
Page 72 - We rely on third parties to conduct, supervise and monitor our clinical trials. If these third parti
Page 73 - We may seek to form strategic alliances in the future with respect to our product candidates or comp
Page 74 - Risks Related to Commercialization of our Product Candidates and Companion Diagnostic
Page 75 - Our decision as to whether to exercise the construction trigger under our facility construction and
Page 76 - If we are unable to establish sales and marketing capabilities or enter into agreements with third p
Page 77 - If the market size for MYDICAR is considerably smaller than we anticipate, it could significantly an
Page 78 - The commercial success of any current or future gene therapy product candidate will depend upon the
Page 79 - If we are unable to achieve and maintain adequate levels of coverage and reimbursement for MYDICAR,
Page 80 - N/A
Page 81 - Healthcare reform measures may have a material adverse effect on our business and results of operati
Page 82 - If we obtain approval to commercialize our product candidates outside of the United States, a variet
Page 83 - If CUPID 2 data are positive, we will need to expand our organization substantially in a short perio
Page 84 - N/A
Page 85 - We face potential product liability, and, if successful claims are brought against us, we may incur
Page 86 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 87 - Unfavorable global economic conditions could adversely affect our business, financial condition or r
Page 88 - We or the third parties upon whom we depend may be adversely affected by earthquakes or other natura
Page 89 - N/A
Page 90 - If we fail to comply with our obligations in the agreements under which we license intellectual prop
Page 91 - Third-party claims of intellectual property infringement may prevent or delay our development and co
Page 92 - We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, wh
Page 93 - The patent protection and patent prosecution for some of our product candidates and companion diagno
Page 94 - We may be subject to claims that our employees, consultants or independent contractors have wrongful
Page 95 - Issued patents covering our product candidates and companion diagnostic could be found invalid or un
Page 96 - Intellectual property rights do not necessarily address all potential threats to our competitive adv
Page 97 - N/A
Page 98 - If securities or industry analysts issue an adverse or misleading opinion regarding our stock, our s
Page 99 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 100 - We are at risk of securities class action litigation.
Page 101 - Our employment agreements with our executive officers and certain other employees may require us to
Page 102 - PART II
Page 103 - Use of Proceeds
Page 104 - ITEM 6. Selected Financial Data
Page 105 - ITEM 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 106 - Financial Overview
Page 107 - MYDICAR
Page 108 - Small Molecule Program
Page 109 - Clinical Trial Accruals
Page 110 - Other Information
Page 111 - Results of Operations
Page 112 - Research and Development Expenses.
Page 113 - Operating activities
Page 114 - Future Funding Requirements
Page 115 - Contractual Obligations and Commitments
Page 116 - Off-Balance Sheet Arrangements
Page 117 - ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk
Page 118 - ITEM 8. Financial Statements and Supplementary Data
Page 119 - Celladon Corporation
Page 120 - Celladon Corporation
Page 121 - Celladon Corporation
Page 122 - Celladon Corporation
Page 123 - Celladon Corporation
Page 124 - Celladon Corporation
Page 125 - Segment Reporting
Page 126 - Property and Equipment
Page 127 - Deferred Rent
Page 128 - Comprehensive Loss
Page 129 - Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Inc
Page 130 - 3. Balance Sheet Details
Page 131 - N/A
Page 132 - N/A
Page 133 - 5. Commitments and Contingencies
Page 134 - Amended and Restated License Agreement
Page 135 - Material Transfer and Exclusivity Agreement
Page 136 - Other License Agreements
Page 137 - Capital Lease
Page 138 - Contractual Payments and Carrying-Value Reconciliation
Page 139 - Common Stock and Common Stock Warrants
Page 140 - Stock Options
Page 141 - 2013 Employee Stock Purchase Plan
Page 142 - Common Stock Reserved for Future Issuance
Page 143 - Income Taxes
Page 144 - 10. Subsequent Events
Page 145 - 11. Selected Quarterly Financial Data (Unaudited)
Page 146 - ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 147 - PART III
Page 148 - PART IV
Page 149 - N/A
Page 150 - N/A
Page 151 - N/A
Page 152 - SIGNATURES
Page 153 - INDEX TO EXHIBITS
Page 154 - N/A
Page 155 - N/A
Page 156 - Exhibit
Subdocument 2 - EX-10.32 - EX-10.32
Page 1 - Exhibit 10.32
Page 2 - (d)
Page 3 - 5. Confidentiality.
Page 4 - Agreed to and accepted as of the date first set forth above:
Page 5 - Schedule A
Page 6 - Exhibit B
Subdocument 3 - EX-10.33 - EX-10.33
Page 1 - Exhibit 10.33
Page 2 - 2. BORROWER S REPRESENTATIONS AND WARRANTIES
Page 3 - 4. RESERVED
Page 4 - IN WITNESS WHEREOF
Subdocument 4 - EX-10.34 - EX-10.34
Page 1 - Exhibit 10.34
Page 2 - Table of Contents
Page 3 - N/A
Page 4 - Recitals
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
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Page 40 - N/A
Page 41 - N/A
Page 42 - N/A
Page 43 - N/A
Page 44 - IN WITNESS WHEREOF
Page 45 - Appendix A
Page 46 - Appendix C
Page 47 - Appendix D
Page 48 - Appendix E
Page 49 - Appendix G
Page 50 - Appendix H
Subdocument 5 - EX-10.35 - EX-10.35
Page 1 - Exhibit 10.35
Page 2 - 1.1 Acceptance Period
Page 3 - 1.13 Celladon Initial Project IP
Page 4 - Celladon New Project IP
Page 5 - 1.26 Confidentiality Agreement
Page 6 - 1.39 Initial Forecast
Page 7 - 1.52 Novasep Development Site
Page 8 - 1.57 Patented Novasep Background IP
Page 9 - 1.69 Release
Page 10 - 1.79 Validation Criteria
Page 11 - 2.3 Project Governance Team.
Page 12 - 2.4 Limitations on POT and PGT Authority.
Page 13 - 3.3 Use of the Modified Novasep Facility; Celladon s Right of First Refusal.
Page 14 - (i)
Page 15 - 3.4 Process Development and Scale-Up; Engineering Batches.
Page 16 - Validation Criteria
Page 17 - 3.9 Additional Services.
Page 18 - 4.3 Purchase Orders.
Page 19 - (b) Extension Terms.
Page 20 - (c)
Page 21 - 4.9 Storage and Handling.
Page 22 - 4.14 Third Party Suppliers.
Page 23 - (c)
Page 24 - (iii)
Page 25 - 6.3 Cooperation and Assistance.
Page 26 - 6.6 Records.
Page 27 - Proposed Response
Page 28 - 7.1 Development Service Fees.
Page 29 - (x)
Page 30 - 7.2 Batch Prices.
Page 31 - (a)
Page 32 - 7.6 Taxes.
Page 33 - 8.3 Licenses.
Page 34 - 8.4 Technology Transfer.
Page 35 - 9.3 Novasep Representations and Warranties.
Page 36 - 9.4 Novasep Responsibility for Performance by Affiliates.
Page 37 - 10.1 Confidentiality.
Page 38 - 10.5 Public Announcements.
Page 39 - 11.1 Term.
Page 40 - (c)
Page 41 - 12.1 Celladon Indemnification.
Page 42 - 13.1 Disputes.
Page 43 - (c) Costs.
Page 44 - 14.4 Non-Waiver.
Page 45 - (a)
Page 46 - 14.10 Interpretation.
Page 47 - IN WITNESS WHEREOF,
Page 48 - Exhibit Index:
Page 49 - N/A
Page 50 - N/A
Subdocument 6 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 7 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 8 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 9 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Subdocument 10 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2
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