Eiger Mountains
Form 10-K
EIGER BIOPHARMACEUTICALS, INC. filed this Form 10-K on 03/31/2014
Document Outline
Entire Document (1748.1 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - CELLADON CORPORATION
Page 3 - PART I
Page 4 - ITEM 1. Business
Page 5 - N/A
Page 6 - Strategy
Page 7 - Our SERCA Platform
Page 8 - N/A
Page 9 - Our Product Pipeline
Page 10 - Role of SERCA2a in Heart Failure
Page 11 - in vitro
Page 12 - MYDICAR: Genetic Enzyme Replacement Therapy of SERCA2a Deficiency
Page 13 - MYDICAR Previous Human Experience in Systolic Heart Failure
Page 14 - CUPID 1, Phase 1 (CELL-001
Page 15 - Clinical Events in CELL-001 Phase 2a
Page 16 - N/A
Page 17 - CUPID 1 (CELL-001) Long-term Follow-up
Page 18 - Current and Future Clinical Development of MYDICAR for Systolic Heart Failure
Page 19 - MYDICAR for Systolic Heart Failure
Page 20 - N/A
Page 21 - AGENT-HF Trial (AAV1-CMV-SERCA2a Gene Therapy Trial in Heart Failure)
Page 22 - Preclinical Studies of MYDICAR in Systolic Heart Failure
Page 23 - MYDICAR in Arteriovenous Fistula Maturation Failure (SERCA2a-AVF)
Page 24 - MYDICAR LVAD Trial Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Pati
Page 25 - MYDICAR in Pulmonary Arterial Hypertension (SERCA2a-PAH)
Page 26 - Our Approach for Producing AAV1/SERCA2a
Page 27 - MYDICAR Clinical and Commercial Supply
Page 28 - MYDICAR Administration Devices
Page 29 - Intellectual Property
Page 30 - International Patent Protection for MYDICAR
Page 31 - Patent Protection of Pipeline Products
Page 32 - Patent Term
Page 33 - Exclusive License Agreement with Dr. Martin J. Kaplitt
Page 34 - Sublicense Agreement and Amended and Restated License Agreement with AmpliPhi
Page 35 - License Agreement with AdVec
Page 36 - Non-Exclusive License Agreement with AskBio
Page 37 - Material Transfer and Exclusivity Agreement with Les Laboratoires Servier
Page 38 - Government Regulation
Page 39 - U.S. Biological Products Development Process
Page 40 - in vitro
Page 41 - U.S. Review and Approval Processes
Page 42 - N/A
Page 43 - Fast Track Designation, Accelerated Approval, Priority Review and Breakthrough Therapy Programs
Page 44 - Regulation of Companion Diagnostics
Page 45 - Coverage and Reimbursement
Page 46 - Additional Regulation
Page 47 - Employees
Page 48 - ITEM 1A. Risk Factors
Page 49 - We have never generated any revenue from product sales and may never be profitable.
Page 50 - We will need to raise additional funding, which may not be available on acceptable terms, or at all.
Page 51 - Raising additional funds through debt or equity financing could be dilutive and may cause the market
Page 52 - MYDICAR is based on a novel technology, which makes it difficult to predict the time and cost of pro
Page 53 - Failure to successfully validate, commercialize and obtain regulatory approval for our companion dia
Page 54 - N/A
Page 55 - We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and
Page 56 - Success in early clinical trials may not be indicative of results obtained in later trials.
Page 57 - Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Pro
Page 58 - Even if we complete the necessary preclinical studies and clinical trials, we cannot predict when or
Page 59 - Public opinion and increased regulatory scrutiny of gene therapy and genetic research may impact pub
Page 60 - If approved, MYDICAR or any future products may cause or contribute to adverse medical events that w
Page 61 - Risks Related to our Reliance on Third Parties
Page 62 - We and our contract manufacturers are subject to significant regulation with respect to manufacturin
Page 63 - We rely on third parties to conduct, supervise and monitor our clinical trials. If these third parti
Page 64 - We may seek to form strategic alliances in the future with respect to our product candidates or comp
Page 65 - If we are unable to establish sales and marketing capabilities or enter into agreements with third p
Page 66 - N/A
Page 67 - If the market size for MYDICAR is considerably smaller than we anticipate, it could significantly an
Page 68 - The commercial success of any current or future gene therapy product candidate will depend upon the
Page 69 - If we are unable to achieve and maintain adequate levels of coverage and reimbursement for MYDICAR,
Page 70 - Healthcare reform measures may have a material adverse effect on our business and results of operati
Page 71 - If we obtain approval to commercialize our product candidates outside of the United States, a variet
Page 72 - We will need to expand our organization and we may experience difficulties in managing this growth,
Page 73 - We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, fal
Page 74 - We face potential product liability, and, if successful claims are brought against us, we may incur
Page 75 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 76 - We may use our financial and human resources to pursue a particular research program or product cand
Page 77 - Our business and operations would suffer in the event of system failures.
Page 78 - Risks Related to our Intellectual Property
Page 79 - If we fail to comply with our obligations in the agreements under which we license intellectual prop
Page 80 - Third-party claims of intellectual property infringement may prevent or delay our development and co
Page 81 - We may not be successful in obtaining or maintaining necessary rights to product components and proc
Page 82 - We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, wh
Page 83 - Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecut
Page 84 - We may be subject to claims challenging the inventorship or ownership of our patents and other intel
Page 85 - Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our abi
Page 86 - Risks Related to Ownership of our Common Stock
Page 87 - If securities or industry analysts issue an adverse or misleading opinion regarding our stock, our s
Page 88 - We are an emerging growth company, and we cannot be certain if the reduced reporting requirements ap
Page 89 - If we fail to maintain an effective system of internal control over financial reporting, we may not
Page 90 - We are at risk of securities class action litigation.
Page 91 - Our employment agreements with our executive officers may require us to pay severance benefits to an
Page 92 - ITEM 4. Mine Safety Disclosures
Page 93 - PART II
Page 94 - Use of Proceeds
Page 95 - ITEM 6. Selected Financial Data
Page 96 - ITEM 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 97 - N/A
Page 98 - Initial Public Offering and Related Transactions
Page 99 - MYDICAR
Page 100 - General and Administrative Expenses
Page 101 - Stock-Based Compensation
Page 102 - Valuation of Privately Held Company Equity Securities Issued as Compensation
Page 103 - Other Information
Page 104 - Results of Operations
Page 105 - Comparison of the Year Ended December 31, 2012 and the Six Months Ended December 31, 2011
Page 106 - General and Administrative Expenses.
Page 107 - Investing Activities
Page 108 - N/A
Page 109 - Contractual Obligations and Commitments
Page 110 - Recent Accounting Pronouncements
Page 111 - ITEM 8. Financial Statements and Supplementary Data
Page 112 - Celladon Corporation
Page 113 - Celladon Corporation
Page 114 - Celladon Corporation
Page 115 - Celladon Corporation
Page 116 - Celladon Corporation
Page 117 - Celladon Corporation
Page 118 - Celladon Corporation
Page 119 - Celladon Corporation
Page 120 - Segment Reporting
Page 121 - Property and Equipment
Page 122 - Preferred Stock
Page 123 - Comprehensive Loss
Page 124 - 2. Celladon Europe B.V.
Page 125 - 4. Fair Value Measurements
Page 126 - N/A
Page 127 - 5. Commitments and Contingencies
Page 128 - Sublicense Agreement and Amended and Restated License Agreement with AmpliPhi
Page 129 - Exclusive Patent License with the Regents of the University of Minnesota
Page 130 - Other License Agreements
Page 131 - Description of Securities
Page 132 - Redemption Requirements
Page 133 - 2013 Equity Incentive Plan
Page 134 - Risk-free interest rate.
Page 135 - 7. Income Taxes
Page 136 - Income Taxes
Page 137 - 9. Subsequent Events
Page 138 - 10. Quarterly Financial Data (Unaudited)
Page 139 - ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 140 - PART III
Page 141 - PART IV
Page 142 - N/A
Page 143 - N/A
Page 144 - N/A
Page 145 - SIGNATURES
Page 146 - INDEX TO EXHIBITS
Page 147 - N/A
Page 148 - ExhibitNumber
Subdocument 2 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Subdocument 6 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2