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Form S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 01/23/2007
Document Outline
Entire Document (1986.8 KB)
Subdocument 1 - S-1/A - AMENDMENT NO. 1 TO FORM S-1
Page 1 - As filed with the Securities and Exchange Commission on January 23, 2007
Page 2 - Subject to Completion
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - Contrave
Page 6 - Excalia
Page 7 - Commercialization
Page 8 - Corporate Information
Page 9 - THE OFFERING
Page 10 - SUMMARY FINANCIAL DATA
Page 11 - N/A
Page 12 - RISK FACTORS
Page 13 - Our product candidates may cause undesirable side effects or have other properties that could delay
Page 14 - Delays in the commencement or completion of clinical testing could result in increased costs to us a
Page 15 - Our product candidates are combinations of generically-available pharmaceutical products, and our su
Page 16 - We rely on third parties to conduct our clinical trials. If these third parties do not successfully
Page 17 - We have limited sales and marketing experience or resources, and we may not be able to effectively m
Page 18 - Our development and commercialization strategy depends upon access to findings of safety and effecti
Page 19 - Even if our product candidates receive regulatory approval, they may still face future development a
Page 20 - If the contract manufacturers upon whom we rely fail to produce our product candidates in the volume
Page 21 - We are combining drugs in novel combinations and cannot be sure that the combined drugs can co-exist
Page 22 - If any of our product candidates for which we receive regulatory approval does not achieve broad mar
Page 23 - We are subject to uncertainty relating to reimbursement policies which, if not favorable to our prod
Page 24 - Health care reform measures could hinder or prevent our product candidates commercial success.
Page 25 - We will need to increase the size of our organization, and we may experience difficulties in managin
Page 26 - We will need to obtain FDA approval of our proposed product names, Contrave and Excalia, and any fai
Page 27 - If we fail to comply with healthcare regulations, we could face substantial penalties and our busine
Page 28 - Our business and operations would suffer in the event of system failures.
Page 29 - Although we have international patent applications pending, we do not currently have patent protecti
Page 30 - Restrictions on our patent rights relating to our product candidates may limit our ability to preven
Page 31 - N/A
Page 32 - Although we have entered into a settlement agreement designed to prevent the parties to the agreemen
Page 33 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 34 - We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secre
Page 35 - Our short operating history makes it difficult to evaluate our business and prospects.
Page 36 - Our quarterly operating results may fluctuate significantly.
Page 37 - Risks Relating to Securities Markets and Investment in Our Stock
Page 38 - We expect that the price of our common stock will fluctuate substantially.
Page 39 - Future sales of our common stock may depress our stock price.
Page 40 - Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a chang
Page 41 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 42 - N/A
Page 43 - USE OF PROCEEDS
Page 44 - CAPITALIZATION
Page 45 - N/A
Page 46 - DILUTION
Page 47 - N/A
Page 48 - SELECTED FINANCIAL DATA
Page 49 - N/A
Page 50 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 51 - General and Administrative
Page 52 - Critical Accounting Policies and Estimates
Page 53 - N/A
Page 54 - Accounting for Equity Instruments
Page 55 - That are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods and Serv
Page 56 - Comparison of year ended December 31, 2004 to year ended December 31, 2003
Page 57 - N/A
Page 58 - Contractual Obligations and Commitments
Page 59 - Related Party Transactions
Page 60 - BUSINESS
Page 61 - The Obesity Epidemic
Page 62 - The Orexigen Solution
Page 63 - Our Lead Product Candidates
Page 64 - Scientific Rationale
Page 65 - Contrave Clinical Results
Page 66 - Contrave Phase II Mean Weight Loss through 24 Weeks
Page 67 - N/A
Page 68 - Contrave Phase IIb Mean Weight Loss at 24 Weeks
Page 69 - N/A
Page 70 - Contrave Phase IIb Mean Weight Loss at 36 Weeks
Page 71 - Contrave Phase IIb Mean Weight Loss Over 36 Weeks
Page 72 - Future Contrave Clinical Development Plans
Page 73 - Excalia
Page 74 - Scientific Rationale
Page 75 - Excalia Phase II Mean Weight Loss at 24 Weeks
Page 76 - Excalia Phase II Mean Weight Loss Over 24 Weeks
Page 77 - Future Excalia Clinical Development Plans
Page 78 - Intellectual Property
Page 79 - Licensing Agreements
Page 80 - Lee Dante License Agreement
Page 81 - Cypress Bioscience, Inc. License Agreement
Page 82 - Competition
Page 83 - Third-Party Reimbursement
Page 84 - Medicare
Page 85 - New Drug Approval (NDA)
Page 86 - Section 505(b)(2) New Drug Applications
Page 87 - Manufacturing cGMP Requirements
Page 88 - Other Regulatory Requirements
Page 89 - Legal Proceedings
Page 90 - MANAGEMENT
Page 91 - Graham K. Cooper
Page 92 - James C. Lancaster, Jr.
Page 93 - Joseph S. Lacob
Page 94 - Board Committees
Page 95 - Compensation Committee Interlocks and Insider Participation
Page 96 - COMPENSATION DISCUSSION AND ANALYSIS
Page 97 - Annual Performance Bonus.
Page 98 - Restricted Stock and Restricted Stock Units.
Page 99 - N/A
Page 100 - Executive Compensation
Page 101 - Employee Benefit and Stock Plans
Page 102 - Administration.
Page 103 - N/A
Page 104 - Change in Control.
Page 105 - Amendment and Termination of the 2007 Plan.
Page 106 - Eligibility.
Page 107 - Amendment and Termination of the 2004 plan.
Page 108 - Option Exercises and Stock Vested at Fiscal Year End
Page 109 - Potential Payments Upon Termination Without Cause
Page 110 - Potential Payments Upon Termination Due to Change in Control
Page 111 - Limitations of Liability and Indemnification Matters
Page 112 - N/A
Page 113 - PRINCIPAL STOCKHOLDERS
Page 114 - (footnotes continued on following page)
Page 115 - N/A
Page 116 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 117 - Common Stock Issuances
Page 118 - Investors Rights Agreement
Page 119 - Employment Agreements
Page 120 - Other Transactions and Arrangements
Page 121 - DESCRIPTION OF CAPITAL STOCK
Page 122 - Registration Rights
Page 123 - Stockholder Meetings
Page 124 - SHARES ELIGIBLE FOR FUTURE SALE
Page 125 - Rule 144
Page 126 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO
Page 127 - Gain on Disposition of Common Stock
Page 128 - Federal Estate Tax
Page 129 - UNDERWRITING
Page 130 - No Sales of Similar Securities
Page 131 - Price Stabilization, Short Positions and Penalty Bids
Page 132 - LEGAL MATTERS
Page 133 - Orexigen Therapeutics, Inc.
Page 134 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 135 - OREXIGEN THERAPEUTICS, INC.
Page 136 - OREXIGEN THERAPEUTICS, INC.
Page 137 - OREXIGEN THERAPEUTICS, INC.
Page 138 - OREXIGEN THERAPEUTICS, INC.
Page 139 - OREXIGEN THERAPEUTICS, INC.
Page 140 - OREXIGEN THERAPEUTICS, INC.
Page 141 - OREXIGEN THERAPEUTICS, INC.
Page 142 - OREXIGEN THERAPEUTICS, INC.
Page 143 - OREXIGEN THERAPEUTICS, INC.
Page 144 - OREXIGEN THERAPEUTICS, INC.
Page 145 - OREXIGEN THERAPEUTICS, INC.
Page 146 - OREXIGEN THERAPEUTICS, INC.
Page 147 - OREXIGEN THERAPEUTICS, INC.
Page 148 - OREXIGEN THERAPEUTICS, INC.
Page 149 - OREXIGEN THERAPEUTICS, INC.
Page 150 - OREXIGEN THERAPEUTICS, INC.
Page 151 - OREXIGEN THERAPEUTICS, INC.
Page 152 - OREXIGEN THERAPEUTICS, INC.
Page 153 - OREXIGEN THERAPEUTICS, INC.
Page 154 - OREXIGEN THERAPEUTICS, INC.
Page 155 - OREXIGEN THERAPEUTICS, INC.
Page 156 - Shares
Page 157 - PART II
Page 158 - N/A
Page 159 - Exhibits
Page 160 - Financial Statement Schedules
Page 161 - SIGNATURES
Page 162 - EXHIBIT INDEX
Subdocument 2 - EX-10.19 - EXHIBIT 10.19
Page 1 - EXHIBIT 10.19
Page 2 - N/A
Page 3 - Database applications developed by Consultant:
Page 4 - and not as an employee, agent or authorized representative of the Company
Page 5 - N/A
Page 6 - Work Order
Subdocument 3 - EX-10.20 - EXHIBIT 10.20
Page 1 - EXHIBIT 10.20
Subdocument 4 - EX-23.1 - EXHIBIT 23.1
Page 1 - EXHIBIT 23.1