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Form S-1/A
OREXIGEN THERAPEUTICS, INC. filed this Form S-1/A on 04/25/2007
Document Outline
Entire Document (1897.9 KB)
Subdocument 1 - S-1/A - AMENDMENT NO. 4 TO FORM S-1
Page 1 - As filed with the Securities and Exchange Commission on April 25, 2007
Page 2 - Subject to Completion
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - Contrave
Page 6 - Empatic
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 clinical trials may fail to demonstrate acceptable levels of safety and efficacy of our product
Page 14 - N/A
Page 15 - Delays in the commencement or completion of clinical testing could result in increased costs to us a
Page 16 - Our product candidates are combinations of generically-available pharmaceutical products, and our su
Page 17 - N/A
Page 18 - We have limited sales and marketing experience or resources, and we may not be able to effectively m
Page 19 - Even if our product candidates receive regulatory approval, they may still face future development a
Page 20 - If the suppliers upon whom we rely for active pharmaceutical ingredients, or API, fail to produce su
Page 21 - N/A
Page 22 - We are combining drugs in novel combinations and cannot be sure that the combined drugs can co-exist
Page 23 - We are subject to uncertainty relating to reimbursement policies which, if not favorable to our prod
Page 24 - Our failure to successfully acquire, develop and market additional product candidates or approved pr
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 Empatic, 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 involves the use of hazardous materials and we and our third-party manufacturers must c
Page 29 - Although we have international patent applications pending, we do not currently have patent protecti
Page 30 - We have in-licensed the rights to our product candidates from third parties. If we default on any of
Page 31 - If we are sued for infringing intellectual property rights of third parties, it will be costly and t
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 have not yet registered our trademarks in all of our potential markets, and failure to secure tho
Page 35 - We have not generated any revenue from our product candidates and may never be profitable.
Page 36 - Our quarterly operating results may fluctuate significantly.
Page 37 - Raising additional funds by issuing securities may cause dilution to existing stockholders and raisi
Page 38 - Risks Relating to Securities Markets and Investment in Our Stock
Page 39 - Our management team may invest or spend the proceeds of this offering in ways with which you may not
Page 40 - Our executive officers and directors and their affiliates will exercise control over stockholder vot
Page 41 - We have never paid dividends on our capital stock, and because we do not anticipate paying any cash
Page 42 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 43 - N/A
Page 44 - USE OF PROCEEDS
Page 45 - CAPITALIZATION
Page 46 - N/A
Page 47 - DILUTION
Page 48 - N/A
Page 49 - SELECTED FINANCIAL DATA
Page 50 - N/A
Page 51 - MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 52 - General and Administrative
Page 53 - Beneficial Conversion Feature
Page 54 - N/A
Page 55 - N/A
Page 56 - Accounting for Equity Instruments That are Issued to Other Than Employees for Acquiring, or in Conju
Page 57 - Research and Development Expenses.
Page 58 - N/A
Page 59 - Contractual Obligations and Commitments
Page 60 - Related Party Transactions
Page 61 - Off-Balance Sheet Arrangements
Page 62 - BUSINESS
Page 63 - The Obesity Epidemic
Page 64 - The Orexigen Solution
Page 65 - Our Lead Product Candidates
Page 66 - Scientific Rationale
Page 67 - Contrave Clinical Results
Page 68 - Contrave Phase II Mean Weight Loss through 24 Weeks
Page 69 - N/A
Page 70 - Contrave Phase IIb Mean Weight Loss at 24 Weeks
Page 71 - N/A
Page 72 - Contrave Phase IIb Mean Weight Loss at 48 Weeks
Page 73 - Contrave Phase IIb Mean Weight Loss Over 48 Weeks
Page 74 - Future Contrave Clinical Development Plans
Page 75 - Empatic
Page 76 - Scientific Rationale
Page 77 - Empatic Phase II Mean Weight Loss at 24 Weeks
Page 78 - Empatic Phase II Mean Weight Loss Over 24 Weeks
Page 79 - Future Empatic Clinical Development Plans
Page 80 - Intellectual Property
Page 81 - Licensing Agreements
Page 82 - Lee Dante License Agreement
Page 83 - Cypress Bioscience, Inc. License Agreement
Page 84 - Manufacturing
Page 85 - N/A
Page 86 - Third-Party Reimbursement
Page 87 - Government Regulation
Page 88 - N/A
Page 89 - Section 505(b)(2) New Drug Applications
Page 90 - Manufacturing cGMP Requirements
Page 91 - Employees
Page 92 - N/A
Page 93 - MANAGEMENT
Page 94 - Graham K. Cooper
Page 95 - James C. Lancaster, Jr.
Page 96 - Joseph S. Lacob
Page 97 - Board Committees
Page 98 - Compensation Committee Interlocks and Insider Participation
Page 99 - COMPENSATION DISCUSSION AND ANALYSIS
Page 100 - Long-Term Incentive Program.
Page 101 - Restricted Stock and Restricted Stock Units.
Page 102 - Executive Compensation
Page 103 - Grants of Plan-Based Awards
Page 104 - Employee Benefit and Stock Plans
Page 105 - Administration.
Page 106 - N/A
Page 107 - Change in Control.
Page 108 - Amendment and Termination of the 2007 Plan.
Page 109 - Eligibility.
Page 110 - Change in Control.
Page 111 - Option Exercises and Stock Vested at Fiscal Year End
Page 112 - Potential Payments Upon Termination Without Cause
Page 113 - Potential Payments Upon Termination Due to Change in Control
Page 114 - Limitations of Liability and Indemnification Matters
Page 115 - N/A
Page 116 - PRINCIPAL STOCKHOLDERS
Page 117 - (footnotes continued on following page)
Page 118 - N/A
Page 119 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 120 - Common Stock Issuances
Page 121 - Investors Rights Agreement
Page 122 - Employment Agreements
Page 123 - Other Transactions and Arrangements
Page 124 - DESCRIPTION OF CAPITAL STOCK
Page 125 - Registration Rights
Page 126 - Stockholder Meetings
Page 127 - SHARES ELIGIBLE FOR FUTURE SALE
Page 128 - Rule 144
Page 129 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO
Page 130 - Gain on Disposition of Common Stock
Page 131 - Federal Estate Tax
Page 132 - UNDERWRITING
Page 133 - No Sales of Similar Securities
Page 134 - Price Stabilization, Short Positions and Penalty Bids
Page 135 - LEGAL MATTERS
Page 136 - Orexigen Therapeutics, Inc.
Page 137 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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 - OREXIGEN THERAPEUTICS, INC.
Page 157 - OREXIGEN THERAPEUTICS, INC.
Page 158 - OREXIGEN THERAPEUTICS, INC.
Page 159 - OREXIGEN THERAPEUTICS, INC.
Page 160 - 6,000,000 Shares
Page 161 - PART II
Page 162 - N/A
Page 163 - Exhibits
Page 164 - Financial Statement Schedules
Page 165 - SIGNATURES
Page 166 - EXHIBIT INDEX
Subdocument 2 - EX-23.1 - EXHIBIT 23.1
Page 1 - EXHIBIT 23.1