##### Table of Contents



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 WASHINGTON, DC 20549
 FORM 10-Q
 
 (Mark One)
 þ
    
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2007
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 FOR THE TRANSITION PERIOD FROM                      TO
 Commission file number: 001-33415
 
 OREXIGEN THERAPEUTICS, INC.
  Delaware
    
    65-1178822(State or Other Jurisdiction of Incorporation or Organization)
    
    (I.R.S. Employer Identification No.)
 12481 High Bluff Drive, Suite 160, San Diego, CA
    
    92130(Address of Principal Executive Offices)
    
    (Zip Code)
 (858) 436-8600
 
 þ o
  o o þ
  o þ




---



##### 



OREXIGEN THERAPEUTICS, INC.
TABLE OF CONTENTS
 PART I. FINANCIAL INFORMATION
    
    
    3Item 1. Financial Statements
    
    
    3Balance Sheets as of September 30, 2007 (Unaudited) and December 31, 2006
    
    
    3Unaudited Statements of Operations for the three and nine months ended September 30, 2007 and 2006
    
    
    4Unaudited Statements of Cash Flows for the nine months ended September 30, 2007 and 2006
    
    
    5Notes to Unaudited Financial Statements
    
    
    6Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
    
    
    14Item 3. Quantitative and Qualitative Disclosure about Market Risk
    
    
    20Item 4. Controls and Procedures
    
    
    21PART II. OTHER INFORMATION
    
    
    21Item 1. Legal Proceedings
    
    
    21Item 1A. Risk Factors
    
    
    21Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
    
    
    47Item 3. Defaults Upon Senior Securities
    
    
    48Item 4. Submission of Matters to a Vote of Security Holders
    
    
    48Item 5. Other Information
    
    
    48Item 6. Exhibits
    
    
    48SIGNATURES
    
    
    49EXHIBIT 31.1EXHIBIT 31.2EXHIBIT 32.1EXHIBIT 32.2
  2




---



##### Table of Contents



PART I. FINANCIAL INFORMATION
 
 ITEM 1. FINANCIAL STATEMENTS
 
 Orexigen Therapeutics, Inc.
(a development stage company)
Balance Sheets
(In thousands, except share and par value amounts)
 September 30,
    
    
    December 31,2007
    
    
    2006(Unaudited)AssetsCurrent assets:Cash and cash equivalents
    
    $
    33,791
    
    
    $
    19,425Investment securities, available-for-sale
    
    
    64,294
    
    
    
    14,988Prepaid expenses and other current assets
    
    
    805
    
    
    
    222Total current assets
    
    
    98,890
    
    
    
    34,635Property and equipment, net
    
    
    895
    
    
    
    528Restricted cash
    
    
    125
    
    
    
    155Other assets
    
    
    615
    
    
    
    1,492Total assets
    
    $
    100,525
    
    
    $
    36,810Liabilities and stockholders equity (deficit)Current liabilities:Accounts payable and accrued expenses
    
    $
    7,443
    
    
    $
    4,903Deferred revenue, current portion
    
    
    88
    
    
    
    88Long-term debt, current portion
    
    
    3,333
    
    
    
    Total current liabilities
    
    
    10,864
    
    
    
    4,991Deferred revenue, less current portion
    
    
    1,169
    
    
    
    1,235Long-term debt, less current portion
    
    
    5,278
    
    
    
    Other long-term liabilities
    
    
    540
    
    
    
    534Commitments and contingenciesSeries A and B redeemable convertible preferred
stock, $.001 par value, no shares and 24,152,544
shares authorized, issued and outstanding at
September 30, 2007 and December 31, 2006,
respectively; aggregate liquidation preference of
$46,000 at December 31, 2006
    
    
    
    
    
    
    45,897Stockholders equity (deficit):Preferred stock, $.001 par value, 10,000,000 and
no shares authorized at September 30, 2007 and
December 31, 2006, respectively; no shares
issued and outstanding at September 30, 2007
    
    
    
    
    
    
    Series C convertible preferred stock, $.001 par
value, no shares and 8,771,930 shares
authorized, issued and outstanding at September
30, 2007 and December 31, 2006, respectively;
aggregate liquidation preference of $30,000 at
December 31, 2006
    
    
    
    
    
    
    9Common stock, $.001 par value, 100,000,000 and
50,000,000 shares authorized at September 30,
2007 and December 31, 2006, respectively;
26,910,270 and 2,398,039 shares issued and
outstanding at September 30, 2007 and December
31, 2006, respectively
    
    
    27
    
    
    
    2Additional paid-in capital
    
    
    170,061
    
    
    
    33,299Accumulated other comprehensive income
    
    
    101
    
    
    
    11Deficit accumulated during the development stage
    
    
    (87,515
    )
    
    
    (49,168
    )Total stockholders equity (deficit)
    
    
    82,674
    
    
    
    (15,847
    )Total liabilities and stockholders equity (deficit)
    
    $
    100,525
    
    
    $
    36,810
  3




---



##### Table of Contents



Orexigen Therapeutics, Inc.
(a development stage company)
Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
 Period fromThree months ended
    
    
    Nine months ended
    
    
    September 12, 2002September 30,
    
    
    September 30,
    
    
    (Inception) to2007
    
    
    2006
    
    
    2007
    
    
    2006
    
    
    September 30, 2007Revenues:Collaborative agreement
    
    $
    
    
    
    $
    
    
    
    $
    
    
    
    $
    
    
    
    $
    174License revenue
    
    
    22
    
    
    
    21
    
    
    
    66
    
    
    
    62
    
    
    
    243Total revenues
    
    
    22
    
    
    
    21
    
    
    
    66
    
    
    
    62
    
    
    
    417Operating expenses:Research and development
    
    
    12,938
    
    
    
    6,018
    
    
    
    33,215
    
    
    
    14,990
    
    
    
    72,819General and administrative
    
    
    2,694
    
    
    
    1,601
    
    
    
    7,402
    
    
    
    3,764
    
    
    
    18,916Total operating expenses
    
    
    15,632
    
    
    
    7,619
    
    
    
    40,617
    
    
    
    18,754
    
    
    
    91,735Loss from operations
    
    
    (15,610
    )
    
    
    (7,598
    )
    
    
    (40,551
    )
    
    
    (18,692
    )
    
    
    (91,318
    )Other income (expense):Interest income
    
    
    1,322
    
    
    
    174
    
    
    
    2,800
    
    
    
    649
    
    
    
    4,463Interest expense
    
    
    (260
    )
    
    
    
    
    
    
    (596
    )
    
    
    
    
    
    
    (660
    )Total other income (expense)
    
    
    1,062
    
    
    
    174
    
    
    
    2,204
    
    
    
    649
    
    
    
    3,803Net loss
    
    
    (14,548
    )
    
    
    (7,424
    )
    
    
    (38,347
    )
    
    
    (18,043
    )
    
    
    (87,515
    )Accretion to redemption value of redeemable
convertible preferred stock
    
    
    
    
    
    
    (7
    )
    
    
    (11
    )
    
    
    (23
    )
    
    
    (78
    )Deemed dividend of beneficial conversion
for Series C preferred stock
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (13,860
    )Net loss attributable to common stockholders
    
    $
    (14,548
    )
    
    $
    (7,431
    )
    
    $
    (38,358
    )
    
    $
    (18,066
    )
    
    $
    (101,453
    )Net loss per share attributable to common
stockholders  basic and
diluted(1)
    
    $
    (0.54
    )
    
    $
    (3.34
    )
    
    $
    (2.40
    )
    
    $
    (8.36
    )Shares used in computing net loss per share
attributable to common stockholders 
basic and diluted(1)
    
    
    26,905
    
    
    
    2,223
    
    
    
    16,003
    
    
    
    2,160
 
 (1)
    
    As a result of the issuance of 8,050,000 shares of common
stock in the Companys initial public offering in May 2007
and the conversion of the Companys preferred stock into
16,462,231 shares of common stock upon completion of the
Companys initial public offering, there is a lack of
comparability in the basic and diluted net loss per share
amounts for the periods presented. See Note 3 for further
discussion.  4




---



##### Table of Contents



Orexigen Therapeutics, Inc.
(a development stage company)
Statements of Cash Flows
(In thousands)
(Unaudited)
 Period fromNine months ended
    
    
    September 12, 2002September 30,
    
    
    (Inception) to2007
    
    
    2006
    
    
    September 30, 2007Operating activitiesNet loss
    
    $
    (38,347
    )
    
    $
    (18,043
    )
    
    $
    (87,515
    )Adjustments to reconcile net loss to net cash used by operating
activities:Depreciation
    
    
    91
    
    
    
    25
    
    
    
    149Loss on disposal of assets
    
    
    
    
    
    
    
    
    
    
    4Amortization of premium (discount) on securities available-for-sale
    
    
    (1,824
    )
    
    
    92
    
    
    
    (1,717
    )Amortization of debt issuance costs
    
    
    145
    
    
    
    
    
    
    
    153Stock-based compensation
    
    
    2,990
    
    
    
    1,237
    
    
    
    6,366Issuance of common stock in exchange for technology and services
    
    
    
    
    
    
    
    
    
    
    47Changes in operating assets and liabilities:Prepaid expenses and other current assets
    
    
    (583
    )
    
    
    129
    
    
    
    (805
    )Accounts payable and accrued expenses
    
    
    2,540
    
    
    
    580
    
    
    
    7,498Other assets
    
    
    109
    
    
    
    (61
    )
    
    
    (85
    )Deferred rent
    
    
    6
    
    
    
    
    
    
    
    40Deferred revenue
    
    
    (66
    )
    
    
    (62
    )
    
    
    1,257Net cash used by operating activities
    
    
    (34,939
    )
    
    
    (16,103
    )
    
    
    (74,608
    )Investing activitiesPurchases of securities available-for-sale
    
    
    (98,642
    )
    
    
    (6,728
    )
    
    
    (154,777
    )Maturities of securities available-for-sale
    
    
    51,250
    
    
    
    19,427
    
    
    
    92,301Purchases of property and equipment
    
    
    (458
    )
    
    
    (230
    )
    
    
    (1,048
    )Restricted cash
    
    
    30
    
    
    
    (125
    )
    
    
    (125
    )Net cash provided (used) by investing activities
    
    
    (47,820
    )
    
    
    12,344
    
    
    
    (63,649
    )Financing activitiesProceeds from issuance of common stock, net of issuance costs
    
    
    87,891
    
    
    
    3
    
    
    
    87,906Proceeds from issuance of redeemable convertible preferred stock
for cash, net of issuance costs
    
    
    
    
    
    
    
    
    
    
    44,109Proceeds from issuance of convertible preferred stock for cash,
net of issuance costs
    
    
    
    
    
    
    
    
    
    
    29,940Proceeds from borrowings on long-term debt
    
    
    10,000
    
    
    
    
    
    
    
    10,000Payments on borrowings on long-term debt
    
    
    (1,389
    )
    
    
    
    
    
    
    (1,389
    )Proceeds from promissory notes
    
    
    
    
    
    
    
    
    
    
    1,665Costs paid in connection with loan agreement
    
    
    
    
    
    
    
    
    
    
    (183
    )Costs paid in connection with initial public offering
    
    
    623
    
    
    
    
    
    
    
    Net cash provided by financing activities
    
    
    97,125
    
    
    
    3
    
    
    
    172,048Net increase (decrease) in cash and cash equivalents
    
    
    14,366
    
    
    
    (3,756
    )
    
    
    33,791Cash and cash equivalents at beginning of period
    
    
    19,425
    
    
    
    8,740
    
    
    
    Cash and cash equivalents at end of period
    
    $
    33,791
    
    
    $
    4,984
    
    
    $
    33,791
  5




---



##### Table of Contents



OREXIGEN THERAPEUTICS, INC.
NOTES TO UNAUDITED FINANCIAL STATEMENTS
 1. The Company and Basis of Presentation
 Organization
   Basis of Presentation
   Reverse Stock Split
  Initial Public Offering
  6




---



##### Table of Contents



2. Summary of Significant Accounting Policies
 Research and Development Costs
  Revenue Recognition
 Revenue Recognition Revenue Arrangements with Multiple Deliverables
  New Accounting Standards Not Yet Adopted
 The Fair Value Option for Financial Assets and Financial
Liabilities
 Fair
Value Measurements
 7




---



##### Table of Contents



3. Net Loss per Share
 Earnings Per Share
   Three months ended
    
    
    Nine months endedSeptember 30,
    
    
    September 30,2007
    
    
    2006
    
    
    2007
    
    
    2006Numerator:Net loss attributable to common stockholders
    
    $
    (14,548
    )
    
    $
    (7,431
    )
    
    $
    (38,358
    )
    
    $
    (18,066
    )Denominator:Weighted average shares of common stock outstanding
    
    
    26,910
    
    
    
    2,388
    
    
    
    16,046
    
    
    
    2,366Weighted average unvested shares of common stock
subject to repurchase
    
    
    (5
    )
    
    
    (165
    )
    
    
    (43
    )
    
    
    (206
    )Denominator for basic and diluted net loss per share
attributable to common stockholders
    
    
    26,905
    
    
    
    2,223
    
    
    
    16,003
    
    
    
    2,160Basic and diluted net loss per share attributable to
common stockholders
    
    $
    (0.54
    )
    
    $
    (3.34
    )
    
    $
    (2.40
    )
    
    $
    (8.36
    )Historical outstanding anti-dilutive securities not
included in diluted net loss per share calculation
include the following:Convertible preferred stock, as converted
    
    
    
    
    
    
    12,076
    
    
    
    
    
    
    
    12,076Common stock options
    
    
    2,554
    
    
    
    2,320
    
    
    
    2,554
    
    
    
    2,320Common shares subject to repurchase
    
    
    
    
    
    
    151
    
    
    
    
    
    
    
    1512,554
    
    
    
    14,547
    
    
    
    2,554
    
    
    
    14,547
  8




---



##### Table of Contents



Pro Forma Net Loss per Share
  Three months ended
    
    
    Nine months endedSeptember 30,
    
    
    September 30,2007
    
    
    2006
    
    
    2007
    
    
    2006Numerator:Net loss attributable to common
stockholders
    
    $
    (14,548
    )
    
    $
    (7,431
    )
    
    $
    (38,358
    )
    
    $
    (18,066
    )Adjustment to eliminate accretion on
preferred stock and beneficial conversion
of series C preferred stock
    
    
    
    
    
    
    7
    
    
    
    11
    
    
    
    23Pro forma net loss
    
    $
    (14,548
    )
    
    $
    (7,424
    )
    
    $
    (38,347
    )
    
    $
    (18,043
    )Denominator:Weighted average shares of common stock
outstanding
    
    
    26,905
    
    
    
    2,223
    
    
    
    16,003
    
    
    
    2,160Pro forma adjustment to reflect assumed
conversion of preferred stock,
as-if-converted
    
    
    
    
    
    
    12,076
    
    
    
    7,296
    
    
    
    12,076Denominator for pro forma basic and diluted
net loss per share
    
    
    26,905
    
    
    
    14,299
    
    
    
    23,299
    
    
    
    14,236Pro forma basic and diluted net loss per share
    
    $
    (0.54
    )
    
    $
    (0.52
    )
    
    $
    (1.65
    )
    
    $
    (1.27
    )
 4. Investment Securities, Available-for-Sale
  UnrealizedSeptember 30, 2007
    
    Maturity in Years
    
    Amortized Cost
    
    Gains
    
    Losses
    
    Fair ValueCorporate debt obligations
    
    Less than 1
    
    $
    61,438
    
    
    $
    99
    
    
    $
    
    
    
    $
    61,537Corporate debt obligations
    
    
    23
    
    
    
    2,755
    
    
    
    2
    
    
    
    
    
    
    
    2,757Total investment securities
    
    
    
    
    
    $
    64,193
    
    
    $
    101
    
    
    $
    
    
    
    $
    64,294UnrealizedDecember 31, 2006
    
    Maturity in Years
    
    Amortized Cost
    
    Gains
    
    Losses
    
    Fair ValueCorporate debt obligations
    
    Less than 1
    
    $
    33,069
    
    
    $
    11
    
    
    $
    
    
    
    $
    33,080Less cash equivalents
    
    
    
    
    
    
    (18,092
    )
    
    
    
    
    
    
    
    
    
    
    (18,092
    )Amounts classified as investments
    
    
    
    
    
    $
    14,977
    
    
    $
    11
    
    
    $
    
    
    
    $
    14,988
 9




---



##### Table of Contents



5. Property and Equipment
  September 30,
    
    
    December 31,2007
    
    
    2006Furniture and fixtures
    
    $
    311
    
    
    $
    311Computers and equipment
    
    
    111
    
    
    
    105Leasehold improvements
    
    
    42
    
    
    
    36Laboratory equipment
    
    
    154
    
    
    
    126Equipment not yet placed in service
    
    
    418
    
    
    
    1,036
    
    
    
    578Less accumulated depreciation and amortization
    
    
    (141
    )
    
    
    (50
    )$
    895
    
    
    $
    528
 6. Accounts Payable and Accrued Expenses
  September 30,
    
    
    December 31,2007
    
    
    2006Accounts payable
    
    $
    3,761
    
    
    $
    1,699Accrued and unbilled preclinical and clinical trial expenses
    
    
    2,044
    
    
    
    2,269Accrued compensation related expenses
    
    
    1,046
    
    
    
    762Accrued legal and professional expenses
    
    
    155
    
    
    
    104Other accrued liabilities
    
    
    437
    
    
    
    69$
    7,443
    
    
    $
    4,903
 7. Comprehensive Income (Loss)
  Period fromThree months ended
    
    
    Nine months ended
    
    
    September 12, 2002September 30,
    
    
    September 30,
    
    
    (Inception) to2007
    
    
    2006
    
    
    2007
    
    
    2006
    
    
    September 30, 2007Net loss, as reported
    
    $
    (14,548
    )
    
    $
    (7,424
    )
    
    $
    (38,347
    )
    
    $
    (18,043
    )
    
    $
    (87,515
    )Unrealized gains on investment securities
    
    
    10
    
    
    
    20
    
    
    
    90
    
    
    
    47
    
    
    
    101Comprehensive loss
    
    $
    (14,538
    )
    
    $
    (7,404
    )
    
    $
    (38,257
    )
    
    $
    (17,996
    )
    
    $
    (87,414
    )
 8. Stock-Based Compensation
   Share-Based Payment
 10




---



##### Table of Contents



Period fromThree months ended
    
    
    Nine months ended
    
    
    September 12, 2002September 30,
    
    
    September 30,
    
    
    (Inception) to2007
    
    
    2006
    
    
    2007
    
    
    2006
    
    
    September 30, 2007General and administrative
    
    $
    686
    
    
    $
    410
    
    
    $
    1,871
    
    
    $
    1,056
    
    
    $
    4,425Research and development
    
    
    398
    
    
    
    96
    
    
    
    1,119
    
    
    
    181
    
    
    
    1,941$
    1,084
    
    
    $
    506
    
    
    $
    2,990
    
    
    $
    1,237
    
    
    $
    6,366
  Three months ended
    
    Nine months endedSeptember 30,
    
    September 30,2007
    
    2006
    
    2007
    
    2006Expected life (in years)
    
    
    6.2
    
    
    
    6.2
    
    
    
    6.2
    
    
    
    6.2Expected volatility
    
    
    70.00
    %
    
    
    70.00
    %
    
    
    70.00
    %
    
    
    70.00
    %Risk-free interest rate
    
    
    4.8
    %
    
    
    4.7
    %
    
    
    4.9
    %
    
    
    4.7
    %Expected dividend yield
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
 9. Commitments and Contingencies
 Credit and Security Agreement
   11




---



##### Table of Contents



Due in:2007
    
    $
    8332008
    
    
    3,3332009
    
    
    3,3332010
    
    
    1,1128,611Less current portion

    
    (3,333
    )$
    5,278
 Technology and License Agreement
 Cypress Bioscience, Inc.
    10. Income Taxes
 Accounting for Uncertainty in Income
Taxes  An Interpretation of FASB Statement No. 109
 12




---



##### Table of Contents



11. Related Party Transactions
  13




---



##### Table of Contents



ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 The following discussion contains forward-looking statements, which involve risks and
uncertainties. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including those set forth below under
Part II, Item 1A, Risk Factors. The interim financial statements and this Managements Discussion
and Analysis of Financial Condition and Results of Operations should be read in conjunction with
the financial statements and notes thereto for the year ended December 31, 2006 and the related
Managements Discussion and Analysis of Financial Condition and Results of Operations, both of
which are contained in our Prospectus filed pursuant to Rule 424(b) under the Securities Act with
the Securities and Exchange Commission on April 26, 2007. Except as required by law, we assume no
obligation to update these forward-looking statements, whether as a result of new information,
future events or otherwise.
 Overview
 Background
     Revenues
  14




---



##### Table of Contents



Research and Development Expenses
     General and Administrative Expenses
  Interest and Other Income
  Income Taxes
  15




---



##### Table of Contents



Beneficial Conversion Feature
 Accounting for Convertible Securities with Beneficial
Conversion Features
 Critical Accounting Policies and Estimates
   Accounting for Income Taxes
 Accounting for Uncertainty in Income Taxes  An Interpretation
of FASB Statement No. 109 Accounting for Income
Taxes,
 Results of Operations
 Comparison of three months ended September 30, 2007 to three months ended September 30, 2006
 Revenues.
 Research and Development Expenses.
 16




---



##### Table of Contents



General and Administrative Expenses.
 Interest and Other Income.
 Interest Expense.
 Comparison of nine months ended September 30, 2007 to nine months ended September 30, 2006
 Revenues.
 Research and Development Expenses.
 General and Administrative Expenses.
 Interest and Other Income.
 Interest Expense.
 Liquidity and Capital Resources
  
    
    from September 12, 2002 to December 31, 2006, we issued and sold a
total of 1,053,572 shares of common stock for aggregate net proceeds
of $14,801;
    
    in March 2004, we issued and sold a total of 9,322,035 shares of Series A redeemable convertible preferred stock for
aggregate net proceeds of $9.2 million and the conversion of promissory notes and interest thereon totaling $1.7
million;
 17




---



##### Table of Contents




    
    from April 2005 to May 2005, we issued and sold 14,830,509 shares of Series B redeemable convertible preferred stock
for aggregate net proceeds of $34.9 million;
    
    in November 2006, we issued and sold a total of 8,771,930 shares of Series C convertible preferred stock for aggregate
net proceeds of $29.9 million; and
    
    in May 2007, we issued and sold a total of 8,050,000 shares of common stock for aggregate net proceeds of $87.9 million.
        
    
    the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable;
    
    our ability to establish and maintain strategic collaborations, including licensing and other arrangements;
    
    the costs involved in enforcing or defending patent claims or other intellectual property rights;
    
    the costs and timing of regulatory approvals;
 18




---



##### Table of Contents




    
    the costs of establishing sales or distribution capabilities;
    
    the successful commercialization of our products; and
    
    the extent to which we in-license, acquire or invest in other indications, products, technologies and businesses.
     19




---



##### Table of Contents



Contractual Obligations and Commitments
  Payments Due by PeriodLess than1 Year
    
    
    13 Years
    
    
    45 YearsTotal
    
    
    (Remainder of 2007)
    
    
    (2008  2010)
    
    
    (2011  2012)
    
    
    After 5 YearsLong-term debt obligations(1)
    
    $
    8,611
    
    
    $
    833
    
    
    $
    7,778
    
    
    $
    
    
    
    $
    Long-term liabilities(2)
    
    
    540
    
    
    
    
    
    
    
    520
    
    
    
    20
    
    
    
    Operating lease obligations
    
    
    874
    
    
    
    50
    
    
    
    636
    
    
    
    188
    
    
    
    License obligations(3)
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Total
    
    $
    10,025
    
    
    $
    883
    
    
    $
    8,934
    
    
    $
    208
    
    
    $
    
 
 (1)
    
    In December 2006, we entered into a credit and security agreement with
Merrill Lynch Capital providing for the potential borrowing of up to
$17.0 million. In November 2007, the amount available for borrowing
under the credit and security agreement was increased to $25.0
million. In March 2007, we drew down $10.0 million under the credit
and security agreement.(2)
    
    Primarily represents costs incurred in connection with our credit and security agreement with Merrill Lynch Capital.(3)
    
    License obligations do not include additional payments of up to $2.7 million due upon the occurrence of certain
milestones related to regulatory or commercial events or potential payments of up to $5.7 million to Duke
University should we receive milestone payments from Cypress under our agreement with Cypress (up to $3.7 million
excluding milestone payments unrelated to sleep apnea). We may also be required to pay royalties on any net sales
of the licensed products. License payments may be increased based on the timing of various milestones and the
extent to which the licensed technologies are pursued for other indications. These milestone payments and royalty
payments under our license agreements are not included in the table above because we cannot, at this time,
determine when or if the related milestones will be achieved or the events triggering the commencement of payment
obligations will occur.  Off-Balance Sheet Arrangements
  
 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
  20




---



##### Table of Contents



ITEM 4. CONTROLS AND PROCEDURES
 Disclosure Controls and Procedures
   Changes in Internal Control over Financial Reporting
  
 PART II. OTHER INFORMATION
 
 ITEM 1. LEGAL PROCEEDINGS
   
 ITEM 1A. RISK FACTORS
 Investing in our common stock involves a high degree of risk. You should carefully consider
the following risk factors, which have been updated since the filing of our Form 10-Q filed with
the Securities and Exchange Commission on August 10, 2007, in their entirety, as well as the other
information in this report, before deciding whether to invest in shares of our common stock. The
occurrence of any of the following risks could harm our business, financial condition, results of
operations and/or growth prospects. In that case, the trading price of our common stock could
decline, and you may lose all or part of your investment.
 We have marked with an asterisk (*) those risk factors below that reflect substantive changes
from the risk factors included in our previously filed Quarterly Report on Form 10-Q for the quarter ended June 30,
2007.
 21




---



##### Table of Contents



Risks Related to Our Business and Industry
 We are largely dependent on the success of our two product candidates in clinical development:
Contrave (naltrexone/bupropion, each in a sustained release, or SR, formulation) and Empatic (zonisamide SR/bupropion SR). We cannot be certain that either product candidate will receive
regulatory approval or be successfully commercialized.
  
    
    the FDA may not deem a product candidate safe and effective;
 
    
    the FDA may not find the data from preclinical studies and clinical trials sufficient to support approval;
    
    the FDA may require additional preclinical studies;
    
    the FDA may not approve of our third-party manufacturers processes and facilities; or
    
    the FDA may change its approval policies or adopt new regulations.
  Our clinical trials may fail to demonstrate acceptable levels of safety and efficacy of our product
candidates, which could prevent or significantly delay their regulatory approval.*
   22




---



##### Table of Contents



Our product candidates may cause undesirable side effects or have other properties that could delay
or prevent their regulatory approval or limit the commercial profile of any approved label *
   23




---



##### Table of Contents




    
    regulatory authorities may withdraw their approval of the product;
    
    regulatory authorities may require the addition of labeling
statements, such as a black box warning with Contrave or Empatic or
a contraindication;
    
    we may be required to create a Medication Guide outlining the risks of such side effects for distribution to patients;
    
    we may be required to change the way the product is administered, conduct additional clinical trials or change the
labeling of the product;
    
    we could be asked to formulate a risk mitigation plan that could include a program of post-marketing surveillance for
patients receiving our products;
    
    we could be sued and held liable for harm caused to individuals exposed to or taking our product candidates; and
    
    our reputation may suffer.
  24




---



##### Table of Contents



Delays in the commencement or completion of clinical testing could result in increased costs to us
and delay or limit our ability to generate revenues.
  
    
    obtaining regulatory approval to commence a clinical trial;
    
    reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and
trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among
different CROs and trial sites;
    
    manufacturing sufficient quantities of a product candidate for use in clinical trials;
    
    obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;
    
    recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including
competition from other clinical trial programs for the treatment of obesity or similar indications; and
    
    retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects
from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up.
  
    
    failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
    
    inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold;
    
    unforeseen safety issues; and
    
    lack of adequate funding to continue the clinical trial.
  Our product candidates are combinations of generically-available pharmaceutical products, and our
success is dependent on our ability to compete against off-label generic substitutes and
demonstrate the advantages of our proprietary combination products.*
  25




---



##### Table of Contents



We rely on third parties to conduct our clinical trials. If these third parties do not successfully
carry out their contractual duties or meet expected deadlines, we may not be able to obtain
regulatory approval for or commercialize our product candidates within our expected timeframes or
at all.
  We expect intense competition in the obesity marketplace for Contrave and Empatic, and new products
may emerge that provide different or better therapeutic alternatives for obesity and weight loss.*
    26




---



##### Table of Contents




    
    research and development resources, including personnel and technology;
    
    regulatory experience;
    
    drug development and clinical trial experience;
    
    experience and expertise in exploitation of intellectual property rights; and
    
    capital resources.
   We have limited sales and marketing experience or resources, and we may not be able to effectively
market and sell our products.
  Our development and commercialization strategy depends upon access to findings of safety and
effectiveness based on data not developed by us but which the FDA may reference in reviewing our
U.S. marketing applications. In territories outside the United States, we must either negotiate
access to these safety and effectiveness findings or develop them ourselves.
  27




---



##### Table of Contents



Even if our product candidates receive regulatory approval, they may still face future development
and regulatory difficulties.
  
    
    issue warning letters or untitled letters;
    
    impose civil or criminal penalties;
    
    suspend regulatory approval;
    
    suspend any ongoing clinical trials;
 28




---



##### Table of Contents




    
    refuse to approve pending applications or supplements to applications filed by us;
    
    impose restrictions on operations, including costly new manufacturing requirements; or
    
    seize or detain products or require us to initiate a product recall.
 Even if our product candidates receive regulatory approval in the United States, we may never
receive approval or commercialize our products outside of the United States.
  If the suppliers upon whom we rely for active pharmaceutical ingredients, or API, fail to produce
such ingredients in the volumes that we require on a timely basis, or to comply with stringent
regulations applicable to pharmaceutical drug manufacturers, we may face delays in the conduct of
our clinical trials.*
     If the contract manufacturers upon whom we rely fail to produce our product candidates in the
volumes that we require on a timely basis, or fail to comply with stringent regulations applicable
to pharmaceutical drug manufacturers, we may face delays in the development and commercialization
of our product candidates.*
 29




---



##### Table of Contents



We are combining drugs in novel combinations and cannot be sure that the combined drugs can
co-exist for extended periods in close proximity.*
  30




---



##### Table of Contents



We face potential product liability exposure, and, if successful claims are brought against us, we
may incur substantial liability.
  
    
    decreased demand for our product candidates;
    
    impairment of our business reputation;
    
    withdrawal of clinical trial participants;
    
    costs of related litigation;
    
    distraction of managements attention from our primary business;
    
    substantial monetary awards to patients or other claimants;
    
    loss of revenues; and
    
    the inability to commercialize our product candidates.
  If any of our product candidates for which we receive regulatory approval does not achieve broad
market acceptance, the revenues that we generate from their sales will be limited.
  
    
    our ability to provide acceptable evidence of safety and efficacy;
    
    the relative convenience and ease of administration;
    
    the prevalence and severity of any adverse side effects;
    
    limitations or warnings contained in a products FDA-approved
labeling, including, for example, potential black box warnings or
pregnancy precautions associated with the active ingredients of
Contrave and/or Empatic;
    
    availability of alternative treatments, including, in the case of
Contrave and/or Empatic, a number of competitive products already
approved for the treatment of weight loss or expected to be
commercially launched in the near future;
 31




---



##### Table of Contents




    
    pricing and cost effectiveness;
    
    the effectiveness of our or any future collaborators sales and marketing strategies;
    
    our ability to obtain sufficient third-party coverage or reimbursement; and
    
    the willingness of patients to pay out of pocket in the absence of third-party coverage.
  We are subject to uncertainty relating to reimbursement policies which, if not favorable to our
product candidates, could hinder or prevent our product candidates commercial success.
     Our failure to successfully acquire, develop and market additional product candidates or approved
products would impair our ability to grow.*
   32




---



##### Table of Contents




    
    exposure to unknown liabilities;
    
    disruption of our business and diversion of our managements time and attention to develop
acquired products or technologies;
    
    incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
    
    higher than expected acquisition and integration costs;
    
    increased amortization expenses;
    
    difficulty and cost in combining the operations and personnel of any acquired businesses
with our operations and personnel;
    
    impairment of relationships with key suppliers or customers of any acquired businesses due
to changes in management and ownership; and
    
    inability to retain key employees of any acquired businesses.
  Healthcare reform measures could hinder or prevent our product candidates commercial success.
   
    
    our ability to set a price we believe is fair for our products;
    
    our ability to generate revenues and achieve or maintain profitability; and
    
    the availability of capital.
 33




---



##### Table of Contents



We will need to increase the size of our organization, and we may experience difficulties in
managing growth.*
  
    
    manage our clinical trials effectively, including our upcoming Phase
III clinical trial for Contrave and our upcoming Phase II clinical
trial for Empatic, which are being conducted at numerous clinical
trial sites;
    
    manage our internal development efforts effectively while carrying out our
contractual obligations to licensors, contractors, collaborators and other third
parties;
    
    continue to improve our operational, financial and management controls, reporting
systems and procedures; and
    
    attract and retain the breadth and depth of sufficient numbers of talented employees.
  We may not be able to manage our business effectively if we are unable to attract and retain key
personnel.
     34




---



##### Table of Contents



We will need to obtain FDA approval of our proposed product names, Contrave and Empatic, and any
failure or delay associated with such approval may adversely impact our business.
  Recent federal legislation and actions by state and local governments may permit re-importation of
drugs from foreign countries into the United States, including foreign countries where the drugs
are sold at lower prices than in the United States, which could materially adversely affect our
operating results and our overall financial condition.
  If we fail to comply with healthcare regulations, we could face substantial penalties and our
business, operations and financial condition could be adversely affected.
  
    
    the federal healthcare program Anti-Kickback Law, which prohibits,
among other things, persons from soliciting, receiving or providing
remuneration, directly or indirectly, to induce either the referral of
an individual, for an item or service or the purchasing or ordering of
a good or service, for which payment may be made under federal
healthcare programs such as the Medicare and Medicaid programs;
    
    federal false claims laws which prohibit, among other things,
individuals or entities from knowingly presenting, or causing to be
presented, claims for payment from Medicare, Medicaid, or other
third-party payors that are false or fraudulent, and which may apply
to entities like us which provide coding and billing advice to
customers;
 35




---



##### Table of Contents




    
    the federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, which prohibits executing a scheme to defraud any
healthcare benefit program or making false statements relating to
healthcare matters and which also imposes certain requirements
relating to the privacy, security and transmission of individually
identifiable health information;
    
    the Federal Food, Drug, and Cosmetic Act, which among other things,
strictly regulates drug product marketing, prohibits manufacturers
from marketing drug products for off-label use and regulates the
distribution of drug samples; and
    
    state law equivalents of each of the above federal laws, such as
anti-kickback and false claims laws which may apply to items or
services reimbursed by any third-party payor, including commercial
insurers, and state laws governing the privacy and security of health
information in certain circumstances, many of which differ from each
other in significant ways and often are not preempted by HIPAA, thus
complicating compliance efforts.
  Our business involves the use of hazardous materials and we and our third-party manufacturers must
comply with environmental laws and regulations, which can be expensive and restrict how we do
business.
  Our business and operations would suffer in the event of system failures.
  Risks Related to Intellectual Property
 The issued patent rights that we have in-licensed covering Contrave and Empatic are limited to the
United States, and our market opportunity for these product candidates may be limited by the lack
of patent protection in other territories.*
 36




---



##### Table of Contents



Although we have international patent applications pending, we do not currently have patent
protection for our Contrave and Empatic product candidates outside the United States.
  37




---



##### Table of Contents



We have in-licensed the rights to our product candidates from third parties. If we default on any
of our material obligations under those licenses, we could lose rights to Contrave and Empatic.
  Restrictions on our patent rights relating to our product candidates may limit our ability to
prevent third parties from competing against us.*
     38




---



##### Table of Contents



If we are sued for infringing intellectual property rights of third parties, it will be costly and
time consuming, and an unfavorable outcome in that litigation would have a material adverse effect
on our business.
    
    
    infringement and other intellectual property claims which, regardless
of merit, may be expensive and time-consuming to litigate and may
divert our managements attention from our core business;
    
    substantial damages for infringement, which we may have to pay if a
court decides that the product at issue infringes on or violates the
third partys rights, and if the court finds that the infringement was
willful, we could be ordered to pay treble damages and the patent
owners attorneys fees;
    
    a court prohibiting us from selling or licensing the product unless
the third party licenses its product rights to us, which it is not
required to do;
    
    if a license is available from a third party, we may have to pay
substantial royalties, fees and/or grant cross-licenses to
intellectual property rights for our products; and
    
    redesigning our products or processes so they do not infringe, which
may not be possible or may require substantial monetary expenditures
and time.
  39




---



##### Table of Contents



Although we have entered into a settlement agreement designed to prevent the parties to the
agreement from asserting infringement and other specified claims against our Empatic product
candidate in the United States, and abroad, disputes with third parties relating to our Empatic
product could nevertheless affect our intellectual property rights.*
    40




---



##### Table of Contents



Obtaining and maintaining our patent protection depends on compliance with various procedural,
document submission, fee payment and other requirements imposed by governmental patent agencies,
and our patent protection could be reduced or eliminated for non-compliance with these
requirements.
  We have not yet registered our trademarks in all of our potential markets, and failure to secure
those registrations could adversely affect our business.*
  41




---



##### Table of Contents



We may be subject to claims that our employees have wrongfully used or disclosed alleged trade
secrets of their former employers.
  Risks Related to Our Finances and Capital Requirements
 We have incurred significant operating losses since our inception and anticipate that we will incur
continued losses for the foreseeable future.*
  We have not generated any revenue from our product candidates and may never be profitable.
  
    
    successfully complete our ongoing and planned clinical trials for Contrave and Empatic;
    
    obtain regulatory approval for Contrave and Empatic;
    
    manufacture commercial quantities of our product candidates at
acceptable cost levels if regulatory approvals are received; and
    
    identify and enter into one or more strategic collaborations to
effectively market and sell our product candidates.
  Our short operating history makes it difficult to evaluate our business and prospects.
  42




---



##### Table of Contents



We will need additional funding and may be unable to raise capital when needed, which would force
us to delay, reduce or eliminate our product development programs or commercialization efforts.*
  
    
    fund our operations and continue to conduct clinical trials to support potential
regulatory approval of marketing applications;
    
    qualify and outsource the commercial-scale manufacturing of our products under cGMPs; and
    
    commercialize Contrave, Empatic or any other product candidates that
we may develop, in-license or acquire, if any of these product
candidates receive regulatory approval.
  
    
    the rate of progress and cost of our clinical trials and other product
development programs for Contrave, Empatic and any other product
candidates that we may develop, in-license or acquire;
 
    
    the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual
property rights associated with our product candidates;
 
    
    the costs and timing of completion of outsourced commercial manufacturing supply arrangements for
each product candidate;
 
    
    the timing of regulatory approval of our product candidates, if at all;
 
    
    the costs of establishing sales, marketing and distribution capabilities, should we elect to do so;
 
    
    the effect of competing technological and market developments; and
 
    
    the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we
may establish.
   Our quarterly operating results may fluctuate significantly.
  
    
    variations in the level of expenses related to our two existing product candidates
or future development programs;
 43




---



##### Table of Contents




    
    addition or termination of clinical trials or funding support;
 
    
    any intellectual property infringement lawsuit in which we may become involved;
 
    
    regulatory developments affecting our product candidates or those of our competitors;
 
    
    our execution of any collaborative, licensing or similar arrangements, and the
timing of payments we may make or receive under these arrangements; and
 
    
    if either of our product candidates receives regulatory approval, the level of
underlying demand for our product candidates and wholesalers buying patterns.
  Raising additional funds by issuing securities may cause dilution to existing stockholders and
raising funds through lending and licensing arrangements may restrict our operations or require us
to relinquish proprietary rights.
   We will incur significant increased costs as a result of operating as a public company, and our
management will be required to devote substantial time to new compliance initiatives.
   44




---



##### Table of Contents



Risks Relating to Securities Markets and Investment in Our Stock
 There may not be a viable public market for our common stock.*
  Future sales of our common stock may cause our stock price to decline.
   We expect that the price of our common stock will fluctuate substantially.*
  
    
    the results from our clinical trials, including our current and
planned Phase III clinical trials for Contrave and our upcoming Phase
II clinical trial for Empatic;
 
    
    FDA or international regulatory actions, including failure to receive regulatory
approval for any of our product candidates;
 
    
    failure of any of our product candidates, if approved, to achieve commercial success;
 
    
    announcements of the introduction of new products by us or our competitors;
 
    
    market conditions in the pharmaceutical and biotechnology sectors;
 
    
    announcements concerning product development results or intellectual property rights of others;
 45




---



##### Table of Contents




    
    litigation or public concern about the safety of our potential products;
 
    
    actual and anticipated fluctuations in our quarterly operating results;
 
    
    deviations in our operating results from the estimates of securities analysts or other analyst comments;
 
    
    additions or departures of key personnel;
 
    
    third-party coverage and reimbursement policies;
 
    
    developments concerning current or future strategic collaborations; and
 
    
    discussion of us or our stock price by the financial and scientific press and in online investor
communities.
  Our management team may invest or spend the proceeds from our initial public offering in ways with
which our stockholders may not agree or in ways which may not yield a significant return.
  Our executive officers and directors and their affiliates will exercise control over stockholder
voting matters in a manner that may not be in the best interests of all of our stockholders.*
  Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a
change of control which could limit the market price of our common stock and may prevent or
frustrate attempts by our stockholders to replace or remove our current management.
  
    
    a board of directors divided into three classes serving staggered
three-year terms, such that not all members of the board will be
elected at one time;
 
    
    a prohibition on stockholder action through written consent;
 
    
    a requirement that special meetings of stockholders be called only by
the chairman of the board of directors, the chief executive officer,
the president or by a majority of the total number of authorized
directors;
 46




---



##### Table of Contents




    
    advance notice requirements for stockholder proposals and nominations;
 
    
    a requirement of approval of not less than 662/3% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by
stockholder action, or to amend specific provisions of our certificate
of incorporation; and
 
    
    the authority of the board of directors to issue preferred stock on
terms determined by the board of directors without stockholder
approval.
  We have never paid dividends on our capital stock, and because we do not anticipate paying any cash
dividends in the foreseeable future, capital appreciation, if any, of our common stock will be your
sole source of gain on an investment in our stock.
  We may become involved in securities class action litigation that could divert managements
attention and harm our business.
  
 ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 Recent Sales of Unregistered Securities
  Use of Proceeds
   47




---



##### Table of Contents



ITEM 3. DEFAULTS UPON SENIOR SECURITIES
  
 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
  
 ITEM 5. OTHER INFORMATION
  
 ITEM 6. EXHIBITS
 ExhibitNumber
    
    Description3.1(1)
    
    Amended and Restated Certificate of Incorporation3.2(1)
    
    Amended and Restated Bylaws4.1(2)
    
    Form of Specimen Stock Certificate4.2(3)
    
    Second Amended and Restated Investors Rights Agreement dated November 20, 200610.24(4)
    
    First Amendment to Credit and Security Agreement dated July 2, 2007 by and between the Registrant
and Merrill Lynch Capital10.25(5)#
    
    Amendment No. 1 to Employment Agreement dated August 22, 2007 by and between the Registrant and
Gary D. Tollefson10.26(6)
    
    Settlement Agreement dated September 12, 2007 by and among the Registrant, Duke University,
Eisai, Inc. and Eisai Co. Ltd.31.1*
    
    Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant
to the Securities Exchange Act of 1934, as amended31.2*
    
    Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant
to the Securities Exchange Act of 1934, as amended32.1*
    
    Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 200232.2*
    
    Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
 (1)
    
    Filed with Amendment No. 2 to the Registrants Registration Statement on Form S-1 on February
16, 2007.(2)
    
    Filed with Amendment No. 3 to the Registrants Registration Statement on Form S-1 on April 9,
2007.(3)
    
    Filed with the Registrants Registration Statement on Form S-1 on December 19, 2006.(4)
    
    Filed with the Registrants Current Report on Form 8-K on July 3, 2007 (as Exhibit 10.1).(5)
    
    Filed with the Registrants Current Report on Form 8-K on August 28, 2007 (as Exhibit 10.1).(6)
    
    Filed with the Registrants Current Report on Form 8-K on September 18, 2007 (as Exhibit
10.1).#
    
    Indicates management contract or compensatory plan.*
    
    These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Orexigen Therapeutics, Inc., whether made before or after the date hereof, regardless of any
general incorporation language in such filing. 48




---



##### Table of Contents



SIGNATURES
  OREXIGEN THERAPEUTICS, INC.Date: November 9, 2007
    By:
    /S/ GARY D. TOLLEFSONGary D. Tollefson, M.D., Ph.D.President and Chief Executive Officer
(Principal Executive Officer)Date: November 9, 2007
    By:
    /S/ GRAHAM K. COOPERGraham K. CooperChief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) 49




---



##### Table of Contents



INDEX TO EXHIBITS
 ExhibitNumber
    
    Description3.1(1)
    
    Amended and Restated Certificate of Incorporation3.2(1)
    
    Amended and Restated Bylaws4.1(2)
    
    Form of Specimen Stock Certificate4.2(3)
    
    Second Amended and Restated Investors Rights Agreement dated November 20, 200610.24(4)
    
    First Amendment to Credit and Security Agreement dated July 2, 2007 by and between the Registrant
and Merrill Lynch Capital10.25(5)#
    
    Amendment No. 1 to Employment Agreement dated August 22, 2007 by and between the Registrant and
Gary D. Tollefson10.26(6)
    
    Settlement Agreement dated September 12, 2007 by and among the Registrant, Duke University,
Eisai, Inc. and Eisai Co. Ltd.31.1*
    
    Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant
to the Securities Exchange Act of 1934, as amended31.2*
    
    Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated pursuant
to the Securities Exchange Act of 1934, as amended32.1*
    
    Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 200232.2*
    
    Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
 (1)
    
    Filed with Amendment No. 2 to the Registrants Registration Statement on Form S-1 on February
16, 2007.(2)
    
    Filed with Amendment No. 3 to the Registrants Registration Statement on Form S-1 on April 9,
2007.(3)
    
    Filed with the Registrants Registration Statement on Form S-1 on December 19, 2006.(4)
    
    Filed with the Registrants Current Report on Form 8-K on July 3, 2007 (as Exhibit 10.1).(5)
    
    Filed with the Registrants Current Report on Form 8-K on August 28, 2007 (as Exhibit 10.1).(6)
    
    Filed with the Registrants Current Report on Form 8-K on September 18, 2007 (as Exhibit
10.1).#
    
    Indicates management contract or compensatory plan.*
    
    These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Orexigen Therapeutics, Inc., whether made before or after the date hereof, regardless of any
general incorporation language in such filing.