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Organization and Basis of Presentation
9 Months Ended
Sep. 30, 2017
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Organization and Basis of Presentation

1. Organization and Basis of Presentation

Organization

Orexigen Therapeutics, Inc., or the Company, a Delaware corporation, is a biopharmaceutical company focused on the development and commercialization of pharmaceutical product candidates for the treatment of obesity. The Company was incorporated in September 2002 and commenced operations in 2003. The Company operates in one segment.

The Company’s primary activities since incorporation have been organizational activities, including recruiting personnel, conducting research and development, including clinical trials, raising capital, and preparing for the marketing and commercialization of its sole product, Contrave®, in the United States. Contrave was launched commercially in the United States by the Company’s former partner, Takeda Pharmaceutical Company Limited, or Takeda, in October 2014. In August 2016, the collaboration agreement between the Company and Takeda was terminated and the Company is now solely responsible for developing and commercializing Contrave within the United States and the rest of the world. The Company has experienced losses since its inception, and as of September 30, 2017, had an accumulated deficit of $765.6 million. The Company expects to continue to incur losses for at least the next several years. The Company’s ability to successfully transition to profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure, and until that time, the Company may need to continue to raise additional equity or debt financing.

Basis of Presentation

The Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. generally accepted accounting principles, or GAAP, for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The unaudited condensed consolidated financial statements of the Company include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

The Company follows the provisions of the Financial Accounting Standards Board, or the FASB, Accounting Standard Codification, or ASC, Topic 205-40, Presentation of Financial Statements – Going Concern, which requires that management evaluate whether there are relevant conditions and events that in aggregate raise substantial doubt about the entity’s ability to continue as a going concern and to meet its obligations as they become due within one year from the date that the financial statements are issued.  Furthermore, the standard does not permit management, in performing its evaluation, to take into consideration the potential mitigating effects of plans or actions that have not been fully implemented or concluded as of the date the financial statements are issued.

In performing its evaluation, management first assessed the Company’s ability to satisfy a covenant under the indenture for its 0% Convertible Senior Secured Notes due 2020, or the 2016 Notes, that provides the noteholders with a redemption right after June 30, 2018 if consolidated net product sales (a non-GAAP measure defined in the indenture as the Company’s net sales plus aggregate net sales by the Company’s distributors outside the United States) for fiscal year 2017 are less than  $100 million.  Given the Company’s and its distribution partners’ limited history of selling and forecasting sales for Contrave and Mysimba in the United States and worldwide, it is difficult to accurately project whether consolidated net product sales for fiscal year 2017 will equal or exceed $100 million.  The Company’s current forecast, however, projects that this requirement may not be met, such that the Company would be required to offer to redeem all of the 2016 Notes.  Furthermore, the Company does not currently have adequate capital resources to redeem the entire $165 million in aggregate principal amount of the 2016 Notes if all of the notes were tendered.  The Company is currently pursuing a number of potential actions to enable it to address its potential redemption obligations in the event that the covenant were not met.  These actions include attempting to negotiate waivers or amendments with holders of the 2016 Notes, pursue recapitalization or restructuring transactions involving the 2016 Notes and/or the Company’s other indebtedness, which could also potentially result in raising additional working capital, and pursue various other strategic transactions that could result in repayment of the indebtedness, including a merger or sale of the Company.  The Company, however, cannot guarantee that any of these potential actions would be successful.  As a result, due to the uncertainty regarding the Company’s ability to comply with this covenant and redeem all of the 2016 Notes if they were tendered, and the uncertainty regarding the Company’s ability to conclude one or more of the actions it is pursuing to address the potential redemption requirements, management has concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern and to meet all of its obligations as they become due within one year after the accompanying financial statements are issued.

Separate from the covenant assessment discussed above, management also assessed its operating plan and the capital resources that it projects would be required to fund its business operations. In that regard, the Company’s operating plan projects that the Company’s existing working capital can fund its business operations for one year after the accompanying financial statements are issued. This plan is based on management’s best estimate and assumptions for U.S. sales of Contrave, for which the Company reacquired the rights to sell in August 2016, and sales of Contrave or Mysimba™ outside the U.S. for which there is limited historical information. Due to the inherent uncertainty in achieving the forecasted global revenues in the plan, the Company has identified certain forecasted expenses that can be reduced starting in the first quarter of 2018 and through November 2018 if revenues are less than forecasted or if the Company is not able to raise additional equity or debt financing during the interim period. The identified cost-cutting actions could include a reduction of certain discretionary sales, general and administrative expenses. Management has evaluated that, if required, the cost cutting measures described above could be effectively implemented during the first quarter of 2018 and through November 2018, and that when implemented, would allow the Company to reduce its working capital requirements.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and therefore do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of the uncertainty regarding the Company’s ability to continue as a going concern.

The financial statements of the Company’s foreign subsidiary with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. Foreign currency transaction gains and losses are included in the results of operations in other income (expense).

The balance sheet as of December 31, 2016 has been derived from the audited financial statements as of December 31, 2016 but does not include all information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.  For more complete financial information, the accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited financial statements for the year ended December 31, 2016 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.