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Orexigen Therapeutics Reports Corporate and Financial Results for the Second Quarter Ended June 30, 2014
Date:8/7/2014

SAN DIEGO, Aug. 7, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced corporate and financial results for the second quarter ended June 30, 2014.

"We are making progress with the FDA discussing the alternatives for the post-marketing obligation for evaluation of cardiovascular outcomes, and we are confident that we can reach agreement on these final details of the NB32 review," said Michael Narachi, CEO of Orexigen.

 

Financial results for the three months ended June 30, 2014
For the three months ended June 30, 2014, Orexigen reported a net loss of $24.5 million, or $0.21 per share, as compared to a net loss of $18.2 million, or $0.19 per share, for the second quarter of 2013.

Total operating expenses for the second quarter of 2014 were $23.7 million compared to $19.1 million for the second quarter of 2013. This overall increase in operating expenses reflects an increase in raw materials, inventory, and manufacturing-related expenses and in stock based compensation expense. While Orexigen is responsible for manufacturing NB32, Takeda Pharmaceuticals will reimburse Orexigen for manufacturing related costs, including finished goods.

As of June 30, 2014, Orexigen had $31.1 million in cash and cash equivalents and an additional $102.2 million in marketable securities, for a total of $133.3 million. Orexigen is eligible to receive cash milestone payments of $100 million from Takeda Pharmaceuticals, between US approval and first commercial sale of NB32.

NB32 program update:

  • NB32 (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR), an investigational medicine for weight loss and the maintenance of weight loss: In June 2014, the United States Food and Drug Administration (FDA) extended its review of the resubmitted New Drug Application (NDA) for NB32. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014. The FDA indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. Discussions with the Agency on the post-marketing obligation are progressing, and Orexigen is confident it can reach agreement with the FDA. Orexigen has licensed North American NB32 rights to Takeda. Takeda is preparing a well resourced primary care U.S. launch for NB32 with approximately 900 sales representatives. In October 2013 Orexigen submitted a Marketing Authorization Application for NB32 to the European Medicines Agency (EMA). Orexigen received the Day 180 List of Outstanding Issues from the EMA's Committee for Medicinal Products for Human Use (CHMP) and will submit the Company's responses in September. Orexigen owns NB32 rights outside of North America and will seek a partner to commercialize NB32 in those territories.
  • Conference Call Today at 8 a.m. Eastern Time (5:00 a.m. Pacific Time)
    The Orexigen management team will host a teleconference and webcast to discuss the second quarter 2014 financial results and recent business highlights. The live call may be accessed by calling (800) 708-4540 (domestic) or (847) 619-6397 (international), participant code 37792592. The webcast can be accessed live on the Investor Relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.

    About Orexigen Therapeutics
    Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is NB32. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen's strategy for NB32 is to pursue approvals worldwide and pharmaceutical partnerships for global commercialization. The Company has submitted applications for marketing authorization in the United States and Europe, with potential approvals in 2014. If approved, North American partner Takeda Pharmaceuticals will commercialize NB32 in the United States. The Company's other product candidate, Empatic™, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.

     

     

     

    Forward-Looking Statements
    Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "should," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding: the timing of potential approval of the NDA for NB32 in the U.S. and the MAA for NB32 by the European Medicines Agency (EMA); the ability to reach agreement with the FDA on a post-marketing requirement for cardiovascular outcomes; the timing of Orexigen's response to the Day 180 List of Outstanding Issues; the timing and potential for a Takeda launch of NB32; the benefit risk profile for NB32; the use by Takeda of 900 sales representatives focusing on primary care physicians in the U.S.; the success of a U.S. primary care launch of NB32; and the potential to obtain a partner to commercialize NB32 in certain territories outside of North America.  The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential for the FDA to not approve NB32 even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis of the Light Study would later be deemed to jeopardize the integrity of the Light Study potentially resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study; the results from the interim analysis may not be sufficient to successfully respond to the questions raised regarding safety of NB32; the possibility that the CHMP requests additional or new data to be provided; the possibility that the CHMP determines to not approve NB32; the potential for early termination of Orexigen's North American collaboration agreement with Takeda; the possibility that Orexigen is unable to find a partner for NB32 in territories outside of North America, the final results of the Light Study may not support continued approval of NB32; the therapeutic and commercial value of NB32; the potential for additional costly clinical trials needed for Empatic; and other risks described in Orexigen's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Annual Report on Form 10-K filed with the Securities and Exchange Commission March 13, 2014 and its other reports, which are available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


     

    Orexigen Contact:

    Media Contact:  McDavid Stilwell

    Denise PowellVP, Corporate Communications and Business Development

    BrewLife(858) 875-8629

    (510) 703-9491

     



     
     
     
     
     
     

                                                                              Orexigen Therapeutics, Inc.                                                                                    Balance Sheets                                                        (In thousands, except share and par value amounts)  
     
     
     
     
     

     
     
     
     
     

     
     
     
     

     

    June 30,  

    December 31,  

    2014  

    2013  

    (Unaudited)  
      Assets  
     
     

    Current assets:  
     
     

    Cash and cash equivalents 

    $                 31,107  

    $                98,121Investment securities, available-for-sale 

    102,194  

    78,875Prepaid expenses and other current assets 

    5,840  

    1,286Total current assets 

    139,141  

    178,282Property and equipment, net 

    675  

    630Other long-term assets 

    884  

    1,032Restricted cash 

    177  

    177Total assets 

    $               140,877  

    $              180,121  
     
     
      Liabilities and stockholders' equity   
     
     

    Current liabilities:  
     
     

    Accounts payable 

    $                   8,071  

    $                  4,787Accrued clinical trial expenses

    7,746  

    7,886Accrued expenses

    5,326  

    6,751Deferred revenue, current portion 

    3,429  

    3,429Total current liabilities 

    24,572  

    22,853Long term convertible debt

    81,928  

    80,031Deferred revenue, less current portion 

    33,429  

    35,143Other long-term liabilities 

    401  

    232Commitments and contingencies  
     
     

    Stockholders' equity:  
     
     

    Preferred stock, $.001 par value,10,000,000 shares authorized at June 30, 2014 and December 31, 2013; no shares issued and outstanding at June 30, 2014 and December 31, 2013  
     
     

     
     
     
     
     

     
     
     
     
     

     

    -  
     

    -Common stock, $.001 par value, 300,000,000 shares authorized at June 30, 2014 and December 31, 2013 and; 122,531,843 and 104,970,200 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively  
     
     

     
     
     

     
     
     
     
     

     
     
     

    123  

    105Additional paid-in capital 

    564,292  

    556,235Accumulated other comprehensive income (loss)

    12  

    (3)Accumulated deficit

    (563,880)  

    (514,475)Total stockholders' equity 

    547  

    41,862Total liabilities and stockholders' equity 

    $               140,877  

    $              180,121  
     
     
     
     
     

     

     

     



     
     
     
     
     
     
     
     
     
     
     
     
     

     
     
     
     
     
     
     
     
     
     
     
     
     

     

    Orexigen Therapeutics, Inc. 

    Statements of Operations 

    (In thousands, except per share amounts) 

    (Unaudited)  
     
     
     
     
     
     
     
     
     
     
     
     

     
     
     
     
     
     
     
     
     

     
     
     
     
     

     

    Three Months Ended Six Months Ended   

    June 30, June 30,   

    2014  

    2013  

    2014  

    2013Revenues:  
     
     
     
     
     
     
     
     

    Collaborative agreement 

    $

    857  

    $

    857  

    $

    1,714  

    $

    1,714License revenue   

    -  
     

    -  

    -  

    -Total revenues 

    857  

    857  

    1,714  

    1,714Operating expenses:  
     
     
     
     
     
     

    Research and development 

    16,726  

    13,094  

    33,727  

    28,249General and administrative 

    6,933  

    6,026  

    13,943  

    11,126Total operating expenses 

    23,659  

    19,120  

    47,670  

    39,375Loss from operations 

    (22,802)  

    (18,263)  

    (45,956)  

    (37,661)Other income (expense):  
     
     
     
     
     
     

    Interest income 

    26  

    17  

    52  

    48Interest expense 

    (1,731)  

    -  

    (3,501)  

    (1)Total other income (expense) 

    (1,705)  

    17  

    (3,449)  

    47Net loss 

    $

    (24,507)  

    $

    (18,246)  

    $

    (49,405)  

    $

    (37,614)  
     
     
     
     
     
     
     
     

    Net loss per share - basic and diluted 

    $

    (0.21)  

    $

    (0.19)  

    $

    (0.43)  

    $

    (0.41)Shares used in computing net loss per share – basic and diluted 

    117,987  

    94,986  

    113,642  

    92,674  
     
     
     
     
     
     
     
     
     

     
     
     
     
     
     
     
     
     
     
     
     

     

     


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    SOURCE Orexigen Therapeutics, Inc.
    Copyright©2014 PR Newswire.
    All rights reserved


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