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8-K - FORM 8-K - Orexigen Therapeutics, Inc.d303770d8k.htm

Exhibit 99.1

Orexigen® Therapeutics Reports Fourth Quarter and Year Ended December 31, 2011

Financial Results

San Diego, CA, March 8, 2012 – Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2011.

Three months ended December 31, 2011

For the three months ended December 31, 2011, Orexigen reported a net loss of $4.3 million, or $0.09 per share, as compared to a net loss of $11.3 million, or $0.24 per share, for the fourth quarter of 2010. As of December 31, 2011, Orexigen had $101.7 million in cash and cash equivalents and an additional $45.8 million in marketable securities, for a total of $147.5 million.

Total operating expenses for the fourth quarter of 2011 were $5.2 million compared to $12.0 million for the fourth quarter of 2010. The decrease in operating expenses primarily reflects a decrease in research and development expenses of $4.8 million principally related to decreases in salaries and personnel-related costs.

Year ended December 31, 2011

For the year ended December 31, 2011, Orexigen reported a net loss of $28.1 million, or $0.58 per share, as compared to a net loss of $51.9 million, or $1.10 per share, for 2010. Total operating expenses for the year ended December 31, 2011 were $32.3 million compared to $52.6 million for 2010. This decrease in operating expenses primarily reflects a decrease in research and development expenses of $15.3 million principally related to the decrease in expenses related to our Contrave® development program. This overall decrease in operating expenses also reflects a decrease in general and administrative costs of $5.0 million principally related to decreases in salaries and personnel-related costs and market research costs.

2011 and recent highlights

 

   

Written feedback from the FDA’s Office of New Drugs (OND) on a feasible cardiovascular outcomes trial (CVOT) design that enables the Company to continue development of its lead program, Contrave (September 2011)

 

   

Completion of a public offering that raised $86.9 million in net proceeds, which are expected to fund the CVOT through 2014 during which time the Company anticipates completion of the interim analysis, resubmission and potential approval of the Contrave New Drug Application (NDA) (December 2011)

 

   

Agreement on the CVOT protocol via a Special Protocol Assessment (SPA) with the Division of Metabolic and Endocrinology Products (DMEP) of the FDA (February 2012)

“We believe the rapid progress we made with DMEP on the detailed protocol is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA,” said Michael Narachi, president and CEO of Orexigen. “I want to thank my colleagues at Orexigen, our key consultants and strategic partners helping us with the CVOT, and our commercialization partner, Takeda, for their outstanding efforts as we work to begin enrolling patients in this innovative large streamlined trial late in the second quarter of this year.”

Conference Call Today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the fourth quarter 2011 financial results and recent business highlights. The live call may be accessed by phone by calling (866) 804-6923 (domestic) or (857) 350-1669 (international), participant code 46352287. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://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 Contrave®, which has completed Phase 3 clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment for the Contrave cardiovascular outcomes trial. 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,” “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 Special Protocol Assessment, the cost of the Contrave outcomes trial, the feasibility of the Contrave outcomes trial, the timing for initiation of enrollment for the Contrave outcomes trial late in the second quarter of 2012, the timing expected for the interim analysis of the Contrave outcomes trial and potential NDA resubmission, the speed of enrollment for the Contrave outcomes trial, and the potential for, and timing of, approval for Contrave. 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 from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen may not be able to initiate and conduct the Contrave outcomes trial and the progress and timing thereof; Orexigen’s ability to demonstrate in the Contrave outcomes trial that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate’s benefit-risk profile; the potential that earlier clinical trials may not be predictive of future results in the Contrave outcomes trial; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen’s ability to attract and retain key personnel; Orexigen’s ability to maintain sufficient capital; and other risks described in the Company’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, which we intend to file with the Securities and Exchange Commission early next week and which will be 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   Media
Jay Hagan   Denise Powell
Chief Business Officer   WeissComm Partners
(858) 875-8673   (510) 703-9491


Orexigen Therapeutics, Inc.

Balance Sheets

(In thousands, except share and par value amounts)

 

     December 31,
2011
    December 31,
2010
 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 101,749      $ 24,926   

Investment securities, available-for-sale

     45,844        67,440   

Prepaid expenses and other current assets

     1,126        2,502   
  

 

 

   

 

 

 

Total current assets

     148,719        94,868   

Property and equipment, net

     439        894   

Restricted cash

     542        881   

Other assets

     —          203   
  

 

 

   

 

 

 

Total assets

   $ 149,700      $ 96,846   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 4,277      $ 10,355   

Deferred revenue, current portion

     3,429        3,517   

Long-term debt, current portion

     —          2,416   
  

 

 

   

 

 

 

Total current liabilities

     7,706        16,288   

Deferred revenue, less current portion

     42,000        46,311   

Other long-term liabilities

     288        459   

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $.001 par value, 10,000,000 shares authorized at December 31, 2011 and 2010; no shares issued and outstanding at December 31, 2011 and 2010

     —          —     

Common stock, $.001 par value, 300,000,000 and 100,000,000 shares authorized at December, 2011 and 2010, respectively;

    

61,285,514 and 47,767,313 shares issued and outstanding at December 31, 2011 and 2010, respectively

     61        48   

Additional paid-in capital

     446,357        352,401   

Accumulated other comprehensive income (loss)

     (2     (9

Accumulated deficit

     (346,710     (318,652
  

 

 

   

 

 

 

Total stockholders’ equity

     99,706        33,788   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 149,700      $ 96,846   
  

 

 

   

 

 

 


Orexigen Therapeutics, Inc.

Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2011     2010     2011     2010  

Revenues:

        

Collaborative agreement

   $ 857      $ 857      $ 3,428      $ 1,143   

License revenue

     0        22        971        88   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     857        879        4,399        1,231   

Operating expenses:

        

Research and development

     1,543        6,378        12,780        28,131   

General and administrative

     3,632        5,668        19,502        24,495   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     5,175        12,046        32,282        52,626   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,318     (11,167     (27,883     (51,395

Other income (expense):

        

Interest income

     11        23        46        124   

Interest expense

     —          (143     (221     (644
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

     11        (120     (175     (520
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (4,307   $ (11,287   $ (28,058   $ (51,915
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share - basic and diluted

   $ (0.09   $ (0.24   $ (0.58   $ (1.10
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     49,048        47,622        48,273        47,377