Navigation Links
Orexigen(R) Therapeutics Announces Fourth Quarter and Year Ended December 31, 2009 Financial Results
Date:3/9/2010

SAN DIEGO, March 9 /PRNewswire-FirstCall/ -- 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, 2009.

Three months ended December 31, 2009

As of December 31, 2009, Orexigen held $37.7 million in cash and cash equivalents and an additional $54.5 million in investment securities, available-for-sale.  Together, these amounts total $92.2 million.

For the three months ended December 31, 2009, Orexigen reported a net loss of $15.0 million, or $0.32 per share attributable to common stockholders, as compared to a net loss of $22.1 million, or $0.64 per share attributable to common stockholders, for the same period in 2008.  

Total operating expenses for the three months ended December 31, 2009 were $14.8 million compared to $22.1 million for the same period in 2008.  The decreased operating expenses were due primarily to a decrease in research and development expenses of $8.7 million related to the completion of our Contrave® Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic™, offset partly by an increase in general and administrative costs of $1.3 million due principally to increases in salaries and personnel related costs, marketing and consulting expenses and medical affairs expense.  

Year ended December 31, 2009

For the year ended December 31, 2009, Orexigen reported a net loss of $66.6 million, or $1.67 per share attributable to common stockholders, as compared to a net loss of $93.2 million, or $2.76 per share attributable to common stockholders, for 2008.  

Total operating expenses for the year ended December 31, 2009 were $65.6 million compared to $94.9 million for 2008.  The decreased operating expenses were due primarily to a decrease in research and development expenses of $31.8 million related to the completion of our Contrave Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic, offset partly by an increase in general and administrative costs of $2.5 million due principally to increases in salaries and personnel related costs, medical affairs expense, recruiting expense and public relations costs.

"Orexigen has made significant progress in the past year that positions us for our transformation to a commercial enterprise," said Michael Narachi, President and CEO of Orexigen.  "We completed our Contrave Phase 3 Program and our Empatic Phase 2 program, both with very positive results, and have nearly completed all sections of our New Drug Application for Contrave, which we expect to file with the FDA by the end of April.  In addition, we raised additional capital which has allowed us to advance our preparations for a targeted commercial launch, and to outline the value proposition for potential partners that would enable access to the broader primary care markets."

2009 Highlights

  • Orexigen made a number of key additions to its management team and staff, which will help position the Company for long term regulatory and commercial success.  In April, Orexigen announced that it appointed Michael Narachi, a 20 year veteran of Amgen, as President and Chief Executive Officer.  Later in the year, the Company announced a number of other strategic hires:  Jay Hagan as Head of Corporate Development and Strategy, Mark Booth as Chief Commercial Officer, Dawn Viveash M.D. as Head of Global Regulatory Affairs, Suzanne McDonald as Head of Managed Markets and Government Affairs, Preston Klassen, M.D., MHS as Head of the Global Contrave Program and Whedy Wang, Ph.D., MPH as Head of Global Biomedical Information.  

Contrave

Orexigen announced the results of all four of its Phase 3 trials in the Contrave Obesity Research, or COR, program in 2009.  Each trial met its co-primary endpoints. Data from these trials demonstrated the following:

  • In the COR-I and COR-II trials, approximately 48% and 56% of patients on Contrave32 lost at least 5% of their body weight after 56 weeks on an intent-to-treat basis, as compared to placebo patients who lost approximately 16% and 17% (p<0.001).  Additionally, approximately 34% to 48% of patients who completed one year of therapy on Contrave32 in these two trials lost at least 10% of their baseline body weight.
  • In the COR-BMOD trial, which incorporated an intensive diet and exercise behavior modification regimen, approximately 55% of patients who completed one year of therapy on Contrave32 lost at least 10% of their baseline body weight.
  • In the COR-Diabetes trial, patients with type 2 diabetes taking Contrave lost significantly more weight than patients on placebo, and they also achieved substantial improvements in glycemic control.  Specifically, Contrave patients showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo.
  • Key secondary endpoints met across the entire COR Phase 3 program included significant improvements in markers of cardiometabolic risk such as waist circumference, HDL cholesterol and triglycerides.  Additional analyses indicate that Contrave patients experienced an increased ability to control their eating compared to placebo.
  • Contrave was generally well tolerated by patients across the COR Phase 3 program. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.

The results from the successfully completed COR program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application with the FDA by the end of April

Empatic

In September, Orexigen announced the data from the Phase 2b clinical trial of Empatic.  The results of this trial demonstrated the following:

  • Patients completing 24 weeks of Empatic360 (bupropion SR 360mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight compared to 1.7% for placebo patients (p<0.001).  Importantly, mean weight loss for patients on Empatic continued to decline through the endpoint of the trial, with no evidence of a weight loss plateau.  
  • Improvements were observed in key markers of cardiometabolic risk, such as waist circumference, triglycerides, fasting insulin and blood pressure, compared to placebo.  
  • The most commonly reported adverse events, as well as those leading to discontinuation, for all Empatic patients were headache, nausea and insomnia.  Adverse events and laboratory findings appeared to be consistent with the individual components of Empatic.  There were no statistically or clinically meaningful differences between Empatic and placebo on measures of cognitive function, depression, suicidality or anxiety.

Corporate

  • In July, the Company completed a public offering of 11.5 million shares of common stock at $7.50 per share, which resulted in net proceeds to the Company of approximately $81.6 million.

Conference Call Today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the three months and year ended December 31, 2009 financial results and recent business highlights.  The live call may be accessed by phone by calling (866) 730-5769 (domestic) or (857) 350-1593 (international), participant code 19470590.  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 investigational product, Contrave®, has completed Phase 3 clinical trials.  The Company's second product, Empatic™, has completed Phase 2 clinical development.  Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches.  Further information about the Company can be found at http://www.Orexigen.com.

Forward-Looking Statements  

Orexigen cautions you that statements included in this press release and in the teleconference/webcast 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 potential for, and timing of, filing an NDA 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: risks inherent in the continued analyses of clinical trial results, including Contrave Phase 3 trials; the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave and Empatic; reliance on third parties to assist with the development of Contrave and Empatic and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave or Empatic; the potential to enter into and the terms of any commercial partnership or other strategic transaction relating to Contrave or Empatic; 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. 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 Therapeutics, Inc.                         
                         (a development stage company)                        
                            Statements of Operations                          
                    (In thousands, except per share amounts)                  
                                  (Unaudited)                                 
                                                                              
                                                                  Period from 
                                                                 September 12,
                      Three Months Ended         Year Ended           2002    
                         December 31,            December 31,     (Inception) 
                        -------------           -------------          to     
                                                                  December 31,
                       2009        2008        2009        2008        2009   
                       ----        ----        ----        ----        ----  
    Revenues:                                                                 
      Collaborative                                                             
       agreement          $-          $-         $-           $-       $174 
      License revenue     22          22         88           88        441 
                         ---         ---        ---          ---        --- 
    Total revenues        22          22         88           88        615 
    Operating                                                               
     expenses:                                                              
      Research and                                                            
       development     8,862      17,526     47,441       79,261    216,559 
      General and                                                             
       administrative  5,923       4,602     18,177       15,651     55,999 
                       -----       -----     ------       ------     ------ 
    Total operating                                                         
     expenses         14,785      22,128     65,618       94,912    272,558 
                      ------      ------     ------       ------    ------- 
    Loss from                                                               
     operations      (14,763)    (22,106)   (65,530)     (94,824)  (271,943)
    Other income                                                          
     (expense):                                                           
      Interest
       income             38         315        333        3,115      9,012 
      Interest
       expense          (295)       (335)    (1,365)      (1,531)    (3,806)
                        ----        ----     ------       ------     ------ 
    Total other                                                             
     income                                                                 
     (expense)          (257)        (20)    (1,032)       1,584      5,206 
                        ----         ---     ------        -----      ----- 
    Net loss         (15,020)    (22,126)   (66,562)     (93,240)  (266,737)
    Accretion to                                                            
     redemption                                                             
     value of                                                               
     redeemable                                                             
     convertible                                                            
     preferred
     stock                 -           -          -            -        (78)
    Deemed dividend                                                         
     of beneficial                                                          
     conversion for                                                         
     Series C                                                               
     preferred
     stock                 -           -          -            -    (13,860)
                         ---         ---        ---          ---    ------- 
    Net loss                                                                
     attributable
     to common                                                                 
     stockholders   $(15,020)   $(22,126)  $(66,562)    $(93,240) $(280,675)
                    ========    ========   ========     ========  ========= 
                                                                            
    Net loss per                                                            
     share                                                                  
     attributable
     to                                                                     
     common                                                                 
     stockholders -                                                         
     basic and                                                              
     diluted          $(0.32)     $(0.64)    $(1.67)      $(2.76)           
                      ======      ======     ======       ======            
    Shares used in                                                          
     computing net                                                          
     loss per share                                                         
     attributable to                                                        
     common                                                                 
     stockholders –                                                         
     basic and                                                              
     diluted          47,088      34,429     39,905       33,762            
                      ======      ======     ======       ======            
    
    
    
    
    
                         Orexigen Therapeutics, Inc.                 
                        (a development stage company)                    
                                Balance Sheets                           
              (In thousands, except share and par value amounts)         
                                                                 
                                                 December 31,  December 31,
                                                     2009          2008  
                                                     ----          ----  
                                                  (Unaudited)            
    Assets                                                               
      Current assets:                                                    
        Cash and cash equivalents                    $37,658     $45,451 
        Investment securities, available-                                
         for-sale                                     54,500      40,716 
        Prepaid expenses and other current                               
         assets                                        1,529       1,184 
                                                       -----       ----- 
      Total current assets                            93,687      87,351 
      Property and equipment, net                      1,324       2,059 
      Restricted cash                                  1,290       1,375 
      Other assets                                       547       1,123 
                                                         ---       ----- 
      Total assets                                   $96,848     $91,908 
                                                     =======     ======= 
                                                                         
    Liabilities and stockholders' equity                                 
      Current liabilities:                                               
        Accounts payable and accrued expenses         $9,828     $18,810 
        Deferred revenue, current portion                 88          88 
        Long-term debt, current portion                6,384       7,591 
                                                       -----       ----- 
      Total current liabilities                       16,300      26,489 
      Deferred revenue, less current portion             971       1,058 
      Long-term debt, less current portion             2,416       8,800 
      Other long-term liabilities                      1,258       1,767 
      Commitments and contingencies                                      
      Stockholders’ equity:                                              
        Preferred stock, $.001 par value,                                
         10,000,000 shares                                               
         authorized at December 31, 2009                              
         and 2008; no shares issued and outstanding 
         at December 31, 2009 and 2008                     -           -
        Common stock, $.001 par value,                                   
         100,000,000 shares                                              
         authorized at December 31, 2009 
         and 2008; 47,215,479 and 34,433,322
         shares issued and outstanding                                   
         at December 31, 2009 and 2008,                                  
         respectively                                     47          34 
        Additional paid-in capital                   342,599     253,782 
        Accumulated other comprehensive income                           
         (loss)                                           (6)        153 
        Deficit accumulated during the                                   
         development stage                          (266,737)   (200,175)
                                                    --------    -------- 
      Total stockholders’ equity                      75,903      53,794 
                                                      ------      ------ 
      Total liabilities and stockholders’                                
       equity                                        $96,848     $91,908 
                                                     =======     ======= 
    
    
    

SOURCE Orexigen Therapeutics, Inc.

Back to top

RELATED LINKS
http://www.orexigen.com

'/>"/>

SOURCE Orexigen Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved


Related medicine technology :

1. Orexigen(R) Initiates Second Phase IIb Empatic(TM) Trial on Schedule
2. Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)
3. Orexigen(R) Therapeutics Announces Changes to Its Clinical Programs and Management Team
4. Orexigen(R) Therapeutics Schedules July 20, 2009 Teleconference and Webcast Discussion of Contrave(R) Phase 3 Results
5. Orexigen(R) Therapeutics Schedules September 30, 2009 Teleconference and Webcast to Discuss Phase 2b Trial Results From Second Obesity Drug Candidate, Empatic(TM)
6. Orexigen(R) Therapeutics Releases New Efficacy Data for Contrave(R) in Late Breaker Presentations at the 27th Annual Scientific Meeting of The Obesity Society
7. Orexigen(R) Therapeutics Announces Third Quarter 2009 Financial Results
8. Orexigen(R) Therapeutics to Speak at Lazard Capital Markets Healthcare Conference
9. Orexigen(R) Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635
10. Orexigen(R) Therapeutics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)
11. Orexigen(R) Therapeutics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 2016 /PRNewswire/ - Demers Ambulances announces its first delivery in the ... Okaloosa County Emergency Medical Services (EMS) consisting of ... LT2 van. Quality Emergency Vehicles in Lecanto, FL ... sale.  This is the latest in Demers, ongoing expansion of ... at Demers. --> Benoit LaFortune , Executive Vice ...
(Date:2/12/2016)... 2016  SI-BONE, Inc., a medical device company that pioneered the ... invasive surgical (MIS) device indicated for fusion for certain disorders of ... the Medicare Administrative Contractor (MAC) covering the states of ... , Massachusetts , Minnesota ... , Rhode Island , Vermont ...
(Date:2/12/2016)... Feb. 12, 2016  Sequent Medical, Inc. announced today ... to evaluate the safety and effectiveness of the WEB™ ... ruptured intracranial aneurysms.  Prof Laurent Spelle , MD, ... Paris, France and Principal Investigator of ... France and Germany.  Although patients with ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... According to an article ... account for a significant portion of hernia repairs throughout the United States. Commenting on ... Hernia Center notes that this trend has not only been expected, but it seems ...
(Date:2/12/2016)... ... 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & Bassett ... of these scholarships is to encourage applicants to pursue a degree in their field ... two parishes. , “We have available jobs in St. Landry and Evangeline Parishes ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Lymphoma Research Foundation (LRF) ... and serving the lymphoma community through a comprehensive series of education programs, outreach ... community at its 10th anniversary Fashion Luncheon on Monday, February 8, 2016. The ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... — 1:30 p.m. – 3:00 p.m. EST, http://www.fdanews.com/fixeddosecombination ... cycle of pharmaceutical products, garnering increased attention from all stakeholders in the development ...
(Date:2/12/2016)... ... 12, 2016 , ... As a former television executive, owner Tal Rabinowitz knows ... time to decompress, Rabinowitz found herself drawn to a casual meditation class while working ... her life, implementing a 20-minute-per-day meditation practice with her team. After her tenure at ...
Breaking Medicine News(10 mins):