Adolor Corporation Reports Year End 2007 Financial Results

  
    
  
  
    
      Adolor Corporation (Nasdaq:ADLR) today reported financial results for 
      the year and fourth quarter ended December 31, 2007 and provided an 
      update on its Delta Program.
    
    
      2007 Financial Results
    
    
      For the twelve months ended December 31, 2007, the company reported a 
      net loss of $48.4 million or $(1.05) per basic and diluted share, 
      compared to a net loss of $69.7 million, or $(1.56) per basic and 
      diluted share for the same period in 2006. For the three month period 
      ended December 31, 2007, the company reported a net loss of $10.1 
      million or $(0.22) per basic and diluted share, compared to a net loss 
      of $18.4 million or $(0.40) per basic and diluted share in the three 
      months ended December 31, 2006.
    
    
      “We enter 2008 with two strong lead 
      development programs, increasing momentum in discovery research, and a 
      solid financial foundation,” said Michael R. 
      Dougherty, president and chief executive officer of Adolor Corporation. “With 
      our PDUFA date for Entereg on May 10, 2008, we await the FDA’s 
      completion of its review of our NDA for postoperative ileus. We look 
      ahead to realizing our objective of making this important new product 
      available to patients in the near future.”
    
    
      “A highlight of the fourth quarter of 2007 was 
      our collaboration with Pfizer Inc for the Delta Program,” 
      continued Dougherty. “Pfizer shares our vision 
      for this program, the development of an entirely new class of opioid 
      receptor agonists, and our joint efforts are now well underway. Finally, 
      we are increasingly enthusiastic about our early discovery and research 
      programs, and believe our efforts here will lead to the identification 
      of new development candidates for our growing pipeline.”
    
    
      Contract revenues were approximately $9.1 million and $15.1 million for 
      the twelve months ended December 31, 2007 and 2006, respectively. The 
      decrease in revenues was primarily the result of a reduction in expenses 
      incurred by us relating to Entereg and reimbursable by 
      GlaxoSmithKline (Glaxo) under the collaboration agreement of $4.0 
      million and a reduction in co-promotion revenues of $2.4 million 
      relating to our Arixtra® co-promotion with 
      Glaxo which is no longer in place. These decreases were partially offset 
      by an increase in amortization of up-front fees and cost reimbursements 
      associated with the Pfizer collaboration of $1.3 million. Contract 
      revenues were approximately $3.7 million and $4.3 million for the three 
      months ended December 31, 2007 and 2006, respectively.
    
    
      Research and development expenses were $41.6 million and $56.7 million 
      for the twelve months ended December 31, 2007 and 2006, respectively. 
      The decrease was primarily related to a reduction in costs associated 
      with our Entereg® (alvimopan) program and 
      discontinued sterile lidocane patch program, partially offset by an 
      increase in expenses related to our Delta program. Research and 
      development expenses in the three months ended December 31, 2007 were 
      $8.7 million, compared to $13.6 million for the same period in 2006.
    
    
      Marketing, general and administrative expenses were $24.0 million and 
      $37.7 million for the twelve months ended December 31, 2007 and 2006, 
      respectively. The expense decrease was principally related to decreased 
      personnel expenses, including expense primarily associated with 
      disbanding of the sales force in 2006, as well as lower marketing and 
      sales expenses. Marketing, general and administrative expenses in the 
      three months ended December 31, 2007 were $6.8 million, compared to 
      $11.6 million for the same period in 2006.
    
    
      As of December 31, 2007, the company had approximately $167.2 million in 
      cash, cash equivalents and short-term investments.
    
    
      Delta Program Update
    
    
      Top-line results from a recently completed Phase 2a exploratory study in 
      acute dental surgery pain, 33CL230 (Study 230), indicated that ADL5859 
      was generally well tolerated, but showed no efficacy signal in this 
      model.
    
    
      “The novelty of our Delta compounds will 
      require a broad exploratory effort and we have designed a Phase 2a 
      development program to understand their role in treating various types 
      of pain,” commented David Jackson, M.D., 
      senior vice president and chief medical officer of Adolor. “We 
      look forward to seeing the results from our multi-dose chronic and 
      neuropathic pain studies.”
    
    
      Adolor is collaborating with Pfizer in conducting additional Phase 2a 
      studies of ADL5859 to explore its utility in treating chronic pain 
      associated with rheumatoid arthritis and peripheral neuropathic pain 
      associated with diabetes. The companies are also planning to conduct an 
      additional study of ADL5859 in treating pain associated with 
      osteoarthritis.
    
    
      Study 230 was a randomized double-blind, single-dose, active and placebo 
      controlled parallel group study of ADL5859 for the treatment of acute 
      pain following surgical removal of impacted third molars. The active 
      control in Study 230 was ibuprofen, and the primary endpoint for the 
      study was a measure of pain relief. A total of 201 patients were 
      enrolled in the study.
    
    
      Further, Adolor and Pfizer have begun Phase 1 clinical testing of 
      ADL5747, a second Delta agonist, in healthy volunteers to investigate 
      its safety, tolerability and pharmacokinetics.
    
    
      About Adolor Corporation
    
    
      Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company 
      specializing in the discovery, development and commercialization of 
      novel prescription pain management products. Adolor has two lead product 
      candidates in development: Entereg® 
      (alvimopan) for the management of the gastrointestinal side effects 
      associated with opioid use; and, novel Delta opioid receptor agonists 
      for a variety of pain indications. Adolor and GlaxoSmithKline are 
      collaborating in the worldwide development and commercialization of Entereg 
      in multiple indications. Adolor and Pfizer are collaborating in the 
      worldwide development and commercialization of two Delta agonists for 
      pain. Adolor also has a number of discovery research programs focused on 
      the identification of novel compounds for the treatment of pain. By 
      applying its knowledge and expertise in pain management, along with 
      ingenuity, Adolor is seeking to make a positive difference for patients, 
      caregivers and the medical community. For more information, visit www.adolor.com.
    
    
      Arixtra® is a registered trademark of 
      GlaxoSmithKline.
    
    
      This release, and oral statements made with respect to information 
      contained in this release, may constitute forward-looking statements 
      within the meaning of the Private Securities Litigation Reform Act of 
      1995. Such forward-looking statements include those which express 
      plan, anticipation, intent, contingency, goals, targets or future 
      development and/or otherwise are not statements of historical fact. These 
      statements are based upon management's current expectations and are 
      subject to risks and uncertainties, known and unknown, which could cause 
      actual results and developments to differ materially from those 
      expressed or implied in such statements. Such known risks and 
      uncertainties relate to, among other factors: the risk that Adolor may 
      not receive regulatory approval of ENTEREG ® 
      (alvimopan) for POI, OBD, or any other indication; the risk that the 
      PDUFA date extended to May 10, 2008 is further extended or not met; the 
      risk that a risk management plan acceptable to the FDA could materially 
      adversely affect the commercial prospects for ENTEREG, if regulatory 
      approval is achieved; the risk that Adolor may not be able to adequately 
      address the deficiencies in the November 2006 FDA approvable letter; the 
      risk that Adolor may not obtain FDA approval for ENTEREG in POI, whether 
      due to Adolor's inability to provide additional data satisfactory to the 
      FDA to obtain approval for the NDA, the adequacy of the safety and 
      efficacy data from all of the ENTEREG studies, changing regulatory 
      requirements, the risk that the FDA may not agree with Adolor's and 
      GSK's analyses of the ENTEREG studies (including Study 014) and may 
      evaluate the results of these studies by different methods or conclude 
      that the results from the studies, whether or not statistically 
      significant, do not support safety, efficacy, a favorable risk/benefit 
      profile, or there were human errors in the conduct of the studies, or 
      otherwise; adverse safety findings in any ENTEREG studies; the risk that 
      the alvimopan Investigational New Drug Applications (INDs) remain on 
      clinical hold indefinitely; the risk that filing targets for regulatory 
      submissions or user fee goal dates are not met; the risk that the 
      results of other clinical trials of Adolor's drug product candidates, 
      including our Delta product candidates are not positive; the risk of 
      product liability claims; reliance on third party manufacturers; the 
      costs, delays and uncertainties inherent in scientific research, drug 
      development, clinical trials and the regulatory approval process; 
      Adolor's history of operating losses since inception and its need for 
      additional funds to operate its business; Adolor's reliance on its 
      collaborators, including GSK, in connection with the development and 
      commercialization of ENTEREG; market acceptance of Adolor's products, if 
      regulatory approval is achieved; competition; and securities litigation.
    
    
      Further information about these and other relevant risks and 
      uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 
      10-K filed with the U.S. Securities and Exchange Commission. Adolor 
      urges you to carefully review and consider the disclosures found in its 
      filings which are available in the SEC EDGAR database at http://www.sec.gov 
      and from Adolor at http://www.adolor.com. 
      Given the uncertainties affecting pharmaceutical companies in the 
      development stage, you are cautioned not to place undue reliance on any 
      such forward-looking statements, any of which may turn out to be wrong 
      due to inaccurate assumptions, unknown risks, uncertainties or other 
      factors. Adolor undertakes no obligation to (and expressly 
      disclaims any such obligation to) publicly update or revise the 
      statements made herein or the risk factors that may relate thereto 
      whether as a result of new information, future events, or otherwise.
    
    
      This press release is available on the website http://www.adolor.com.
    
    
      [Financial data table follows]
    
    
      
        
          ADOLOR CORPORATION
        
      
      
        
          STATEMENTS OF OPERATIONS DATA
        
      
      
        
          (Unaudited)
        
      
      
        
        
        
        
        
           
        
        
        
      
      
        
        
        
          FOR THE TWELVE MONTHS
        
        
        
        
          FOR THE THREE MONTHS
        
      
      
        
        
        
          ENDED DECEMBER 31,
        
        
        
        
          ENDED DECEMBER 31,
        
      
      
        
        
        
        
        
        
        
           
        
      
      
        
        
        
          2007
        
        
           
        
        
          2006
        
        
        
        
          2007
        
        
           
        
        
          2006
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          REVENUES
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
      
      
        
          Contract revenues
        
        
          $
        
        
          9,119,991
        
        
        
        
        
        
          $
        
        
          15,087,411
        
        
        
        
        
        
          $
        
        
          3,673,291
        
        
        
        
        
        
          $
        
        
          4,285,728
        
        
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          OPERATING EXPENSES
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
      
      
        
          Research and development
        
        
        
        
          41,609,722
        
        
        
        
        
        
        
        
          56,659,750
        
        
        
        
        
        
        
        
          8,660,977
        
        
        
        
        
        
        
        
          13,598,294
        
        
        
      
      
        
          
            Marketing, general and administrative
          
        
        
           
        
        
          23,970,339
        
        
           
        
        
        
        
           
        
        
          37,689,565
        
        
           
        
        
        
        
           
        
        
          6,827,949
        
        
           
        
        
        
        
           
        
        
          11,583,773
        
        
           
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          Total operating expenses
        
        
           
        
        
          65,580,061
        
        
           
        
        
        
        
           
        
        
          94,349,315
        
        
           
        
        
        
        
           
        
        
          15,488,926
        
        
           
        
        
        
        
           
        
        
          25,182,067
        
        
           
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          Loss from operations
        
        
        
        
          (56,460,070
        
        
          )
        
        
        
        
        
        
          (79,261,904
        
        
          )
        
        
        
        
        
        
          (11,815,635
        
        
          )
        
        
        
        
        
        
          (20,896,339
        
        
          )
        
      
      
        
          Interest income and other, net
        
        
           
        
        
          8,017,095
        
        
           
        
        
        
        
           
        
        
          9,523,526
        
        
           
        
        
        
        
           
        
        
          1,715,087
        
        
           
        
        
        
        
           
        
        
          2,481,396
        
        
           
        
      
      
        
          Net loss
        
        
          $
        
        
          (48,442,975
        
        
          )
        
        
        
        
          $
        
        
          (69,738,378
        
        
          )
        
        
        
        
          $
        
        
          (10,100,548
        
        
          )
        
        
        
        
          $
        
        
          (18,414,943
        
        
          )
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          
            Basic and diluted net loss per share
          
        
        
          $
        
        
          (1.05
        
        
          )
        
        
        
        
          $
        
        
          (1.56
        
        
          )
        
        
        
        
          $
        
        
          (0.22
        
        
          )
        
        
        
        
          $
        
        
          (0.40
        
        
          )
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          
            Shares used in computing basic and diluted net loss per share
          
        
        
        
        
          45,932,981
        
        
        
        
        
        
        
        
          44,731,350
        
        
        
        
        
        
        
        
          45,940,460
        
        
        
        
        
        
        
        
          45,915,827
        
        
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
        
        
        
        
        
        
          BALANCE SHEET DATA
        
      
      
        
        
        
        
        
        
        
          (Unaudited)
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
        
        
        
        
        
        
        
        
        
        
          DECEMBER 31,
        
        
        
        
          DECEMBER 31,
        
      
      
        
        
        
        
        
        
        
        
        
        
        
          2007
        
        
        
        
          2006
        
      
      
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
           
        
      
      
        
          
            Cash, cash equivalents and short-term investments
          
        
        
        
        
        
        
        
        
        
        
          $
        
        
          167,189,499
        
        
        
        
        
        
          $
        
        
          185,562,009
        
        
        
      
      
        
          Working capital
        
        
        
        
        
        
        
        
        
        
        
        
          147,543,363
        
        
        
        
        
        
        
        
          173,130,129
        
        
        
      
      
        
          Total assets
        
        
        
        
        
        
        
        
        
        
        
        
          178,676,652
        
        
        
        
        
        
        
        
          200,597,580
        
        
        
      
      
        
          Total stockholders' equity
        
        
        
        
        
        
        
        
        
        
        
        
          112,353,478
        
        
        
        
        
        
        
        
          153,180,628