EX-99.1 2 h38532aexv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
     
Investors:
  Media:
Ann Tanabe
  Dan Budwick
VP, Investor Relations and Corporate Communications
  BMC Communications
Encysive Pharmaceuticals
  (212) 477-9007 ext. 14
(713) 796-8822
    
 
    
Marcy Strickler
    
The Trout Group
    
(212) 477-9007 ext. 27
    
FOR IMMEDIATE RELEASE
ENCYSIVE PHARMACEUTICALS REPORTS SECOND QUARTER 2006 FINANCIAL RESULTS
Conference Call Scheduled for Today at 8:00 a.m. Eastern
HOUSTON — August 7, 2006 — Encysive Pharmaceuticals (NASDAQ: ENCY) today announced financial results for the second quarter ended June 30, 2006.
Second Quarter Financial Overview
  •   Revenues in the second quarter of 2006 were $3.7 million, as compared to $3.0 million for the second quarter of 2005. This increase was due to higher royalties on sales of Argatroban by GlaxoSmithKline. Royalty income increased 23% to $3.3 million, as compared to $2.7 million earned in the same period last year.
 
  •   For the second quarter of 2006, the Company reported a net loss of $28.0 million, or $0.48 per basic and diluted share, compared to a net loss of $19.2 million, or $0.33 per basic and diluted share, for the second quarter of 2005. The increased loss in the current quarter, as compared to the second quarter of 2005, was primarily the result of the investment in the U.S. sales force and increased commercialization-related expenses.
 
  •   Cash, cash equivalents and accrued interest at June 30, 2006, were $75.4 million, compared to $127.9 million at December 31, 2005, and $100.5 million at March 31, 2006. Due to the delay in the approval of THELIN™ (sitaxsentan sodium), the Company now anticipates the need to raise additional cash and is exploring various financing options.
Recent Company Events
  •   On May 25, 2006, the Company submitted its complete response to the U.S. Food and Drug Administration (FDA), to address the issues and concerns detailed in the March 24, 2006, approvable letter for THELIN. The FDA, in turn, designated the review as a Class 1 resubmission. A new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006, was established.
 
  •   On July 24, 2006, Encysive received a second approvable letter from the FDA for THELIN. One of the substantive items raised in the March 24 approvable letter remains unresolved. The FDA acknowledged that the unresolved item is a matter of judgment and expressed a willingness to consider new arguments to address this remaining item. The FDA again offered the alternative of conducting additional clinical work. The Company has initiated active

 

 

      discussions with the Agency, and is in the process of setting up a face-to-face meeting with the goal of attempting to resolve the remaining item.
  •   On June 2, 2006, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a positive opinion recommending the approval of THELIN™ 100 mg tablets as a once daily oral treatment for patients with pulmonary arterial hypertension. The CHMP’s positive opinion will be considered by the European Commission, and a final decision regarding marketing approval for THELIN is expected within approximately 90 days from the opinion date. Under the EMEA’s centralized licensing procedure, if approved, Encysive would be granted marketing authorization for THELIN in all 25 member states of the European Union.
 
  •   In preparation for the launch of THELIN in Europe, Encysive has established a European commercial organization, headquartered in London. Sales and marketing organizations are currently being developed in the United Kingdom, Germany and France, with other countries to follow.
 
  •   The Company presented new THELIN data from the STRIDE-2X trial at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in June 2006.
Upcoming Presentations
  •   Sept. 2-6           World Congress of Cardiology
                          Barcelona, Spain
 
  •   Sept. 2-6           European Respiratory Society 16th Annual Congress
                          Munich, Germany
 
  •   Sept. 11-14      ThinkEquity Partners 4th Annual Growth Conference
                         San Francisco*
 
  •   Sept. 25-28      UBS Global Life Sciences Conference
                         New York City*
*Meeting will be webcast at www.encysive.com
Conference Call Information
Encysive Pharmaceuticals will host a conference call to discuss second quarter 2006 earnings today at 8:00 a.m. ET. You may access the call either through the call-in number below or through the audio webcast. Please dial in 15 minutes prior to the start time to allow for call processing. The access number for the call is:
Number: (612) 332-0226
Passcode: Encysive Pharmaceuticals
This call is being webcast and can be accessed via Encysive’s web site at www.encysive.com.
A replay of the webcast will be available on the Company’s web site through September 7, 2006. Additionally, a replay of the call will be available from Monday, August 7, 2006, at 11:30 a.m. ET until Thursday, August 10, 2006, at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844
Access Code: 838078

 

 

About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are our estimate of the sufficiency of our existing capital resources, our ability to raise additional capital to fund cash requirements for future operations, timelines for initiating new clinical trials, planned announcements of clinical data, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, potential drug candidates, their potential therapeutic effect, market acceptance or our ability to earn a profit from sales or licenses of any drug candidate, our ability to discover new drugs in the future, and our ability to establish future collaborative arrangements. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. Encysive undertakes no duty to update or revise these forward-looking statements.
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ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
UNAUDITED SELECTED FINANCIAL DATA
Amounts in thousands (except per share data)
Consolidated Summary of Operations
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30  
    2006     2005     2006     2005  
Revenues
   $ 3,662     $ 2,976     $ 7,223     $ 5,462  
Operating expenses:
                                
Research and development
     14,676       17,366       33,055       33,681  
Sales and marketing
     11,767       3,263       21,603       4,380  
General and administrative
     5,364       3,605       11,106       6,199  
 
                        
Total expenses
     31,807       24,234       65,764       44,260  
 
                        
Operating loss
     (28,145 )     (21,258 )     (58,541 )     (38,798 )
Investment income
     1,085       1,339       2,384       1,933  
Interest expense
     (978 )     (976 )     (1,958 )     (1,147 )
 
                        
Loss from continuing operations
     (28,038 )     (20,895 )     (58,115 )     (38,012 )
Income from discontinued operations
     —       1,661       —       1,335  
 
                        
Loss before cumulative effect of change in accounting principle
   $ (28,038 )   $ (19,234 )   $ (58,115 )   $ (36,677 )
Cumulative effect of change in accounting principle
     —       —       107       —  
 
                        
Net loss
   $ (28,038 )   $ (19,234 )   $ (58,008 )   $ (36,677 )
Net loss per common share
                                
Basic and diluted
   $ (0.48 )   $ (0.33 )   $ (0.99 )   $ (0.63 )
 
                        
Weighted average common shares
                                
Outstanding: basic and diluted
     58,465       57,895       58,368       57,776  
 
                        
Condensed Consolidated Balance Sheets
                 
    June 30,     June 30,  
    2006     2005  
Assets:
                
Cash, cash equivalents and
Accrued interest
   $ 75,417     $ 127,913  
Other assets
     17,727       18,789  
 
            
Total assets
     93,144       146,702  
 
            
Liabilities and stockholders’ deficit
                
Current liabilities
     26,664       26,151  
Deferred revenue, long-term
     642       1,286  
Long-term debt
     130,000       130,000  
 
            
Total liabilities
     157,306       157,437  
Stockholders’ deficit
     (64,162 )     (10,735 )
 
            
Liabilities and stockholders’ deficit
   $ 93,144     $ 146,702