Trimeris Reports Financial Results for the Third Quarter 2009

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Thu Nov 12, 2009 4:00pm EST

http://www.businesswire.com/news/home/20091112006132/en

DURHAM, N.C.--(Business Wire)--
Trimeris, Inc. (Nasdaq: TRMS) ("Trimeris" or the "Company") today announced
financial results for the three months ended September 30, 2009, reporting net
income of $1.6 million, or $0.07 per share, compared with $3.6 million, or $0.16
per share, for the three months ended September 30, 2008. This result was
primarily driven by decreased FUZEON® sales and an increase in tax expense,
offset, in part, by lower operating expenses. 

For the nine months ended September 30, 2009, the Company reported net income of
$5.1 million, or $0.23 per share, compared with $6.5 million, or $0.29 per share
for the nine months ended September 30, 2008. 

Royalty revenue for the quarter ended September 30, 2009 was $2.1 million
compared with $3.4 million for the quarter ended September 30, 2008. This
decrease was driven by a decrease in net FUZEON® sales outside the U.S. and
Canada. Net sales of FUZEON® outside the U.S. and Canada for the third quarter
of 2009 were $19.4 million, down 37 percent from $30.6 million in the third
quarter of 2008. 

Collaboration income for the quarter ended September 30, 2009 was $1.7 million
compared with $1.8 million for the quarter ended September 30, 2008. The
decrease was primarily driven by a decrease in net sales of FUZEON® in the U.S
and Canada offset, in part, by reduced selling and marketing expenses. Net sales
of FUZEON in the U.S. and Canada for the third quarter of 2009 were $10.4
million, down 31 percent from $14.9 million in the third quarter of 2008. 

Operating expenses for the quarter ended September 30, 2009 of $1.7 million
compared with $1.9 million for the quarter ended September 30, 2008. The
decrease was primarily driven by reduced business activities including research
and development offset, in part, by increased costs related to the negotiation
of the Company`s previously announced agreement and plan of merger with Arigene
Co., Ltd. and RTM Acquisition Company as further described below. 

The income tax provision for the quarter ended September 30, 2009 was $833,000
compared with $47,000 for the quarter ended September 30, 2008. This increase
was driven by an "ownership change" as defined under Section 382 of the Internal
Revenue Code of 1986, as amended, which occurred in December 2008. The effects
of this ownership change were the imposition of a $457,000 annual limitation on
the use of net operating loss carryforwards, tax credits and built-in loss items
attributable to periods before the ownership change. Earnings in excess of the
annual limitation will now be subject to corporate income taxes. 

Cash, cash equivalents and investment securities available-for-sale totaled
$35.6 million at September 30, 2009, compared to $31.6 million at December 31,
2008. 

As previously announced, the Company has signed an agreement and plan of merger
with Arigene Co., Ltd., a Korean corporation ("Arigene"), pursuant to which,
upon completion of a tender offer for the outstanding shares of common stock of
the Company, the Company will become a wholly-owned subsidiary of Arigene. The
Company has previously filed a Schedule 14D-9 Solicitation/Recommendation
Statement and amendments thereto with the Securities and Exchange Commission
containing additional information regarding the tender offer and merger. 

Earnings Conference Call

The Company announced today that it will not be conducting a conference call in
connection with this earnings release. 

About Trimeris, Inc.

Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the
commercialization of therapeutic agents for the treatment of viral disease. The
core technology platform of fusion inhibition is based on blocking viral entry
into host cells. FUZEON, approved in the U.S., Canada and European Union, is the
first in a new class of anti-HIV drugs called fusion inhibitors. For more
information about Trimeris, please visit the Company's website at
http://www.trimeris.com. 

Trimeris Safe Harbor Statement

This document and any attachments may contain forward-looking information about
the Company's financial results and business prospects that involve substantial
risks and uncertainties. These statements can be identified by the fact that
they use words such as "expect," "project," "intend," "plan," "believe" and
other words and terms of similar meaning. Among the factors that could cause
actual results to differ materially are the following: there is uncertainty
regarding the success of research and development activities, regulatory
authorizations and product commercializations; we are dependent on third parties
for the sale, marketing and distribution of the Company`s drug candidates; the
market for HIV therapeutics is very competitive with regular new product entries
that could affect the sales of the Company`s products; the results of the
Company`s previous clinical trials are not necessarily indicative of future
clinical trials; and the Company`s drug candidates are based upon novel
technology, are difficult and expensive to manufacture and may cause unexpected
side effects. For a detailed description of these factors, see Trimeris' Form
10-K filed with the Securities and Exchange Commission on March 13, 2009.

 Trimeris, Inc.                                                                                                                             
 
Statements of Operations                                                                                                                  
 
[in thousands, except per share amounts]                                                                                                  
 
(unaudited)                                                                                                                               
                                                                                                                                         
                                         Three Months Ended                               Nine Months Ended                              
                                         
September 30,                                   
September 30,                                 
                                         2009                     2008                  2009                     2008                
 Revenue:                                                                                                                            
 Milestone revenue                       $    67                $    67             $    199               $    199          
 Royalty revenue                              2,141                  3,373               6,251                  8,663        
 Collaboration income [1]                     1,702                  1,756               5,555                  6,154        
 Total revenue and collaboration income       3,910                  5,196               12,005                 15,016       
                                                                                                                                     
 Operating expenses:                                                                                                                 
 Research and development                     -                      367                 -                      2,923        
 General and administrative                   1,669                  1,519               4,805                  5,778        
 (Gain) loss on disposal of equipment         -                      (10     )           (23     )              496          
 Total operating expenses                     1,669                  1,876               4,782                  9,197        
                                                                                                                                     
 Operating income                             2,241                  3,320               7,223                  5,819        
                                                                                                                                     
 Other income (expense)                                                                                                              
 Interest income                              59                     397                 338                    1,756        
 Gain/(loss) on investments                   241                    (15     )           298                    (703    )    
 Interest expense                             (64     )              (96     )           (192    )              (285    )    
 Total other income (expense)                 236                    286                 444                    768          
                                                                                                                                     
 Income before taxes                          2,477                  3,606               7,667                  6,587        
 Income tax provision                         833                    47                  2,612                  110          
                                                                                                                                     
 Net income                              $    1,644             $    3,559          $    5,055             $    6,477        
                                                                                                                                     
 Basic net income per share              $    0.07              $    0.16           $    0.23              $    0.29         
                                                                                                                                     
 Diluted net income per share            $    0.07              $    0.16           $    0.23              $    0.29         
                                                                                                                                     
 Weighted average                             22,320                 22,186              22,297                 22,180       
 shares outstanding - basic                                                                                                  
 Weighted average                             22,320                 22,271              22,297                 22,270       
 shares outstanding - diluted                                                                                                
                                                                                                                                     
 Dividends declared per common share          --                     --                  --                $    1.50         


Notes:

[1] Collaboration income represents the Company`s share of the net operating
results from the sale of FUZEON in the United States and Canada under the
Company`s Development and License Agreement with F.Hoffmann-La Roche, Ltd.
("Roche"), the Company`s collaboration partner. These net operating results
consist of net sales less cost of goods (gross margin), less selling and
marketing expenses, other costs related to the sale of FUZEON and development
expenses or post marketing commitments. 

On January 1, 2009, the Company adopted Financial Accounting Standards Board
Emerging Issues Task Force Issue Number 07-1 "Accounting for Collaborative
Arrangements," which falls under the guidance of Accounting Standards
Codification Topic 808, "Collaborative Arrangements." As a result, all
development expenses generated at Roche related to FUZEON are included in the
Company`s collaboration income. For the three months ended September 30, 2009
and 2008, the Company`s share of the development expenses of $62,000 and
$205,000, respectively, was included in the Company`s collaboration income. For
the nine months ended September 30, 2009 and 2008, the Company`s share of the
development expenses of $594,000 and $716,000, respectively, was included in the
Company`s collaboration income. In previous periods, such expenses were included
in research and development expenses and have been reclassified to conform to
the current presentation. 

The Company has entered into negotiations with Roche, in accordance with the
Development and License Agreement, related to excess capacity charges and cost
of goods sold variances for 2008 and overall cost of goods sold for 2009.
Accordingly, the Company cannot accurately determine if cost of goods sold as a
percentage of net sales will increase, decrease or remain the same in the
future. Although active discussions are on-going, the Company cannot be certain
when a final resolution will be reached. Depending upon the resolution of the
Company`s negotiations with Roche, cost of goods sold may increase or decrease
in future periods. 

During 2008, the Company recorded a reserve for 2008 excess capacity charges in
the amount of $4.1 million to be shared equally between Roche and the Company.
In the first quarter of 2009, Roche informed the Company that actual excess
capacity charges for 2008 were $1.9 million. The difference of $2.2 million has
been recorded as a credit to cost of goods sold for the first quarter of 2009.
The Company`s share of this credit was $1.1 million. The Company is disputing
with Roche the remainder of the excess capacity charges for 2008. The resolution
of this dispute may result in an additional credit to cost of goods sold for the
collaboration in future periods.

 Trimeris, Inc.                                                                                                               
 
Condensed Balance Sheets                                                                                                    
 
[$ in thousands]                                                                                                            
 
(unaudited)                                                                                                                 
                                                                                                                           
                                                                                 September 30,          December 31,       
                                                                                 2009                   2008               
 Assets                                                                                                                    
 Cash, cash equivalents and short-term investment securities available-for-sale  $         35,617      $        28,750   
 Other current assets                                                                      3,185                3,334    
 Total current assets                                                                      38,802               32,084   
 Long-term investment securities available-for-sale                                        -                    2,827    
 Total other assets                                                                        9,427                9,301    
 Total assets                                                                    $         48,229      $        44,212   
 Liabilities and Stockholders` Equity                                                                                      
 Total current liabilities                                                       $         1,594       $        3,541    
 Long term portion of deferred revenue                                                     1,105                1,304    
 Accrued marketing costs                                                                   18,463               18,271   
 Accrued compensation - long-term                                                          -                    74       
 Total liabilities                                                                         21,162               23,190   
                                                                                                                           
 Total stockholders` equity                                                                27,067               21,022   
 Total liabilities and stockholders` equity                                      $         48,229      $        44,212   
                                                                                                                         


 FUZEON Net Sales                                                                                                                             
 
(Recognized by Roche, the Company`s collaborative partner)                                                                                  
 
[$ in millions]                                                                                                                             
 
(unaudited)                                                                                                                                 
                                                                                                                                           
                           Three Months Ended,**                                        Nine Months Ended, **                              
                           September 30,                       September 30,          September 30,               September 30,        
                           2009                                2008                   2009                        2008                 
                                                                                                                                       
 United States and Canada  $                 10.4             $         14.9        $         30.1             $         48.0      
 Rest of World                               19.4                       30.6                  56.6                       78.5      
 Worldwide Total           $                 29.8             $         45.5        $         86.7             $         126.5     
                                                                                                                                   
 ** may not add due to rounding                                                                                                     


Trimeris, Inc.
Andrew Graham, Chief Financial Officer
919-806-4682 

Copyright Business Wire 2009

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