-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, LBj71ng3hpk7dBlDAWTP+sTL865hMhbociGCbDiSX2uDrNTCLynYusmBra9Wlh/W TkPSigF7LOYB+jMFqaf9JA== 0001193125-04-013711.txt : 20040203 0001193125-04-013711.hdr.sgml : 20040203 20040203160243 ACCESSION NUMBER: 0001193125-04-013711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20040203 ITEM INFORMATION: FILED AS OF DATE: 20040203 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRIMERIS INC CENTRAL INDEX KEY: 0000911326 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 561808663 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23155 FILM NUMBER: 04563093 BUSINESS ADDRESS: STREET 1: 3518 WESTGATE DRIVE, SUITE 300 CITY: DURHAM STATE: NC ZIP: 27707 BUSINESS PHONE: 9194196050 MAIL ADDRESS: STREET 1: 3518 WESTGATE DRIVE, SUITE 300 CITY: DURHAM STATE: NC ZIP: 27707 8-K 1 d8k.htm FORM 8-K FORM 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): February 3, 2004

 


 

TRIMERIS, INC.

(Exact Name of Registrant as Specified in Charter)

 


 

Delaware   0-23155   56-1808663

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)   (I.R.S. Employer Identification No.)

 

3518 Westgate Drive, Suite 300, Durham, North Carolina   27707
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code (919) 419-6050

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 



ITEM 12. RESULTS OF OPERATION AND FINANCIAL CONDITION

 

The following information is furnished pursuant to Item 12, “Results of Operations and Financial Condition”:

 

On February 3, 2004, Trimeris, Inc. (the “Company”) announced via press release the Company’s financial results for its fourth quarter and fiscal year ended December 31, 2003. A copy of the Company’s press release is attached hereto as Exhibit 99.1. This Form 8-K, the information contained herein, and the attached exhibit are furnished under this Item 12 of Form 8-K and are furnished to, but not filed with, the Securities and Exchange Commission. The information contained herein and in the accompanying exhibit shall not be incorporated by reference to any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing.


SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

TRIMERIS, INC.

By:

 

/s/ Dani P. Bolognesi


   

Dani P. Bolognesi

   

Chief Executive Officer and

   

Chief Scientific Officer

 

Dated February 3, 2004

EX-99.1 3 dex991.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.1

 

LOGO

 

LOGO

 

Contacts:     

Timothy Creech

  

Robin Fastenau

Vice President of Finance

  

Manager of Corporate Communications

Trimeris, Inc.

  

Trimeris, Inc.

(919) 419-6050

  

(919) 419-6050

 

TRIMERIS ANNOUNCES FOURTH QUARTER AND YEAR-END 2003 RESULTS

 

DURHAM, N.C., February 3, 2004 – Trimeris, Inc. (Nasdaq: TRMS) today announced financial results for the fourth quarter and year ended December 31, 2003.

 

For the fourth quarter of 2003, the Company reported a loss of $15.1 million, or ($0.70) per share, compared with a loss of $16.6 million ($0.77 per share) in the third quarter of 2003, and $23.1 million ($1.09 per share) in the fourth quarter of 2002. For the year ended 2003, the Company’s net loss totaled $65.7 million, or ($3.06) per share, compared with a loss of $75.7 million ($3.93 per share) for 2002.

 

The decrease in net loss for the quarter is primarily due to the gross profit from the sale of FUZEON®, net of increased marketing expenses related to the commercial launch of FUZEON. In 2003, marketing expenses increased and were partially offset by reduced research and development expenses incurred compared to 2002 for the Company’s phase III clinical trials for FUZEON and the production of drug material for clinical trials. These costs are net of reimbursements from Hoffmann-La Roche, Inc., the Company’s collaborative partner. During the quarter, Trimeris extended its research agreement with Roche and received reimbursement for certain research expenses incurred during 2003. Cash and cash equivalents and short-term investments totaled $92.2 million at December 31, 2003.

 

Total worldwide net sales for FUZEON during the fourth quarter were $17.6 million, compared to $13.1 million during the third quarter. These amounts include net sales in the United States and Canada of $13.3 million during the fourth quarter, compared to $10.7 million during the third quarter. Net sales outside the U.S. and Canada were $4.3 million during the fourth quarter, compared to $2.4 million during the third quarter.

 

“2003 was an eventful year for Trimeris with the approval and launch of FUZEON,” commented Dr. Dani Bolognesi, Chief Executive Officer of Trimeris. “We will continue to work with our colleagues at Roche to ensure the commercial success of FUZEON and its broad adoption as a new standard of care in the management of treatment-experienced HIV patients. We look forward to seeing the results of our heightened marketing initiatives on the uptake of FUZEON during 2004.”

 

A live webcast of our conference call on February 3 at 5:00 p.m. Eastern Time will be available at http://www.trimeris.com.

 

About Trimeris, Inc.

 

Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialization of novel 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. Trimeris is developing FUZEON and future generations of peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the Company’s website at 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; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and our 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 27, 2003 and its periodic reports filed with the SEC.


Trimeris, Inc.

Statements of Operations

[in thousands, except per share amounts]

(unaudited)

 

     Three Months Ended
December 31,


   

Year Ended

December 31,


 
     2003

    2002

    2003

    2002

 

Milestone revenue

   $ 989     $ 155     $ 2,964     $ 1,133  

Royalty revenue

     434       —         755       —    
    


 


 


 


Total revenue

     1,423       155       3,719       1,133  
    


 


 


 


Operating expenses:

                                

Collaboration loss**

     10,069       —         25,515       —    
    


 


 


 


Marketing expense**

     —         8,572       —         16,722  
    


 


 


 


Research and development:

                                

Non-cash compensation*

     (19 )     24       (1 )     250  

Other research and development

     5,597       12,060       36,824       50,976  
    


 


 


 


Total research and development expense

     5,578       12,084       36,823       51,226  
    


 


 


 


General and administrative:

                                

Non-cash compensation*

     —         413       767       1,645  

Other general and administrative

     1,155       2,942       7,810       9,340  
    


 


 


 


Total general and administrative expense

     1,155       3,355       8,577       10,985  
    


 


 


 


Total operating expenses

     16,802       24,011       70,915       78,933  
    


 


 


 


Operating loss

     (15,379 )     (23,856 )     (67,196 )     (77,800 )
    


 


 


 


Other income (expense)

                                

Interest income

     291       731       1,534       2,230  

Interest expense

     (6 )     (20 )     (41 )     (108 )
    


 


 


 


       285       711       1,493       2,122  
    


 


 


 


Net loss

   $ (15,094 )   $ (23,145 )   $ (65,703 )   $ (75,678 )
    


 


 


 


Basic and diluted net loss per share

   $ (0.70 )   $ (1.09 )   $ (3.06 )   $ (3.93 )
    


 


 


 


Weighted average shares outstanding

     21,530       21,281       21,460       19,272  
    


 


 


 



* Non cash compensation represents non-cash charges or credits related to stock options granted to employees and non-employees. The change in this expense is primarily due to the change in the market price of our stock at the end of each quarter.
** Collaboration loss represents our 50% share of the net operating loss from the sale of FUZEON in the United States under our collaboration agreement with Hoffmann-La Roche, Inc., our collaborative partner. This net operating loss consists of net sales less cost of goods (gross margin), less selling and marketing expenses. Selling and marketing expenses exceeded the gross margin from FUZEON sales in the three months and year ended December 31, 2003. Marketing expense for 2002 consisted of our 50% share of expenses incurred for pre-launch activities related to FUZEON.


Trimeris, Inc.

Condensed Balance Sheets

[$ in thousands]

 

     December 31,
2003


   December 31,
2002


Assets

             

Total current assets

   $ 94,304    $ 150,313

Property, furniture and equipment – net

     2,578      2,816

Total other assets

     1,718      1,410
    

  

Total assets

   $ 98,600    $ 154,539
    

  

Liabilities and Stockholders’ Equity

             

Total current liabilities

   $ 18,563    $ 21,924

Capital lease obligations, less current installments

     —        321

Deferred revenue

     11,369      2,167
    

  

Total liabilities

     29,932      24,412
    

  

Total stockholders’ equity

     68,668      130,127
    

  

Total liabilities and stockholders’ equity

   $ 98,600    $ 154,539
    

  

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