CORRECTING and REPLACING Trimeris Announces Third Quarter 2003 Results.Business Editors/Health/Medical Writers CORRECTION...by Trimeris Trimeris is a genus of the plant family Campanulaceae endemic to the island of St Helena in the South Atlantic Ocean.
DURHAM Durham, town and district, England Durham, town (1991 pop. 38,105) and district, county seat of Durham, NE England, on the sides of a hill nearly encircled by the Wear River. The town's small factories produce organs and carpets. , N.C.--(BUSINESS WIRE)--Oct. 15, 2003 In BW5902 issued Oct. 15, 2003: Fourth graph, third sentence should be ommitted. Corrected release follows: TRIMERIS ANNOUNCES THIRD QUARTER 2003 RESULTS Trimeris, Inc. (Nasdaq: TRMS TRMS The Rachel Maddow Show (radio program) TRMS Tightrope Media Systems TRMS Tycom Readiness Management System TRMS Training Records Management System TRMS Tuttle Risk Management Services, Inc TRMS Test Resource Management System ) today announced results for the third quarter ended September September: see month. 30, 2003. For the third quarter of 2003, the Company reported a loss of $16.6 million, or ($0.77) per share, compared with a loss of $18.1 million ($0.97 per share) in the comparable 2002 period. The decrease in net loss for the quarter is primarily due to the gross profit from the sale of FUZEON Fu·ze·on A trademark for the drug enfuvirtide. enfuvirtide Fuzeon Pharmacologic class: Human immunodeficiency-1 (HIV-1) fusion inhibitor Therapeutic class: Antiretroviral (R), 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 Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for FUZEON and the production of drug material for clinical trials. These costs are net of reimbursements from Hoffmann-La Roche n. 1. Rock. , Inc., the Company's collaborative partner. Cash and cash equivalents and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments totaled $110.8 million at September 30, 2003. "Actual net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight in the U.S. for the third quarter 2003 were $10.7 million, which is slightly above the range of $9.5 to $10.5 million we provided on September 25th. Net sales outside the U.S. were $2.4 million, " commented Dr. Dani DANI Department of Agriculture Northern Ireland DANI Deaf Association Northern Ireland (UK) Bolognesi, Chief Executive Officer of Trimeris. A live webcast of our conference call on October October: see month. 15 at 5:00 p.m. Eastern Time will be available at http://www.trimeris.com and archived for replay until December 31, 2003. 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 Meaning "related or caused by a virus," with regard to computers and information technology, the term refers less to a computer virus than it does to information that spreads quickly via the Internet. See viral marketing and viral video. disease. The core technology platform of fusion inhibition inhibition In enzymology, a phenomenon in which a compound (an inhibitor), usually similar in structure to the substance on which an enzyme acts (substrate), interacts with the enzyme so that the resulting complex cannot undergo the usual reaction or cannot form the usual is based on blocking viral entry Viral entry is the earliest stage of infection in the "viral life cycle", as the virus comes into contact with the host cell and introduces viral material into the cell. The major steps involved in viral entry are:[1]
European Community , is the first in a new class of anti-HIV drugs called fusion inhibitors fusion inhibitor n. A drug that interferes with the entry of HIV into helper T cells by inhibiting the fusion of the viral and cell membranes. . Trimeris' second fusion inhibitor product candidate, T-1249, has received fast track status from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and is in Phase I/II clinical testing. Trimeris is developing FUZEON and T-1249 in collaboration Working together on a project. See collaborative software. with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the Company's website at www.trimeris.com. Trimeris Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 Side effects Effects of a proposed project on other parts of the firm. . For a detailed description of these factors, see Trimeris' Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 Nine Months
Ended Sept. 30, Ended Sept. 30,
------------------- ------------------
2003 2002 2003 2002
------------------- ------------------
Milestone revenue $989 $326 $1,975 $978
Royalty revenue 234 -- 321 --
------------------- ------------------
Total revenue 1,223 326 2,296 978
------------------- ------------------
Operating expenses:
Collaboration loss/b 5,231 -- 15,446 --
------------------- ------------------
Marketing expense/b -- 3,640 -- 8,150
------------------- ------------------
Research and
development:
Non-cash compensation/a (125) 98 18 226
Other research and
development 10,850 12,232 31,227 38,916
------------------- ------------------
Total research and
development expense 10,725 12,330 31,245 39,142
------------------- ------------------
General and
administrative:
Non-cash compensation/a 122 414 767 1,232
Other general and
administrative 2,088 2,502 6,655 6,398
------------------- ------------------
Total general and
administrative expense 2,210 2,916 7,422 7,630
------------------- ------------------
Total operating
expenses 18,166 18,886 54,113 54,922
------------------- ------------------
Operating loss (16,943) (18,560) (51,817) (53,944)
------------------- ------------------
Other income (expense)
Interest income 323 446 1,243 1,499
Interest expense (9) (24) (35) (88)
------------------- ------------------
314 422 1,208 1,411
------------------- ------------------
Net loss $(16,629) $(18,138) $(50,609) $(52,533)
=================== ==================
Basic and diluted net
loss per share $ (0.77) $ (0.97) $(2.36) $ (2.82)
=================== ==================
Weighted average
shares outstanding 21,513 18,776 21,436 18,602
=================== ==================
/a: 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.
/b: 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 nine months ended September
30, 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)
Sept. 30, Dec. 31,
2003 2002
(unaudited)
-------------- -------------
Assets
Total current assets $111,114 $150,313
Property, furniture and equipment -
net 2,534 2,816
Total other assets 1,933 1,410
---------------- -------------
Total assets $115,581 $154,539
================ =============
Liabilities and Stockholders' Equity
Total current liabilities $20,351 $21,924
Capital lease obligations, less
current installments -- 321
Deferred revenue 12,357 2,167
---------------- -------------
Total liabilities 32,708 24,412
---------------- -------------
Total stockholders' equity 82,873 130,127
---------------- -------------
Total liabilities and stockholders'
equity $115,581 $154,539
================ =============
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