08.05.2008 20:13:00
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Trimeris Reports Financial Results for the First Quarter 2008
Trimeris, Inc. (Nasdaq: TRMS) today announced financial results for the
quarter ended March 31, 2008, reporting net income of $2.3 million, or
$0.10 per share. This compares to adjusted net income for the quarter
ended March 31, 2007 of $3.8 million, or $0.17 per share, excluding the
impact of two non-recurring events in the first quarter of 2007, or $8.2
million, or $0.37 per share on a GAAP basis, including these events. As
previously reported, Trimeris recognized two one-time events in the
first quarter of 2007, the acceleration of $8.7 million of revenue for
past milestone payments received from Roche and a $4.3 million charge
for a reduction-in-force. A reconciliation and explanation of the
differences between GAAP and adjusted earnings is detailed in the table
below.
Total revenue and collaboration income for the quarter ended March 31,
2008 totaled $5.6 million. In the first quarter of 2007, total revenue
and collaboration income, excluding the non-recurring acceleration of
milestone revenues, was $8.7 million. This decrease was primarily driven
by lower worldwide FUZEON®
sales. Total revenue and collaboration income in the first quarter of
2007, including the one-time acceleration of milestone revenues from
Roche, was $17.4 million.
Total operating expenses for the quarter ended March 31, 2008 were $3.0
million compared with $9.6 million in the first quarter of 2007, which
included a $4.3 million charge for the reduction-in-force recorded
during the first quarter of 2007. First quarter 2008 operating expenses
have further declined as a result of the Company’s
2008 strategic plan which significantly reduced personnel levels at
Trimeris compared to the first quarter of 2007.
Cash, cash equivalents and investment securities available-for-sale
totaled $80.0 million at March 31, 2008, compared to $69.6 million at
December 31, 2007. As previously reported, in the first quarter of 2008,
the Company received approximately $4.7 million from Roche related to a
credit derived from collaboration calculations of costs of goods sold.
This amount was included in our other current assets as of December 31,
2007.
In addition, based on a preliminary analysis of changes in our common
stock ownership, the Company believes that the threshold for an
"ownership change" under Section 382 of the Internal Revenue Code has
been surpassed. If an ownership change has occurred, this would limit
our utilization of NOL's generated prior to such ownership change. These
financial statements included for the first quarter of 2008 have been
prepared based on an assumption that an ownership change occurred during
the first quarter of 2008.
Special Cash Dividend and Stock Repurchase Program
As part of its plan to return up to $50 million to shareholders by the
end of 2008, the Board of Directors has declared a one-time special cash
dividend of $1.50 per share of common stock to stockholders of record on
May 22, 2008. The aggregate dividend payment will total approximately
$33 million based on the number of shares of common stock currently
outstanding. The dividend will be paid on June 6, 2008.
As a further step in this plan, the Board of Directors authorized a
share repurchase program to purchase up to $17.0 million of Trimeris
common stock from time to time on the open market, in block trades or
otherwise.
The timing of repurchases and the amount of any shares repurchased will
be determined by Trimeris management based on its evaluation of market
conditions and other factors. The repurchase program may be suspended or
discontinued at any time. Any repurchased shares will be available for
use in connection with Trimeris stock plans and for other corporate
purposes.
Both the special cash dividend and any repurchases under the stock
repurchase program will be funded using Trimeris working capital. As of
March 31, 2008, Trimeris had cash, cash equivalents and investment
securities available-for-sale of approximately $80.0 million and
approximately 22.2 million shares of common stock outstanding.
2008 and 2009 Guidance
As a convenience to investors, Trimeris is providing its outlook for
2008. This outlook is based upon numerous assumptions, all of which are
subject to certain risks and uncertainties. For a discussion of the
risks and uncertainties associated with these forward-looking
statements, please see the Trimeris Safe Harbor Statement below.
The Company reiterates its previous guidance that total operating
expenses are expected to be in the range of $10.0 million to $14.0
million in 2008, down from $24.0 million in 2007. The Company expects
total operating expenses in 2009 to be in the range of $5.0 million to
$10.0 million.
Conference Call
Trimeris will host a live conference call to discuss the first quarter
2008 financial results at 5:00 p.m. Eastern Time, today. To access the
live call, please dial (800) 399-8403 (U.S.) or (706) 634-6565
(International). The conference ID number is 46124941. Telephone replay
is available approximately two hours after the call through 11:59 p.m.
Eastern Time, May 22, 2008. To access the replay, please call (800)
642-1687 (U.S.) or (706) 645-9291 (international). The information
provided on the teleconference is only accurate at the time of the
conference call, and Trimeris will take no responsibility for providing
updated information.
Live audio of the conference call will be simultaneously broadcast over
the Internet and will be available to members of the news media,
investors and the general public. The webcast can be accessed by going
to Trimeris’ website, http://www.trimeris.com.
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.
Statements in this press release regarding the Company’s
intention to repurchase shares of its common stock from time to time
under the stock repurchase program, the intended use of any repurchased
shares and the source of funding are forward-looking statements. There
are a number of important factors that could cause actual events to
differ materially from those suggested or indicated by such
forward-looking statements. These include, among others, the market
price of the Company’s stock prevailing from
time to time, the nature of other investment opportunities presented to
the Company from time to time, the Company’s
cash flows from operations, general economic conditions, and other
factors identified in the Company’s most
recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q
filed with the SEC.
Statement Regarding Adjusted (Non-GAAP) Financial Information
In addition to disclosing financial results calculated in accordance
with Generally Accepted Accounting Principles ("GAAP”),
the Company has included certain adjusted financial results.
Reconciliations between GAAP and adjusted earnings for the three months
ended March 31, 2008 and 2007 are provided in the table below. The
Company believes that the presentation of adjusted results provides
meaningful supplemental information regarding our financial results for
the three months ended March 31, 2008 as compared to the three months
ended March 31, 2007 because the adjustments between GAAP and adjusted
earnings provides information related to the ongoing operations of the
Company. The Company believes that this financial information is useful
to management and investors in assessing our historical performance and
results. The Company will use these adjusted financial measures when
evaluating its financial results, as well as for internal planning and
forecasting purposes. The adjusted financial measures disclosed by the
Company should not be considered a substitute for or superior to
financial measures calculated in accordance with GAAP, and the financial
results calculated in accordance with GAAP and reconciliations to those
financial statements should be carefully evaluated. The adjusted
financial measures used by the Company may be calculated differently
from, and therefore may not be comparable to, similarly titled measures
used by other companies.
Our results under GAAP have been adjusted for the following events that
occurred during the three months ended March 31, 2007: (1) an amendment
to our research agreement with Roche that resulted in the accelerated
recognition of milestone revenue, and (2) reductions to the Company’s
workforce that resulted in additional expense. See the table and
accompanying footnotes below for a detailed reconciliation of GAAP and
adjusted earnings.
Reconciliations of GAAP and adjusted earnings for the three months ended
March 31, 2008 and 2007 are provided in the following table:
Three Months Ended
March 31,
2008
[in thousands except per share amounts]
(unaudited)
March 31,
2007
[in thousands except per share amounts]
(unaudited)
Net income (GAAP)
2,328
8,151
Milestone Revenue [1]
-
(8,678
)
Charges related to reductions in workforce[2]
-
4,344
Net income (adjusted)
2,328
3,817
Diluted net income per share (GAAP)
0.10
0.37
Diluted net income per share (adjusted)
0.10
0.17
[1] On March 13,
2007, the Company entered into an agreement with Roche that amended the
terms of the Research Agreement. Under this agreement, all rights and
joint patents and other intellectual property rights to the next
generation fusion inhibitor peptides falling under the Research
Agreement, which includes our lead drug candidate, TRI-1144, reverted to
Trimeris. As a result of this agreement, the Company accelerated revenue
recognition for past milestone payments received from Roche into the
first quarter of 2007 because our period of joint development ended.
These milestone payments were previously being amortized over the length
of the joint research and development period of the next generation
fusion inhibitor peptides or through December 2012.
[2] During the
three months ended March 31, 2007, the Company recorded charges to the
Statement of Operations related to reductions in workforce.
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 our drug candidates;
the market for HIV therapeutics is very competitive with regular new
product entries that could affect the sales of our products; 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 17, 2008.
Trimeris, Inc. Statements of Operations [in thousands, except per
share amounts]
Three Months Ended March 31, (unaudited)
2008 2007
Milestone revenue [1]
$
66
$
9,208
Royalty revenue
2,840
3,862
Collaboration income [2]
2,682
4,368
Total revenue and collaboration income
5,588
17,438
Operating expenses:
Research and development expense
1,719
3,097
General and administrative expense
1,692
6,539
Gain on sale of equipment
(418
)
(2
)
Total operating expenses [3]
2,993
9,634
Operating income
2,595
7,804
Other income (expense)
Interest income
822
670
Loss on investments
(738
)
-
Interest/accretion expense
(94
)
(201
)
Total other income (expense)
(10
)
469
Income before income taxes
2,585
8,273
Income tax provision
257
122
Net income
$
2,328
$
8,151
Basic net income per share
$
0.11
$
0.37
Diluted net income per share
$
0.10
$
0.37
Weighted average
shares outstanding – basic
22,167
22,008
Weighted average
shares outstanding – diluted
22,252
22,124
Notes: [1] On March 13,
2007, the Company entered into an agreement with Roche that amended the
terms of the Research Agreement. Under this agreement, all rights and
joint patents and other intellectual property rights to the next
generation fusion inhibitor peptides falling under the Research
Agreement, which includes the lead drug candidate, TRI-1144, reverted to
Trimeris. As a result of this agreement, the Company accelerated revenue
recognition for past milestone payments received from Roche into the
first quarter of 2007 because our period of joint development had ended.
These milestone payments were previously being amortized over the length
of the joint research and development period of the next generation
fusion inhibitor peptides or through December 2012.
[2] Collaboration
income represents our share of the net operating results from the sale
of FUZEON in the United States and Canada under our collaboration
agreement with Hoffmann-La Roche, Inc., our collaborative partner. These
net operating results consist of net sales less cost of goods (gross
margin), less selling and marketing expenses and other costs related to
the sale of FUZEON.
[3] Included in
operating expenses for the three months ended March 31, 2007 are
expenses of $4.3 million for the reduction-in-force that occurred during
the first quarter of 2007.
Trimeris, Inc. Condensed Balance Sheets [$ in thousands]
March 31, 2008 (unaudited) December 31, 2007 Assets
Cash, cash equivalents and short-term investment securities
available-for-sale
$
65,249
$
60,640
Other current assets
4,227
12,979
Total current assets
69,476
73,619
Property, furniture and equipment – net
1,178
1,644
Long-term investment securities available-for-sale
14,727
8,952
Total other assets
9,904
9,906
Total assets
$
95,285
$
94,121
Liabilities and Stockholders’ Equity
Total current liabilities
$
4,602
$
6,439
Long term portion of deferred revenue
1,503
1,569
Accrued marketing costs
18,017
17,923
Accrued compensation – long-term
206
150
Other liabilities
712
718
Total liabilities
25,040
26,799
Total stockholders’ equity
70,245
67,322
Total liabilities and stockholders’ equity
$
95,285
$
94,121
FUZEON Net Sales (Recognized by Roche, our collaborative partner) [$ in millions]
Three Months Ended March 31, (unaudited) 2008 2007
United States and Canada
$
17.0
$
29.3
Rest of World
25.7
35.0
Worldwide Total
$
42.7
$
64.3
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