13.03.2008 20:00:00
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Trimeris Reports Financial Results for the Fourth Quarter and Year End 2007
Trimeris, Inc. (NASDAQ: TRMS) today announced that the Company earned
$0.41 per share for the quarter ended December 31, 2007, compared with
$0.21 per share in the fourth quarter of 2006. Net income for the fourth
quarter totaled $9.1 million, compared with $4.7 million in the prior
year’s fourth quarter. This increase was
primarily driven by decreased operating expenses which were $4.0 million
for the quarter ended December 31, 2007, compared to $8.1 million for
the same period last year.
For the quarter ended December 31, 2007, the Company reported adjusted
net income of $4.1 million, or $0.18 per share compared with $8.1
million, or $0.37 per share in the fourth quarter of 2006. This decrease
was primarily driven by decreased collaboration income offset, in part,
by increased royalty revenue and decreased operating expenses.
Collaboration income decreased as a result of lower FUZEON®
sales in North America and higher cost of goods sold.
For the year ended December 31, 2007, the Company reported net income of
$27.4 million, or $1.24 per share, compared with $7.4 million, or $0.34
per share, for the year ended December 31, 2006. This increase was
primarily driven by increased revenue, increased collaboration income
and decreased operating expenses. Total revenue and collaboration income
was $49.4 million for the year ended December 31, 2007, compared to
$37.0 million for 2006. This increase was primarily driven by increased
milestone revenue as a result of the acceleration of revenue in the
first quarter of 2007, increased royalty revenue from FUZEON sales
outside of North America and increased collaboration income.
Collaboration income increased as a result of a cost of goods sold
credit recognized in the fourth quarter of 2007, offset, in part, by
lower FUZEON sales in North America and higher cost of goods sold in
2007. All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd. ("Roche”),
Trimeris’ collaborative partner.
For the year ended December 31, 2007, the Company reported adjusted net
income of $19.2 million, or $0.87 per share, compared with $12.2
million, or $0.55 per share for the year ended December 31, 2006. This
increase was primarily driven by decreased operating expenses and
increased revenue. The increase in revenue between the periods was
driven by increased royalty revenue from FUZEON sales outside of North
America offset, in part by decreased collaboration income. Collaboration
income decreased as a result of lower FUZEON sales in North America and
higher cost of goods sold for the collaboration in 2007.
Cash, cash equivalents and investment securities available-for-sale
totaled $69.6 million at December 31, 2007, compared to $48.6 million at
December 31, 2006.
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.
In December 2007, the Company announced its strategic plan for 2008
designed to maximize cash flows from FUZEON while also advancing
TRI-1144 to a value-creating milestone. In March 2008, the Company
initiated a single ascending dose ("SAD”)
Phase I clinical trial for TRI-1144. The Company expects that the Phase
I SAD study will be complete by the end of the third quarter. The
Company may release interim data prior to the completion of the trial.
After June 30, 2008, the Company expects that it will no longer staff
any research or development functions. As a result, 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 fourth quarter
2007 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 37940721. Telephone replay
is available approximately two hours after the call through 11:59 p.m.
Eastern Time, March 27, 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, 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.
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 December 31, 2007 and 2006 and for year ended December 31, 2007
and 2006 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 and twelve
months ended December 31, 2007 as compared to the three and twelve
months ended December 31, 2006 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 2007: (1) an amendment to our research agreement with
Roche that resulted in the accelerated recognition of milestone revenue,
(2) reductions to the Company’s workforce
that resulted in additional expense, (3) a change in the method for
calculating the cost of goods sold of FUZEON that resulted in a credit
to the Company, and (4) an adjustment to our estimate of non-cash
employee stock compensation expense as a result of the reduction in
workforce. 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
December 31, 2007 and 2006 and for the year ended December 31, 2007 and
2006 are provided in the following table:
Three Months Ended
Year Ended
Dec. 31, 2007
[in thousands except per share amounts]
(unaudited)
Dec. 31, 2006
[in thousands except per share amounts]
(unaudited)
Dec. 31, 2007
[in thousands except per share amounts]
Dec. 31, 2006
[in thousands except per share amounts]
Net income (GAAP)
9,059
4,699
27,425
7,384
Milestone Revenue [1]
(66
)
(530
)
(9,435
)
(3,430
)
Charges related to reductions in workforce[2]
1,645
3,161
5,909
3,161
Cost of Goods Sold Credit[3]
(5,470
)
-
(5,470
)
-
Non-cash employee stock compensation expense[4]
(1,074
)
803
735
5,063
Net income (adjusted)
4,094
8,133
19,164
12,178
Diluted net income per share (GAAP)
0.41
0.21
1.24
0.34
Diluted net income per share (adjusted)
0.18
0.37
0.87
0.55
[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. We have excluded all
milestone revenue for all periods.
[2] During the
three and twelve months ended December 31, 2007 and 2006, the Company
recorded charges to the Statement of Operations related to reductions in
workforce.
[3] Recently, the
Company entered into discussions with Roche related to the models used
to calculate cost of goods sold for FUZEON. During the course of our
discussions, the Company and Roche have concluded that the models being
used resulted in an overestimate in the costs of goods sold being
charged to the collaboration. As a result, the Company has received a
credit from Roche of approximately $5.5 million for over charges to
FUZEON cost of goods sold during the period from 2003 to 2006. The
credit appears in the calculation of collaboration income for the fourth
quarter 2007. The credit is reflected on our balance sheet as a
receivable from Roche which is included in other current assets, as
opposed to cash or cash equivalents.
At present, the Company remains in active discussions related to the
calculation of cost of goods sold for 2007 and 2008 and, as such, cannot
accurately determine if cost of goods sold as a percentage of net sales
will increase, decrease or remain the same. Although discussions are
on-going, the Company cannot be certain when a final resolution will be
reached.
[4] As a result of
the reduction in workforce, in the fourth quarter of 2007, the Company
experienced increased forfeitures for employee stock options resulting
in a credit to non-cash employee stock compensation expense.
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 16, 2007 and its subsequent periodic reports filed
with the SEC.
Trimeris, Inc. Statements of Operations [in thousands, except per
share amounts]
Three Months Ended December 31, (unaudited) Year Ended December 31,
2007
2006
2007
2006
Revenue:
Milestone revenue [1]
$
66
$
530
$
9,435
$
3,430
Royalty revenue
3,865
3,433
15,727
11,812
Collaboration income [2]
8,531
8,570
24,223
21,738
Total revenue and collaboration income
12,462
12,533
49,385
36,980
Operating expenses:
Research and development
3,018
4,352
12,883
18,333
General and administrative
950
3,712
11,100
12,453
Total operating expenses [3]
3,968
8,064
23,983
30,786
Operating income
8,494
4,469
25,402
6,194
Other income (expense)
Interest income
808
580
3,010
1,987
Gain on sale of equipment
7
--
24
7
Interest/accretion expense
(116)
(199)
(635)
(781)
Total other income
699
381
2,399
1,213
Income before income taxes and cumulative effect of change in
accounting principle
9,193
4,850
27,801
7,407
Income tax provision
134
151
376
275
Income before cumulative effect of change in accounting principle
9,059
4,699
27,425
7,132
Cumulative effect of change in accounting principle
--
--
-
252
Net income
$
9,059
$
4,699
$
27,425
$
7,384
Basic income per share before cumulative effect of accounting change
$
0.41
$
0.21
$
1.24
$
0.33
Accounting change
--
--
--
0.01
Basic net income per share
$
0.41
$
0.21
$
1.24
$
0.34
Diluted income per share before cumulative effect of accounting
change
$
0.41
$
0.21
$
1.24
$
0.33
Accounting change
--
--
--
0.01
Diluted net income per share
$
0.41
$
0.21
$
1.24
$
0.34
Weighted average
shares outstanding – basic
22,117
21,913
22,065
21,895
Weighted average
shares outstanding – diluted
22,141
22,018
22,085
22,005
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 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. Recently, the Company has entered into discussions
with Roche related to the models used to calculate cost of goods sold
for FUZEON. During the course of our discussions, the Company and Roche
have concluded that the models being used resulted in an overestimate in
the costs of goods sold being charged to the collaboration. As a result,
the Company has received a credit from Roche of approximately $5.5
million for over charges to FUZEON cost of goods sold during the period
from 2003 to 2006. The credit appears in the calculation of
collaboration income for the fourth quarter 2007.
[3] Included in
operating expenses for the three and twelve months ended December 31,
2007 and 2006 are expenses of $1.6 million, $5.9 million, $3.2 million
and $3.2 million, respectively, for the reductions in workforce that
occurred during these periods.
Trimeris, Inc. Condensed Balance Sheets [$ in thousands]
December 31, 2007 December 31, 2006 Assets
Cash, cash equivalents and short-term investment securities
available-for-sale
$
60,640
$
48,035
Other current assets
12,979
14,445
Total current assets
73,619
62,480
Property, furniture and equipment – net
1,644
2,160
Long-term investment securities available-for-sale
8,952
604
Total other assets
9,906
9,659
Total assets
$
94,121
$
74,903
Liabilities and Stockholders’ Equity
Total current liabilities
$
6,439
$
8,907
Long term portion of deferred revenue
1,569
9,151
Accrued marketing costs
17,923
17,288
Accrued compensation – long-term
150
1,072
Other liabilities
718
713
Total liabilities
26,799
37,131
Total stockholders’ equity
67,322
37,772
Total liabilities and stockholders’ equity
$
94,121
$
74,903
FUZEON Net Sales (Recognized by Roche, our collaborative partner) [$ in millions]
Three Months Ended December 31, (unaudited) Years Ended December 31,
2007
2006
2007
2006
United States and Canada
$
31.5
$
42.2
$
124.3
$
134.2
Rest of World
35.0
31.1
142.5
114.8
Worldwide Total
$
66.5
$
73.3
$
266.8
$
249.0
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