14.02.2008 21:05:00
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XenoPort Reports Fourth Quarter and Year-End 2007 Financial Results
XenoPort, Inc. (Nasdaq: XNPT) announced today its financial results for
the fourth quarter and year ended December 31, 2007. Revenues for the
quarter were $25.8 million, compared to $3.1 million for the same period
in 2006. Revenues and net income for the fourth quarter were positively
impacted by recognition of revenue associated with up-front and
milestone payments from XenoPort’s
collaborations with GlaxoSmithKline, Astellas Pharma Inc. and Xanodyne
Pharmaceuticals, Inc. Net income for the fourth quarter was $2.5
million, compared to a net loss of $18.6 million for the same period in
2006. At December 31, 2007, XenoPort had cash and cash equivalents and
short-term investments of $160.1 million.
XenoPort Business Highlights
XenoPort made significant progress in advancing its clinical development
programs and meeting its business objectives since the beginning of
2007, including achievement of the following milestones:
Announced positive, top-line results of two pivotal Phase 3 clinical
trials of XP13512 as a potential treatment for patients with restless
legs syndrome, or RLS.
Astellas, XenoPort’s partner for the
development and commercialization of XP13512 in Japan and five other
Asian countries, initiated separate Phase 2 clinical trials of XP13512
in Japan for the potential treatment of patients with RLS and of
patients with painful diabetic neuropathy, or PDN.
Entered into an exclusive agreement with GSK in February 2007 to
co-develop and commercialize XP13512 in the United States and other
countries worldwide, excluding certain Asian countries previously
licensed to Astellas.
Completed a Phase 1 repeat dose clinical trial of XP19986 that
identified a formulation suitable for once-daily dosing.
Initiated separate Phase 2 clinical trials of XP19986 as a potential
treatment of patients with gastroesophageal reflux disease, or GERD,
and spasticity.
Initiated a Phase 1 clinical trial of XP21279, a product candidate
that will be evaluated for the treatment of patients with Parkinson’s
disease.
Entered into an exclusive agreement with Xanodyne in October 2007 that
provided rights to Xanodyne to develop and commercialize XP21510 in
the United States as a potential treatment for menorrhagia, or
excessive menstrual bleeding.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "We
are very pleased with our progress in advancing and broadening our
pipeline of product candidates. Our agreements with Astellas, GSK and
Xanodyne exemplify the types of business relationships that we believe
will broaden the availability and maximize the commercial value of our
product candidates.” XenoPort 2008 Milestones
XenoPort plans to release top-line data from its third Phase 3 clinical
trial of XP13512 for the treatment of RLS in the first quarter of this
year. GSK has indicated that it plans to file the NDA in the third
quarter of this year. In addition, GSK has announced its intention to
initiate additional studies with XP13512 this year, including:
polysomnography studies in RLS patients; studies in patients with
post-herpetic neuralgia, or PHN, and PDN; and studies in migraine
patients as a potential prophylactic treatment, pending agreement with
the FDA.
XenoPort intends to report results from its Phase 1 clinical trial of
XP21279 in the first quarter of 2008. XenoPort has indicated that
results from separate Phase 2 clinical trials of XP19986 in spinal cord
injury patients with spasticity and in patients with GERD may be
available by the end of 2008.
XenoPort Fourth Quarter and Year-End 2007 Financial Results
Revenues for the fourth quarter of 2007 were $25.8 million, compared to
$3.1 million for the same period in 2006. Revenues for the 12 months
ended December 31, 2007 were $113.8 million, compared to $10.6 million
for the same period in 2006. The increase in fourth quarter and 2007
revenues was principally due to recognition of revenue associated with
XenoPort’s collaboration with GSK that
commenced in February 2007.
Research and development expenses for the fourth quarter of 2007 were
$19.9 million, compared to $19.8 million for the same period in 2006.
Expenses in the quarter reflected a decrease in clinical and
manufacturing costs for XP13512, offset by increased personnel costs
resulting from increased headcount, including increased non-cash
stock-based compensation. Research and development expenses for the 12
months ended December 31, 2007 were $74.4 million, compared to $65.4
million for the same period in 2006. The increase in expenses for the
12-month period was primarily due to increased development activities
for XP19986, as well as increased personnel costs resulting from
increased headcount, including increased non-cash stock-based
compensation, partially offset by decreased expenses for XP13512 and
XP21279.
General and administrative expenses were $5.6 million for the fourth
quarter of 2007, compared to $3.6 million for the same period in 2006.
General and administrative expenses were $18.7 million for the 12 months
ended December 31, 2007, compared to $14.8 million for the same period
in 2006. The increase for both periods was primarily due to increased
personnel and related costs resulting from increased headcount,
including non-cash stock-based compensation.
Net income for the fourth quarter of 2007 was $2.5 million, compared to
a net loss of $18.6 million for the same period in 2006. Net income per
diluted share was $0.09 for the fourth quarter of 2007, compared to a
net loss per basic and diluted share of $0.76 for the same period in
2006. Net income for the 12 months ended December 31, 2007 was $28.2
million, compared to a net loss of $64.3 million for the same period in
2006. Net income per diluted share was $1.08 for the 12 months ended
December 31, 2007, compared to a net loss per basic and diluted share of
$2.91 for the same period in 2006.
Due to the recognition of revenues from up-front and milestone payments
from the collaborations with GSK, Astellas and Xanodyne, XenoPort was
profitable in the fourth quarter of 2007 and may have profitable
quarters from time to time. However, while recognition of revenues from
its collaborations resulted in a profitable year for 2007, XenoPort
continues to expect to incur losses for the next several years.
At December 31, 2007, XenoPort had cash and cash equivalents and
short-term investments of $160.1 million, which included payments of
$11.0 million and $6.0 million that were received in the fourth quarter
from GSK and Xanodyne, respectively.
2008 Financial Guidance
XenoPort anticipates its net use of cash for 2008 to be in the range of
$55 million to $65 million, assuming the receipt of expected milestone
payments under its various collaboration agreements.
Conference Call
XenoPort will host a conference call at 5:00 p.m. Eastern Time today. To
access the conference call via the Internet, go to www.XenoPort.com.
To access the conference call via phone, dial 1-888-275-3514.
International callers may access the call by dialing 1-706-679-1417.
The replay of the conference call may be accessed via the Internet,
after 8:00 p.m. Eastern Time today, at www.XenoPort.com,
or via phone at 1-800-642-1687 for domestic callers or 1-706-645-9291
for international callers. The reference number to enter the call and
the replay of the call is 33536165.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing a
portfolio of internally discovered product candidates that utilize the
body’s natural nutrient transport mechanisms
to improve the therapeutic benefits of existing drugs. XenoPort’s
most advanced product candidate, XP13512, has successfully completed two
pivotal trials in its Phase 3 clinical program for the treatment of RLS
and has successfully completed a Phase 2a clinical trial for the
management of PHN. XenoPort has also reported positive results from a
Phase 2a clinical trial of its second product candidate, XP19986, in
patients with GERD.
To learn more about XenoPort, please visit the web site at www.XenoPort.com.
Forward-Looking Statements
This press release contains "forward-looking”
statements, including, without limitation, all statements related to
XenoPort’s and its partners’
future clinical development of XP13512 and the timing thereof; XenoPort’s
future clinical development programs for XP19986 and XP21279 and the
timing thereof; the release of additional clinical trial data and the
timing thereof; the therapeutic and commercial potential of XP13512,
XP19986 and XP21279; the suitability of XP19986 as a treatment for GERD
and spasticity; the suitability of XP21279 as a treatment for Parkinson’s
disease; the timing of future regulatory submissions, including the
filing of a new drug application for XP13512 for RLS with the U.S. Food
and Drug Administration; XenoPort’s and its
partners’ future clinical trials; and
financial guidance. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes,” "plans,” "expects,” "will,” "intends,” "potential,” "may,” "could,” "anticipate”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon XenoPort’s
current expectations. Forward-looking statements involve risks and
uncertainties. XenoPort’s actual results and
the timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to the
uncertain results of clinical trials; XenoPort’s
or its partners’ ability to successfully
conduct the clinical trials for XP13512, XP19986, XP21279 and XP21510 in
the anticipated timeframes, or at all; the uncertainty of the FDA
approval process and other regulatory requirements; XenoPort’s
dependence on its current and additional collaborative partners; and the
uncertain therapeutic and commercial value of its compounds. These and
other risk factors are discussed under the heading "Risk
Factors” in XenoPort’s
Quarterly Report on Form 10-Q for the quarter ended September 30, 2007,
filed with the Securities and Exchange Commission on November 9, 2007.
XenoPort expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the company’s
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
XenoPort and Transported Prodrug are U.S. trademarks. XNPT2F XENOPORT, INC.
BALANCE SHEETS (Unaudited, in thousands)
December 31, December 31,
2007
2006
Current assets:
Cash and cash equivalents
$
17,961
$
14,857
Short-term investments
142,180
103,997
Accounts receivable
1,392
2,796
Other current assets
2,682
1,332
Total current assets
164,215
122,982
Property and equipment, net
6,791
3,532
Long-term assets and other
1,871
2,151
Total assets
$ 172,877
$ 128,665
Current liabilities:
Current liabilities
$
25,354
$
20,955
Current borrowings
176
500
Total current liabilities
25,530
21,455
Other noncurrent liabilities
21,805
23,744
Noncurrent borrowings
5
181
Stockholders’ equity
Common stock
25
24
Additional paid-in capital and other
301,575
287,517
Accumulated deficit
(176,063 )
(204,256 )
Total stockholders’ equity
125,537
83,285
Total liabilities and stockholders’ equity
$ 172,877
$ 128,665
XENOPORT, INC.
STATEMENTS OF OPERATIONS (Unaudited, in thousands, except per share amounts)
Three Months Ended December 31, Year Ended December 31,
2007
2006
2007
2006
Revenues:
Collaboration revenue
$ 25,761
$ 3,106
$ 113,822
$ 10,606
Total revenues
25,761
3,106
113,822
10,606
Operating expenses:
Research and development(a)
19,883
19,823
74,397
65,434
General and administrative(a)
5,599
3,639
18,652
14,834
Total operating expenses
25,482
23,462
93,049
80,268
Income (loss) from operations
279
(20,356
)
20,773
(69,662
)
Interest income
2,057
1,775
8,198
5,634
Interest expense
(11 )
(36 )
(156 )
(285 )
Income (loss) before income taxes
2,325
(18,617
)
28,815
(64,313
)
Income tax (benefit) provision
(126 )
—
622
—
Net income (loss)
2,451
(18,617 )
28,193
(64,313 )
Basic income (loss) per share
$ 0.10
$ (0.76 ) $ 1.14
$ (2.91 )
Diluted income (loss) per share
$ 0.09
$ (0.76 ) $ 1.08
$ (2.91 )
Shares used to compute basic income (loss) per share
24,933
24,463
24,773
22,101
Shares used to compute diluted income (loss) per share
26,398
24,463
25,992
22,101
(a) Includes non-cash amortization of deferred stock-based
compensation as follows:
Research and development
$
1,332
$
755
$
5,044
$
2,782
General and administrative
1,080
659
3,878
2,595
$
2,412
$
1,414
$
8,922
$
5,377
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