XenoPort, Inc. (Nasdaq:XNPT) announced today financial results for the
third quarter and nine months ended September 30, 2008. Revenues for the
third quarter were $4.9 million, compared to $35.4 million for the same
period in 2007. Net loss for the third quarter was $24.1 million,
compared to net income of $15.6 million for the same period in 2007. At
September 30, 2008, XenoPort had cash, cash equivalents and short-term
investments of $125.1 million.
Pipeline Update
Since the start of the third quarter, XenoPort or its partners have
advanced the development of XenoPort’s product
candidates as follows:
-
GlaxoSmithKline, or GSK, filed a new drug application, or NDA, with
the Food and Drug Administration, or FDA, for Solzira™
(the U.S. trademark for XP13512) as a potential treatment for
moderate-to-severe restless legs syndrome, or RLS. XenoPort expects to
receive related milestone payments of $23 million in the aggregate
from GSK and Astellas Pharma Inc. in the fourth quarter.
-
GSK completed enrollment in a U.S.-based Phase 2 clinical trial of Solzira
in subjects with painful diabetic neuropathy, or PDN.
-
GSK initiated a Phase 2b clinical trial of Solzira as a
potential prophylactic treatment for migraine headaches.
-
GSK initiated a Phase 3b polysomnography clinical trial of Solzira
in RLS subjects with the objective of exploring further the potential
sleep benefits of Solzira.
-
A Phase 2 clinical trial of XP13512 in Japanese subjects with PDN
conducted by Astellas has been terminated based on the results of a
planned interim analysis. An independent data monitoring committee
determined that continuation of the study was not likely to
demonstrate a statistically significant advantage of XP13512 over
placebo on the primary endpoint of the study. There were no safety
concerns identified in the interim analysis. Astellas and XenoPort
plan to evaluate all available data prior to determining the future
development strategy for XP13512 in PDN patients in Japan.
-
Astellas completed enrollment of its Phase 2 clinical trial of XP13512
in RLS patients in Japan.
-
XenoPort completed enrollment in a Phase 2 clinical trial of XP19986
as a potential treatment for gastroesophageal reflux disease, or GERD.
Top-line results of this trial are expected by the end of this year.
-
XenoPort announced its plans to initiate later this year a Phase 2
clinical trial of XP19986 in patients with acute back spasms of
neuromuscular origin.
-
XenoPort initiated a Phase 1 clinical trial in healthy subjects
designed to assess the pharmacokinetics and safety/tolerability of two
new formulations of XP21279 compared to oral L-Dopa. Results of this
trial are expected in the first quarter of 2009.
-
Xanodyne Pharmaceuticals, Inc. reported preliminary positive results
from two Phase 3 clinical trials testing XP12B, its sustained-release
tranexamic acid product candidate for the treatment of menorrhagia, or
excessive menstrual bleeding. Pursuant to the terms of the license
agreement with Xanodyne, XenoPort would be eligible to receive
escalating, single-digit royalties on the potential future sales of
XP12B. In addition, under the terms of the agreement, Xanodyne has
exclusive U.S. rights to develop and commercialize XP21510, which is
XenoPort’s Transported Prodrug of tranexamic
acid. In October, XenoPort received the final $6 million payment of an
aggregate $12 million up-front payment from Xanodyne.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “We
are pleased to report the significant advancement of our development
programs since the start of the third quarter. The filing of the Solzira
NDA for RLS was the culmination of a tremendous effort by XenoPort and
GSK. We are also pleased with the progress that both GSK and Astellas
have made in the further development of XP13512 in their respective
territories. We anticipate results from many of these clinical trials in
2009. We are disappointed that the efficacy results from the interim
analysis of the Astellas PDN trial indicated that the study should be
stopped. However, we believe that the data from this trial will be
valuable in understanding the impact of demographics and baseline
characteristics on the magnitude of placebo and XP13512 effects in
Japanese patients with PDN. Understanding these factors is important, as
there have been no reports of large, placebo-controlled studies
conducted in Japan that use pain as an endpoint in this PDN patient
population.”
Barrett continued, “The remainder of our
pipeline continues to advance as planned. As we look forward, we believe
that the results from the various trials of XP19986 and XP21279, in
addition to the results of multiple trials of XP13512, should provide
important information about the potential of these three product
candidates to help patients with RLS, neuropathic pain, GERD,
spasticity, acute back spasms and Parkinson’s
disease.”
XenoPort Third Quarter and Nine-Month Financial Results
Revenues for the third quarter of 2008 were $4.9 million, compared to
$35.4 million for the same period in 2007. Revenues for the nine months
ended September 30, 2008 were $31.4 million, compared to $88.1 million
for the same period in 2007. The decrease in revenues for the third
quarter of 2008 compared to the same quarter in the prior year was the
result of a decrease in the recognition of revenues related to up-front
and milestone payments under our GSK agreement. The decrease in revenues
for the nine months ended September 30, 2008 compared to the same period
in 2007 was the result of a decrease in the recognition of revenues
related to up-front and milestone payments under our GSK and Astellas
agreements, partially offset by revenue recognized under our Xanodyne
agreement.
Research and development expenses for the third quarter of 2008 were
$23.7 million, compared to $16.8 million for the same period in 2007.
Research and development expenses for the nine months ended September
30, 2008 were $60.9 million, compared to $54.5 million for the same
period in 2007. The increase in research and development expenses in the
third quarter and nine months ended September 30, 2008 compared to the
same periods in 2007 was principally due to increased development
activities for XP19986, increased preclinical development activities and
increased personnel costs resulting from increased headcount and
increased non-cash stock-based compensation, partially offset by
decreased costs for the clinical development of Solzira.
General and administrative expenses were $6.5 million for the third
quarter of 2008, compared to $4.5 million for the same period in 2007.
General and administrative expenses were $18.5 million for the nine
months ended September 30, 2008, compared to $13.1 million for the same
period in 2007. The increase in general and administrative expenses in
the third quarter and nine months ended September 30, 2008 compared to
the same periods in 2007 was primarily due to increased personnel and
related costs resulting from an increase in headcount and increased
non-cash stock-based compensation.
Net loss for the third quarter of 2008 was $24.1 million, compared to
net income of $15.6 million for the same period in 2007. Net loss for
the nine months ended September 30, 2008 was $43.8 million, compared to
net income of $25.7 million for the same period in 2007. Net loss per
diluted share was $0.96 in the third quarter of 2008 versus net income
per diluted share of $0.60 for the same period in the prior year. For
the nine-month period ended September 30, 2008, net loss per diluted
share was $1.74 versus net income per diluted share of $1.00 for the
same period in 2007.
Due to the recognition of revenues from up-front and milestone payments
from our collaborations with GSK and Astellas, XenoPort was profitable
in the third quarter and nine months ended September 2007 and may have
profitable quarters from time to time. However, while recognition of
revenues from our collaborations resulted in a profitable year for 2007,
we continue to expect to incur losses for the next several years.
Conference Call
XenoPort will host a conference call at 5:00 p.m. Eastern Time today to
discuss its financial results and provide an update on XenoPort’s
business. To access the conference call via the Internet, go to www.XenoPort.com.
To access the live conference call via phone, dial 1-888-275-3514.
International callers may access the live call by dialing 706-679-1417.
The reference number to enter the call is 68806524.
The replay of the conference call may be accessed after 8:00 p.m.
Eastern Time today via the Internet, at www.XenoPort.com,
or via phone at 1-800-642-1687 for domestic callers, or 706-645-9291 for
international callers. The reference number to enter the replay of the
call is 68806524. Dial-in access to the replay of the call will be
available for approximately one week, and the Internet replay of the
call will be available for approximately one month following the live
call.
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 is
developing its lead product candidate in partnership with Astellas
Pharma Inc. and GlaxoSmithKline. GlaxoSmithKline has filed with the FDA
an NDA for this product candidate, known as Solzira™
in the United States, for the treatment of RLS. XenoPort’s
product candidates are also being studied for the potential treatment of
GERD, migraine headaches, neuropathic pain, spasticity related to spinal
chord injury, acute back spasms and Parkinson’s
disease.
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 GSK’s
future clinical development of Solzira and the timing thereof;
the receipt of future milestone payments or royalties under XenoPort’s
collaborative agreements and the timing thereof; Astellas’
future clinical development programs for 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 XP13512 as a treatment for neuropathic pain; the
suitability of XP19986 as a treatment for GERD, spasticity and acute
back spasms; the suitability of XP21279 as a treatment for Parkinson’s
disease; future profitability; and XenoPort’s
and its partners’ future clinical trials. 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,”
“anticipates,” “expects,”
“would,” “should,”
“plans,” “will,”
“intends,” “potential”
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 clinical trials for XP13512,
XP19986 and XP21279 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 June 30, 2008, filed
with the Securities and Exchange Commission on August 7, 2008. 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 trademarks of XenoPort, Inc.
Solzira is a U.S. trademark of GSK.
XNPT2F
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XENOPORT, INC.
|
|
|
|
BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
|
(In thousands)
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
21,730
|
|
|
$
|
17,961
|
|
|
Short-term investments
|
|
|
103,359
|
|
|
|
142,180
|
|
|
Accounts receivable
|
|
|
1,972
|
|
|
|
1,392
|
|
|
Other current assets
|
|
|
5,023
|
|
|
|
2,682
|
|
|
Total current assets
|
|
|
132,084
|
|
|
|
164,215
|
|
|
Property and equipment, net
|
|
|
11,123
|
|
|
|
6,791
|
|
|
Long-term assets and other
|
|
|
1,912
|
|
|
|
1,871
|
|
|
Total assets
|
|
$
|
145,119
|
|
|
$
|
172,877
|
|
|
Current liabilities:
|
|
|
|
|
|
Current liabilities
|
|
$
|
29,146
|
|
|
$
|
25,354
|
|
|
Current borrowings
|
|
|
19
|
|
|
|
176
|
|
|
Total current liabilities
|
|
|
29,165
|
|
|
|
25,530
|
|
|
Other noncurrent liabilities
|
|
|
20,910
|
|
|
|
21,810
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
Common stock
|
|
|
25
|
|
|
|
25
|
|
|
Additional paid-in capital and other
|
|
|
314,896
|
|
|
|
301,575
|
|
|
Accumulated deficit
|
|
|
(219,877
|
)
|
|
|
(176,063
|
)
|
|
Total stockholders’ equity
|
|
|
95,044
|
|
|
|
125,537
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
145,119
|
|
|
$
|
172,877
|
|
|
XENOPORT, INC.
|
|
|
|
STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
Three Months
Ended September 30,
|
|
Nine Months
Ended September 30,
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
|
(In thousands, except per share amounts)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
$
|
4,863
|
|
|
$
|
35,425
|
|
|
$
|
31,381
|
|
|
$
|
88,061
|
|
|
Total revenues
|
|
|
4,863
|
|
|
|
35,425
|
|
|
|
31,381
|
|
|
|
88,061
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development1
|
|
|
23,709
|
|
|
|
16,788
|
|
|
|
60,869
|
|
|
|
54,514
|
|
|
General and administrative1
|
|
|
6,537
|
|
|
|
4,459
|
|
|
|
18,485
|
|
|
|
13,053
|
|
|
Total operating expenses
|
|
|
30,246
|
|
|
|
21,247
|
|
|
|
79,354
|
|
|
|
67,567
|
|
|
Income (loss) from operations
|
|
|
(25,383
|
)
|
|
|
14,178
|
|
|
|
(47,973
|
)
|
|
|
20,494
|
|
|
Interest income
|
|
|
909
|
|
|
|
2,208
|
|
|
|
3,934
|
|
|
|
6,141
|
|
|
Interest and other expenses
|
|
|
(29
|
)
|
|
|
(44
|
)
|
|
|
(165
|
)
|
|
|
(145
|
)
|
|
Income (loss) before income taxes
|
|
$
|
(24,503
|
)
|
|
$
|
16,342
|
|
|
$
|
(44,204
|
)
|
|
$
|
26,490
|
|
|
Income tax provision (benefit)
|
|
|
(390
|
)
|
|
|
748
|
|
|
|
(390
|
)
|
|
|
748
|
|
|
Net income (loss)
|
|
$
|
(24,113
|
)
|
|
$
|
15,594
|
|
|
$
|
(43,814
|
)
|
|
$
|
25,742
|
|
|
Basic net income (loss) per share
|
|
$
|
(0.96
|
)
|
|
$
|
0.63
|
|
|
$
|
(1.74
|
)
|
|
$
|
1.04
|
|
|
Diluted net income (loss) per share
|
|
$
|
(0.96
|
)
|
|
$
|
0.60
|
|
|
$
|
(1.74
|
)
|
|
$
|
1.00
|
|
|
Shares used to compute basic net income (loss) per share
|
|
|
25,215
|
|
|
|
24,856
|
|
|
|
25,135
|
|
|
|
24,720
|
|
|
Shares used to compute diluted net income (loss) per share
|
|
|
25,215
|
|
|
|
26,156
|
|
|
|
25,135
|
|
|
|
25,818
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 Includes employee non-cash
stock-based compensation as follows:
|
|
|
|
Research and development
|
|
|
2,116
|
|
|
|
1,254
|
|
|
|
5,669
|
|
|
|
3,712
|
|
|
General and administrative
|
|
|
1,747
|
|
|
|
1,071
|
|
|
|
4,764
|
|
|
|
2,798
|
|
|
Total stock-based compensation expense
|
|
$
|
3,863
|
|
|
$
|
2,325
|
|
|
$
|
10,433
|
|
|
$
|
6,510
|
|
XenoPort, Inc.
Jackie Cossmon, 408-616-7220
ir@XenoPort.com