XenoPort Reports Third Quarter Financial Results
SANTA CLARA, Calif.--(BUSINESS WIRE)--
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results for the
third quarter and nine months ended September 30, 2012. Revenues for the
third quarter were $0.4 million, compared to $0.4 million for the same
period in 2011. Net loss for the third quarter was $16.8 million,
compared to a net loss of $18.8 million for the same period in 2011. At
September 30, 2012, XenoPort had cash, cash equivalents and short-term
investments of $112.9 million.
XenoPort Business Updates
Since the start of the third quarter, XenoPort's business updates
include:
-
Astellas Pharma Inc. launched Regnite® (gabapentin enacarbil)
Extended-Release Tablets. Regnite is approved in Japan for the
treatment of moderate-to-severe primary restless legs syndrome (RLS).
It is estimated that there are approximately 2.1 million people in
Japan with RLS.
-
XenoPort reported favorable preliminary results from a Phase 1
clinical trial in healthy adults designed to assess the
pharmacokinetics (PK), safety and tolerability of single doses of four
different oral formulations of XP23829, a novel fumaric acid ester
compound that is a prodrug of monomethyl fumarate (MMF). XP23829 is
being developed for the potential treatment of relapsing-remitting
multiple sclerosis (RRMS) and/or psoriasis.
-
XenoPort was awarded a $0.3 million grant from The Michael J. Fox
Foundation (MJFF) for Parkinson's Research to support preclinical
studies to explore XP23829 for its potential ability to protect
against neurodegeneration in experimental preclinical models of
Parkinson's disease.
-
XenoPort completed an underwritten public offering generating net cash
proceeds of approximately $43.1 million, after deducting the
underwriting discounts and commissions and offering expenses payable
by XenoPort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
"Our efforts in the third quarter yielded progress on several fronts. We
are encouraged by the results from our first human study of XP23829, and
we are excited to be working with MJFF to explore how XP23829 may be
useful as a potential treatment for Parkinson's disease. We are close to
completing enrollment of patients in our Phase 3 arbaclofen placarbil
(AP) clinical trial for multiple sclerosis patients with spasticity and
now expect preliminary top-line results early in the second quarter of
2013."
XenoPort Third Quarter and Nine-Month Financial Results
Revenues for the third quarter were $0.4 million, compared to $0.4
million for the same period in 2011. Revenues for both periods reflected
the amortization of revenue recognized from an up-front license payment
related to the company's agreement with Astellas Pharma Inc. Revenues
for the nine months ended September 30, 2012 were $21.1 million,
compared to $38.1 million for the same period in 2011. The decrease in
revenues was primarily due to the recognition of a $30.0 million
contingent payment from GlaxoSmithKline (GSK) in connection with the
first shipment of Horizant® (gabapentin enacarbil)
Extended-Release Tablets to a wholesaler in 2011, compared to the
recognition of a $10.0 million contingent payment from GSK in connection
with the first commercial sale of Horizant for the management of
postherpetic neuralgia in adults in 2012. Pursuant to the terms of the
company's collaboration agreement with GSK, XenoPort's share of losses
from the Horizant joint profit and loss (P&L) statement will be
forgiven up to a maximum of $10.0 million. XenoPort's share of joint P&L
losses totaled approximately $9.6 million as of September 30, 2012. Net
sales of Horizant for the third quarter and nine months ended
September 30, 2012, as recorded by GSK, were $1.6 million and $4.4
million, respectively.
Research and development expenses for the third quarter of 2012 were
$9.4 million, compared to $11.5 million for the same period in 2011. The
decrease in research and development expenses in the three months ended
September 30, 2012 compared to the same period in 2011 was principally
due to decreased net costs for XP21279 and XP23829, decreased personnel
costs primarily related to decreased headcount and decreased non-cash
stock-based compensation, as well as decreased office and facilities
overhead costs. Research and development expenses for the nine months
ended September 30, 2012 were $32.3 million, compared to $31.3 million
for the same period in 2011. The increase in research and development
expenses in the nine months ended September 30, 2012 compared to the
same period in 2011 was principally due to increased net costs for AP
and XP23829, partially offset by decreased net costs for XP21279 and
decreased office and facilities overhead costs.
Selling, general and administrative expenses were $7.8 million for the
third quarter of 2012, compared to $7.7 million for the same period in
2011. Selling, general and administrative expenses were $22.8 million
for the nine months ended September 30, 2012, compared to $23.5 million
for the same period in 2011.
Net loss for the third quarter of 2012 was $16.8 million, compared to a
net loss of $18.8 million for the same period in 2011. Net loss for the
nine months ended September 30, 2012 was $33.9 million, compared to a
net loss of $16.5 million for the same period in 2011. Basic and diluted
net loss per share were both $0.41 in the third quarter of 2012 versus
basic and diluted net loss per share of $0.53 for the same period in the
prior year. For the nine-month period ended September 30, 2012, basic
and diluted net loss per share were both $0.90 versus basic and diluted
net loss per share of $0.47 for the same period in 2011.
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 51875216.
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 51875216. 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 is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates
for the potential treatment of neurological disorders. Horizant®
(gabapentin enacarbil) Extended-Release Tablets is approved in the
United States for the treatment of moderate-to-severe primary restless
legs syndrome (RLS) in adults and for the management of postherpetic
neuralgia in adults. GlaxoSmithKline holds commercialization rights and
certain development rights for Horizant in the United States.
Regnite® (gabapentin enacarbil) Extended-Release Tablets is approved for
the treatment of RLS in Japan. Astellas Pharma Inc. holds all
development and commercialization rights for Regnite in Japan and
five other Asian countries. XenoPort holds all other world-wide rights
and has co-promotion and certain development rights to gabapentin
enacarbil in the United States. XenoPort's pipeline of product
candidates includes potential treatments for patients with spasticity,
Parkinson's disease and relapsing-remitting multiple sclerosis.
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 the commercial opportunity
for Regnite in Japan; XenoPort's clinical development programs
for XP23829 and AP, and the timing and results thereof; the potential
suitability of XP23829 as a treatment for RRMS and/or psoriasis; the
potential of XP23829 to protect against neurodegeneration in
experimental preclinical models of Parkinson's disease; the potential
suitability of AP as a treatment for spasticity; XenoPort's clinical
trials, and the timing of enrollment and results; and the therapeutic
and commercial potential of XenoPort's product candidates. 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 "estimated," "expect," "potential," "may," "will," 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 XenoPort's dependence on Astellas
to commercialize Regnite and GSK to commercialize Horizant;
the uncertain results and timing of clinical trials and other studies,
including the risk that success in preclinical testing and early
clinical trials do not ensure that later clinical trials will be
successful, and that the results of clinical trials by other parties may
not be indicative of the results in trials that XenoPort may conduct;
XenoPort's ability to successfully complete enrollment and conduct
clinical trials in the anticipated timeframes, or at all; XenoPort's
dependence on its current and future collaborative partners; the
availability of resources to develop XenoPort's product candidates; and
the uncertain therapeutic and commercial value of XenoPort's product
candidates. 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, 2012, filed with the Securities and Exchange
Commission on August 8, 2012. 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 Regnite are registered trademarks of XenoPort, Inc.
Horizant
is a registered trademark of GSK.
XNPT2F
|
XENOPORT, INC.
|
|
|
|
|
|
|
|
|
BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
|
(In thousands)
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
18,702
|
|
|
$
|
25,386
|
|
|
Short-term investments
|
|
|
|
94,159
|
|
|
|
69,056
|
|
|
Prepaids and other current assets
|
|
|
|
3,023
|
|
|
|
3,010
|
|
|
Restricted investments
|
|
|
|
1,955
|
|
|
|
—
|
|
|
Total current assets
|
|
|
|
117,839
|
|
|
|
97,452
|
|
|
Property and equipment, net
|
|
|
|
1,995
|
|
|
|
3,921
|
|
|
Restricted investments and other assets
|
|
|
|
—
|
|
|
|
2,663
|
|
|
Total assets
|
|
|
$
|
119,834
|
|
|
$
|
104,036
|
|
|
Liabilities:
|
|
|
|
|
|
|
Current liabilities
|
|
|
$
|
13,199
|
|
|
$
|
13,530
|
|
|
Noncurrent liabilities
|
|
|
|
13,131
|
|
|
|
15,371
|
|
|
Total liabilities
|
|
|
|
26,330
|
|
|
|
28,901
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
Common stock
|
|
|
|
43
|
|
|
|
35
|
|
|
Additional paid-in capital and other
|
|
|
|
548,103
|
|
|
|
495,886
|
|
|
Accumulated deficit
|
|
|
|
(454,642
|
)
|
|
|
(420,786
|
)
|
|
Total stockholders' equity
|
|
|
|
93,504
|
|
|
|
75,135
|
|
|
Total liabilities and stockholders' equity
|
|
|
$
|
119,834
|
|
|
$
|
104,036
|
|
|
XENOPORT, INC.
|
|
|
|
STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
|
(In thousands, except per share amounts)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
Net revenue from
unconsolidated joint
operating
activities
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,000
|
|
|
$
|
30,000
|
|
|
Collaboration revenue
|
|
|
|
379
|
|
|
|
379
|
|
|
|
11,137
|
|
|
|
8,137
|
|
|
Total revenues
|
|
|
|
379
|
|
|
|
379
|
|
|
|
21,137
|
|
|
|
38,137
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and development*
|
|
|
|
9,365
|
|
|
|
11,518
|
|
|
|
32,347
|
|
|
|
31,276
|
|
|
Selling, general and
administrative*
|
|
|
|
7,833
|
|
|
|
7,713
|
|
|
|
22,822
|
|
|
|
23,539
|
|
|
Total operating expenses
|
|
|
|
17,198
|
|
|
|
19,231
|
|
|
|
55,169
|
|
|
|
54,815
|
|
|
Loss from operations
|
|
|
|
(16,819
|
)
|
|
|
(18,852
|
)
|
|
|
(34,032
|
)
|
|
|
(16,678
|
)
|
|
Interest income
|
|
|
|
66
|
|
|
|
59
|
|
|
|
176
|
|
|
|
184
|
|
|
Net loss
|
|
|
$
|
(16,753
|
)
|
|
$
|
(18,793
|
)
|
|
$
|
(33,856
|
)
|
|
$
|
(16,494
|
)
|
|
Basic and diluted net loss
per share
|
|
|
$
|
(0.41
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.90
|
)
|
|
$
|
(0.47
|
)
|
|
Shares used to compute
basic and diluted net loss
per
share
|
|
|
|
41,016
|
|
|
|
35,444
|
|
|
|
37,480
|
|
|
|
35,372
|
|
|
|
|
* Includes employee non-cash stock-based compensation as follows:
|
|
Research and development
|
|
|
$
|
935
|
|
|
$
|
1,223
|
|
|
$
|
3,043
|
|
|
$
|
4,009
|
|
|
Selling, general
and administrative
|
|
|
|
1,881
|
|
|
|
2,278
|
|
|
|
6,096
|
|
|
|
6,961
|
|
|
Total non-cash stock-based
compensation expense
|
|
|
$
|
2,816
|
|
|
$
|
3,501
|
|
|
$
|
9,139
|
|
|
$
|
10,970
|
|
XenoPort
Jackie Cossmon, 408-616-7220
ir@XenoPort.com
Source: XenoPort, Inc.
News Provided by Acquire Media
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