XenoPort, Inc. : XenoPort Reports Second Quarter Financial Results
08/07/2012| 04:10pm US/Eastern
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XenoPort, Inc. (Nasdaq: XNPT) announced today financial results for the
second quarter and six months ended June 30, 2012. Revenues for the
second quarter were $10.4 million, compared to $37.4 million for the
same period in 2011. Net loss for the second quarter was $8.0 million,
compared to net income of $19.5 million for the same period in 2011. At
June 30, 2012, XenoPort had cash, cash equivalents and short-term
investments of $81.7 million.
XenoPort Business Updates
The following key events occurred since the beginning of the second
quarter of 2012:
The U.S. Food and Drug Administration (FDA) approved Horizant®
(gabapentin enacarbil) Extended-Release Tablets for the management of
postherpetic neuralgia (PHN) in adults, which resulted in a $10.0
million payment received from GlaxoSmithKline (GSK) in June 2012. GSK
started promoting Horizant for the management of PHN in the
United States in July 2012.
Regnite® (gabapentin enacarbil) Extended-Release Tablets
was launched in Japan on July 10, 2012, by Astellas Pharma Inc. Regnite
is approved in Japan for the treatment of moderate-to-severe primary
restless legs syndrome (RLS) in adults. Astellas' promotional efforts
are expected to focus on sleep and neurology specialists.
Approximately 1,200 Astellas sales representatives are expected to
participate in the promotion of Regnite.
XenoPort conducted an End-of-Phase 2 meeting with the FDA in which it
received feedback that a proposed development program for XP21279, a
novel prodrug of levodopa, could support a potential New Drug
Application (NDA) submission under Section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act. Based on its discussions with the FDA,
XenoPort believes that a single, pivotal, Phase 3 clinical trial
comparing optimized doses of XP21279 to Sinemet, along with an
open-label safety study, could form the basis for an NDA submission as
a potential treatment of the symptoms of advanced idiopathic
Parkinson's disease. XenoPort plans to initiate certain activities in
preparation for potential Phase 3 development of XP21279.
XenoPort submitted an Investigational New Drug (IND) application to
the FDA and initiated a Phase 1 clinical trial of XP23829. XP23829 is
a prodrug of monomethyl fumarate (MMF) being developed as a potential
treatment for relapsing-remitting multiple sclerosis (RRMS), and also
may be a potential treatment for psoriasis.
XenoPort was awarded a grant from The Michael J. Fox Foundation (MJFF)
for Parkinson's disease research that will support preclinical studies
to explore XP23829 for its ability to protect against
neurodegeneration in preclinical models of Parkinson's disease. The
grant of $0.3 million was awarded under the Foundation's Therapeutics
Development Initiative Program.
XenoPort completed an underwritten public offering, raising net
proceeds of approximately $43.0 million, after deducting underwriting
discounts and commissions and other estimated offering expenses.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
"We have made significant progress on a number of our programs since the
start of the second quarter. I am especially pleased that we have been
able to rapidly move XP23829 into its first human trial since we
selected the compound for development in May 2011. We are also excited
about our grant from MJFF to evaluate XP23829 in a preclinical model
with the ultimate goal of providing a potential treatment to slow the
progression of Parkinson's disease."
Dr. Barrett continued, "I am also encouraged by our meeting with the FDA
regarding the possible future development of XP21279. The potential use
of the 505(b)(2) regulatory pathway could expedite the development of
XP21279 as a potential treatment for the symptoms of advanced idiopathic
Parkinson's disease. Finally, we are excited that Astellas has now
launched Regnite in Japan, and we look forward to receiving our
first revenues based on product sales later this year."
XenoPort Second Quarter and Six-Month Financial Results
Net revenue from unconsolidated joint operating activities was $10.0
million for both the second quarter and six months ended June 30, 2012,
compared to $30.0 million for both the second quarter and six months
ended June 30, 2011. The decrease in net revenue from unconsolidated
joint operating activities in both the second quarter and six months
ended June 30, 2012 compared to the same periods in 2011 was due to the
receipt and recognition of a $10.0 million payment from GSK under our
collaboration agreement in connection with the approval of Horizant
for the management of PHN in adults in the second quarter of 2012,
compared with a $30.0 million payment from GSK under our collaboration
agreement in connection with the approval of Horizant for RLS in
the same period of the prior year. Pursuant to the terms of our
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 $8.3 million as of June 30, 2012. Net sales of Horizant
for the second quarter and six months ended June 30, 2012, as recorded
by GSK, were $1.6 million and $2.9 million, respectively.
Collaboration revenues were $0.4 million and $10.8 million for the
second quarter and six months ended June 30, 2012, respectively,
compared to $7.4 million and $7.8 million, respectively, for the same
periods in 2011. The decrease in collaboration revenues for the second
quarter of 2012 compared to the same period in 2011 was due to the
receipt and recognition of a $7.0 million milestone payment from
Astellas related to the FDA's U.S. approval of Horizant in 2011.
The increase in collaboration revenues for the six months ended June 30,
2012 compared to the same period in 2011 was due to the receipt and
recognition of a $10.0 million milestone payment from Astellas in
connection with the approval of Regnite in Japan in 2012 compared
to the recognition of the $7.0 million milestone payment from Astellas
related to the FDA's U.S. approval of Horizant in 2011.
Research and development expenses for the second quarter and six months
ended June 30, 2012 were $10.8 million and $23.0 million, respectively,
compared to $9.9 million and $19.8 million, respectively, for the same
periods in 2011. The increase in research and development expenses for
the second quarter of 2012 compared to the same period in 2011 was
primarily due to increased net costs for the arbaclofen placarbil (AP)
development program as well as increased personnel costs due to
severance benefits charges, partially offset by decreased net costs for
XP21279. The increase in research and development expenses for the six
months ended June 30, 2012 compared to the same period in 2011 was
primarily due to increased net costs for the AP and XP23829 development
programs as well as increased personnel costs due to severance benefits
charges, partially offset by decreased net costs for XP21279.
Selling, general and administrative expenses remained relatively
constant for the second quarter and six months ended June 30, 2012, and
were $7.6 million and $15.0 million, respectively, compared to $8.1
million and $15.8 million, respectively, for the same periods in 2011.
Net loss for the second quarter of 2012 was $8.0 million, compared to a
net income of $19.5 million for the same period in 2011. Net loss for
the six months ended June 30, 2012 was $17.1 million, compared to net
income of $2.3 million for the same period in 2011. Basic and diluted
net loss per share were both $0.22 in the second quarter of 2012 versus
basic and diluted net income per share of $0.55 for the same period in
the prior year. For the six-month period ended June 30, 2012, basic and
diluted net loss per share were both $0.48 versus basic net income per
share of $0.07 and diluted net income per share of $0.06 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 of 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 15718592.
The replay of the conference call will be available for one week and 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 15718592.
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
is approved in the United States for the treatment of RLS in adults and
for the management of PHN in adults. GSK holds commercialization rights
and certain development rights for Horizant in the United States. Regnite
is approved for the treatment of RLS in adults in Japan. Astellas 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 company Website at www.XenoPort.com.
Forward-Looking Statements
This press release contains "forward-looking" statements, including,
without limitation, all statements related to Astellas' expected
commercialization and marketing efforts regarding Regnite;
XenoPort's XP21279 clinical development program and the timing and
results thereof; XenoPort's future pre-clinical studies and clinical
trials and the timing thereof; FDA discussions, the regulatory process
and the timing and outcome of regulatory actions; the potential for the
filing of an NDA for XP21279 with the FDA under Section 505(b)(2); the
suitability of XP21279 as a treatment for Parkinson's disease;
XenoPort's XP23829 clinical development program and the timing and
results thereof; the potential suitability of XP23829 as a treatment for
relapsing-remitting MS and/or psoriasis; the potential of XP23829 to
protect against neurodegeneration in preclinical models of Parkinson's
disease; the expectations of revenues based on product sales and the
timing thereof; and the therapeutic and commercial potential of
XenoPort's preclinical and clinical 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
"believe," "could," "expect," "future," "goal," "may," "plans,"
"possible," "potential," "proposed," "will," "would" 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;
XenoPort's ability to successfully conduct clinical trials in the
anticipated timeframes, or at all; the uncertainty of the FDA's review
process and other regulatory requirements, including uncertainty as to
whether the FDA would approve an NDA filed under Section 505(b)(2) and
as to the requirements for acceptance and approval of any such filings;
XenoPort's dependence on its current and additional 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 Prospectus
Supplement dated July 25, 2012 and filed with the Securities and
Exchange Commission under Rule 424(b)(5) on July 26, 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 GlaxoSmithKline.
XNPT2F
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
June 30,
December 31,
2012
2011
Current assets:
Cash and cash equivalents
$
21,115
$
25,386
Short-term investments
60,633
69,056
Prepaids and other current assets
3,077
3,010
Total current assets
84,825
97,452
Property and equipment, net
2,631
3,921
Restricted investments and other assets
2,232
2,663
Total assets
$
89,688
$
104,036
Liabilities:
Current liabilities
$
11,528
$
13,530
Noncurrent liabilities
13,786
15,371
Total liabilities
25,314
28,901
Stockholders' equity (deficit):
Common stock
36
35
Additional paid-in capital and other
502,227
495,886
Accumulated deficit
(437,889
)
(420,786
)
Total stockholders' equity
64,374
75,135
Total liabilities and stockholders' equity
$
89,688
$
104,036
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2012
2011
2012
2011
(In thousands, except per share amounts)
Revenues:
Net revenue from unconsolidated joint operating activities
$
10,000
$
30,000
$
10,000
$
30,000
Collaboration revenue
379
7,379
10,758
7,758
Total revenues
10,379
37,379
20,758
37,758
Operating expenses:
Research and development*
10,804
9,904
22,982
19,758
Selling, general and administrative*
7,589
8,075
14,989
15,826
Total operating expenses
18,393
17,979
37,971
35,584
Income (loss) from operations
(8,014
)
19,400
(17,213
)
2,174
Interest income
55
55
110
125
Net income (loss)
$
(7,959
)
$
19,455
$
(17,103
)
$
2,299
Basic net income (loss) per share
$
(0.22
)
$
0.55
$
(0.48
)
$
0.07
Diluted net income (loss) per share
$
(0.22
)
$
0.55
$
(0.48
)
$
0.06
Shares used to compute basic net income (loss) per share
35,794
35,400
35,712
35,336
Shares used to compute diluted net income (loss) per share
35,794
35,635
35,712
35,665
* Includes employee non-cash stock-based compensation, as follows:
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