| [February 14, 2012] |
 |
XenoPort Reports Fourth Quarter and Year-End 2011 Financial Results
SANTA CLARA, Calif. --(Business Wire)--
XenoPort, Inc. (Nasdaq:XNPT) announced today its financial results for
the fourth quarter and year ended December 31, 2011. Revenues for the
quarter were $5.4 million, compared to $1.9 million for the same period
in 2010. Net loss for the fourth quarter was $16.9 million, compared to
a net loss of $14.8 million for the same period in 2010. At December 31,
2011, XenoPort had cash and cash equivalents and short-term investments
of $94.4 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2011, XenoPort:
-
Announced that Astellas Pharma Inc. has received marketing approval in
Japan for Regnite® (gabapentin enacarbil) as a treatment
for patients with moderate-to-severe primary restless legs syndrome
(RLS), giving rise to a $10.0 million milestone payment to XenoPort.
-
Reported that the U.S. Food and Drug Administration (FDA) has accepted
for review the supplemental New Drug Application (sNDA) filed by
GlaxoSmithKline (GSK) requesting approval of Horizant®
(gabapentin enacarbil) Extended-Release Tablets for the treatment of
postherpetic neuralgia (PHN) in adults. The FDA has set a Prescription
Drug User Fee Act (PDUFA) date of June 9, 2012 as a goal for the
completion of their review of the sNDA. Under the terms of XenoPort's
collaboration agreement with GSK, the FDA's acceptance of the sNDA
triggered a milestone payment to XenoPort of $5.0 million.
-
Announced preliminary top-line results of a Phase 2, randomized,
crossover clinical trial that compared optimized treatment with either
Sinemet (immediate-release levodopa/carbidopa) or XP21279
co-formulated with carbidopa (279/CD) in advanced Parkinson's disease
patients with motor fluctuations. 279/CD dosed three times per day
reduced mean daily "off time" by 46% compared to baseline when the
patients were taking their pre-trial Sinemet dosing regimen. However,
in the primary analysis of the trial, the improvement with 279/CD was
not statistically better than the improvement seen with optimized
Sinemet dosed four or five times per day during the double-blind phase
of the trial. XenoPort will defer further investment in this program
pending additional discussion with Parkinson's disease experts and
potentially regulatory authorities.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
"The last year has been a landmark time for XenoPort, with the approval
of XenoPort's first product, gabapentin enacarbil, in both the United
States and Japan, two of the largest pharmaceutical markets in the
world. We are gratified that patients in the United States and Japan
will have access to Horizant and Regnite, respectively, as
the first non-dopaminergic treatment option for adult patients with RLS.
We also made significant progress on the development of arbaclofen
placarbil (AP) for the potential treatment of spasticity. The remaining
clinical trials that we believe will be needed to file an NDA are now
all underway, and we expect the top-line results from our Phase 3 safety
and efficacy trial in multiple sclerosis patients near the end of 2012.
We have completed most of the preclinical studies and formulation work
required for filing an investigational new drug (IND) application for
XP23829, which we anticipate will occur in the second quarter of this
year. We believe this product candidate could offer unique benefits over
current products and those in development for the potential treatment of
relapsing-remitting multiple sclerosis or psoriasis. We are excited by
the opportunities that lie ahead for XenoPort."
Other XenoPort News
In January 2012, XenoPort provided a notice of dispute and notice of
breach and termination (Notice) to GSK that provided notice of
XenoPort's belief that, among other matters, GSK has materially breached
its contractual obligation to use commercially reasonable efforts to (i)
maximize the sales of Horizant in an expeditious manner and (ii)
achieve the sales milestones set forth in the collaboration agreement
between XenoPort and GSK. The Notice provides that the termination of
the collaboration agreement would become effective at the end of a
90-day period provided for under the collaboration agreement, which will
expire on April 24, 2012, unless GSK has cured any such breach or
default prior to such date. XenoPort cannot predict whether GSK will
cure the breach that is the subject of the Notice or allege that such a
breach has not occurred, or otherwise how GSK will respond to the
Notice. Accordingly, XenoPort cannot predict when or if the
collaboration agreement will be terminated, or the ultimate terms of any
termination of the agreement. In addition, XenoPort cannot predict
whether it or GSK will initiate legal proceedings related to the
collaboration agreement or the timing or outcome of any such proceedings.
XenoPort Fourth Quarter and Year-End 2011 Financial Results
Net revenue from unconsolidated joint operating activities was $5.0
million and $35.0 million for the fourth quarter and year ended December
31, 2011, compared to $1.5 million and $1.4 million for the same periods
in 2010. The increases in net revenue from unconsolidated joint
operating activities for the fourth quarter and year ended 2011 compared
to the same periods in the prior year were primarily due to a $5.0
million milestone payment associated with the acceptance of the sNDA for
PHN in the fourth quarter of 2011 and the recognition and receipt of a
$30.0 million milestone payment associated with the first commercial
sale of Horizant in the United States in the second quarter of
2011. Pursuant to the terms of XenoPort's collaboration agreement with
GSK, as currently in effect, 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 Horizant joint P&L losses
totaled approximately $6.6 million as of the end of 2011. Net sales for
the fourth quarter and year ended December 31, 2011 as recorded by GSK
were $0.8 million and $2.0 million, respectively.
Collaboration revenues were $0.4 million and $8.5 million for the fourth
quarter and year ended December 31, 2011, compared to $0.4 million and
$1.5 million for the same periods in 2010. The increase in collaboration
revenue for the year ended December 31, 2011 compared to the same period
in 2010 was due to the receipt of a $7.0 million milestone payment
associated with the U.S. approval of Horizant.
Research and development expenses for the fourth quarter of 2011 were
$12.5 million, compared to $10.8 million for the same period in 2010.
The increase in expenses for the quarter was primarily due to increased
development activities for XP23829. Research and development expenses
for 2011 were $43.8 million, compared to $52.5 million for the same
period in 2010. The decrease in research and development expenses for
2011 was primarily due to decreased development activities for AP,
decreased personnel costs resulting primarily from decreased headcount
and decreased non-cash stock-based compensation, partially offset by
increased development expenses for XP23829.
Selling, general and administrative expenses were $6.9 million for the
fourth quarter of 2011, compared to $6.4 million for the same period in
2010. Selling, general and administrative expenses were $30.4 million
for 2011, compared to $28.3 million for 2010. The increase for the year
ended December 31, 2011 was primarily due to increased personnel,
consulting and market research costs.
In March 2010, XenoPort implemented a restructuring plan to reduce
expenses, focus XenoPort's resources on advancement of its later-stage
product candidates and eliminate XenoPort's discovery research efforts,
resulting in a reduction in force of 107 employees, or approximately 50%
of XenoPort's workforce at the time. In December 2011, as part of
XenoPort's ongoing evaluation of its facilities requirements in light of
future plans, XenoPort recorded a restructuring charge of $2.9 million
in the year ended December 31, 2011 in connection with the permanent
cease use of office space. The restructuring charges consisted of $2.5
million of facility-related charges and $0.4 million of property and
equipment write-offs. XenoPort expected to make all cash payments
associated with this action by August 2013, which coincides with the end
of the lease term for the office space.
Net loss for the fourth quarter of 2011 was $16.9 million, compared to a
net loss of $14.8 million for the same period in 2010. Net loss per
basic and diluted share was $0.48 for the fourth quarter of 2011,
compared to a net loss per basic and diluted share of $0.47 for the same
period in 2010. Net loss for 2011 was $33.4 million, compared to a net
loss of $82.5 million in 2010. Net loss per basic and diluted share was
$0.94 for 2011, compared to a net loss per basic and diluted share of
$2.68 for 2010.
Financial Guidance
XenoPort announced that it expects the net use of cash for 2012 to be in
the range of $45 million to $55 million (net use of cash is the
difference between the balances of cash and cash equivalents plus
short-term investments at 12/31/12 and 12/31/11). This estimate includes
the $10.0 million Regnite approval milestone received from
Astellas in February and assumes receipt of a potential $10.0 million
milestone payment from GSK associated with the possible approval of Horizant
as a treatment for PHN, assuming such approval occurs and the
collaboration agreement with GSK is effective at the time of such
approval.
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 48229726.
The replay of the conference call may be accessed that same day after
8:00 p.m. Eastern Time, 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 48229726.
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 XenoPort's first FDA-approved product. GSK holds commercialization
rights and certain development rights for Horizant in the United
States. Regnite is approved for the treatment of RLS in Japan.
Astellas holds all development and commercialization rights for Regnite
in Japan and five 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 neuropathic
pain, spasticity and Parkinson's disease.
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 potential future actions
by the FDA related to the sNDA for Horizant for the treatment of
PHN and timing thereof; XenoPort's and its partners' future sales of Horizant/Regnite
and the timing thereof; XenoPort's future clinical development programs
for AP and XP21279 and the timing thereof; the release of AP clinical
data and the timing thereof; the clinical trials needed to submit an NDA
to the FDA for AP; the therapeutic and commercial potential of Horizant/Regnite
and XenoPort's product candidates; the suitability of Horizant/Regnite
as a treatment for RLS or neuropathic pain; the suitability of AP as a
treatment of spasticity; the suitability of XP21279 as a treatment for
Parkinson's disease; the regulatory process and the timing of regulatory
actions; matters relating to the GSK collaboration, including any
resolution of the GSK dispute, potential cure of breach, termination of
the collaboration agreement or related litigation, as well as the
receipt of potential milestone payments provided for thereunder; and
sufficiency of XenoPort's existing cash, expected net cash usage and
other 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 "anticipate," "assuming,"
"believe," "could," "estimate," "expect," "potential," "predict,"
"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 the uncertain
outcome of the dispute with GSK, including termination of the
collaboration agreement and the timing and terms on which such
termination might occur; the uncertainty of the FDA approval process and
other regulatory requirements, including the risk that any approval of
the sNDA for Horizant for the treatment of PHN may be
substantially delayed or may never occur; the uncertain results and
timing of clinical trials; XenoPort's or its partners' ability to
successfully conduct clinical trials in the anticipated timeframes, or
at all; XenoPort's dependence on its current and additional
collaborative partners; 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 September 30, 2011, filed with
the Securities and Exchange Commission on November 4, 2011. 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.
XNPT2F
XENOPORT is a registered trademark of XenoPort, Inc.
Horizant is a registered trademark of GlaxoSmithKline.
Regnite is a registered trademark of Astellas Pharma Inc.
|
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
25,386
|
|
|
$
|
23,192
|
|
|
Short-term investments
|
|
|
69,056
|
|
|
|
85,403
|
|
|
Prepaids and other current assets
|
|
|
3,010
|
|
|
|
2,206
|
|
|
Total current assets
|
|
|
97,452
|
|
|
|
110,801
|
|
|
Property and equipment, net
|
|
|
3,921
|
|
|
|
7,209
|
|
|
Restricted investments and other assets
|
|
|
2,663
|
|
|
|
3,219
|
|
|
Total assets
|
|
$
|
104,036
|
|
|
$
|
121,229
|
|
|
Liabilities:
|
|
|
|
|
|
Current liabilities
|
|
$
|
13,530
|
|
|
$
|
11,487
|
|
|
Noncurrent liabilities
|
|
|
15,371
|
|
|
|
15,783
|
|
|
Total liabilities
|
|
|
28,901
|
|
|
|
27,270
|
|
|
Stockholders' equity (deficit):
|
|
|
|
|
|
Common stock
|
|
|
35
|
|
|
|
35
|
|
|
Additional paid-in capital and other
|
|
|
495,886
|
|
|
|
481,330
|
|
|
Accumulated deficit
|
|
|
(420,786
|
)
|
|
|
(387,406
|
)
|
|
Total stockholders' equity
|
|
|
75,135
|
|
|
|
93,959
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
104,036
|
|
|
$
|
121,229
|
|
|
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Year Ended December
31,
|
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Net revenue from unconsolidated joint operating activities
|
|
$
|
5,000
|
|
|
$
|
1,528
|
|
|
$
|
35,000
|
|
|
$
|
1,364
|
|
|
Collaboration revenue
|
|
|
378
|
|
|
|
378
|
|
|
|
8,515
|
|
|
|
1,515
|
|
|
Total revenues
|
|
|
5,378
|
|
|
|
1,906
|
|
|
|
43,515
|
|
|
|
2,879
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development*
|
|
|
12,512
|
|
|
|
10,837
|
|
|
|
43,788
|
|
|
|
52,546
|
|
|
Selling, general and administrative*
|
|
|
6,888
|
|
|
|
6,446
|
|
|
|
30,427
|
|
|
|
28,323
|
|
|
Restructuring charges
|
|
|
2,923
|
|
|
|
-
|
|
|
|
2,923
|
|
|
|
5,275
|
|
|
Total operating expenses
|
|
|
22,323
|
|
|
|
17,283
|
|
|
|
77,138
|
|
|
|
86,144
|
|
|
Loss from operations
|
|
|
(16,945
|
)
|
|
|
(15,377
|
)
|
|
|
(33,623
|
)
|
|
|
(83,265
|
)
|
|
Interest and other income
|
|
|
59
|
|
|
|
554
|
|
|
|
243
|
|
|
|
796
|
|
|
Net loss
|
|
$
|
(16,886
|
)
|
|
$
|
(14,823
|
)
|
|
$
|
(33,380
|
)
|
|
$
|
(82,469
|
)
|
|
Basic and diluted net loss per share
|
|
$
|
(0.48
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(0.94
|
)
|
|
$
|
(2.68
|
)
|
|
Shares used to compute basic and diluted net loss per share
|
|
|
35,482
|
|
|
|
31,735
|
|
|
|
35,400
|
|
|
|
30,813
|
|
|
|
|
* Includes employee non-cash stock-based compensation,
excluding non-cash stock-based compensation resulting from
XenoPort's restructuring plan, as follows:
|
|
|
|
Research and development
|
|
$
|
1,199
|
|
|
$
|
1,702
|
|
|
$
|
5,208
|
|
|
$
|
7,930
|
|
|
Selling, general and administrative
|
|
|
2,219
|
|
|
|
2,113
|
|
|
|
9,180
|
|
|
|
9,210
|
|
|
Total
|
|
$
|
3,418
|
|
|
$
|
3,815
|
|
|
$
|
14,388
|
|
|
$
|
17,140
|
|

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