XenoPort, Inc. (Nasdaq: XNPT) announced today its financial results for
the fourth quarter and year ended December 31, 2012. Revenues for the
quarter were $0.5 million, compared to $5.4 million for the same period
in 2011. Net income for the fourth quarter was $3.0 million, which
resulted from a non-cash gain on XenoPort’s litigation settlement with
Glaxo Group Limited (GSK), compared to a net loss of $16.9 million for
the same period in 2011. At December 31, 2012, XenoPort had cash and
cash equivalents and short-term investments of $139.0 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2012:
-
XenoPort and GSK announced that they had terminated their
collaboration agreement concerning Horizant® (gabapentin enacarbil)
Extended-Release Tablets under which GSK held commercialization rights
and certain development rights in the United States. The termination
and transition agreement also released all claims and resolved all
pending litigation between the parties. During a transition period
that will end on April 30, 2013, GSK will continue to exclusively
commercialize, promote, manufacture and distribute Horizant in
the United States. Following the transition period, XenoPort
will assume all responsibilities for the further development,
manufacturing and commercialization of Horizant in the United
States.
-
As part of the termination and settlement, GSK purchased $40.0 million
of common stock of XenoPort, or 4,031,212 shares at an average price
of $9.923 per share. Such shares were purchased in two tranches at a
12.5% premium to the average of the closing price of XenoPort common
stock during a ten-trading-day period prior to each tranche.
-
XenoPort completed enrollment in its Phase 3 pivotal trial of
arbaclofen placarbil (AP) as a potential treatment for spasticity in
patients with multiple sclerosis (MS).
-
XenoPort announced 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). The trial
demonstrated that administration of XP23829 resulted in the expected
levels of MMF in the blood. XP23829 was generally well-tolerated in
the trial.
-
XenoPort initiated a Phase 1, multiple ascending dose clinical trial
of XP23829 designed to determine the safety and steady-state PK
profile of XP23829 in once-per-day and twice-per-day formulations.
-
XenoPort also initiated a Phase 1 radiolabeled XP23829 clinical trial
in healthy subjects designed to establish the metabolism and
disposition of XP23829.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
“The reacquisition of Horizant represents an exciting opportunity
for XenoPort and will mark the transition of the company into a
commercial entity. We look forward to educating key stakeholders about
the benefits and risks of Horizant starting May 1. We are working
to finalize a focused commercial plan intended to grow the Horizant
business in a cost efficient manner while maintaining flexibility to
potentially expand our commercial efforts. Meanwhile, we are awaiting
our Phase 3 AP clinical trial results in the second quarter. Assuming
positive results, we would target the submission of a New Drug
Application (NDA) in the United States for AP for the treatment of
spasticity for patients with MS or spinal cord injury by the end of this
year.”
Dr. Barrett continued, “We are equally excited about our progress on
XP23829. Our first clinical trial provided the type of positive results
we expected, and we are looking forward to receiving the results of two
additional Phase 1 trials and of 13-week toxicology studies by mid-year.
With these data in hand, we hope to speak to regulatory authorities
about potential development paths in several indications, including
relapsing-remitting multiple sclerosis (RRMS) and psoriasis. We are
looking forward to reporting our progress later in 2013.”
XenoPort Fourth Quarter and Year-End 2012 Financial Results
Revenues for the fourth quarter and year ended December 31, 2012 were
$0.5 million and $21.6 million, respectively, compared to $5.4 million
and $43.5 million for the same periods in 2011. The decrease in revenues
for the fourth quarter and year ended December 31, 2012 compared to the
same periods in 2011 were primarily due to the receipt and recognition
of a $5.0 million milestone payment associated with the acceptance of
the supplemental NDA for the management of PHN in the fourth quarter of
2011 and a $30.0 million contingent payment associated with the first
commercial sale of Horizant in the United States in the second
quarter of 2011, partially offset by the receipt and recognition of a
$10.0 million milestone payment for the approval of Regnite® (gabapentin
enacarbil) Extended-Release Tablets for RLS in Japan in the first
quarter of 2012 and a $10.0 million contingent payment associated with
the approval of Horizant for the management of PHN in the second
quarter of 2012. Net sales for Horizant for the fourth quarter
and year ended 2012 as recorded by GSK were $2.1 million and $6.5
million, respectively.
Research and development expenses for the fourth quarter of 2012 were
$10.6 million, compared to $12.5 million for the same period in 2011.
The decrease in research and development expenses for the fourth quarter
of 2012 was primarily due to decreased personnel costs resulting
primarily from decreased headcount and decreased development activities
for XP21279. Research and development expenses for 2012 were $42.9
million, compared to $43.8 million for 2011. The decrease in research
and development expenses for 2012 compared to 2011 was principally due
to decreased net costs for XP21279, partially offset by increased net
costs for AP and XP23829 development activities.
Selling, general and administrative expenses were relatively constant at
$7.4 million for the fourth quarter of 2012, compared to $6.9 million
for the same period in 2011. Selling, general and administrative
expenses were $30.2 million for 2012, compared to $30.4 million for 2011.
As a result of the termination and transition agreement with GSK that
resolved all pending litigation between the parties, XenoPort recorded a
non-cash gain on litigation settlement of $20.5 million in the fourth
quarter of 2012, which resulted in a profitable quarter.
Net income for the fourth quarter of 2012 was $3.0 million, compared to
a net loss of $16.9 million for the same period in 2011. Net income per
basic and diluted share was $0.07 for the fourth quarter of 2012,
compared to a net loss per basic and diluted share of $0.48 for the same
period in 2011. Net loss for 2012 was $30.8 million, compared to a net
loss of $33.4 million in 2011. Net loss per basic and diluted share was
$0.78 for 2012, compared to a net loss per basic and diluted share of
$0.94 for 2011.
Financial Guidance
XenoPort announced that it expects the net use of cash for 2013 to be in
the range of $100 million to $110 million (net use of cash is the
difference between the anticipated balances of cash and cash equivalents
plus short-term investments at 12/31/13 and the actual balances at
12/31/12).
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 19426152.
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 1-855-859-2056 for domestic callers, or 404-537-3406 for
international callers. The reference number to enter the replay of the
call is 19426152.
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 our first approved product in the United States. GSK holds
commercialization rights for Horizant in the United States during
a transition period ending on April 30, 2013, following which XenoPort
will be responsible for the further development, manufacturing and
commercialization of Horizant. Regnite is approved and is
being marketed 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 to
gabapentin enacarbil. XenoPort's pipeline of product candidates includes
potential treatments for patients with spasticity, Parkinson's disease
and RRMS.
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 GSK’s future activities
during the transition period with respect to Horizant; XenoPort’s
future development, manufacturing and commercialization activities with
respect to Horizant following such transition period; growing the Horizant
business in a cost-efficient manner and potentially expanding
XenoPort’s commercial efforts; the release of AP clinical data and the
timing and results thereof; the potential submission of an NDA for AP
for the treatment of spasticity and the timing thereof; XenoPort’s
future clinical development programs for XP23829, including potential
indications for development; the therapeutic and commercial potential of
XenoPort’s product candidates; the suitability of AP as a treatment of
spasticity; the suitability of XP23829 as a treatment for RRMS,
psoriasis or other potential indications; and XenoPort’s expected net
cash usage for 2013. 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 “assume,” “expects,” “hope,”
“intends,” “potential,” “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 lack of commercialization experience and its
ability to establish, or contract with third parties to establish,
sales, marketing, distribution, supply chain and other sufficient
capabilities to assume responsibility for and to market and sell Horizant
following the transition period with respect to Horizant;
XenoPort’s ability to successfully market and sell Horizant following
the transition period, including its ability to obtain appropriate
pricing and reimbursement for Horizant in an increasingly
challenging environment, and whether any such sales will be sufficient
to outweigh the costs of establishing and maintaining sales, marketing,
distribution, supply chain and other capabilities; XenoPort’s
ability to comply with applicable regulatory guidelines and requirements
with respect to the marketing and manufacturing of Horizant or
with Horizant post-marketing commitments or requirements mandated
by the FDA; XenoPort’s need for additional funding and the risk
that XenoPort could utilize its available capital resources sooner than
it expects; the uncertainty of the FDA approval process and other
regulatory requirements; the uncertain results and timing of clinical
trials; XenoPort’s ability to successfully conduct clinical trials in
the anticipated timeframes, or at all; the uncertain therapeutic and
commercial value of XenoPort’s product candidates; and risks related to
future opportunities and plans, including the uncertainty of expected
future financial performance and results. 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, 2012, filed with
the Securities and Exchange Commission on October 25, 2012, and in
future filings and reports by XenoPort, including its Annual Report on
Form 10-K for the year ended December 31, 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.
XNPT2F
Horizant, Regnite and XENOPORT are registered trademarks of XenoPort,
Inc.
|
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
36,134
|
|
|
$
|
25,386
|
|
Short-term investments
|
|
|
102,868
|
|
|
|
69,056
|
|
Right to the Horizant business
|
|
|
13,557
|
|
|
|
-
|
|
Prepaids and other current assets
|
|
|
2,529
|
|
|
|
3,010
|
|
Total current assets
|
|
|
155,088
|
|
|
|
97,452
|
|
Property and equipment, net
|
|
|
1,528
|
|
|
|
3,921
|
|
Restricted investments and other assets
|
|
|
2,432
|
|
|
|
2,663
|
|
Total assets
|
|
$
|
159,048
|
|
|
$
|
104,036
|
|
Liabilities:
|
|
|
|
|
Current liabilities
|
|
$
|
13,771
|
|
|
$
|
13,530
|
|
Noncurrent liabilities
|
|
|
15,067
|
|
|
|
15,371
|
|
Total liabilities
|
|
|
28,838
|
|
|
|
28,901
|
|
Stockholders’ equity (deficit):
|
|
|
|
|
Common stock
|
|
|
47
|
|
|
|
35
|
|
Additional paid-in capital and other
|
|
|
581,763
|
|
|
|
495,886
|
|
Accumulated deficit
|
|
|
(451,600
|
)
|
|
|
(420,786
|
)
|
Total stockholders’ equity
|
|
|
130,210
|
|
|
|
75,135
|
|
Total liabilities and stockholders’ equity
|
|
$
|
159,048
|
|
|
$
|
104,036
|
|
|
|
|
|
|
|
|
|
|
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
Year Ended December 31,
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Revenues:
|
|
|
|
|
|
|
|
|
Net revenue from unconsolidated joint operating activities
|
|
$
|
-
|
|
|
$
|
5,000
|
|
|
$
|
10,000
|
|
|
$ 35,000
|
|
Collaboration revenue
|
|
|
378
|
|
|
|
378
|
|
|
|
11,515
|
|
|
8,515
|
|
Royalty revenue
|
|
|
109
|
|
|
|
-
|
|
|
|
109
|
|
|
-
|
|
Total revenues
|
|
|
487
|
|
|
|
5,378
|
|
|
|
21,624
|
|
|
43,515
|
|
Operating expenses (gains):
|
|
|
|
|
|
|
|
|
Research and development*
|
|
|
10,600
|
|
|
|
12,512
|
|
|
|
42,947
|
|
|
43,788
|
|
Selling, general and administrative*
|
|
|
7,422
|
|
|
|
6,888
|
|
|
|
30,244
|
|
|
30,427
|
|
Gain on litigation settlement
|
|
|
(20,499
|
)
|
|
|
-
|
|
|
|
(20,499
|
)
|
|
-
|
|
Restructuring charges
|
|
|
-
|
|
|
|
2,923
|
|
|
|
-
|
|
|
2,923
|
|
Total operating expenses (gains)
|
|
|
(2,477
|
)
|
|
|
22,323
|
|
|
|
52,692
|
|
|
77,138
|
|
Income (Loss) from operations
|
|
|
2,964
|
|
|
|
(16,945
|
)
|
|
|
(31,068
|
)
|
|
(33,623
|
)
|
Interest and other income
|
|
|
78
|
|
|
|
59
|
|
|
|
254
|
|
|
243
|
|
Net income (loss)
|
|
$
|
3,042
|
|
|
$
|
(16,886
|
)
|
|
$
|
(30,814
|
)
|
|
$ (33,380
|
)
|
Basic and diluted net income (loss) per share
|
|
$
|
0.07
|
|
|
$
|
(0.48
|
)
|
|
$
|
(0.78
|
)
|
|
$ (0.94
|
)
|
Shares used to compute basic net income (loss) per share
|
|
|
45,296
|
|
|
|
35,482
|
|
|
|
39,434
|
|
|
35,400
|
|
Shares used to compute diluted net income (loss) per share
|
|
|
46,501
|
|
|
|
35,482
|
|
|
|
39,434
|
|
|
35,400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes employee non-cash stock-based compensation as
follows:
|
Research and development
|
|
$
|
1,321
|
|
|
$
|
1,199
|
|
|
$ 4,364
|
|
|
$
|
5,208
|
|
Selling, general and administrative
|
|
|
1,821
|
|
|
|
2,219
|
|
|
7,917
|
|
|
|
9,180
|
|
Total
|
|
$
|
3,142
|
|
|
$
|
3,418
|
|
|
$ 12,281
|
|
|
$
|
14,388
|
|