XenoPort, Inc. (Nasdaq:XNPT) announced today its financial
results for the fourth quarter and year ended December 31, 2013.
Revenues for the fourth quarter were $2.9 million, compared to $0.5
million for the same period in 2012. Net loss for the fourth
quarter was $19.1 million compared to net income of $3.0 million
that resulted from a non-cash gain from XenoPort’s litigation
settlement with Glaxo Group Limited (GSK) in the fourth quarter of
2012. At December 31, 2013, XenoPort had cash and cash equivalents
and short-term investments of $58.7 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2013:
- XenoPort completed a successful
follow-on public offering of XenoPort common stock, raising net
proceeds of approximately $67.3 million, after deducting
underwriting discounts and commissions and other estimated offering
expenses.
- XenoPort reported that it received
feedback from the U.S. Food and Drug Administration (FDA) Division
of Neurology Products regarding potential development plans for
XP23829 as a potential treatment for patients with relapsing forms
of multiple sclerosis (MS). Based on the feedback, XenoPort
believes that it could initiate Phase 3 clinical development using
XP23829 doses that produce monomethyl fumarate (MMF) exposure
similar to that produced by the approved dose of TECFIDERA
(dimethyl fumarate). XenoPort also believes that the FDA will
require additional information on XP23829 before determining the
applicability of the Section 505(b)(2) pathway for a potential New
Drug Application (NDA) submission.
- XenoPort indicated that it plans to
submit an Investigational New Drug (IND) application to the FDA
Division of Dermatology and Dental Products for XP23829 as a
potential treatment for moderate-to-severe chronic plaque psoriasis
and plans to initiate a Phase 2 clinical trial of XP23829 for this
indication by mid-2014.
- Net sales of HORIZANT® (gabapentin
enacarbil) Extended-Release Tablets in the United States in the
fourth quarter grew 34% compared to the third quarter of 2013,
which was the first full quarter of XenoPort’s commercialization of
HORIZANT. The total number and the trajectory of growth of HORIZANT
prescribed tablets achieved all-time highs. HORIZANT prescribed
pill counts increased 27% nationwide for the fourth quarter ending
December 31, 2013 compared to the third quarter of 2013. In
territories where XenoPort is actively promoting HORIZANT, total
prescribed pills for the fourth quarter ending December 31, 2013
increased by 39% compared to the third quarter of 2013. This
compares to no growth in non-promoted territories.
- XenoPort reported positive top-line
results of a Phase 4 clinical trial that evaluated lower doses of
gabapentin enacarbil for the treatment of moderate-to-severe
primary restless legs syndrome (RLS) in adults. The study was
conducted by XenoPort’s former commercial partner, GSK, as part of
the post-marketing commitments imposed by the FDA in connection
with its approval of HORIZANT for the treatment of adult patients
with moderate-to-severe primary RLS. The most common adverse
reactions in adult patients with moderate-to-severe primary RLS
taking HORIZANT are somnolence/sedation, dizziness, headache,
nausea and fatigue.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “We are currently focused on preparing to initiate Phase 2
development of our novel fumarate product candidate, XP23829, later
this year. Our Phase 1 clinical trial results indicated that
XP23829 can deliver relevant plasma concentrations of MMF with a
desired pharmacokinetic profile. While Phase 1 data in a small
number of subjects must be viewed cautiously, we are intrigued by
the pharmacodynamic effects of XP23829 on immune cells in
peripheral blood of healthy subjects, particularly when XP23829 was
dosed once a day. We hope to establish optimal dosing of XP23829 in
our planned Phase 2 psoriasis study and use this information for
dose selection for potential Phase 3 trials in psoriasis and/or
relapsing forms of MS.”
Dr. Barrett continued, “We also believe we have made progress in
commercializing HORIZANT. In only two full quarters of promotion,
we believe we have demonstrated the potential of our targeted
educational efforts and we continue to receive positive feedback
from physicians who prescribe HORIZANT. We will continue to closely
monitor our progress in increasing the value of HORIZANT through
these commercialization efforts.”
XenoPort Fourth Quarter and Year-End 2013 Financial
Results
Revenues for the fourth quarter and year ended December 31, 2013
were $2.9 million and $8.0 million, respectively, compared to $0.5
million and $21.6 million for the same periods in 2012. The
increase in revenues in the fourth quarter ended December 31, 2013
was principally due to HORIZANT net product sales. HORIZANT net
product sales totaled $6.4 million for the year ended December 31,
2013. The decrease in total revenues for the year ended December
31, 2013 compared to 2012 was primarily due to the recognition in
2012 of a $10.0 million contingent payment from GSK and a $10.0
million milestone payment from Astellas Pharma Inc.
Research and development expenses for the fourth quarter of 2013
decreased to $3.7 million from $10.6 million for the same period in
2012. The decrease in research and development expenses for the
fourth quarter of 2013 was principally due to decreased net costs
for arbaclofen placarbil (AP), decreased personnel costs, which
were primarily due to decreased headcount and decreased non-cash
stock-based compensation, and decreased net costs for XP23829
development activities. Research and development expenses for the
year ended December 31, 2013 decreased to $33.3 million from $42.9
million for 2012. The decrease in research and development expenses
for 2013 compared to 2012 was principally due to decreased net
costs for AP and decreased personnel costs, which were primarily
due to decreased headcount and decreased non-cash stock-based
compensation, partially offset by increased net costs for XP23829
development activities.
Selling, general and administrative expenses were $17.6 million
and $59.1 million for the fourth quarter and year ended December
31, 2013, respectively, compared to $7.4 million and $30.2 million
for the same periods in 2012, respectively. The increase in
selling, general and administrative expenses in both periods of
2013 compared with 2012 was principally due to costs related to the
commercialization and promotion of HORIZANT, which included
increased professional fees, marketing costs and personnel
costs.
Net loss for the fourth quarter of 2013 was $19.1 million,
compared to net income of $3.0 million for the same period in 2012.
Net loss for 2013 was $85.9 million, compared to a net loss of
$30.8 million for 2012. Basic and diluted net loss per share were
$0.40 for the fourth quarter of 2013, compared to basic and diluted
net income per share of $0.07 for the same period in 2012. For the
year ended 2013, basic and diluted net loss per share were $1.81,
compared to basic and diluted net loss per share of $0.78 for
2012.
Financial Guidance
XenoPort announced that it expects the net use of cash for 2014
to be in the range of $60 million to $70 million (net use of cash
is the difference between the anticipated balances of cash and cash
equivalents plus short-term investments at 12/31/14 and the actual
balances at 12/31/13, excluding net proceeds from the January 2014
financing).
Other News
XenoPort also reported today that Clinton Relational Opportunity
Master Fund, L.P. (Clinton) has provided notice of its intent to
nominate three candidates to stand for election to XenoPort’s Board
of Directors and to submit other proposals for consideration at
XenoPort’s 2014 Annual Meeting of Stockholders.
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 25925028.
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 25925028.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on
developing and commercializing a portfolio of internally discovered
product candidates for the potential treatment of neurological
disorders. XenoPort is currently commercializing HORIZANT® in the
United States and developing its novel fumaric acid ester product
candidate, XP23829, as a potential treatment for psoriasis and/or
relapsing forms of multiple sclerosis. REGNITE® (gabapentin
enacarbil) Extended-Release Tablets is being marketed in Japan by
Astellas Pharma Inc. XenoPort's pipeline of product candidates also
includes potential treatments for patients with spasticity related
to spinal cord injury and Parkinson's disease. To learn more about
XenoPort, please visit the website 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 HORIZANT; our ability to build value in
HORIZANT through, and the potential of, our targeted educational
efforts; our current strategy for advancing the XP23829 clinical
development program, including the initiation or conduct of planned
or potential future clinical trials and the timing thereof; the
potential submissions of an IND and an NDA to the FDA for XP23829
and the timing thereof; the potential applicability of the Section
505(b)(2) NDA pathway; the suitability of XP23829 as a potential
treatment for psoriasis or relapsing forms of MS; XenoPort’s
expected net cash usage for 2014; and other statements that are not
historical facts. 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 “anticipated,” “believe,”
“could,” “expects,” “hope,” “plans,” “potential,” “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 lack of commercialization experience and its ability to
successfully market and sell HORIZANT, including XenoPort’s ability
to maintain sales, marketing, distribution, supply chain and other
sufficient capabilities to sell HORIZANT; XenoPort’s dependence on
the success of its strategies for HORIZANT commercialization,
promotion and distribution, as well as its ability to successfully
execute on these activities and to comply with applicable laws,
regulations and regulatory requirements; the competitive
environment for and the degree of market acceptance of HORIZANT;
obtaining appropriate pricing and reimbursement for HORIZANT in an
increasingly challenging environment; the difficulty and
uncertainty of pharmaceutical product development and the uncertain
results and timing of clinical trials and other studies, including
the risk that success in preclinical testing and early clinical
trials does not ensure that later clinical trials will be
successful; XenoPort’s ability to successfully advance XP23829
development and to conduct or initiate clinical trials in the
anticipated timeframes, or at all; the uncertainty of the FDA’s
review process and other regulatory requirements; XenoPort's need
for and the availability of resources to develop XP23829 and to
support XenoPort's operations; the uncertain therapeutic and
commercial value of HORIZANT and XP23829; as well as 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 prospectus supplement filed with the Securities and
Exchange Commission (“SEC”) under Rule 424(b)(5) on January 24,
2014. 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.
Important Additional Information and Where to Find It
XenoPort, Inc., its directors and certain of its executive
officers may be deemed to be participants in the solicitation of
proxies from stockholders in connection with XenoPort’s 2014 Annual
Meeting of Stockholders. XenoPort intends to file with the SEC and
provide to its stockholders a proxy statement and a WHITE proxy
card in connection with such solicitation. XENOPORT STOCKHOLDERS
ARE STRONGLY ENCOURAGED TO READ ANY SUCH PROXY STATEMENT (INCLUDING
ANY AMENDMENTS AND SUPPLEMENTS) AND ANY OTHER RELEVANT DOCUMENTS
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION.
Information regarding the names of XenoPort’s directors and
executive officers and their respective interests in XenoPort by
security holdings or otherwise is set forth in XenoPort’s proxy
statement for the 2013 Annual Meeting of Stockholders, filed with
the SEC on April 12, 2013, in XenoPort’s annual report on Form
10-K, filed with the SEC on March 14, 2013, and in XenoPort’s press
release dated January 29, 2014, which documents are available at
XenoPort’s investor relations website at
http://investor.xenoport.com/index.cfm. To the extent holdings of
such participants in XenoPort’s securities have changed since the
amounts described in the 2013 proxy statement, or if a particular
participant’s holdings are not set forth in the 2013 proxy
statement, such holdings (or changes thereto) have been reflected
on Initial Statements of Beneficial Ownership on Form 3 or
Statements of Change in Ownership on Form 4 filed with the SEC.
Information regarding the special interests of such participants,
if any, in the matters to be voted on at XenoPort’s 2014 Annual
Meeting of Stockholders will be included in the proxy statement
referred to above. You can obtain free copies of these referenced
documents as described below.
These documents, including any proxy statement (and amendments
or supplements thereto) and the accompanying WHITE proxy card, and
any other relevant documents and other material filed by XenoPort
with the SEC, are or will be available for no charge at the SEC's
website at www.sec.gov and at XenoPort’s investor relations website
at http://investor.xenoport.com/index.cfm. Copies may also be
obtained free of charge by contacting XenoPort Investor Relations
by mail at 3410 Central Expressway, Santa Clara, California 95051
or by telephone at (408) 616-7200.
XNPT2F
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
December 31,
December 31,
2013 2012 Current assets: Cash and cash
equivalents $ 20,584 $ 36,134 Short-term investments 38,074 102,868
Accounts receivable, net 939 -
Right to the HORIZANT business
- 13,557 Inventories 1,262 - Prepaids and other current assets
2,826 2,529
Total current assets 63,685 155,088 Property and equipment, net
2,552 1,528 Long-term inventories 10,185 - Restricted investments
and other assets
2,119
2,432 Total assets
$
78,541 $ 159,048
Liabilities: Current liabilities $ 10,069 $ 13,771
Noncurrent liabilities
14,779
15,067 Total liabilities
24,848 28,838
Stockholders’ equity (deficit): Common stock 48 47 Additional
paid-in capital and other 591,128 581,763 Accumulated deficit
(537,483 )
(451,600 ) Total stockholders’ equity
53,693 130,210
Total liabilities and stockholders’ equity
$
78,541 $ 159,048
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per
share amounts)
Three
Months Year Ended December 31,
Ended December 31,
2013 2012
2013 2012 Revenues: Product
sales, net $ 2,737 $ - $ 6,414 $ - Collaboration revenue - 378
1,137 11,515 Royalty revenue 142 109 400 109 Net revenue from
unconsolidated joint operating activities
-
- -
10,000 Total revenues 2,879 487 7,951
21,624 Operating expenses (gains): Cost of product sales 616 -
1,170 - Research and development* 3,689 10,600 33,325 42,947
Selling, general and administrative* 17,633 7,422 59,084 30,244
Gain on litigation settlement
-
(20,499
)
-
(20,499
)
Total operating expenses (gains)
21,938
(2,477
)
93,579 52,692
Income (Loss) from operations
(19,059
)
2,964
(85,628
)
(31,068
)
Net interest income (expense)
(79
)
78
(255
)
254 Net income (loss)
$
(19,138
) $ 3,042
$
(85,883
)
$
(30,814
) Basic and diluted net income (loss) per share
$
(0.40
) $ 0.07
$
(1.81
)
$
(0.78
) Shares used to compute basic net income (loss) per
share
47,768 45,296
47,545 39,434
Shares used to compute diluted net income (loss) per share
47,768 46,501
47,545 39,434
* Includes employee non-cash stock-based compensation
as follows: Research and development $ 536 $ 1,321 $ 3,059 $ 4,364
Selling, general and administrative
1,700
1,821 7,485
7,917 Total
$
2,236 $ 3,142
$ 10,544 $
12,281
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
Xenoport, Inc. (NASDAQ:XNPT)
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