XenoPort, Inc. (Nasdaq: XNPT) announced today its financial
results for the first quarter ended March 31, 2015. Revenues for
the quarter were $7.1 million, compared to $3.4 million for the
same period in 2014. Net loss for the first quarter was $20.4
million, compared to a net loss of $20.5 million for the same
period in 2014. At March 31, 2015, XenoPort had cash and cash
equivalents and short-term and long-term investments of $191.6
million.
Business Updates Since the Start of the First Quarter
- XenoPort completed enrollment in its
Phase 2 clinical trial of XP23829 as a potential treatment for
moderate-to-severe chronic plaque-type psoriasis and reiterated its
plans to disclose top-line data from this trial by the end of the
third quarter.
- XenoPort reached agreement with the
Neurology Products Division of the U.S. Food and Drug
Administration (FDA) on the key aspects of its proposed preclinical
and clinical development program for XP23829 as a potential
treatment for relapsing forms of multiple sclerosis (MS). XenoPort
believes that it could proceed with Phase 3 development upon
obtaining supportive data from currently ongoing chronic and
reproductive toxicology studies and the Phase 2 psoriasis study. In
addition, XenoPort believes that a single positive Phase 3 trial
could support the potential submission of a New Drug Application
(NDA).
- XenoPort reported that it now has 48
issued patents worldwide providing protection to XP23829 and other
monomethyl fumarate (MMF) prodrugs, including composition-of-matter
patents covering XP23829 in Europe, Japan and China, in addition to
the United States.
- Net product sales for HORIZANT®
(gabapentin enacarbil) Extended-Release Tablets were $6.6 million
for the first quarter of 2015, an increase of 125% compared to the
first quarter of 2014.
- According to Symphony Health Solutions,
the nationwide total of HORIZANT prescribed tablets for the first
quarter of 2015 increased 77% compared to the first quarter of
2014.
- On February 3, 2015, XenoPort completed
the sale of $115.0 million aggregate principal amount of its 2.50%
convertible senior notes due 2022, or the convertible notes,
raising net proceeds of $111.3 million, after deducting the initial
purchaser’s discount and offering expenses payable by
XenoPort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “We are happy to report that we completed discussions with
the FDA to define the critical elements of a proposed development
program for the potential treatment of relapsing forms of MS with
XP23829. We also continue to make good progress advancing our
XP23829 development program with the completion of enrollment in
our Phase 2 psoriasis program. Our psoriasis study is designed to
address the important question of the efficacy of an MMF prodrug
other than dimethyl fumarate, and to provide information on the
effect of dose, dosing frequency on efficacy, tolerability, immune
cell modulation and safety of XP23829. We believe we are on track
to deliver top-line results of the psoriasis trial by the end of
the third quarter. This study should enable us to determine our
next steps in development of XP23829 not only for patients with
psoriasis but also as a potential treatment for patients with
relapsing forms of MS.”
Dr. Barrett continued, “We experienced strong year-over-year
growth in HORIZANT net sales. On a sequential quarter basis, we
believe that seasonal effects impacted net sales, similar to last
year. Recent prescription trends have been encouraging and we
continue to believe that HORIZANT net sales for 2015 will be in the
range of $39.0 million to $43.0 million.”
XenoPort First Quarter 2015 Financial Results
Total revenues for the quarter were $7.1 million, compared to
$3.4 million for the same period in 2014. The increase in revenues
for the first quarter of 2015 was principally due to HORIZANT net
product sales, which totaled $6.6 million for the quarter compared
with $3.0 million for the same period in 2014.
Research and development expenses for the first quarter of 2015
were $6.4 million, compared to $4.7 million for the same period in
2014. The increase in research and development expenses for the
first quarter of 2015 was principally due to increased net costs
for XP23829 development primarily due to increased clinical,
manufacturing and toxicology costs, partially offset by decreased
personnel costs, which were primarily due to a reduction in
headcount and corresponding decreased non-cash stock-based
compensation.
Selling, general and administrative expenses were $20.1 million
for the first quarter of 2015, compared to $18.8 million for the
same period in 2014. The increase in selling, general and
administrative expenses for the first quarter of 2015 compared to
the same period in 2014 was principally due to costs related to the
continued and expanded commercialization of, and promotional
activities for, HORIZANT.
Net loss for the first quarter of 2015 was $20.4 million,
compared to a net loss of $20.5 million for the same period in
2014. Basic and diluted net loss per share were $0.33 for the first
quarter of 2015, compared to basic and diluted net loss per share
of $0.36 for the same period in 2014.
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 1-706-679-1417.
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 1-855-859-2056 for domestic callers or 1-404-537-3406
for international callers. The reference number to enter the call
and the replay of the call is 22550328.
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 patients with
moderate-to-severe chronic plaque-type psoriasis and potentially
for relapsing forms of MS. REGNITE® (gabapentin enacarbil)
Extended-Release Tablets is being marketed in Japan by Astellas
Pharma Inc. XenoPort has entered into a collaboration with the
National Institute on Alcohol Abuse and Alcoholism for the
potential development of HORIZANT as a treatment for alcohol use
disorder and has granted exclusive world-wide rights for the
development and commercialization of its clinical-stage oral
product candidate, arbaclofen placarbil, to Indivior PLC for all
indications. XenoPort's pipeline of product candidates also
includes a potential treatment for patients with idiopathic
Parkinson's disease. To learn more about XenoPort, please visit
www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements,
including, without limitation, all statements related to the
XP23829 preclinical and clinical development program, including
XenoPort’s expectations to disclose top-line Phase 2 psoriasis
study results by the end of the third quarter of 2015, XenoPort’s
expectations with respect to the anticipated benefits of the Phase
2 psoriasis study, and XenoPort’s beliefs that it could proceed
with Phase 3 development of XP23829 as a potential treatment of
relapsing forms of MS upon obtaining supportive data from chronic
and reproductive toxicology studies and that a single positive
Phase 3 trial could support the potential submission of an NDA with
the FDA; the suitability of XP23829 as a potential treatment for
moderate-to-severe chronic plaque type psoriasis and/or relapsing
forms of MS; financial guidance regarding XenoPort's expected
HORIZANT net product sales for 2015; 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 “believe,” “could,” “designed,” “plans,” “potential,”
“proposed,” “should,” “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 relative
lack of commercialization experience and its ability to
successfully market and sell HORIZANT, including XenoPort’s ability
to maintain internal and third-party 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 and that
the results of clinical studies by other parties may not be
indicative of the results in trials that XenoPort or its partners
may conduct; XenoPort’s ability to successfully advance XP23829
development and to conduct, initiate or complete clinical trials in
the anticipated timeframes, or at all; the risk that the initiation
or completion of clinical trials for XP23829 may be delayed or
terminated as a result of many factors; the risk that XP23829 will
require significant additional clinical testing prior to any
possible regulatory approvals and failure could occur at any stage
of its development; the uncertainty of the FDA’s review process and
other regulatory requirements; XenoPort's dependence on
collaborative partners; the availability of resources to develop
XenoPort's product candidates and support XenoPort's operations;
XenoPort's substantial outstanding debt and debt service
obligations, which could, among other things, limit its flexibility
in planning for, or reacting to, changes in its business and its
industry; 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 Securities and Exchange Commission filings and
reports, including in its Annual Report on Form 10-K for the year
ended December 31, 2014, filed with the Securities and Exchange
Commission on February 27, 2015, and its future filings and
reports, including its Quarterly Report on Form 10-Q for the
quarter ended March 31, 2015. 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, INC.
BALANCE SHEETS
(Unaudited, in thousands)
March 31,
December 31,
2015 2014 Current assets: Cash and cash
equivalents $ 16,898 $ 11,958 Short-term investments 169,220 90,098
Accounts receivable 2,887 2,895 Inventories 1,907 1,458 Prepaids
and other current assets
4,002
3,185 Total current assets 194,914 109,594
Long-term investments 5,516 - Property and equipment, net 2,299
2,422 Long-term inventories 8,845 9,098 Restricted investments and
other assets
1,915
1,947 Total assets
$
213,489 $ 123,061
Liabilities: Current liabilities $ 15,720 $ 17,788
Convertible senior notes, net 111,419 - Other noncurrent
liabilities
13,983
14,133 Total liabilities
141,122 31,921
Stockholders’ equity: Common stock 63 62 Additional paid-in capital
and other 679,529 677,894 Accumulated deficit
(607,225 ) (586,816
) Total stockholders’ equity
72,367 91,140 Total
liabilities and stockholders’ equity
$
213,489 $ 123,061
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per
share amounts)
Three Months
Ended March 31,
2015
2014
Revenues:
Product sales, net $ 6,639 $ 2,957 Collaboration revenue 284 283
Royalty revenue
144
135 Total revenues
7,067
3,375 Operating expenses: Cost of
product sales 454 430 Research and development* 6,384 4,657
Selling, general and administrative*
20,099
18,771 Total operating expenses
26,937 23,858
Loss from operations (19,870 ) (20,483 ) Net interest expense
(539 ) (65
) Net loss
$ (20,409
) $ (20,548 )
Basic and diluted net loss per share
$ (0.33 ) $
(0.36 ) Shares used to compute basic and
diluted net loss per share
62,722 56,887
* Includes employee non-cash stock-based
compensation as follows:
Research and development
$
382
$
702
Selling, general and administrative
2,289
1,982
Total
$
2,671
$
2,684
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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