HORIZANT Net Product Sales Increased 66% Over
First Quarter 2014
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results
for the second quarter and six months ended June 30, 2014. Total
revenues for the second quarter were $5.3 million, compared to $2.1
million for the same period in 2013. Net loss for the second
quarter was $19.4 million, compared to a net loss of $24.4 million
for the same period in 2013. At June 30, 2014, XenoPort had cash,
cash equivalents and short-term investments of $124.9 million.
XenoPort Business Updates
The following key events occurred since the beginning of the
second quarter of 2014:
- Net product sales for HORIZANT®
(gabapentin enacarbil) Extended-Release Tablets were $4.9 million
in the second quarter, an increase of 66% compared to $3.0 million
in the first quarter of 2014. The nationwide total of HORIZANT
prescribed pills for the second quarter ended June 30, 2014
increased by 24% over the first quarter ended March 31, 2014.
- In the second quarter of 2014, total
prescribed pills in the territories where XenoPort is promoting
HORIZANT represented 85% of the nationwide total HORIZANT
prescribed pills. Total prescribed pills increased by 30% for the
second quarter of 2014 compared to the first quarter of 2014 in
territories where XenoPort is promoting HORIZANT and decreased by
1% in areas of the country in which XenoPort is not promoting
HORIZANT.
- XenoPort announced the initiation of a
Phase 2 clinical trial of XP23829, its proprietary,
investigational, next-generation fumaric acid ester product
candidate. The trial is a multi-center, randomized, double-blind,
placebo-controlled study designed to assess the efficacy and safety
of XP23829 as a potential treatment of patients with
moderate-to-severe chronic plaque-type psoriasis.
- XenoPort entered into an exclusive
license agreement with Reckitt Benckiser Pharmaceuticals, Inc. for
world-wide rights to develop and commercialize arbaclofen
placarbil, or AP. Reckitt intends to advance AP into a Phase 2
proof-of-concept study for the treatment of alcohol use disorders.
XenoPort received an upfront, non-refundable cash payment of $20.0
million in June 2014 and also received an additional $5.0 million
in July 2014 following delivery of certain materials to Reckitt.
XenoPort is also eligible to receive aggregate cash payments of up
to $120.0 million upon the achievement by Reckitt of certain
regulatory and development-based milestones. In addition, XenoPort
is entitled to receive tiered double-digit royalty payments of up
to the mid-teens on a percentage basis on potential future net
sales of products in the United States and high single-digit
royalty payments on potential future net sales of products outside
the United States.
XenoPort also reported today that it intends to increase the
size of its HORIZANT sales force to approximately 65 sales
representatives. This decision followed careful evaluation of the
potential opportunity to increase HORIZANT sales through an
expanded education and promotional effort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “We believe that our first year of commercialization of
HORIZANT has demonstrated that sales can be positively impacted by
our promotional efforts. We indicated at the outset of our launch
of HORIZANT that we believed our initial focused approach would
provide a justification for future expansion. Having achieved
HORIZANT’s current positive prescription and revenue growth trends,
we believe it is the right time to expand promotion to other
regions of the country selected for their potential to produce
results similar to the first 40 territories. We hope to have the
additional representatives trained and promoting HORIZANT early in
the fourth quarter of this year.”
Dr. Barrett continued, “The XP23829 Phase 2 clinical trial in
patients with moderate-to-severe chronic plaque-type psoriasis is
now underway. We expect to enroll about 200 patients in this study,
and we hope to report top-line results in the third quarter of next
year. This trial is an important next step in the development of
XP23829. It is designed to provide important information about the
relationship of XP23829 dose to safety, tolerability, efficacy and
immune cell modulation in psoriasis patients. We believe that this
information will be relevant to further development not only in
psoriasis sufferers, but other conditions, such as relapsing forms
of multiple sclerosis (MS).”
XenoPort Second Quarter and Six-Month Financial
Results
Total revenues for the second quarter and six months ended June
30, 2014 were $5.3 million and $8.7 million, respectively, compared
to $2.1 million and $2.5 million, respectively, for the same
periods in 2013. The increase in revenues in both the second
quarter and six months ended June 30, 2014 was principally due to
HORIZANT net product sales, which totaled $4.9 million and $7.9
million for the second quarter and six months ended June 30, 2014,
respectively.
Research and development expenses for the second quarter and six
months ended June 30, 2014 were $5.2 million and $9.9 million,
respectively, compared to $10.2 million and $23.6 million,
respectively, for the same periods in 2013. The decrease in
research and development expenses in the second quarter 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. For the six months
ended June 30, 2014, the decrease in research and development
expenses was principally due to decreased net costs for AP and
XP23829 development activities, as well as decreased personnel
costs, which were primarily due to decreased headcount and
decreased non-cash stock-based compensation.
Selling, general and administrative expenses for the second
quarter and six months ended June 30, 2014 were $18.9 million and
$37.6 million, respectively, compared to $15.8 million and $26.5
million, respectively, for the same periods in 2013. The increase
in selling, general and administrative expenses in both the second
quarter and six months ended June 30, 2014, compared to the same
periods in 2013, was principally due to increased professional
fees, marketing and personnel costs associated with XenoPort’s
commercialization efforts for HORIZANT.
Net loss for the second quarter of 2014 was $19.4 million,
compared to a net loss of $24.4 million for the same period in
2013. Net loss for the six months ended June 30, 2014 was $39.9
million, compared to a net loss of $47.9 million for the same
period in 2013. Basic and diluted net loss per share were both
$0.31 in the second quarter of 2014 versus basic and diluted net
loss per share of $0.51 for the same period in the prior year. For
the six months ended June 30, 2014, basic and diluted net loss per
share were both $0.67 versus basic and diluted net loss per share
of $1.01 for the same period in 2013.
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 72884596.
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 1-855-859-2056 for
domestic callers, or 404-537-3406 for international callers. The
reference number to enter the replay of the call is 72884596.
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®
(gabapentin enacarbil) Extended-Release Tablets in the United
States and developing its novel fumaric acid ester product
candidate, XP23829, as a potential treatment for moderate-to-severe
chronic plaque-type psoriasis and/or relapsing forms of multiple
sclerosis. REGNITE® (gabapentin enacarbil) Extended-Release Tablets
is being marketed in Japan by Astellas Pharma Inc. XenoPort
recently granted exclusive world-wide rights for the development
and commercialization of its clinical-stage oral product candidate,
arbaclofen placarbil, to Reckitt Benckiser Pharmaceuticals, Inc.
for all indications. 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
XP23829 clinical development program, including expected enrollment
in the Phase 2 clinical trial of XP23829, XenoPort's expectation
that it will obtain top-line results of the Phase 2 clinical trial
of XP23829 in the third quarter of 2015 and XenoPort's belief that
the results of the Phase 2 clinical trial will be relevant to
indications other than moderate-to-severe chronic plaque-type
psoriasis; the suitability of XP23829 as a potential treatment for
moderate-to-severe chronic plaque-type psoriasis and/or relapsing
forms of MS; XenoPort’s commercialization strategies, including
future expansion of the XenoPort sales force, and the timing
thereof, and the potential opportunity to increase HORIZANT sales
through an expanded education and promotional effort; the potential
for new HORIZANT commercial territories to produce similar results
as current territories; Reckitt’s future clinical development plans
for AP; the suitability of AP as a potential treatment for alcohol
use disorders; XenoPort's receipt of potential future development,
regulatory and commercial milestone payments, as well as potential
royalty payments under the license agreement with Reckitt; 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,” “expect,”
“hope,” “intends,” “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 relative lack of commercialization experience and its
ability to successfully market and sell HORIZANT, including
XenoPort's ability to establish a XenoPort-employed sales force,
expand the total sales force through its contract sales
organization and expand and 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 do
not ensure that later clinical trials will be successful, and that
the results of clinical trials by other parties may not be
indicative of the results in trials that XenoPort may conduct;
XenoPort's ability to successfully advance XP23829 development and
to conduct clinical trials in the anticipated timeframes, or at
all; the risk that the completion of clinical trials for XP23829
may be delayed or terminated as a result of many factors, including
delays in patient enrollment; 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 Astellas, Reckitt
and potential future collaborative partners, including the risks
that if Reckitt were to breach or terminate the license agreement
or otherwise fail to successfully develop and commercialize
products thereunder and in a timely manner, XenoPort would not
obtain the anticipated financial and other benefits of the license
agreement and the clinical development or commercialization of AP
could be delayed or terminated; the availability of resources to
develop XenoPort’s product candidates and to support XenoPort’s
operations; 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 Securities
and Exchange Commission filings and reports, including its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2014,
filed with the Securities and Exchange Commission on May 9, 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.
XENOPORT, HORIZANT and REGNITE are registered trademarks of
XenoPort, Inc.
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
June 30,
December 31,
2014 2013 Current assets: Cash and cash
equivalents $ 32,652 $ 20,584 Short-term investments 92,294 38,074
Accounts receivable 1,648 939 Inventories, net 1,217 1,262 Prepaids
and other current assets
3,573
2,826 Total current assets 131,384 63,685
Property and equipment, net 2,376 2,552 Long-term inventories 9,891
10,185 Restricted investments and other assets
1,975 2,119 Total
assets
$ 145,626 $
78,541 Liabilities: Current liabilities $
35,362 $ 10,069 Noncurrent liabilities
14,445
14,779 Total liabilities
49,807 24,848
Stockholders’ equity: Common stock 62 48 Additional paid-in capital
and other 673,175 591,128 Accumulated deficit
(577,418 ) (537,483
) Total stockholders’ equity
95,819 53,693 Total
liabilities and stockholders’ equity
$
145,626 $ 78,541
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three MonthsEnded June
30,
Six MonthsEnded June
30,
2014 2013
2014 2013 (In
thousands, except per share amounts) Revenues: Product sales,
net $ 4,920 $ 1,640 $ 7,877 $ 1,640 Collaboration revenue 283 379
566 758 Royalty revenue
131
67 266
147 Total revenues
5,334
2,086 8,709
2,545 Operating expenses: Cost of
product sales 599 249 1,029 249 Research and development* 5,203
10,236 9,860 23,589
Selling, general and administrative*
18,865 15,788
37,636 26,523
Total operating expenses
24,667
26,273 48,525
50,361 Loss from operations (19,333 ) (24,187 )
(39,816 ) (47,816 ) Interest income 66 58 115 139 Interest expense
(120 ) (252
) (234 )
(252 ) Net loss
$
(19,387 ) $
(24,381 ) $
(39,935 ) $
(47,929 ) Basic and diluted net loss per
share
$ (0.31 )
$ (0.51 ) $
(0.67 ) $ (1.01
) Shares used to compute basic and diluted net loss
per share
61,994
47,473 59,441
47,361
* Includes employee non-cash
stock-based compensation as follows:
Research and development
$
622
$
710
$
1,324
$
1,905
Selling, general and administrative
1,803
1,785
3,785
3,934
Total
$
2,425
$
2,495
$
5,109
$
5,839
XNPT2F
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
Xenoport, Inc. (NASDAQ:XNPT)
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