HORIZANT Net Product Sales Increase 94% Over
Third Quarter 2014
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results
for the third quarter and nine months ended September 30, 2015. Net
product sales for HORIZANT® (gabapentin enacarbil) Extended-Release
Tablets nearly doubled to $11.0 million for the third quarter of
2015 compared to $5.6 million for the same period in 2014. Total
revenues for the third quarter were $11.4 million compared to $31.1
million for the same period in 2014. Revenues for the third quarter
of 2014 included $25.0 million in collaboration revenue resulting
from XenoPort’s license agreement with Indivior PLC. Net loss for
the third quarter was $24.1 million compared to net income of $8.3
million for the same period in 2014. At September 30, 2015,
XenoPort had cash, cash equivalents and short-term investments of
$152.4 million.
XenoPort Business Updates
The following key events occurred since the beginning of the
third quarter of 2015:
- XenoPort announced a strategic shift to
focus on and maximize the value of HORIZANT, its commercial
product. As part of this shift, it is discontinuing development of
XP23829 on its own and is seeking to partner both XP23829 and
XP21279.
- Vincent J. Angotti, who has spearheaded
XenoPort’s effort to commercialize HORIZANT, was named Chief
Executive Officer and has joined its Board of Directors.
- As of July 1, 2015, XenoPort added
approximately 50 new HORIZANT NeuroHealth Specialists, and now has
approximately 120 Specialists providing educational efforts
primarily to neurology, sleep and pain specialists.
- XenoPort reported strong HORIZANT net
product sales of $11.0 million for the third quarter, which was a
34% sequential quarterly increase and a 94% increase over the same
period in 2014.
- The nationwide total of HORIZANT
prescribed tablets in the third quarter increased 17%, compared to
the previous quarter, and increased 62% compared to the third
quarter of 2014, as measured by IMS HEALTH – NPA™ (National
Prescription Audit Family of Services).
- In conjunction with the strategic
shift, XenoPort announced that it would restructure its workforce
to focus on HORIZANT commercialization. XenoPort has recorded
restructuring costs, primarily related to compensation and benefit
expenses as well as severance costs related to its departed CEO, of
$3.0 million in the third quarter, and expects that these actions
will result in future annual cash savings of approximately $6.7
million.
Vincent J. Angotti, chief executive officer of XenoPort, stated,
“We continue to see strong sales performance, which gives us
confidence that our strategy for HORIZANT revenue growth is
succeeding thus far. Our sales in the quarter were primarily
achieved by approximately 70 NeuroHealth Specialists that have been
in the field since at least October 2014. Our 50 new Specialists,
who joined our team in July, are highly motivated and showing early
signs of productivity. We believe that the 120 territories we now
cover, when fully productive, will allow us to address
approximately 25% of the total market opportunity for the
currently-approved indications for HORIZANT.”
XenoPort Third Quarter and Nine-Month Financial
Results
HORIZANT net product sales increased to $11.0 million for the
third quarter of 2015 compared to $5.6 million for the same period
in 2014, and increased to $25.8 million for the nine months ended
September 30, 2015 compared to $13.5 million for the same period in
2014. Total revenues for the third quarter and nine months ended
September 30, 2015 were $11.4 million and $27.1 million,
respectively, compared to $31.1 million and $39.8 million for the
same periods in 2014. The decrease in total revenues for the three
and nine months ended September 30, 2015 compared to the same
periods in 2014 was primarily due to the recognition of $25.0
million in collaboration revenue resulting from the Indivior PLC
licensing agreement during the third quarter of 2014, partially
offset by an increase in HORIZANT net product sales in the third
quarter and nine months ended September 30, 2015.
Research and development expenses for the third quarter and nine
months ended September 30, 2015 were $6.8 million and $19.4
million, respectively, compared to $6.6 million and $16.5 million
for the same periods in 2014. Research and development expenses
were relatively constant for the third quarter of 2015 compared to
the third quarter of the 2014. The increase in research and
development expenses in the nine months ended September 30, 2015
compared to the same period in 2014 was principally due to
increased net costs for XP23829 primarily due to increased
clinical, toxicology and manufacturing costs, offset in part by a
reduction in personnel costs.
Selling, general and administrative expenses for the third
quarter and nine months ended September 30, 2015 were $27.1 million
and $72.8 million, respectively, compared to $15.6 million and
$53.2 million for the same periods in 2014. The increase in
selling, general and administrative expenses in the third quarter
of 2015 and nine months ended September 30, 2015 compared to the
same periods in 2014 was principally due to costs related to the
continued expansion of commercialization and promotion of
HORIZANT.
Net loss for the third quarter of 2015 was $24.1 million
compared to net income of $8.3 million for the same period in 2014.
Net loss for the nine months ended September 30, 2015 was $69.0
million compared to net loss of $31.7 million for the same period
in 2014. Basic and diluted net loss per share were both $0.38 in
the third quarter of 2015 versus basic and diluted net income per
share of $0.13 for the same period in 2014. For the nine months
ended September 30, 2015, basic and diluted net loss per share were
both $1.10 versus basic and diluted net loss per share of $0.52 for
the same period in 2014.
Financial Guidance
Based on actual results for the nine months ended September 30,
2015 and current trends, XenoPort expects full-year net product
sales of HORIZANT to come in at the lower end of the
previously-established guidance range of $39 million to
$43 million.
Conference Call
XenoPort will host a conference call at 5:00 p.m. Eastern Time
today to discuss its financial results and provide general business
updates. To access the conference call via the Internet, go to
www.XenoPort.com. To access the live conference call via phone,
dial 888-275-3514. International callers may access the live call
by dialing 706-679-1417. The reference number to enter the call is
69703455.
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 855-859-2056 for domestic callers, or 404-537-3406 for
international callers. The reference number to enter the replay of
the call is 69703455.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on
commercializing HORIZANT in the United States. XenoPort has entered
into a clinical trial agreement with the National Institute on
Alcohol Abuse and Alcoholism (NIAAA) under which the NIAAA has
initiated a clinical trial evaluating gabapentin enacarbil as a
potential treatment for alcohol use disorder. REGNITE® (gabapentin
enacarbil) Extended-Release Tablets is being marketed in Japan by
Astellas Pharma Inc. XenoPort 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 other product
candidates include XP23829, a novel fumaric acid ester prodrug that
is a potential treatment for patients with moderate-to-severe
chronic plaque-type psoriasis and for patients with relapsing forms
of multiple sclerosis, and XP21279, a prodrug of levodopa that is a
potential treatment for patients with idiopathic Parkinson's
disease.
To learn more about XenoPort, please visit the Web site at
www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements,
including, without limitation, all statements related to: the
anticipated effects of XenoPort’s commercial strategy, including
its recent sales force expansion, and the growth potential for
HORIZANT; XenoPort’s expectation that full-year net product sales
of HORIZANT will come in at the lower end of its
previously-established guidance range; potential future
opportunities for HORIZANT, including XenoPort’s belief regarding
its ability to address 25% of the total market opportunity for
HORIZANT’s currently-approved indications; XenoPort’s efforts to
seek third-party partners for XP23829 and XP21279; XenoPort’s
anticipated restructuring and severance costs and future cash
savings related to XenoPort’s announced restructuring; and the
therapeutic 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 “anticipates,” “believe,” “expects,” “opportunity,”
“potentially,” “seeking,” “would,” “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 a sales force comprising of both
XenoPort-employed sales representatives and contract sales
representatives, and XenoPort’s reliance on its contract sales
organization 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 risk that
XenoPort may be unable to, or may otherwise be unsuccessful in,
expanding the commercial opportunity for and/or enhancing the value
of HORIZANT; the risk that XenoPort’s restructuring and severance
costs may be greater than currently anticipated and the cost
savings related to its restructuring may be less than currently
anticipated; risks related to the impact of the restructuring on
XenoPort’s business and unanticipated charges not currently
contemplated that may occur as a result of the restructuring; risks
related to XenoPort’s dependence on current and potential future
third-party partners to advance any development of, and to derive
any value from, XenoPort’s product candidates, including the risk
that XenoPort may be unable to enter into future partnering
arrangements to advance the development of its product candidates;
the risk that XenoPort’s product candidates will require
significant additional clinical testing prior to any possible
regulatory approvals and failure could occur at any stage of their
development; the uncertainty of the FDA's review process and other
regulatory requirements that must be satisfied in order to further
the development of XenoPort’s product candidates, if at all; the
uncertain therapeutic and commercial value of XenoPort’s product
candidates; the availability of resources to 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; as well as risks related to future
opportunities and plans, including the uncertainty of anticipated
future HORIZANT sales growth and other financial performance and
results, including with respect to XenoPort’s potential inability
to meet its net product sales guidance for 2015. 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
June 30, 2015, filed with the Securities and Exchange Commission on
August 6, 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.
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
XNPT2F
XENOPORT, INC.
BALANCE SHEETS
(In thousands)
September 30,
December 31,
2015 2014 (Unaudited) Current assets: Cash and
cash equivalents $ 36,337 $ 11,958 Short-term investments 116,055
90,098 Accounts receivable 5,277 2,895 Inventories 2,161 1,458
Prepaids, restricted investments and other current assets
6,826 3,185 Total
current assets 166,656 109,594 Property and equipment, net 2,037
2,422 Long-term inventories 7,788 9,098 Restricted investments and
other assets
105
1,947 Total assets
$
176,586 $ 123,061
Liabilities: Current liabilities $ 20,621 $ 17,788
Convertible senior notes, net 111,640 - Other noncurrent
liabilities
13,702
14,133 Total liabilities
145,963 31,921
Stockholders’ equity: Common stock 63 62 Additional paid-in capital
and other 686,330 677,894 Accumulated deficit
(655,770 ) (586,816
) Total stockholders’ equity
30,623 91,140 Total
liabilities and stockholders’ equity
$
176,586 $ 123,061
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three MonthsEnded September 30,
Nine MonthsEnded September 30,
2015
2014
2015
2014
(In thousands, except per share
amounts)
Revenues: Product sales, net $ 10,968 $ 5,648 $ 25,821 $ 13,525
Collaboration revenue 283 25,284 850 25,850 Royalty revenue
142 136
410 402 Total
revenues
11,393
31,068 27,081
39,777 Operating expenses: Cost of product
sales 666 560 1,626 1,589 Research and development* 6,834 6,641
19,433 16,501 Selling, general and administrative*
27,100 15,555
72,753 53,191 Total
operating expenses
34,600
22,756 93,812
71,281 Income (loss) from operations (23,207 )
8,312 (66,731 ) (31,504 ) Interest income 128 70 395 185 Interest
expense
(985 )
(123 ) (2,618
) (357 ) Net income
(loss)
$ (24,064 )
$ 8,259 $
(68,954 ) $
(31,676 ) Basic and diluted net income
(loss) per share
$ (0.38 )
$ 0.13 $
(1.10 ) $ (0.52
) Shares used to compute basic net income (loss) per
share
63,142 62,219
62,930 60,367
Shares used to compute diluted net income (loss) per share
63,142 62,447
62,930 60,367
* Includes non-cash stock-based
compensation as follows:
Research and development
$ 295 $ 525 $ 1,424 $ 1,849
Selling, general and administrative
2,007 1,520
6,745 5,305
Total non-cash stock-based compensation expense
$
2,302 $ 2,045
$ 8,169 $
7,154
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version on businesswire.com: http://www.businesswire.com/news/home/20151104006634/en/
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
Xenoport, Inc. (NASDAQ:XNPT)
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