XenoPort, Inc. (Nasdaq:XNPT) announced today its financial
results for the fourth quarter and year ended December 31, 2014.
Revenues for the fourth quarter were $7.1 million compared to $2.9
million for the same period in 2013. Net loss for the fourth
quarter was $17.7 million compared to a net loss of $19.1 million
for the fourth quarter of 2013. At December 31, 2014, XenoPort had
cash and cash equivalents and short-term investments of $102.1
million.
XenoPort Business Updates
The following key events occurred since the beginning of the
fourth quarter of 2014:
- Net product sales for HORIZANT®
(gabapentin enacarbil) Extended-Release Tablets were $6.6 million
for the fourth quarter, an increase of 143% compared to the fourth
quarter of 2013 and an increase of 18% compared to the third
quarter of 2014.
- According to Symphony Health Solutions,
the nationwide total of HORIZANT prescribed tablets for the fourth
quarter increased by 94% compared to the fourth quarter of 2013 and
17% compared to the third quarter of 2014.*
- XenoPort has continued to expand the
HORIZANT NeuroHealth Sales team and is now promoting HORIZANT in
approximately 70 territories in the United States.
- XenoPort and the National Institute on
Alcohol Abuse and Alcoholism (NIAAA) conducted a
pre-investigational new drug (pre-IND) meeting with the U.S. Food
and Drug Administration (FDA). Based on the meeting, XenoPort
believes that the FDA has accepted the NIAAA’s design of a clinical
trial of HORIZANT as a potential treatment for alcohol use disorder
(AUD). In addition, XenoPort believes that it may be possible for
this proposed clinical trial to support a potential supplemental
new drug application (sNDA) for HORIZANT as a potential treatment
for AUD, if the results from the trial are robust and compelling
and if there is additional confirmatory evidence from the
literature or other sources to support the findings.
- The NIAAA gained clearance for its IND
and plans to commence its proposed clinical trial in the second
quarter of 2015. It is currently anticipated that results from this
trial may be available by the end of 2016.
- 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 approximately $111.4 million, after
deducting the initial purchaser’s discount and estimated offering
expenses payable by XenoPort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “The XenoPort team made great progress on our strategic
objectives for 2014. We built value in HORIZANT by demonstrating
the promotional sensitivity of HORIZANT and growing sales
substantially. We advanced development of XP23829 into Phase 2 and
expect top-line data by the end of the third quarter this year. We
believe that our completed agreements with Indivior PLC for
arbaclofen placarbil and the NIAAA for HORIZANT create the
potential to advance the development of new therapies for AUD,
while creating additional value for our stockholders.”
Dr. Barrett continued, “The recent financing should allow us to
continue to execute our strategy, as we plan to expand our HORIZANT
educational efforts, including increasing the size of our
NeuroHealth Sales team. We also plan to accelerate certain
development activities for XP23829 that we hope will minimize the
time to initiating potential Phase 3 studies and a potential NDA
submission for XP23829.”
XenoPort Fourth Quarter and Year-End 2014 Financial
Results
Revenues for the fourth quarter and year ended December 31, 2014
were $7.1 million and $46.9 million, respectively, compared to $2.9
million and $8.0 million for the same periods in 2013. The increase
in revenues in the fourth quarter ended December 31, 2014 was
principally due to HORIZANT net product sales. The increase in
revenues for the year ended December 31, 2014 was principally due
both to the recognition of $25.0 million in collaboration revenue
related to an arbaclofen placarbil (AP) licensing agreement with
Indivior, as well as to increased HORIZANT net product sales.
HORIZANT net product sales totaled $6.6 million for the fourth
quarter of 2014 compared to $2.7 million for the fourth quarter of
2013 and $20.2 million for the year ended December 31, 2014
compared to $6.4 million for 2013.
Research and development expenses for the fourth quarter of 2014
increased to $7.2 million from $3.7 million for the same period in
2013. The increase in research and development expenses for the
fourth quarter of 2014 was principally due to increased net costs
for XP23829, primarily due to increased clinical, toxicology and
manufacturing costs. Research and development expenses for the year
ended December 31, 2014 decreased to $23.7 million from $33.3
million for 2013. The decrease in research and development expenses
for 2014 compared to 2013 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 relatively
constant at $17.0 million for the fourth quarter of 2014 compared
to $17.6 million for the same period in 2013. Selling, general and
administrative expenses for the year ended year ended December 31,
2014 were $70.2 million compared to $59.1 million for 2013. The
increase in selling, general and administrative expenses in 2014
compared to 2013 was principally due to costs related to the
commercialization and promotion of HORIZANT, which included
increased professional fees and personnel costs.
Net loss for the fourth quarter of 2014 was $17.7 million
compared to a net loss of $19.1 million for the same period in
2013. Net loss for the year ended December 31, 2014 was $49.3
million compared to a net loss of $85.9 million for 2013. Basic and
diluted net loss per share were $0.28 for the fourth quarter of
2014 compared to basic and diluted net loss per share of $0.40 for
the same period in 2013. For the year ended 2014, basic and diluted
net loss per share were $0.81 compared to basic and diluted net
loss per share of $1.81 for 2013.
Financial Guidance
XenoPort announced that it expects HORIZANT net product sales
for 2015 to be in the range of $39.0 million to $43.0 million and
the net use of cash for 2015 to be in the range of $75.0 million to
$85.0 million (net use of cash is the difference between the
anticipated balances of cash and cash equivalents plus short-term
investments at December 31, 2015, excluding the net proceeds from
the sale of the convertible notes completed in February 2015, and
the actual balances at December 31, 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 706-679-1417. The reference number
to enter the call is 77034895.
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 77034895.
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 multiple sclerosis. REGNITE® (gabapentin
enacarbil) Extended-Release Tablets is being marketed in Japan by
Astellas Pharma Inc. XenoPort granted exclusive world-wide rights
for the development and commercialization of its clinical-stage
oral product candidate, AP, 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 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, promotional efforts and value proposition
for HORIZANT; the potential clinical development of HORIZANT by the
NIAAA, including the initiation, conduct and results of the NIAAA’s
proposed clinical trial and the timing thereof; the suitability of
HORIZANT as a potential treatment for AUD; XenoPort’s beliefs
regarding the design of NIAAA’s proposed clinical trial and its
potential to support a potential sNDA for HORIZANT as a potential
treatment for AUD; the XP23829 clinical development program,
including XenoPort’s expectations to obtain top-line Phase 2
XP23829 study results by the end of the third quarter of 2015, to
accelerate and advance XP23829 into Phase 3 development and to
potentially submit an NDA to the FDA for XP23829; the suitability
of XP23829 as a potential treatment for moderate-to-severe plaque
psoriasis and/or relapsing forms of multiple sclerosis; XenoPort’s
2015 financial guidance, including XenoPort’s expected HORIZANT net
product sales and net cash usage 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 “anticipated,” “believes,” “expect,” “hope,” “may,”
“plans,” “possible,” “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 trials 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 or initiate clinical trials in the
anticipated timeframes, or at all; the NIAAA’s ability to
successfully conduct the proposed clinical trial of HORIZANT in the
anticipated timeframe, or at all; the risk that the initiation or
completion of clinical trials for XP23829 or HORIZANT 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 risk that XenoPort and/or the NIAAA may be
required to conduct significant additional clinical testing of
HORIZANT prior to any HORIZANT label expansion to include the AUD
indication; the uncertainty of the FDA’s review process and other
regulatory requirements; the risk that even if HORIZANT is approved
for the treatment of AUD, XenoPort may be unable to, or may
otherwise be unsuccessful in, expanding the commercial opportunity
for HORIZANT; 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 XenoPort’s product candidates;
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 Quarterly Report on Form 10-Q
for the quarter ended September 30, 2014, filed with the Securities
and Exchange Commission on November 5, 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.
HORIZANT, REGNITE and XENOPORT are registered trademarks of
XenoPort, Inc.
XNPT2F
* Source: Symphony Health Solutions, PrescriberSource Weekly,
10/01/2013 through 12/31/14
XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
December 31,2014
December 31,2013
Current assets: Cash and cash equivalents $ 11,958 $ 20,584
Short-term investments 90,098 38,074 Accounts receivable 2,895 939
Inventories 1,458 1,262 Prepaids and other current assets
3,185 2,826 Total
current assets 109,594 63,685 Property and equipment, net 2,422
2,552 Long-term inventories 9,098 10,185 Restricted investments and
other assets
1,947
2,119 Total assets
$
123,061 $ 78,541
Liabilities: Current liabilities $ 17,788 $ 10,069
Noncurrent liabilities
14,133
14,779 Total liabilities
31,921 24,848
Stockholders’ equity (deficit): Common stock 62 48 Additional
paid-in capital and other 677,894 591,128 Accumulated deficit
(586,816 )
(537,483 ) Total stockholders’ equity
91,140 53,693
Total liabilities and stockholders’ equity
$
123,061 $ 78,541
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per
share amounts)
Three Months
Ended December 31,
Year
Ended December 31,
2014
2013
2014
2013
Revenues: Product sales, net $ 6,648 $ 2,737 $ 20,173 $ 6,414
Collaboration revenue 284 - 26,134 1,137 Royalty revenue
159 142
561 400 Total revenues
7,091 2,879 46,868 7,951 Operating expenses: Cost of product sales
505 616 2,094 1,170 Research and development* 7,178 3,689 23,679
33,325 Selling, general and administrative*
17,003 17,633
70,194 59,084 Total
operating expenses
24,686
21,938 95,967
93,579 Loss from operations (17,595 ) (19,059 )
(49,099 ) (85,628 ) Net interest expense
(62
) (79 )
(234 ) (255 )
Net loss
$ (17,657 )
$ (19,138 ) $
(49,333 ) $ (85,883
) Basic and diluted net loss per share
$
(0.28 ) $ (0.40
) $ (0.81 )
$ (1.81 ) Shares used to compute basic
and diluted net loss per share
62,323
47,768 60,856
47,545
* Includes employee non-cash stock-based
compensation as follows:
Research and development $ 213 $ 536 $ 2,062 $ 3,059
Selling, general and administrative
1,674
1,700 6,979
7,485 Total
$ 1,887
$ 2,236 $
9,041 $ 10,544
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
Xenoport, Inc. (NASDAQ:XNPT)
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