- Full-year 2015 net product sales of
HORIZANT® (gabapentin enacarbil) Extended-Release Tablets increased
96% to $39.5 million
- Total HORIZANT prescribed tablet growth
remained strong at 70% year over year*
XenoPort, Inc. (Nasdaq: XNPT) announced today its financial
results for the fourth quarter and year ended December 31, 2015.
Total revenues for the fourth quarter were $14.1 million compared
to $7.1 million for the same period in 2014. Net loss for the
fourth quarter was $13.4 million compared to a net loss of $17.7
million for the fourth quarter of 2014. At December 31, 2015,
XenoPort had cash and cash equivalents and short-term investments
of $139.5 million.
Business Updates:
- XenoPort achieved strong HORIZANT net
product sales of $13.6 million for the fourth quarter, a 105%
increase over the same period in 2014.
- Total HORIZANT prescribed tablets in
the fourth quarter of 2015 increased 57% compared to the fourth
quarter of 2014.*
- XenoPort recently added approximately
15 new NeuroHealth Specialists to be fully trained and deployed in
the first quarter of 2016. With this deployment, NeuroHealth
Specialists will cover approximately 135 territories in the United
States.
- The National Institute on Alcohol Abuse
and Alcoholism (NIAAA) has enrolled over 50% of approximately 350
patients in its clinical trial of HORIZANT in patients with alcohol
use disorder (AUD). The NIAAA has indicated that it anticipates
reporting top-line results of this study in the first half of
2017.
- XenoPort has been granted patent term
extension by the U.S. Patent and Trademark Office, extending
product-specific exclusivity of its composition-of-matter patent
for HORIZANT into April 2025. There are currently six Orange Book
listed patents for HORIZANT with expiration dates from 2022 to
2029.
Vincent J. Angotti, chief executive officer of XenoPort, stated,
“HORIZANT net sales showed continued strong growth in the fourth
quarter achieving an annualized run rate of over $50 million. Our
success in the fourth quarter further validates our strategy to
drive HORIZANT sales growth and strengthens our belief in our
ability to drive the company to profitability with our current cash
resources.”
XenoPort Fourth Quarter and Year-End 2015 Financial
Results
Total revenues for the fourth quarter of 2015 were $14.1 million
compared to $7.1 million for the fourth quarter of 2014. The
increase in revenues in the fourth quarter of 2015 was principally
due to HORIZANT net product sales, which increased to $13.6 million
for the fourth quarter compared to $6.6 million in the fourth
quarter of 2014.
Total revenues for the year ended December 31, 2015 were $41.2
million compared to $46.9 million for 2014. Revenues for 2014
included recognition of $25.0 million in collaboration revenue
related to an arbaclofen placarbil (AP) licensing agreement with
Indivior UK Ltd. HORIZANT net product sales for 2015 were $39.5
million compared to $20.2 million for 2014.
Research and development expenses for the fourth quarter of 2015
decreased to $3.3 million from $7.2 million for the same period in
2014. The decrease in research and development expenses for the
fourth quarter of 2015 was primarily due to decreased development
costs for XP23829 and decreased personnel costs, resulting from the
company’s decision at the end of the third quarter to cease further
internal development of XP23829 and shift the company’s focus to
commercializing HORIZANT. Research and development expenses for the
year ended December 31, 2015 decreased to $22.7 million from $23.7
million for 2014. The decrease in research and development expenses
for 2015 compared to 2014 was primarily from a reduction in
personnel costs, offset in part by increased net development costs
for XP23829 as well as severance charges related to XenoPort’s
strategic shift to focus on the commercialization of HORIZANT and
discontinue internal development of XP23829.
Selling, general and administrative expenses were $22.5 million
for the fourth quarter of 2015 compared to $17.0 million for the
same period in 2014. Selling, general and administrative expenses
for the year ended December 31, 2015 were $95.3 million compared to
$70.2 million for 2014. The increases in selling, general and
administrative expenses in both the fourth quarter and full-year
2015 were principally due to costs related to the continued and
expanded commercialization and promotion of HORIZANT, which
included increased professional fees and personnel costs. The
increases also included severance charges relating to a reduction
in workforce implemented in the third quarter of 2015 in connection
with the company’s strategic shift, as well as the retirement of
XenoPort’s prior CEO.
Net loss for the fourth quarter of 2015 was $13.4 million
compared to a net loss of $17.7 million for the same period in
2014. Net loss for the year ended December 31, 2015 was $82.3
million compared to a net loss of $49.3 million for 2014. Basic and
diluted net loss per share were $0.21 for the fourth quarter of
2015 compared to basic and diluted net loss per share of $0.28 for
the same period in 2014. For the year ended 2015, basic and diluted
net loss per share were $1.30 compared to basic and diluted net
loss per share of $0.81 for 2014.
Financial Guidance
XenoPort announced that it expects HORIZANT net product sales
for 2016 to be in the range of $61 million to $65 million. XenoPort
expects research and development expenses to be in the range of $4
million to $6 million and selling, general and administrative
expenses to be in the range of $100 million to $110 million, which
includes employee non-cash stock-based compensation of
approximately $10 million. Finally, XenoPort expects that the net
use of cash for 2016 will be in the range of $40 million to $50
million (net use of cash is the difference between the anticipated
balances of cash and cash equivalents plus short-term investments
at December 31, 2016 and the actual balances at December 31,
2015).
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 51661251.
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 51661251.
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 NIAAA under which the
NIAAA has initiated a clinical trial evaluating gabapentin
enacarbil as a potential treatment for patients with AUD. 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, AP, to Indivior 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 or
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 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 results of the NIAAA’s clinical trial and the
timing thereof; the suitability of HORIZANT as a potential
treatment for AUD; XenoPort’s 2016 financial guidance, including
XenoPort’s expected HORIZANT net product sales, research and
development expenses, selling, general and administrative expenses
and net cash usage for 2016; XenoPort’s beliefs regarding projected
continued growth in net product sales for 2016 and the ability to
achieve profitability through the execution of its new strategy in
focusing on the commercialization of HORIZANT using the company’s
current cash resources; 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; 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 HORIZANT may be delayed or terminated as a result of
many factors, including delays in patient enrollment; 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, 2015, filed with the Securities and Exchange
Commission on November 5, 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.
* This information is an estimate derived from the use of
information under license from the following IMS Health information
service: IMS HEALTH – NPA™ (National Prescription Audit Family of
Services) for the periods of 2014 and 2015, and the fourth quarters
of 2014 and 2015. IMS expressly reserves all rights, including
rights of copying, distribution and republication.
XNPT2F
XENOPORT, INC.
BALANCE SHEETS (Unaudited, in thousands)
December 31,
December 31,
2015 2014 Current
assets: Cash and cash equivalents $ 61,317 $ 11,958 Short-term
investments 78,169 90,098 Accounts receivable 6,439 2,895
Inventories 2,068 1,458 Prepaids and other current assets
6,553 3,185 Total
current assets 154,546 109,594 Property and equipment, net 1,792
2,422 Long-term inventories 7,581 9,098 Restricted investments and
other assets
74
1,947 Total assets
$
163,993 $ 123,061
Liabilities: Current liabilities $ 19,284 $ 17,788
Noncurrent liabilities
124,409
14,133 Total liabilities
143,693 31,921
Stockholders’ equity:
Common stock 63 62 Additional paid-in capital and other 689,366
677,894 Accumulated deficit
(669,129
) (586,816 ) Total
stockholders’ equity
20,300
91,140 Total liabilities and stockholders’
equity
$ 163,993 $
123,061
XENOPORT, INC. STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
Three Months
Year
Ended December 31,
Ended December 31,
2015
2014
2015
2014
Revenues: Product sales, net $ 13,638 $ 6,648 $ 39,459 $
20,173 Collaboration revenue 284 284 1,134 26,134 Royalty revenue
157 159
567 561 Total
revenues 14,079 7,091 41,160 46,868 Operating expenses: Cost of
product sales 740 505 2,366 2,094 Research and development* 3,282
7,178 22,715 23,679 Selling, general and administrative*
22,548 17,003
95,301 70,194 Total
operating expenses
26,570
24,686 120,382
95,967 Loss from operations (12,491 )
(17,595 ) (79,222 ) (49,099 ) Net interest expense
(868 ) (62
) (3,091 )
(234 ) Net loss
$
(13,359 ) $
(17,657 ) $
(82,313 ) $
(49,333 ) Basic and diluted net loss per
share
$ (0.21 )
$ (0.28 ) $
(1.30 ) $ (0.81
) Shares used to compute basic and diluted net loss
per share
63,282
62,323 63,193
60,856
* Includes employee non-cash
stock-based compensation as follows:
Research and development
$
213
$
213
$
1,637
$
2,062
Selling, general and administrative
1,796
1,674
8,541
6,979
Total
$
2,009
$
1,887
$
10,178
$
9,041
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160225006511/en/
XenoPort, Inc.Jackie Cossmon, 408-616-7220ir@XenoPort.com
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