Reports Significant Year-Over-Year HORIZANT
Sales Growth
XenoPort, Inc. (Nasdaq: XNPT) announced today financial results
for the third quarter and nine months ended September 30, 2014.
Revenues for the third quarter were $31.1 million compared to $2.5
million for the same period in 2013. Revenues for the third quarter
included $25.0 million in collaboration revenue resulting from
XenoPort’s license agreement with Reckitt Benckiser
Pharmaceuticals, Inc. Net income for the third quarter was $8.3
million compared to a net loss of $18.8 million for the same period
in 2013. At September 30, 2014, XenoPort had cash, cash equivalents
and short-term investments of $113.4 million.
XenoPort Business Updates
The following key events occurred since the beginning of the
third quarter of 2014:
- Net product sales for HORIZANT®
(gabapentin enacarbil) Extended-Release Tablets were $5.6 million
for the third quarter, an increase of 177% compared to the third
quarter of 2013 and 15% compared to the second quarter of
2014.
- The nationwide total of HORIZANT
prescribed tablets for the third quarter increased by 110% compared
to the third quarter of 2013 and 17% compared to the second quarter
of 2014.
- In October, XenoPort completed
expansion of the HORIZANT NeuroHealth Sales team and is now
promoting HORIZANT in approximately 65 territories in the United
States.
- XenoPort announced an agreement with
the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
under which the NIAAA will conduct a clinical trial of HORIZANT as
a potential treatment for alcohol use disorder (AUD). Under the
terms of the agreement, XenoPort will supply clinical trial
material and the NIAAA will conduct and pay all other expenses
associated with the proposed clinical trial of HORIZANT. XenoPort
will have access to study results generated under the proposed
clinical trial to support any potential regulatory filings for
HORIZANT as a potential treatment for AUD.
- XenoPort presented XP23829 data at the
2014 Joint ACTRIMS-ECTRIMS Meeting in Boston. Data included the
results from a clinical trial evaluating the safety, tolerability
and pharmacokinetics of XP23829, an investigational prodrug of
monomethyl fumarate (MMF).
- In connection with its license
agreement with Reckitt, XenoPort recognized revenue of $25.0
million in the third quarter of 2014, of which a $5.0 million
payment was received in July 2014 after the delivery of specified
materials to Reckitt.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort,
stated, “We are excited by the progress we made in the third
quarter in both our development and commercial programs. Enrollment
of patients in our Phase 2 XP23829 clinical trial is proceeding
according to plan, with an estimated availability of top-line data
in the third quarter of 2015. Our efforts to educate healthcare
providers and patients about HORIZANT are yielding continued
prescription and revenue growth. With the expanded HORIZANT sales
effort in place as of October 1, we anticipate continued growth of
HORIZANT sales.”
Dr. Barrett continued, “We are also gratified that the NIAAA has
chosen to study HORIZANT as a potential treatment for AUD, a
disorder that affects millions of patients in the U.S. Success in
potentially obtaining regulatory approval for this indication could
lead to meaningful expansion of the commercial opportunity for
HORIZANT.”
XenoPort Third Quarter and Nine-Month Financial
Results
Revenues for the third quarter and nine months ended September
30, 2014 were $31.1 million and $39.8 million, respectively,
compared to $2.5 million and $5.1 million for the same periods in
2013. The increase in total revenues for the three and nine months
ended September 30, 2014, compared to the same periods in 2013, was
primarily due to the recognition of $25.0 million in collaboration
revenue resulting from the Reckitt licensing agreement during the
third quarter of 2014. The increases were also due to increased
HORIZANT net product sales. HORIZANT net product sales increased to
$5.6 million for the third quarter of 2014 compared to $2.0 million
for the third quarter of the prior year and increased to $13.5
million for the nine months ended September 30, 2014 compared to
$3.7 million for the same period of the prior year.
Research and development expenses for the third quarter and nine
months ended September 30, 2014 were $6.6 million and $16.5
million, respectively, compared to $6.0 million and $29.6 million
for the same periods in 2013. Research and development expenses
were relatively constant for the third quarter of 2014 compared to
the third quarter of the prior year. The decrease in research and
development expenses in the nine months ended September 30, 2014,
compared to the same period in 2013, was due to decreased net costs
for arbaclofen placarbil (AP), resulting primarily from the
termination of further development of AP as a potential treatment
for spasticity in patients with multiple sclerosis (MS) in 2013, as
well as decreased personnel costs, partially offset by increased
net costs for XP23829 development.
Selling, general and administrative expenses for the third
quarter and nine months ended September 30, 2014 were $15.6 million
and $53.2 million, respectively, compared to $14.9 million and
$41.5 million for the same periods in 2013. Selling, general and
administrative expenses were relatively constant for the third
quarter of 2014 compared to the third quarter of the prior year.
The increase in selling, general and administrative expenses in the
nine months ended September 30, 2014, compared to the same period
in 2013, was principally due to costs related to the
commercialization and promotion of HORIZANT.
Net income for the third quarter of 2014 was $8.3 million
compared to a net loss of $18.8 million for the same period in
2013. Net loss for the nine months ended September 30, 2014 was
$31.7 million compared to a net loss of $66.7 million for the same
period in 2013. Basic and diluted net income per share were both
$0.13 in the third quarter of 2014 versus basic and diluted net
loss per share of $0.39 for the same period in the prior year. For
the nine months ended September 30, 2014, basic and diluted net
loss per share were both $0.52 versus basic and diluted net loss
per share of $1.41 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 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
15141774.
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 15141774. Dial-in access to the replay of the call will
be available for approximately one week, and the Internet replay of
the call will be available for approximately one month following
the live call.
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/or relapsing
forms of MS. 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,
arbaclofen placarbil, to Reckitt Benckiser Pharmaceuticals, Inc.
for all indications. XenoPort's pipeline of product candidates also
includes a potential treatment for patients with 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 potential
clinical development of HORIZANT by the NIAAA; the suitability of
HORIZANT as a potential treatment for AUD; any potential regulatory
filings and approval for HORIZANT as a potential treatment for AUD;
anticipated continued growth of HORIZANT sales and the potential
expansion of the commercial opportunity for HORIZANT; the estimated
availability of top-line Phase 2 XP23829 clinical data in the third
quarter of 2015; the suitability of XP23829 as a potential
treatment for moderate-to-severe chronic plaque-type psoriasis
and/or relapsing forms of MS; 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 “anticipate,” “could,” “estimated,” “plan,”
“potential,” “proposed,” “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 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 may conduct; XenoPort’s ability to successfully advance
XP23829 development and to conduct 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 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 U.S. Food and Drug Administration’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;
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 Quarterly Report on
Form 10-Q for the quarter ended June 30, 2014, filed with the
Securities and Exchange Commission on August 7, 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
XENOPORT, INC.
BALANCE SHEETS
(In thousands)
September 30,
December 31,
2014 2013 (Unaudited) Current
assets: Cash and cash equivalents $ 21,853 $ 20,584 Short-term
investments 91,519 38,074 Accounts receivable 2,355 939 Inventories
1,295 1,262 Prepaids, restricted investments and other current
assets
5,039 2,826
Total current assets 122,061 63,685 Property and equipment,
net 2,370 2,552 Long-term inventories 9,488 10,185 Restricted
investments and other assets
175
2,119 Total assets
$
134,094 $ 78,541
Liabilities: Current liabilities $ 14,020 $ 10,069
Noncurrent liabilities
14,286
14,779 Total liabilities
28,306 24,848
Stockholders’ equity: Common stock 62 48 Additional paid-in capital
and other 674,885 591,128 Accumulated deficit
(569,159 ) (537,483
) Total stockholders’ equity
105,788 53,693 Total
liabilities and stockholders’ equity
$
134,094 $ 78,541
XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months
Ended September
30,
Nine Months
Ended September
30,
2014
2013
2014
2013 (In thousands, except per share
amounts) Revenues: Product sales, net $ 5,648 $ 2,037 $ 13,525
$ 3,677 Collaboration revenue 25,284 379 25,850 1,137 Royalty
revenue
136 111
402 258
Total revenues
31,068
2,527 39,777
5,072 Operating expenses: Cost of product sales
560 305 1,589 554 Research and development* 6,641 6,047 16,501
29,636 Selling, general and administrative*
15,555 14,928
53,191 41,451 Total
operating expenses
22,756
21,280 71,281
71,641 Income (loss) from operations 8,312
(18,753 ) (31,504 ) (66,569 ) Interest income 70 43 185 182
Interest expense
(123 )
(106 ) (357
) (358 ) Net income
(loss)
$ 8,259 $
(18,816 ) $
(31,676 ) $
(66,745 ) Basic and diluted net income
(loss) per share
$ 0.13
$ (0.39 ) $
(0.52 ) $ (1.41
) Shares used to compute basic net income (loss) per
share
62,219 47,691
60,367 47,471
Shares used to compute diluted net income (loss) per share
62,447 47,691
60,367 47,471
* Includes employee non-cash
stock-based compensation as follows:
Research
and development
$
525
$
618
$
1,849
$
2,523
Selling, general and administrative
1,520
1,851
5,305
5,785
Total non-cash stock-based compensation
expense
$
2,045
$
2,469
$
7,154
$
8,308
Company Contact:XenoPort, Inc.Jackie Cossmon,
408-616-7220ir@XenoPort.com
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