UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT REPORT
PURSUANT TO SECTION 13
OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): November 4, 2014
XENOPORT,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
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000-51329
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94-3330837
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(State or Other Jurisdiction
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(Commission
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(IRS Employer
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of Incorporation)
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File Number)
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Identification No.)
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3410 Central Expressway
Santa Clara, California 95051
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(Address
of Principal Executive Offices) (Zip Code)
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Registrant’s
telephone number, including area code: (408) 616-7200
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Section 2 – Financial Information
Item 2.02 Results of Operations and Financial Condition.
On November 4, 2014, XenoPort, Inc. issued a press release announcing
financial results for the quarter ended September 30, 2014. A copy of
such press release is furnished herewith as Exhibit 99.1 and is
incorporated herein by reference.
The information in this Current Report on Form 8-K, including the
exhibit hereto, shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that Section or Sections 11 and
12(a)(2) of the Securities Act of 1933, as amended. The information
contained herein and in the accompanying exhibit shall not be
incorporated by reference into any filing with the U.S. Securities and
Exchange Commission made by XenoPort, whether made before or after the
date hereof, regardless of any general incorporation language in such
filing.
Section 9 – Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
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Description
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99.1
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Press release, dated November 4, 2014, relating to XenoPort’s
financial results for the quarter ended September 30, 2014.
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SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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XENOPORT,
INC.
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(Registrant)
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Dated:
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November 4, 2014
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By:
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/s/ William G. Harris
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William G. Harris
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Senior Vice President of Finance and Chief Financial Officer
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EXHIBIT INDEX
Exhibit
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|
Description
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99.1
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Press release, dated November 4, 2014, relating to XenoPort's
financial results for the quarter ended September 30, 2014.
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Exhibit 99.1
XenoPort
Reports Third Quarter Financial Results
Reports
Significant Year-Over-Year HORIZANT Sales Growth
SANTA CLARA, Calif.--(BUSINESS WIRE)--November 4, 2014--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
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XENOPORT, INC.
|
BALANCE SHEETS
(In thousands)
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
September 30,
|
|
|
|
|
|
|
December 31,
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|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
2013
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
21,853
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|
|
|
|
|
|
|
$
|
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
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|
|
|
|
|
|
|
|
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
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|
Total assets
|
|
|
|
|
$
|
134,094
|
|
|
|
|
|
|
|
$
|
78,541
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
$
|
14,020
|
|
|
|
|
|
|
|
$
|
10,069
|
|
Noncurrent liabilities
|
|
|
|
|
|
14,286
|
|
|
|
|
|
|
|
|
14,779
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|
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
|
|
|
|
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|
|
2013
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|
|
|
|
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|
(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
|
|
CONTACT:
Company Contact:
XenoPort, Inc.
Jackie Cossmon,
408-616-7220
ir@XenoPort.com
Xenoport, Inc. (NASDAQ:XNPT)
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