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): February
13, 2015
XENOPORT,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation)
000-51329
|
94-3330837
|
(Commission File No.)
|
(IRS Employer 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
N/A
(Former
name or former address, if changed since last report.)
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 (see General Instruction A.2.
below):
⃞
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 February 19, 2015, XenoPort, Inc. (the “Company”) issued a press
release announcing financial results for the fourth quarter and year
ended December 31, 2014. A copy of such press release is furnished
herewith as Exhibit 99.1 and is incorporated herein by reference.
The information in Item 2.02 of 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 in this Item 2.02 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 5 – Corporate Governance and Management
Item 5.02
|
Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers.
|
On February 13, 2015, Gianna M. Bosko notified the Company of her
decision to resign from her position as senior vice president, chief
legal officer and secretary of the Company, effective as of February 28,
2015. Pursuant to a consulting agreement, made effective March 1, 2015,
Ms. Bosko will be available through March 1, 2016 (the “Consultancy
Period”) to provide additional consulting services to the Company in the
field of general legal, corporate governance and business matters, at a
rate of $500.00 per hour. During the Consultancy Period, the equity
awards previously granted to Ms. Bosko pursuant to the Company’s equity
incentive plans will continue in accordance with their existing terms,
though the vesting of such equity awards will terminate as of February
28, 2015.
Section 9 – Financial Statements and Exhibits
Item 9.01
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Financial Statements and Exhibits.
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Exhibit
|
|
Description
|
|
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99.1
|
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Press release, dated February 19, 2015, relating to XenoPort’s
financial results for the fourth quarter and year ended December 31,
2014.
|
|
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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|
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(Registrant)
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|
|
|
|
|
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Dated:
|
February 19, 2015
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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
|
|
Description
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99.1
|
|
Press release, dated February 19, 2015, relating to XenoPort’s
financial results for the fourth quarter and year ended December
31, 2014.
|
|
Exhibit 99.1
XenoPort
Reports Fourth Quarter and Year-End 2014 Financial Results
SANTA CLARA, Calif.--(BUSINESS WIRE)--February 19, 2015--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
|
|
|
|
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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
|
|
CONTACT:
XenoPort, Inc.
Jackie Cossmon, 408-616-7220
ir@XenoPort.com
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