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): May
6, 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.)
|
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 May 6, 2015, XenoPort, Inc. issued a press release announcing
financial results for the quarter ended March 31, 2015. 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
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Financial Statements and Exhibits.
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(d) Exhibits.
Exhibit
|
|
Description
|
99.1
|
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Press release, dated May 6, 2015, relating to XenoPort’s financial
results for the quarter ended March 31, 2015.
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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.
|
|
XENOPORT,
INC.
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|
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(Registrant)
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|
|
|
|
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Dated:
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May 6, 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
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Description
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99.1
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Press release, dated May 6, 2015, relating to XenoPort’s financial
results for the quarter ended March 31, 2015.
|
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Exhibit 99.1
XenoPort
Reports First Quarter Financial Results
SANTA CLARA, Calif.--(BUSINESS WIRE)--May 6, 2015--XenoPort, Inc.
(Nasdaq: XNPT) announced today its financial results for the first
quarter ended March 31, 2015. Revenues for the quarter were $7.1
million, compared to $3.4 million for the same period in 2014. Net loss
for the first quarter was $20.4 million, compared to a net loss of $20.5
million for the same period in 2014. At March 31, 2015, XenoPort had
cash and cash equivalents and short-term and long-term investments of
$191.6 million.
Business Updates Since the Start of the First Quarter
-
XenoPort completed enrollment in its Phase 2 clinical trial of XP23829
as a potential treatment for moderate-to-severe chronic plaque-type
psoriasis and reiterated its plans to disclose top-line data from this
trial by the end of the third quarter.
-
XenoPort reached agreement with the Neurology Products Division of the
U.S. Food and Drug Administration (FDA) on the key aspects of its
proposed preclinical and clinical development program for XP23829 as a
potential treatment for relapsing forms of multiple sclerosis (MS).
XenoPort believes that it could proceed with Phase 3 development upon
obtaining supportive data from currently ongoing chronic and
reproductive toxicology studies and the Phase 2 psoriasis study. In
addition, XenoPort believes that a single positive Phase 3 trial could
support the potential submission of a New Drug Application (NDA).
-
XenoPort reported that it now has 48 issued patents worldwide
providing protection to XP23829 and other monomethyl fumarate (MMF)
prodrugs, including composition-of-matter patents covering XP23829 in
Europe, Japan and China, in addition to the United States.
-
Net product sales for HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets were $6.6 million for the first quarter of
2015, an increase of 125% compared to the first quarter of 2014.
-
According to Symphony Health Solutions, the nationwide total of
HORIZANT prescribed tablets for the first quarter of 2015 increased
77% compared to the first quarter of 2014.
-
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 $111.3
million, after deducting the initial purchaser’s discount and offering
expenses payable by XenoPort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
“We are happy to report that we completed discussions with the FDA to
define the critical elements of a proposed development program for the
potential treatment of relapsing forms of MS with XP23829. We also
continue to make good progress advancing our XP23829 development program
with the completion of enrollment in our Phase 2 psoriasis program. Our
psoriasis study is designed to address the important question of the
efficacy of an MMF prodrug other than dimethyl fumarate, and to provide
information on the effect of dose, dosing frequency on efficacy,
tolerability, immune cell modulation and safety of XP23829. We believe
we are on track to deliver top-line results of the psoriasis trial by
the end of the third quarter. This study should enable us to determine
our next steps in development of XP23829 not only for patients with
psoriasis but also as a potential treatment for patients with relapsing
forms of MS.”
Dr. Barrett continued, “We experienced strong year-over-year growth in
HORIZANT net sales. On a sequential quarter basis, we believe that
seasonal effects impacted net sales, similar to last year. Recent
prescription trends have been encouraging and we continue to believe
that HORIZANT net sales for 2015 will be in the range of $39.0 million
to $43.0 million.”
XenoPort First Quarter 2015 Financial Results
Total revenues for the quarter were $7.1 million, compared to $3.4
million for the same period in 2014. The increase in revenues for the
first quarter of 2015 was principally due to HORIZANT net product sales,
which totaled $6.6 million for the quarter compared with $3.0 million
for the same period in 2014.
Research and development expenses for the first quarter of 2015 were
$6.4 million, compared to $4.7 million for the same period in 2014. The
increase in research and development expenses for the first quarter of
2015 was principally due to increased net costs for XP23829 development
primarily due to increased clinical, manufacturing and toxicology costs,
partially offset by decreased personnel costs, which were primarily due
to a reduction in headcount and corresponding decreased non-cash
stock-based compensation.
Selling, general and administrative expenses were $20.1 million for the
first quarter of 2015, compared to $18.8 million for the same period in
2014. The increase in selling, general and administrative expenses for
the first quarter of 2015 compared to the same period in 2014 was
principally due to costs related to the continued and expanded
commercialization of, and promotional activities for, HORIZANT.
Net loss for the first quarter of 2015 was $20.4 million, compared to a
net loss of $20.5 million for the same period in 2014. Basic and diluted
net loss per share were $0.33 for the first quarter of 2015, compared to
basic and diluted net loss per share of $0.36 for the same period in
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 1-706-679-1417.
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 1-855-859-2056 for domestic callers or 1-404-537-3406 for
international callers. The reference number to enter the call and the
replay of the call is 22550328.
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 MS. REGNITE®
(gabapentin enacarbil) Extended-Release Tablets is being marketed in
Japan by Astellas Pharma Inc. XenoPort has entered into a collaboration
with the National Institute on Alcohol Abuse and Alcoholism for the
potential development of HORIZANT as a treatment for alcohol use
disorder and has granted exclusive world-wide rights for the development
and commercialization of its clinical-stage oral product candidate,
arbaclofen placarbil, 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 www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including,
without limitation, all statements related to the XP23829 preclinical
and clinical development program, including XenoPort’s expectations to
disclose top-line Phase 2 psoriasis study results by the end of the
third quarter of 2015, XenoPort’s expectations with respect to the
anticipated benefits of the Phase 2 psoriasis study, and XenoPort’s
beliefs that it could proceed with Phase 3 development of XP23829 as a
potential treatment of relapsing forms of MS upon obtaining supportive
data from chronic and reproductive toxicology studies and that a single
positive Phase 3 trial could support the potential submission of an NDA
with the FDA; the suitability of XP23829 as a potential treatment for
moderate-to-severe chronic plaque type psoriasis and/or relapsing forms
of MS; financial guidance regarding XenoPort's expected HORIZANT net
product sales 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 “believe,” “could,”
“designed,” “plans,” “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 studies 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, initiate or complete clinical trials in the
anticipated timeframes, or at all; the risk that the initiation or
completion of clinical trials for XP23829 may be delayed or terminated
as a result of many factors; 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
uncertainty of the FDA’s review process and other regulatory
requirements; 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 HORIZANT
and XP23829; 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 Securities and Exchange Commission filings
and reports, including in its Annual Report on Form 10-K for the year
ended December 31, 2014, filed with the Securities and Exchange
Commission on February 27, 2015, and its future filings and reports,
including its Quarterly Report on Form 10-Q for the quarter ended March
31, 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.
XNPT2F
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XENOPORT, INC.
BALANCE SHEETS
(Unaudited, in thousands)
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March 31,
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December 31,
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2015
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2014
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Current assets:
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Cash and cash equivalents
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$
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16,898
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$
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11,958
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Short-term investments
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169,220
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90,098
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Accounts receivable
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2,887
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2,895
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Inventories
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1,907
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1,458
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Prepaids and other current assets
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4,002
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|
|
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3,185
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Total current assets
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|
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194,914
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|
|
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109,594
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Long-term investments
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5,516
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-
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Property and equipment, net
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2,299
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2,422
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Long-term inventories
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8,845
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9,098
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Restricted investments and other assets
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1,915
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1,947
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Total assets
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$
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213,489
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$
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123,061
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Liabilities:
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Current liabilities
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$
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15,720
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$
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17,788
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Convertible senior notes, net
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111,419
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-
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Other noncurrent liabilities
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13,983
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|
|
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14,133
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Total liabilities
|
|
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141,122
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|
|
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31,921
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Stockholders’ equity:
|
|
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Common stock
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|
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63
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|
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62
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Additional paid-in capital and other
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679,529
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677,894
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Accumulated deficit
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(607,225
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)
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(586,816
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)
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Total stockholders’ equity
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72,367
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|
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91,140
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Total liabilities and stockholders’ equity
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$
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213,489
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|
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$
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123,061
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|
|
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XENOPORT, INC.
STATEMENTS OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
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Three Months
Ended March 31,
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2015
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2014
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Revenues:
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Product sales, net
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$
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6,639
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$
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2,957
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Collaboration revenue
|
|
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284
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|
|
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283
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Royalty revenue
|
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144
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|
|
|
135
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Total revenues
|
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7,067
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|
|
|
3,375
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Operating expenses:
|
|
|
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Cost of product sales
|
|
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454
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|
|
|
430
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Research and development*
|
|
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6,384
|
|
|
|
4,657
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Selling, general and administrative*
|
|
|
20,099
|
|
|
|
18,771
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Total operating expenses
|
|
|
26,937
|
|
|
|
23,858
|
|
Loss from operations
|
|
|
(19,870
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)
|
|
|
(20,483
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)
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Net interest expense
|
|
|
(539
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)
|
|
|
(65
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)
|
Net loss
|
|
$
|
(20,409
|
)
|
|
$
|
(20,548
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)
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Basic and diluted net loss per share
|
|
$
|
(0.33
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)
|
|
$
|
(0.36
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)
|
Shares used to compute basic and diluted net loss per share
|
|
|
62,722
|
|
|
|
56,887
|
|
|
|
|
|
|
|
|
|
|
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* Includes employee non-cash stock-based compensation as follows:
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Research and development
|
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$
|
382
|
|
|
$
|
702
|
|
Selling, general and administrative
|
|
|
2,289
|
|
|
|
1,982
|
|
Total
|
|
$
|
2,671
|
|
|
$
|
2,684
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CONTACT:
XenoPort, Inc.
Jackie Cossmon, 408-616-7220
ir@XenoPort.com
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