CORRECTING and REPLACING XenoPort Reports Second Quarter Financial Results

  CORRECTING and REPLACING XenoPort Reports Second Quarter Financial Results

CORRECTION...by XenoPort

Business Wire

SANTA CLARA, Calif. -- August 6, 2013

In XenoPort Business Updates section, second sentence of third bullet point
should read: Results of thirteen-week toxicology studies... (sted Results of
six-month toxicology studies...)

The corrected release reads:

              XENOPORT REPORTS SECOND QUARTER FINANCIAL RESULTS

XenoPort, Inc. (Nasdaq: XNPT) announced today financial results for the second
quarter and six months ended June 30, 2013. Revenues for the second quarter
were $2.1 million, compared to $10.4 million for the same period in 2012. Net
loss for the second quarter was $24.4 million, compared to a net loss of $8.0
million for the same period in 2012. At June 30, 2013, XenoPort had cash, cash
equivalents and short-term investments of $93.4 million.

XenoPort Business Updates

The following key events occurred since the beginning of the second quarter of
2013:

  *On May 1, XenoPort completed the reacquisition of the exclusive rights to
    commercialize Horizant^® (gabapentin enacarbil) Extended-Release Tablets
    in the United States from Glaxo Group Limited (GSK). XenoPort’s full
    promotional plan commenced upon product availability in June.
  *XenoPort announced the inclusion of gabapentin enacarbil, the active
    ingredient in Horizant, as a first-line therapy in new treatment
    guidelines created by the Task Force of the International Restless Legs
    Syndrome Study Group (IRLSSG) and published in Sleep Medicine (Vol 14; p
    675; 2013). Horizant is the only non-dopamine agonist and the only
    alpha-2-delta ligand approved by the U.S. Food and Drug Administration
    (FDA) for the treatment of moderate-to-severe primary restless legs
    syndrome in adults (RLS).
  *XenoPort continued to advance the development of its novel fumarate
    compound, XP23829. Results of thirteen-week toxicology studies, a Phase 1
    radiolabeled XP23829 metabolism and disposition study and a Phase 1
    multiple ascending dose study that is examining the pharmacokinetics of
    two formulations of XP23829 and Tecfidera™ (dimethyl fumarate) at its
    approved dose, are expected later in the third quarter of 2013.

  *XenoPort completed a Phase 3 clinical trial of arbaclofen placarbil (AP)
    as a potential treatment of spasticity in patients with multiple sclerosis
    (MS). The trial was unsuccessful in demonstrating that AP provided
    statistically significant improvement relative to placebo in the
    co-primary endpoints of the study. As a result, XenoPort decided to
    terminate further investment in AP as a treatment for spasticity in
    patients with MS.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated,
“Working with GSK to correct its prior product stockout and then our relaunch
of Horizant were key accomplishments for the quarter, and I am happy that
Horizant is now broadly available to adult patients with moderate-to-severe
primary restless legs syndrome and postherpetic neuralgia (PHN). We hope that
our focused commercial plan will establish a successful template for
commercializing Horizant. We believe that there is a clear need for a
non-dopaminergic treatment for RLS and were gratified to see Horizant included
as a first-line treatment in the IRLSSG guidelines for restless legs syndrome.
We have also been receiving positive feedback from physicians as we introduce
them to the unique attributes of Horizant for the management of PHN.”

Dr. Barrett continued, “We look forward to the results of our current XP23829
studies. In addition, we are working on scaling up the production of XP23829
and plan to consult with regulatory authorities later this year in preparation
for potential further clinical development.”

XenoPort Second Quarter and Six-Month Financial Results

Total revenues for the second quarter and six months ended June 30, 2013 were
$2.1 million and $2.5 million, respectively, compared to $10.4 million and
$20.8 million, respectively, for the same periods in 2012. The decrease in
revenues in the second quarter of 2013 compared to the same quarter in the
prior year was due to the receipt and recognition of a $10.0 million payment
from GSK under XenoPort’s previous collaboration agreement with GSK in
connection with the approval of Horizant for the management of PHN in adults
in the second quarter of 2012, partially offset by Horizant net product sales
and Regnite^® (gabapentin enacarbil) Extended-Release Tablets royalty revenue
from Astellas Pharma Inc. in Japan. The decrease in revenues for the six
months ended June 30, 2013 compared to the same period in the prior year was
due to the receipt and recognition of both the $10.0 million payment from GSK
under our previous collaboration agreement and a $10.0 million milestone
payment from Astellas in connection with the approval of Regnite in Japan in
2012.

Research and development expenses for the second quarter and six months ended
June 30, 2013 were consistent with the same periods in 2012 and were $10.2
million and $23.6 million, respectively, compared to $10.8 million and $23.0
million, respectively, for the same periods in 2012.

Selling, general and administrative expenses for the second quarter and six
months ended June 30, 2013 were $15.8 million and $26.5 million, respectively,
compared to $7.6 million and $15.0 million, respectively, for the same periods
in 2012. The increase in selling, general and administrative expenses in both
the second quarter and six months ended June 30, 2013 compared to the same
periods in 2012 was principally due to increased professional fees, marketing
and sales costs and compensation and benefits costs associated with XenoPort’s
commercialization efforts for Horizant.

Net loss for the second quarter of 2013 was $24.4 million, compared to a net
loss of $8.0 million for the same period in 2012. Net loss for the six months
ended June 30, 2013 was $47.9 million, compared to a net loss of $17.1 million
for the same period in 2012. Basic and diluted net loss per share were both
$0.51 in the second quarter of 2013 versus basic and diluted net loss per
share of $0.22 for the same period in the prior year. For the six-month period
ended June 30, 2013, basic and diluted net loss per share were both $1.01
versus basic and diluted net loss per share of $0.48 for the same period in
2012.

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 of 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 25662889.

The replay of the conference call will be available for one week and 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
404-537-3406 for international callers. The reference number to enter the
replay of the call is 25662889.

Information about Horizant

Horizant^® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS: Horizant^® (gabapentin enacarbil) Extended-Release Tablets are
indicated for the treatment of moderate-to-severe primary Restless Legs
Syndrome (RLS) in adults.

Horizant is not recommended for patients who are required to sleep during the
daytime and remain awake at night.

Horizant^® (gabapentin enacarbil) Extended-Release Tablets are indicated for
the management of postherpetic neuralgia (PHN) in adults.

CONTRAINDICATION: None.

HORIZANT IMPORTANT SAFETY INFORMATION

Effects on Driving

Horizant may cause significant driving impairment. Patients should not drive
until they have enough experience on Horizant to know if it impairs their
driving. Patients’ ability to assess their driving competence and degree of
somnolence caused by Horizant can be imperfect.

Somnolence/Sedation and Dizziness

Horizant causes somnolence/sedation and dizziness. Patients should not drive
or operate other complex machinery until they have enough experience on
Horizant to know if it impairs their ability to perform these tasks.

Lack of Interchangeability With Gabapentin

Horizant is not interchangeable with other gabapentin products because of
differing pharmacokinetic profiles. The same dose of Horizant results in
different plasma concentrations of gabapentin relative to other gabapentin
products. The safety and effectiveness of Horizant in patients with epilepsy
have not been studied.

Suicidal Behavior and Ideation

Horizant is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs
increase the risk of suicidal thoughts or behavior in patients taking these
drugs for any indication. As a prodrug of gabapentin, Horizant also increases
this risk. Patients treated with any AED for any indication should be
monitored for new or worsening depression, suicidal thoughts or behavior,
and/or any unusual changes in mood or behavior. Anyone considering prescribing
Horizant must balance the risk of suicidal thoughts or behavior with the risk
of untreated illness.

Patients, caregivers, and families should be informed that Horizant increases
the risk of suicidal thoughts and behavior and should be advised of the need
to be alert for new or worsening signs of and symptoms of depression, any
unusual changes in mood or behavior, or the emergence of suicidal thoughts,
behavior, or thoughts of self-harm. Behaviors of concern should be reported
immediately to healthcare providers

Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan
Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as
multiorgan hypersensitivity, has been reported in patients taking
antiepileptic drugs, including gabapentin. Horizant is a prodrug of
gabapentin. Some of these events have been fatal or life-threatening. DRESS
typically, although not exclusively, presents with fever, rash, and/or
lymphadenopathy, in association with other organ system involvement, such as
hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis
sometimes resembling an acute viral infection. Eosinophilia is often present.
Because this disorder is variable in its expression, other organ systems not
noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as
fever or lymphadenopathy, may be present even though rash is not evident. If
such signs or symptoms are present, the patient should be evaluated
immediately. Horizant should be discontinued if an alternative etiology for
the signs or symptoms cannot be established.

Discontinuation of Horizant

When discontinuing Horizant, patients with RLS receiving 600 mg or less once
daily can discontinue the drug without tapering. If the recommended dose is
exceeded, the dose should be reduced to 600 mg daily for 1 week prior to
discontinuation to minimize the potential of withdrawal seizure.

In patients with PHN receiving Horizant twice daily, the dose should be
reduced to once daily for 1 week prior to discontinuation to minimize the
potential of withdrawal seizure.

Tumorigenic Potential

In an oral carcinogenicity study, gabapentin enacarbil increased the incidence
of pancreatic acinar cell adenoma and carcinoma in male and female rats. The
clinical significance of this finding is unknown.

ADVERSE REACTIONS

The most common adverse reactions for patients with RLS receiving Horizant 600
mg, 1,200 mg, and placebo, respectively, were somnolence/sedation (20%, 27%,
and 6%), dizziness (13%, 22%, and 4%), headache (12%, 15%, and 11%), nausea
(6%, 7%, and 5%), and fatigue (6%, 7%, and 4%). A daily dose of 1,200 mg
provided no additional benefit compared with the 600-mg dose, but caused an
increase in adverse reactions.

The most common adverse reactions for patients with PHN taking Horizant 1,200
mg and placebo, respectively, were dizziness (17% and 15%),
somnolence/sedation (10% and 8%), headache (10% and 9%), nausea (8% and 5%),
and fatigue (6% and 1%).

A daily dose greater than 1,200 mg/day provided no additional benefit, but
caused an increase in adverse reactions.

DRUG INTERACTIONS

Gabapentin enacarbil is released faster from Horizant Extended-Release tablets
in the presence of alcohol. Consumption of alcohol is not recommended when
taking Horizant. Horizant taken in conjunction with morphine causes increased
somnolence/sedation, dizziness, and nausea.

USE IN SPECIAL POPULATIONS

Pregnancy and Lactation

Based on animal data, Horizant may cause fetal harm. There are no adequate and
well-controlled studies of Horizant in pregnant women. Horizant should be used
during pregnancy only if potential benefit justifies potential risk to fetus.

Horizant is converted to gabapentin, which is secreted into human milk.
Discontinue nursing or discontinue Horizant, taking into account the
importance of Horizant to the mother, due to potential for adverse reactions
in nursing infants.

Renal Impairment

In patients with RLS who have compromised renal function, Horizant should be
dosed based upon creatinine clearance (CrCl): 30 to 59 mL/min, start with 300
mg per day and increase to 600 mg as needed; 15 to 29 mL/min, use 300 mg per
day; <15 mL/min, use 300 mg every other day. Horizant is not recommended for
use in patients receiving hemodialysis.

In patients with PHN who have compromised renal function, Horizant should be
dosed based upon creatinine clearance (CrCl): 30 to 59 mL/min, a titration
dose of 300 mg in AM for 3 days, increase to maintenance dose of 300 mg twice
daily at Day 4 and increase to 600 mg twice daily as needed, tapering
requirement of reduced current maintenance dose to once daily in AM for 1
week; 15 to 29 mL/min, a titration dose of 300 mg in AM on Day 1 and Day 3,
use 300 mg in AM as maintenance therapy and increase to 300 mg twice daily if
needed, tapering requirement necessary if taking 300 mg twice daily, reduce to
300 mg once daily in AM for 1 week, if taking 300 mg once daily, no tapering
needed; <15 mL/min, no titration dose, 300 mg every other day in AM and
increase to 300 mg once daily in AM if needed, no tapering needed; <15 mL/min
on hemodialysis, no titration dose, 300 mg following every dialysis and
increase to 600 mg following every dialysis if needed, no tapering needed.

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, its first approved product in the United States, and
developing a novel fumaric acid ester product candidate, XP23829, as a
potential treatment for relapsing-remitting multiple sclerosis and/or
psoriasis. Regnite is being marketed in Japan by Astellas Pharma Inc.
XenoPort's pipeline of product candidates also includes potential treatments
for patients with spasticity related to spinal cord injury and Parkinson's
disease.

To learn more about XenoPort, please visit the company Website at
www.XenoPort.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without
limitation, all statements related to the XP23829 clinical development
program, including the release of XP23829 study data and the timing and
results thereof, future discussions with regulatory authorities and the timing
thereof, and planned manufacturing scale-up activities for XP23829 and the
timing thereof; XenoPort’s commercialization strategies and ability to
establish a successful template for commercializing Horizant; the potential
unmet medical need for a non-dopaminergic treatment for RLS; the potential
suitability of XP23829 as a treatment for relapsing-remitting MS and/or
psoriasis; the potential suitability of XenoPort's pipeline of product
candidates as treatments for spasticity related to spinal cord injury and
Parkinson's disease; 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,” “expected,” “hope,” “plan,” “potential,”
“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 lack of commercialization experience and its ability to
successfully market and sell Horizant, including its ability to obtain
uninterrupted drug supply and appropriate pricing and reimbursement for
Horizant in an increasingly challenging environment; XenoPort’s ability to
comply with applicable regulatory guidelines and requirements with respect to
the marketing and manufacturing of Horizant or with Horizant post-marketing
commitments or requirements mandated by the FDA; the uncertain results and
timing of clinical trials and other studies; XenoPort’s ability to
successfully conduct clinical trials in the anticipated timeframes, or at all;
the uncertainty of the FDA’s review process and other regulatory requirements;
XenoPort’s dependence on Astellas and potential future collaborative partners;
the availability of resources to develop XenoPort’s product candidates and to
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 Securities and
Exchange Commission filings and reports, including its Quarterly Report on
Form 10-Q for the quarter ended March 31, 2013, filed with the Securities and
Exchange Commission on April 24, 2013. 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.
Tecfidera is a trademark of Biogen Idec Inc.

XNPT2F

                                                           
XENOPORT, INC.



BALANCE SHEETS

(Unaudited, in thousands)
                                                                
                                               June 30,         December 31,
                                               2013             2012
                                                                
Current assets:
Cash and cash equivalents                      $ 12,623         $ 36,134
Short-term investments                           80,735           102,868
Accounts receivable, net                         1,466            —
Right to the Horizant business                   —                13,557
Inventories                                      948              —
Prepaids and other current assets               3,644          2,529    
Total current assets                             99,416           155,088
Property and equipment, net                      3,187            1,528
Long-term inventories                            10,985           —
Restricted investments and other assets         2,266          2,432    
Total assets                                   $ 115,854       $ 159,048  
Liabilities:
Current liabilities                            $ 14,348         $ 13,771
Noncurrent liabilities                          14,561         15,067   
Total liabilities                               28,909         28,838   
Stockholders’ equity (deficit):
Common stock                                     47               47
Additional paid-in capital and other             586,427          581,763
Accumulated deficit                             (499,529 )      (451,600 )
Total stockholders’ equity                      86,945         130,210  
Total liabilities and stockholders’ equity     $ 115,854       $ 159,048  
                                                                           
                                                                           

XENOPORT, INC.



STATEMENTS OF OPERATIONS

(Unaudited)
                                                          
                    Three Months                   Six Months
                    Ended June 30,                 Ended June 30,
                    2013            2012           2013            2012
                    (In thousands, except per share amounts)
Revenues:
Product sales,      $ 1,640         $ —            $ 1,640         $ —
net
Collaboration         379             379            758             10,758
revenue
Royalty revenue       67              —              147             —
Net revenue
from
unconsolidated       —             10,000       —             10,000  
joint operating
activities
Total revenues       2,086         10,379       2,545         20,758  
Operating
expenses:
Cost of product       249             —              249             —
sales
Research and          10,236          10,804         23,589          22,982
development*
Selling,
general and          15,788        7,589        26,523        14,989  
administrative*
Total operating      26,273        18,393       50,361        37,971  
expenses
Loss from             (24,187 )       (8,014 )       (47,816 )       (17,213 )
operations
Interest income       58              55             139             110
Interest             (252    )      —            (252    )      —       
expense
Net loss            $ (24,381 )     $ (7,959 )     $ (47,929 )     $ (17,103 )
Basic and
diluted net         $ (0.51   )     $ (0.22  )     $ (1.01   )     $ (0.48   )
loss per share
Shares used to
compute basic        47,473        35,794       47,361        35,712  
and diluted net
loss per share
                                                                   
                                                                   
* Includes employee non-cash stock-based compensation, as follows:
                                                                   
Research and        $ 710           $ 993          $ 1,905         $ 2,108
development
Selling,
general and          1,785         1,969        3,934         4,215   
administrative
Total               $ 2,495        $ 2,962       $ 5,839        $ 6,323   

Contact:

XenoPort, Inc.
Jackie Cossmon, 408-616-7220
ir@XenoPort.com
 
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