XenoPort 8K Regulation FD Disclosure | XNPT 16 Oct 14

XenoPort, Inc.

Investor Presentation

October 2014

NASDAQ:XNPT

Exhibit 99.1

These

slides

and

the

accompanying

oral

presentation

XenoPort,

Inc.

contain forward-looking statements that involve risks and uncertainties,

including statements relating to the commercial opportunity and value

proposition for HORIZANT; potential future sales and commercialization

activity for HORIZANT and REGNITE; the planned development of

HORIZANT with the NIAAA for AUD; the planned development of AP by

Reckitt;

the

XP23829

clinical

development

program,

including

the

initiation

conduct of current or potential future clinical trials and regulatory submissions

and the timing thereof; expected patent coverage; and the therapeutic and

commercial potential of XP23829. XenoPort can give no assurance with

respect to these statements, and we assume no obligation to update

them.

For

detailed

information

about

the

risks

and

uncertainties

that

could

cause actual results to differ materially from those implied by,

or anticipated in,

these forward-looking statements, please refer to the Risk Factors section of

our Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 and

filed with the SEC.

October 2014

Investor Slide Presentation

Safe Harbor Language

A commercial-stage biopharmaceutical company with an internally

discovered pipeline focused on CNS and dermatology indications

Growing revenues from HORIZANT sales from 2 FDA-approved

indications. New indication (alcohol use disorder) will enter potential

registration trial in 1H 2015 in collaboration with NIAAA

Differentiated MMF prodrug (XP23829) currently in Phase 2 trial for

psoriasis with results expected in 3Q 2015. Plans to enter Phase 3 in

psoriasis and/or relapsing forms of MS in 2016

Preparing to enter Phase 3 development in advanced Parkinson’s

disease (XP21279) and Phase 2 in alcohol use disorder (arbaclofen

placarbil)

October 2014

Investor Slide Presentation

XenoPort Overview

October 2014

Investor Slide Presentation

GABAPENTIN ENACARBIL

Restless

Legs

Syndrome

(RLS)

–

U.S.

Restless

Legs

Syndrome

–

Japan

Postherpetic

Neuralgia

(PHN)

–

U.S.

Alcohol

Use

Disorder

(AUD)–

U.S.

XP23829

Psoriasis

Relapsing Forms of MS

ARBACLOFEN PLACARBIL (AP)

AUD

XP21279

Advanced Parkinson’s Disease(

(Pending resources),

)

PHASE 1

PHASE 2

PHASE 3

NDA FILED

MARKETED

PRECLINICAL

PARTNER

XenoPort Pipeline

HORIZANT net sales

increased 66% in 2Q vs.

1Q 2014 to $4.9 million

$124.9 million of cash,

cash equivalents and short-

term investments at

6/30/14

$5.0 million in non-dilutive

cash in 3Q 2014

associated with AP

licensing agreement

No debt

Investor Slide Presentation

October 2014

Financials

Approved for moderate-to-severe primary RLS in adults in

April 2011

Approved for the management of PHN in adults in June 2012

XenoPort promotional efforts began in June 2013

6 Orange Book listed patents with expiry dates from 2022 -

2029

•

Patent term extension requested for composition-of-matter patent from 2022 to

2025

October 2014

Investor Slide Presentation

Please review the full prescribing and safety information for HORIZANT. The most common adverse reactions

of HORIZANT in RLS patients: somnolence/sedation and dizziness, and in PHN patients: somnolence, dizziness and headache.

HORIZANT: XenoPort’s First

Commercial Product

Drug class: alpha-2-delta ligand (gabapentin, pregabalin)

Actively transported prodrug of gabapentin

•

Addresses pharmacokinetic deficiencies of gabapentin

Only approved extended-release alpha-2-delta product

Not interchangeable with other gabapentin products

October 2014

Investor Slide Presentation

Please review the full prescribing and safety information for HORIZANT. The most common adverse reactions

of HORIZANT in RLS patients: somnolence/sedation and dizziness, and in PHN patients: somnolence, dizziness and headache.

HORIZANT

Different by Design

Over 5 million U.S. adults

suffer from moderate-to-severe

primary RLS

Widespread use of dopamine

agonists

Growing awareness of issues

related to dopamine agonist

use in treatment of RLS

•

New treatment guidelines

October 2014

Investor Slide Presentation

Sources: RLS Prevelance-NINDs, NIH, Sleep Medicine, Volume 14, No. 7 , 2013,

Mayo Clinic Proceedings, Volume 88, No. 9, 2013,

Sleep, Vol. 35, No. 8, 2012

Moderate-to-Severe Primary RLS

Market Opportunity in U.S.

First and only non-dopamine agonist approved for the treatment of moderate-to-

severe primary RLS in adults

Proven effective in relieving RLS symptoms (clinical trial data)

Convenient once-a-day dosing

No titration required

No evidence of augmentation, rebound or impulse control disorders*

Recommended as a first-line treatment in recently published treatment guidelines

October 2014

*In two 12-week clinical trials, patients taking HORIZANT showed no evidence of symptom augmentation.

The duration of these trials may not have been sufficient to adequately assess symptom augmentation.

Investor Slide Presentation

Please review the full prescribing and safety information for HORIZANT. The most common adverse reactions

of HORIZANT in RLS patients: somnolence/sedation and dizziness, and in PHN patients: somnolence, dizziness and headache.

HORIZANT

Attributes for RLS

Results from damage that

occurs to the peripheral nerve

fibers during a shingles

outbreak

Pain associated with PHN can

be very intense

About 200,000 patients suffer

from PHN in the U.S.

Clear unmet medical need

•

~30% of patients receive

>50%

reduction in PHN pain with gabapentin,

the most widely used agent to treat

PHN

October 2014

Sources: Decision Resources, Inc. 2010, Neurontin Product Label

Investor Slide Presentation

Postherpetic Neuralgia (PHN)

Simple 4-day titration

Efficacy as early as one week

Pharmacokinetic differentiation

•

High bioavailability (75%)

•

Sustained 24-hour gabapentin blood levels

Pivotal trial showed 42% of PHN patients experienced

>50% reduction in pain intensity score from baseline

Pain relief over 24 hours

October 2014

Please review the full prescribing and safety information for HORIZANT. The most common adverse reactions

of HORIZANT in RLS patients: somnolence/sedation and dizziness, and in PHN patients: somnolence, dizziness and headache.

Investor Slide Presentation

1. Adapted from Lal R, et al. J Clin Pharmacol. 2013;53(1):29-40

HORIZANT

Attributes for PHN

Initial Plan Upon Return of

Product Rights

•

Establish responsiveness

quickly and efficiently

•

Focus on specialists and high

prescribing PCPs of RLS and

PHN drugs

•

Personal promotion and

marketing efforts focused in ~ 40

territories

XenoPort Initial Plan: Sales specialists called

on <10% of the potential market

October 2014

Investor Slide Presentation

Initial Plan

Current Plan

•

Expanded to additional ~25 new territories

•

Trained and in field

HORIZANT Commercialization

October 2014

Investor Slide Presentation

Source: SHA, PHAST 2014

Previous Partner’s

Sales Team of ~300-500

XenoPort

Sales Team of ~40

Approved Dose: RLS = 1 tablet per day; PHN = 2 tablets per day

Currently >85% of prescribed

tablets from XenoPort territories

XenoPort Launch

HORIZANT

Dispensed Tablets per Month

Source: SHA, PHAST 2014

XenoPort Launch &

First Promotion of

PHN Indication

Investor Slide Presentation

October 2014

XenoPort Launch &

First Promotion of

PHN Indication

Prescriptions by Specialty

% Prescriptions 1200 mg/day*

*Source: Healthcare Analytics, a Symphony Health Solutions Company

The information attributed to Source Healthcare Analytics herein

is provided as is, and Source Healthcare Analytics, LLC

makes no representation and/or warranty of any kind, including but not limited to the accuracy and/or completeness of such

information. Source Healthcare Analytics is credited as a source of certain data only. The attribution of Source Healthcare

Analytics as the source of such data shall not be construed as an endorsement by Source Healthcare Analytics of the views,

opinions or findings expressed, shared or otherwise published herein.

HORIZANT

Prescribers and Daily Dose

Randomized, double-blind, placebo-controlled trial of the safety and efficacy of HORIZANT in

patients who have AUD

XenoPort to supply clinical trial material

NIAAA will conduct and pay all other expenses associated with proposed clinical trial

•

Six-month treatment duration; Enrolling approximately 350 patients; expect initiation in 1H 2015

XenoPort and NIAAA to meet with FDA to discuss possibility of utilizing the results of this trial as the

basis for a potential supplemental new drug application (sNDA) submission for HORIZANT

October 2014

Investor Slide Presentation

Clinical Trial Agreement

“Scientists at XenoPort designed gabapentin enacarbil extended-release tablets to address certain

limitations

drug

levels

the

body,

which

may

make

attractive

treatment

option

for

people

with

AUD.”

NIAAA press release 9/9/14

XenoPort and NIAAA

Clinical Trial Agreement

XP23829 for Potential

Treatment of Psoriasis

and/or Relapsing

Forms of MS

FUMADERM

mixture of dimethylfumarate (DMF) and

monoethyl fumarate salts

•

Approved in 1990s and widely used for the treatment of psoriasis

in Germany

TECFIDERA (dimethylfumarate)

•

Approved in March 2013 in the U.S. for the treatment of relapsing forms of MS

•

Approved in February 2014 in the EU for relapsing-remitting MS

•

2Q 2014 TECFIDERA revenues were $700 million ($585 million in U.S.; $115

million in sales outside the U.S.)

XP23829 has a novel chemical structure that produces

monomethylfumarate (MMF), the same active metabolite as

dimethylfumarate

October 2014

Investor Slide Presentation

Background:

Fumaric Acid Ester Products

October 2014

Investor Slide Presentation

XP23829

DMF

MMF

Promoiety

Methanol

Esterases

XP23829 and DMF produce the same active metabolite (MMF) in the body

DMF and XP23829 are

Prodrugs of MMF

Lower incidence and/or less severe GI side effects and

flushing

•

Improved compliance; fewer treatment failures

Onset and/or magnitude of efficacy

•

Earlier onset of immunomodulation

Dosing frequency

•

QD rather than BID (TECFIDERA) or TID (FUMADERM)*

Indication

•

TECFIDERA and FUMADERM not approved for psoriasis in the U.S.

October 2014

Investor Slide Presentation

*QD: once daily; BID: twice daily; TID: three times daily.

Potential XP23829 Advantages and

Areas of Differentiation

Completed preclinical PK and safety studies including 13-week

toxicology studies in 3 animal species. Studies included DMF

comparison arms

•

Demonstrated less skin and GI irritation compared to DMF

•

No adverse findings that were not observed with DMF

Demonstrated efficacy in animal models of MS and psoriasis

Completed three Phase 1 trials establishing human PK, metabolites and

disposition and comparison of PK to TECFIDERA

•

XP23829 produced total MMF exposure in blood similar to TECFIDERA

Demonstrated known pharmacodynamic effects on immune blood cells

with once-a-day dosing in humans

Selected novel delayed and extended-release formulation for Phase 2/3

October 2014

Investor Slide Presentation

XenoPort: A Leader in Development of

Generation MMF Prodrugs

October 2014

Investor Slide Presentation

•

pH-independent delayed-release

mechanism to reduce gastric irritation and

food effects on pharmacokinetics

•

Releases XP23829 over 8-10 hours

avoiding high local concentrations in

upper small intestine, lower Cmax and

extended blood levels of MMF

Differentiation from TECFIDERA/FUMADERM

In Vitro Dissolution

XP23829 in a Novel Formulation to

Potentially Provide Differentiation

XP23829 Intellectual Property

October 2014

Investor Slide Presentation

•

Three issued U.S. patents (US8148414, US8778991 and US8785443)

including claim covering composition-of-matter of XP23829 (expiration

date 2029)

•

17 filed patent application families with pending claims including:

•

Specific MMF prodrug compositions and their uses

•

Crystalline forms of XP23829

•

Oral dosage forms of MMF prodrugs*

•

Methods of treatment with MMF prodrugs*

•

Methods of selecting and/or administering MMF prodrugs* to reduce

side effects

•

Applications filed broadly in major pharmaceutical markets

* “MMF prodrug”

may include XP23829, DMF and certain other MMF prodrug molecules

Conducting Phase 2 psoriasis study to assess the effect of dose and dosing

regimen on efficacy, tolerability, safety and immune cell modulation of XP23829

•

Trial initiated June 2014

•

Top-line results expected in 3Q 2015

•

Optimal dose(s) expected to translate to relapsing forms of MS, based on

TECFIDERA precedent

Preclinical studies and manufacturing scale-up are underway to allow Phase 3

study in 2016

Clear precedent for psoriasis Phase 3 program

•

Two Phase 3 trials, at least one demonstrating maintenance of efficacy at one year

Discussions ongoing with FDA on potential abbreviated Phase 3 program for

relapsing form of MS

October 2014

Investor Slide Presentation

XP23829

Current Development Plan

Study Design

Randomized, double-blind, multicenter, parallel group, placebo-controlled, dose-finding

efficacy and safety study in subjects with moderate-to-severe chronic plaque-type psoriasis

Number of Sites

~35 sites in United States

Number of Subjects

~200 randomized 1:1:1:1

Primary Endpoint

The percent change in Psoriasis Area and Severity Index (PASI) score from Baseline (12

weeks)

October 2014

Investor Slide Presentation

400 mg BID

Placebo

800 mg QD

400 mg QD

Screening/

Washout

Week -4

Week 0

Week 3

Week 12

Week 16

Post-Treatment

Follow-up

Titration

Maintenance Phase

XP23829 Phase 2 Clinical Trial in

Psoriasis Patients

October 2014

Investor Slide Presentation

Phase 2 Psoriasis Study

Biogen Press Release 2004

Langner, J Am Acad Dermatol 2005

Week 12

Phase 2 Relapsing Forms of MS Study

Kappos, Lancet 2008

Similar Dose Response for TECFIDERA in

Psoriasis & Relapsing Forms of MS

October 2014

Investor Slide Presentation

•

Worldwide psoriasis prevalence rates vary from 0.6%

to 4.8%

Epidemiology

•

In the U.S., it is estimated that direct costs on health

care approach ~$7B

•

Psoriasis affects the daily lives of patients; studies

estimate 60% of psoriasis patients missed an average of

26 days of work per year due to their illness

Economic Burden

Sources: UpToDate, BioMedTracker, National Psoriasis Foundation,

Horn EJ, et al 2007 J Am Acad Dermatol. 57:963-71;

Fowler et al-

2008 J of Am Acad Derm 3 Clin Exp Rheumatol 2002; 20 (Suppl. 28): S27-S33

Psoriasis is Prevalent, Reduces Quality of Life and

is an Economic Burden to Health Systems

In the U.S., estimates of psoriasis prevalence

range from 2.5-3.5%

Epidemiological studies of prevalence in the

EU range from 1-3%

Moderate and severe psoriasis represent 35%

and 12% of all patients, respectively

October 2014

Investor Slide Presentation

* Assumes no arthritic involvement

Sources: Back Bay Physician Interviews, DataMonitor 2013 Treatment Flow and Physician Quantitative Survey

U.S.

•

Orals have 40-50% market share

and

line

Germany

•

Orals

have

80-90%

market

line

•

FUMADERM

has

highest

market

Oral Therapy Market Share for Moderate and Severe

Psoriasis Differs in U.S. and Germany

October 2014

Investor Slide Presentation

Safety/Tolerability

Unfavorable

Favorable

Qualitative Positioning

Efficacy similar to FUMADERM

(PASI 75 = 40-50%)

with favorable tolerability

and long-term safety

Desired XP23829 Profile

Desired Product Positioning for XP23829 in

Moderate-to-Severe Chronic Plaque-Type

Psoriasis

October 2014

Investor Slide Presentation

2Q 2014 Sales

U.S.

Ex-U.S.

$585M

$115M

$91M

$27M

$284M

$322M

Source: Symphony Health Solutions, PHAST Prescription Monthly, April 2013 –

August 2014

1% market share is ~$100M in annual U.S. product sales at current prices

Oral Treatments for Relapsing

Forms of MS

FUTURE

OPPORTUNITIES

XP21279 for Parkinson’s Disease

AP for Alcohol Use Disorder

October 2014

Investor Slide Presentation

avg

Threshold for

“off-time”

SINEMET

Dyskinesia

Threshold

XP21279

A dose of XP21279

resulting in a higher Cavg

concentration could

reduce “off”

time without

increasing dyskinesias

High peak-trough ratios of

levodopa concentrations

result from SINEMET’s

inherent PK properties

Therapeutic

Window

XP21279: Designed to Keep Levodopa Exposure

in the Target Therapeutic Window

Achieved levodopa levels with XP21279/Carbidopa tablet

within the target therapeutic window

Minimal Fluctuation in Levodopa Blood Levels

October 2014

Investor Slide Presentation

XP21279 Phase 2 Study in

Advanced Parkinson’s Patients

A single successful pivotal 12-week Phase 3 study comparing optimized

doses of XP21279 to SINEMET could support approval for treatment

patients with advanced Parkinson’s disease with motor fluctuations

•

Data comparing to SINEMET would be in product label

Gained agreement on long-term safety database size and duration of

exposures

A single successful 3-month placebo-controlled study could support

approval of XP21279 in patients with early Parkinson’s disease

•

Based on 505(b)(2) cross-reference to SINEMET

Program ready to enter Phase 3 development with further funding

October 2014

Investor Slide Presentation

FDA Agreements For Potential

XP21279 Phase 3 Program

Exclusive world-wide rights granted to Reckitt Benckiser Pharmaceuticals

•

Proven leader in commercialization of addiction treatments, e.g., SUBOXONE

Planned initial development focus: AUD

$20 million up-front plus $5 million for material transfer

Up to $70 million in development and regulatory milestones

Up to $50 million in commercial milestones

Tiered double-digit royalty payments up to mid-teens on a percentage basis

on potential future net sales in the U.S.

High single-digit royalty payments on potential future net sales outside the

U.S.

October 2014

Investor Slide Presentation

AP Agreement with Reckitt Benckiser

Pharmaceuticals

HORIZANT

•

Growing net sales in U.S. and royalties in Japan

•

Additional ex-U.S. partnership(s)

•

FDA agreement of AUD development plan

•

Initiation of AUD pivotal study in 1H 2015

XP23829

•

Top-line results of Phase 2 psoriasis study expected in 3Q 2015

•

Completion of non-clinical studies to support Phase 3 in 2016

•

FDA agreement on Phase 3 plan for psoriasis and/or relapsing forms of MS

XP21279

•

Partner and/or initiate Phase 3 development activities as resources permit

•

Expected initiation of Phase 2 study in AUD by partner Reckitt Benckiser

Pharmaceuticals

October 2014

Investor Slide Presentation

XenoPort Anticipated Milestones

NASDAQ:XNPT

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XenoPort (XNPT) Inactive 8-KRegulation FD Disclosure