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Roth OC Growth Stock Conference February 16-18, 2009.

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Roth OC Growth Stock Conference February 16-18, 2009
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Page 1: Roth OC Growth Stock Conference February 16-18, 2009.

Roth OC Growth Stock ConferenceFebruary 16-18, 2009

Page 2: Roth OC Growth Stock Conference February 16-18, 2009.

2

Forward Looking Statements

The Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:

Except for the historical information herein, the matters discussed in this presentation

include forward-looking statements that may involve a number of risks and uncertainties,

including but not limited to, projections of future sales, operating income, returns on

invested assets, obtaining and maintaining regulatory approval processes, market

acceptance of, and continuing demand for, NeurogesX’ products and other risks detailed

from time to time in the Company’s Securities and Exchange Commission filings. The

forward-looking statements are based on management's current expectations and are

subject to risks and uncertainties that could cause actual results to differ materially.

Page 3: Roth OC Growth Stock Conference February 16-18, 2009.

NeurogesX – Pain Management Focus

• Locally-acting analgesic formulated in dermal patch

• Pain relief up to 12 weeks demonstratedDifferentiated Lead Product: QUTENZA™Differentiated Lead Product: QUTENZA™

Strong Clinical Dossier /Marketing Applications Under Review

Strong Clinical Dossier /Marketing Applications Under Review

Commercialization StrategyCommercialization Strategy

Deep Pain Management PipelineDeep Pain Management Pipeline

Strong Management Track RecordStrong Management Track Record

• NDA (PHN) submitted October 2008 • MAA (peripheral neuropathic pain) filed Sept 2007• Potential regulatory decisions in 1H09 (MAA) and

3Q09 (NDA)

• U.S: specialty sales force; potential co-promotion• EU: partner (discussions in process)

• Multiple early stage pain prodrug candidates• Potential co-development opportunities

• Drug development, regulatory and commercialization• Results oriented – proven track record

Page 4: Roth OC Growth Stock Conference February 16-18, 2009.

4

Meeting our IPO Commitments

2H07 Confirmatory Phase 3 study in PHN

2H07 NGX-4010 EU Marketing Application

1H08 Confirmatory Phase 3 study in HIV-DSP

1H08 NGX-1998 IND filing

1H08 Continue NGX-1998 clinical program

1H08 Initiate NGX-4010 PDN program

2H08 NGX-4010 NDA filing (PHN)

Page 5: Roth OC Growth Stock Conference February 16-18, 2009.

Product Pipeline

Preclinical Phase 1 Phase 2 Phase 3Marketing

Application

Clinical Program Initiated 2008

MAA Filed 2007

QUTENZA™ (NGX-4010): PHN

Qutenza: HIV-DSP

Qutenza: PDN

NGX-1998

NDA Filed and

Accepted

Opioid Prodrug Partnering OpportunitiesNGX-6052

Acetaminophen Prodrug Partnering Opportunities

NGX-6100

NGX-9674

NGX-1576

Page 6: Roth OC Growth Stock Conference February 16-18, 2009.

6

$3B Neuropathic Pain Market Opportunity

Indication

• Chronic (PHN, PDN, HIV-DSP)

• Caused by sensory nerve damage

• Substantial unmet medical need

• Current therapy limitations

Market Opportunity

• Large and growing

• 6 M sufferers (U.S.)

• >$3 B annual sales (69% from anticonvulsants)

• Branded product access

CAGR 11%

$9

$8

$7

$6

$5

$4

$3

$2

$1

0 2005 2010 2015

Source: Jain Biopharma 2006

Annual US Pain Product Sales

$ in Billions

Page 7: Roth OC Growth Stock Conference February 16-18, 2009.

7

Anticonvulsants AntidepressantsTopical

AnestheticOpioids

QUTENZA™ (NGX-4010)

Efficacy +++ +++ ++ +++ +++

Dosing BID-TID QD-BID 12-hours / day QD-TIDSingle

application

Duration of Effect

6-12 hours 6-24 hours 12 hours 4-48 hours >12 weeks

Onset 1-3 weeks 1-3 weeks 1-3 weeks Hours 1-14 days

Safety

Somnolence dizziness, nausea,

confusion, weight gain

Somnolence, nausea,

constipationRash, pruritis

Sedation, respiratory depression,

nausea, vomiting, bowel dysfunction,

disorientation

No systemic side effectsTransient

procedure- related burning and erythema

Pain Management Options

Page 8: Roth OC Growth Stock Conference February 16-18, 2009.

8

QUTENZA™ (NGX-4010): Localized Pain Management Therapy

• Direct delivery to pain site• Dermal patch formulation• High concentration trans-capsaicin• Simple, well-tolerated in-office

procedure• 3 months relief from single application

Page 9: Roth OC Growth Stock Conference February 16-18, 2009.

9

Qutenza: A Simple Effective Procedure

• Identify painful area

• Apply topical anesthetic

• Apply Qutenza patch Cut to conform to painful area Apply 30 to 60 minutes Remove Clean area with proprietary gel

Page 10: Roth OC Growth Stock Conference February 16-18, 2009.

10

Initial Qutenza Indication

Post-Herpetic Neuralgia (PHN)

NDA Submitted, Accepted for Review by FDA…

Page 11: Roth OC Growth Stock Conference February 16-18, 2009.

Postherpetic Neuralgia (PHN)

Indication• Shingles (herpes zoster): reactivation of

chickenpox• Persistent post-shingles pain

Patient Population• Up to 20% of shingles patients • Poor treatment response• Population estimates vary

Orphan to 500K in U.S.

Page 12: Roth OC Growth Stock Conference February 16-18, 2009.

12

  

Phase 3 Trial IndicationPrimary

Endpoint MetSecondaryEndpoint

C117 PHN32% avg. pain

reduction during weeks 2-8 (p=0.01)

Responders (30%) 46% (p=0.019)

C116 PHN

30% avg. pain reduction during

weeks 2-8 (p = 0.001)

Responders (30%) 42% (p=0.034)

Qutenza: Positive Phase 3 Data in PHN

Page 13: Roth OC Growth Stock Conference February 16-18, 2009.

C116 PHN

Qutenza: Value Proposition in PHN

% Decrease from

Baseline

-50

-45

-40

-35

-30

-25

-20

-15

-10

-5

0

1 2 3 4 5 6 7 8 9 10 11 12Baseline

Week

C108 PHN

C110 PHN

C111 PHN

C117 PHN

% Change from Baseline in NPRS Scores [mean SE]

13

Page 14: Roth OC Growth Stock Conference February 16-18, 2009.

14

  Lyrica ® 300 mg

(Study 045)Lyrica ® 300 mg

(Study 196)Qutenza

(Study C116)†Qutenza

(Study C117)†

Change -2.1 -1.7 -1.7 -1.8

% Change -30.0%* -25.4%* -30.1% -33.5%

50% Response 28% 27% 29% 31%

PGIC (much/very much)

40% 27% 36% 37%

Qutenza Versus Lyrica in PHN

† Week 8

• Calculated from mean absolute change/mean baseline scores

Lyrica data from FDA SBA

Page 15: Roth OC Growth Stock Conference February 16-18, 2009.

15

Qutenza Market Research:

Significant Potential…

Page 16: Roth OC Growth Stock Conference February 16-18, 2009.

16

All groupsQ26. What advantages does this product have over currently available treatments for moderate to severe neuropathic pain? (Check all that apply)

Physician Survey on Qutenza Advantages

Source: NeurogesX quantitative market study (n=305).

57%

67%

69%

71%

76%

79%

83%

Rapid onset

Can use in combination therapy

No / low systemic side effects

Good safety profile

Non-sedating

Site specific

Three-month duration of action

Product X Advantages

Page 17: Roth OC Growth Stock Conference February 16-18, 2009.

17

Favorable Physician Consideration as First-Line Therapy

SOURCE: NeurogesX quantitative research (n=208)

Percentage of PHN prescriptions for first-line therapy(mean)

Total(n =208)

Before Profile After Profile Change

Qutenza 25.4%

gabapentin 25.1% 17.8% -7.3%

pregabalin (Lyrica®) 19.5% 14.9% -4.6%

duloxetine (Cymbalta®) 11.8% 8.4% -3.4%

lidocaine patch 5% (Lidoderm®) 9.1% 6.1% -3.0%

Other 34.5% 27.4% -7.1%

Page 18: Roth OC Growth Stock Conference February 16-18, 2009.

18

Positive Patient Feedback

• ~2/3 respondents would ask physicians about Qutenza or try it upon physician recommendation

Source: NeurogesX qualitative market research (n=78).

“I would definitely try it once -- it’s all-natural, how is it going to hurt me?” – PHN patient, NY

“I would definitely try it once -- it’s all-natural, how is it going to hurt me?” – PHN patient, NY

63% 64%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Likelihood to ask physician about drug

Likelihood to try drug if physician recommends

Likelihood to ask about and try drug (Patients responding 6 or 7 on a 7-

point scale)

Page 19: Roth OC Growth Stock Conference February 16-18, 2009.

19

Qutenza

Commercialization Strategy

Page 20: Roth OC Growth Stock Conference February 16-18, 2009.

20

IM

FP

N

Others

AN

PM

APM

RHU

P

Source: NDC 6/04 - Prometrics Analysis

18%

20%

10%

24%

6%

4%

4%

5%

9%

Commercialization Strategy

Source: FIRSTMARK April 2006

Office Pain

Services

Pain Clinic

Hospital

Pain Clinic

• Concentrated market

~5,000 clinics

~10,000 physicians

• U.S. sales force targeting specialists

Phased roll out likely

80 – 100 reps at peak

Co-promotion potential in PC market

EU Commercialization Partner

23%14%

63%

Page 21: Roth OC Growth Stock Conference February 16-18, 2009.

Temporary Codes: Improve Ease of Reimbursement/Market Access

2009 2010 2011 2012

PDUFA Date

Qutenza J-Code

Permanent CPT code for

procedure

Misc. J-Code

Temporary Q or Misc CPT or Category III CPT code for procedure

Qutenza C-Code (Medicare - Hospital

Outpatient ONLY)

Misc. C-Code (Medicare -

Hospital Outpatient

ONLY)NGX-4010Reimbursement

Treatment ProcedureReimbursement

• Temporary codes (product + procedure) shortly after launch• Permanent Codes 1-2 years post-launch

Page 22: Roth OC Growth Stock Conference February 16-18, 2009.

Qutenza Summary

• $3B Growing Neuropathic Pain Market Large, underserved market with current product limitations Strong growth for branded products (> generics growth) Positive patient and physician feedback

• Approaching commercialization Marketing applications filed in EU and U.S. Pre-commercialization activities ongoing (pricing, reimbursement) Potential regulatory decisions in 1H09 (EMEA) and 3Q09 (FDA)

• Potential Commercialization in late 2009 and early 2010 Europe: Launch 2H 09 with commercial partner (discussions ongoing) US: Launch 1H 10 with own sales force and/or potential partner

Page 23: Roth OC Growth Stock Conference February 16-18, 2009.

23

NGX-1998:

Next Generation Pain Management

Non-Patch Formulation Using Qutenza’s API

Page 24: Roth OC Growth Stock Conference February 16-18, 2009.

24

NGX-1998: Phase 1 ResultsSimilar Efficacy in Less Time versus Qutenza

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

20.0

Control NGX-4010 (60 min) NGX-1998 (25 min) NGX-1998 (15 min) NGX-1998 (5 min)

* Preliminary data: N=28

ENF counts [mean SEM]*

ENF Counts (fibers/mm)

Potential control formulations under evaluation for future trials

Page 25: Roth OC Growth Stock Conference February 16-18, 2009.

Product Pipeline

Preclinical Phase 1 Phase 2 Phase 3Marketing

Application

Clinical Program Initiated 2008

MAA Filed 2007

QUTENZA™ (NGX-4010): PHN

Qutenza: HIV-DSP

Qutenza: PDN

NGX-1998

NDA Filed and

Accepted

Opioid Prodrug Partnering OpportunitiesNGX-6052

Acetaminophen Prodrug Partnering Opportunities

NGX-6100

NGX-9674

NGX-1576

Page 26: Roth OC Growth Stock Conference February 16-18, 2009.

NGX-1576 (Hybrid Prodrug)

• Simultaneously releases both acetaminophen and precursor for glutathione synthesis in liver

• Murine model showed NGX-1576 at equimolar dose levels provides:– Comparable systemic

exposure to acetaminophen– Significantly reduced acute

hepatoxicityA

PA

P (

µg/

mL)

100

75

50

25

Time (hr)321 4

NGX-1576APAP

AST ALT

APAPAPAP

NGX-1576

Control

NGX-1576

Control100

200

300

Uni

ts/L

Page 27: Roth OC Growth Stock Conference February 16-18, 2009.

27

Financial Summary

• $30.8 M cash (9/30/08) Runway through EU and US regulatory decisions Evaluating non-equity based funding strategies No plans for near-term equity financing in public markets

• Conservative cash management focused on priorities U.S. and EU regulatory review process Pre-commercialization activities – reimbursement strategies

• Dedicated partnership effort EU commercialization partnership strategy Potential U.S. co-promotion Potential for opioid and acetaminophen prodrug collaborations

Page 28: Roth OC Growth Stock Conference February 16-18, 2009.

28

2009 – 2010 Milestones

1H09 MAA Decision for Qutenza (neuropathic

pain)

1H09 EU Commercial Partnership

2H09 PDUFA for Qutenza (PHN)

2H09 Qutenza EU Launch

1H10 Qutenza U.S. Launch

Page 29: Roth OC Growth Stock Conference February 16-18, 2009.

NASDAQ: NGSX


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