Transcript NGX-1998

Roth OC Growth Stock Conference
February 16-18, 2009
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.
2
NeurogesX – Pain Management Focus
Differentiated Lead
Product: QUTENZA™
• Locally-acting analgesic formulated in dermal patch
• Pain relief up to 12 weeks demonstrated
Strong Clinical
Dossier /
Marketing
Applications Under
Review
• NDA (PHN) submitted October 2008
• MAA (peripheral neuropathic pain) filed Sept 2007
• Potential regulatory decisions in 1H09 (MAA) and
3Q09 (NDA)
Commercialization
Strategy
• U.S: specialty sales force; potential co-promotion
• EU: partner (discussions in process)
Deep Pain
Management Pipeline
• Multiple early stage pain prodrug candidates
• Potential co-development opportunities
Strong Management
Track Record
• Drug development, regulatory and commercialization
• Results oriented – proven track record
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)
4
Product Pipeline
Preclinical
Phase 1
Phase 2
Phase 3
NDA Filed and
QUTENZA™ (NGX-4010): PHN
Accepted
Qutenza: HIV-DSP
MAA Filed 2007
Qutenza: PDN
NGX-1998
NGX-6052
Clinical Program Initiated 2008
Opioid Prodrug Partnering Opportunities
NGX-6100
NGX-9674
NGX-1576
Marketing
Application
Acetaminophen Prodrug Partnering Opportunities
$3B Neuropathic Pain Market Opportunity
Annual US Pain Product Sales
Indication
• Chronic (PHN, PDN, HIV-DSP)
$ in
Billions
• Caused by sensory nerve damage
$9
• Substantial unmet medical need
$8
$7
• Current therapy limitations
$6
$5
$4
Market Opportunity
$3
• Large and growing
$2
$1
0
2005
2010
2015
• 6 M sufferers (U.S.)
• >$3 B annual sales (69% from
anticonvulsants)
Source: Jain Biopharma 2006
• Branded product access
6
Pain Management Options
Anticonvulsants
Antidepressants
Topical
Anesthetic
Opioids
QUTENZA™
(NGX-4010)
Efficacy
+++
+++
++
+++
+++
Dosing
BID-TID
QD-BID
12-hours / day
QD-TID
Single
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
Rash, pruritis
Sedation,
respiratory
depression,
nausea, vomiting,
bowel dysfunction,
disorientation
No systemic
side effects
Transient
procedurerelated burning
and erythema
Somnolence,
nausea,
constipation
7
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
8
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
9
Initial Qutenza Indication
Post-Herpetic Neuralgia (PHN)
NDA Submitted, Accepted for Review by FDA…
10
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.
Qutenza: Positive Phase 3 Data in PHN
Phase 3 Trial
C117
C116
Indication
PHN
PHN
Primary
Endpoint Met
Secondary
Endpoint
32% avg. pain
reduction during
weeks 2-8
(p=0.01)
Responders (30%)
46% (p=0.019)
30% avg. pain
reduction during
weeks 2-8
(p = 0.001)
Responders (30%)
42% (p=0.034)
12
Qutenza: Value Proposition in PHN
% Change from Baseline in NPRS Scores [mean  SE]
0
-5
-10
-15
C108 PHN
C110 PHN
C116 PHN
C111 PHN
-20
% Decrease
from -25
Baseline
C117 PHN
-30
-35
-40
-45
-50
Baseline
1
2
3
4
5
6
7
8
9
10
11
12
Week
13
Qutenza Versus Lyrica in PHN
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%
† Week 8
• Calculated from mean absolute
change/mean baseline scores
Lyrica data from FDA SBA
14
Qutenza Market Research:
Significant Potential…
15
Physician Survey on Qutenza Advantages
Product X Advantages
Three-month duration of action
83%
Site specific
79%
Non-sedating
76%
Good safety profile
71%
No / low systemic side effects
69%
Can use in combination therapy
Rapid onset
67%
57%
All groups
Q26. What advantages does this product have over currently available treatments for moderate to severe neuropathic pain? (Check all that apply)
16
Source: NeurogesX quantitative market study (n=305).
Favorable Physician Consideration as First-Line Therapy
Total
(n =208)
Percentage of PHN prescriptions for first-line therapy
(mean)
Before Profile
Qutenza
After Profile
Change
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%
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SOURCE: NeurogesX quantitative research (n=208)
Positive Patient Feedback
• ~2/3 respondents would ask physicians about Qutenza or try it upon physician recommendation
Likelihood to ask about and try drug
(Patients responding 6 or 7 on a 7point scale)
100%
90%
“I would definitely try it once -- it’s allnatural, how is it going to hurt me?” –
PHN patient, NY
80%
70%
63%
64%
Likelihood to ask
physician about drug
Likelihood to try drug if
physician recommends
60%
50%
40%
30%
20%
10%
0%
Source: NeurogesX qualitative market research (n=78).
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Qutenza
Commercialization Strategy
19
Commercialization Strategy
• Concentrated market
Pain Clinic
Office Pain
Services
14%
23%
 ~5,000 clinics
 ~10,000 physicians
63%
• U.S. sales force targeting specialists
Hospital
Pain Clinic
Source:
FIRSTMARK April 2006
Phased roll out likely
AN
80 – 100 reps at peak
PM
10%
Co-promotion potential in PC market
IM
9%
APM
5%
18%
4%
 EU Commercialization Partner
4%
20%
FP
Source:
NDC 6/04 - Prometrics Analysis
6%
RHU
P
Others
24%
N
20
Temporary Codes:
Improve Ease of Reimbursement/Market Access
• Temporary codes (product + procedure) shortly after launch
• Permanent Codes 1-2 years post-launch
NGX-4010
Reimbursement
Misc. C-Code
(Medicare Hospital
Outpatient
ONLY)
Qutenza C-Code
(Medicare - Hospital
Outpatient ONLY)
Qutenza J-Code
Misc. J-Code
Treatment
Procedure
Reimbursement
Temporary Q or Misc CPT or Category III CPT code for procedure
2009
PDUFA Date
2010
2011
Permanent CPT
code for
procedure
2012
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
NGX-1998:
Non-Patch Formulation Using Qutenza’s API
Next Generation Pain Management
23
NGX-1998: Phase 1 Results
Similar Efficacy in Less Time versus Qutenza
Potential control formulations under evaluation for future trials
20.0
ENF counts [mean  SEM]*
18.0
16.0
14.0
ENF Counts
(fibers/mm)
12.0
10.0
8.0
6.0
4.0
2.0
0.0
Control
* Preliminary data: N=28
NGX-4010 (60 min)
NGX-1998 (25 min)
NGX-1998 (15 min)
NGX-1998 (5 min)
24
Product Pipeline
Preclinical
Phase 1
Phase 2
Phase 3
NDA Filed and
QUTENZA™ (NGX-4010): PHN
Accepted
Qutenza: HIV-DSP
MAA Filed 2007
Qutenza: PDN
NGX-1998
NGX-6052
Clinical Program Initiated 2008
Opioid Prodrug Partnering Opportunities
NGX-6100
NGX-9674
NGX-1576
Marketing
Application
Acetaminophen Prodrug Partnering Opportunities
NGX-1576 (Hybrid Prodrug)
– Comparable systemic
exposure to acetaminophen
– Significantly reduced acute
hepatoxicity
APAP (µg/mL)
100
NGX-1576
APAP
75
50
25
4
3
2
1
Time (hr)
300
APAP
Units/L
• Simultaneously releases
both acetaminophen and
precursor for glutathione
synthesis in liver
• Murine model showed
NGX-1576 at equimolar
dose levels provides:
APAP
200
100
NGX1576
Control
NGX1576
Control
AST
ALT
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
27
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
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NASDAQ: NGSX