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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:
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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.
NeurogesX – Pain Management Focus Locally-acting analgesic formulated in dermal patch Pain relief up to 12 weeks demonstrated Differentiated Lead Product: QUTENZA™ 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 2H07Confirmatory Phase 3 study in PHN 2H07NGX-4010 EU Marketing Application 1H08Confirmatory Phase 3 study in HIV-DSP 1H08NGX-1998 IND filing 1H08Continue NGX-1998 clinical program 1H08 Initiate NGX-4010 PDN program 2H08 NGX-4010 NDA filing (PHN) 4
Product Pipeline Clinical Program Initiated 2008 NDA Filed and Accepted QUTENZA™ (NGX-4010): PHN Qutenza: HIV-DSP MAA Filed 2007 Qutenza: PDN NGX-1998 Opioid Prodrug Partnering Opportunities NGX-6052 NGX-6100 NGX-9674 Acetaminophen Prodrug Partnering Opportunities NGX-1576
2005 2010 2015 $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 Annual US Pain Product Sales $ in Billions $9 $8 $7 $6 $5 $4 $3 $2 $1 0 CAGR 11% Source: Jain Biopharma 2006
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
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 IndicationPost-Herpetic Neuralgia (PHN) • NDA Submitted, Accepted for Review by FDA…
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: Value Proposition in PHN 0 -5 -10 -15 C108 PHN C110 PHN -20 C116 PHN C111 PHN -25 C117 PHN -30 -35 -40 -45 4 9 10 11 12 1 2 3 5 6 7 8 -50 % Change from Baseline in NPRS Scores [mean SE] % Decrease from Baseline Baseline Week 13
Qutenza Versus Lyrica in PHN • † Week 8 • Calculated from mean absolute change/mean baseline scores • Lyrica data from FDA SBA 14
Qutenza Market Research: • Significant Potential…
Physician Survey on Qutenza Advantages All groupsQ26. 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 17 SOURCE: NeurogesX quantitative research (n=208)
Positive Patient Feedback ~2/3 respondents would ask physicians about Qutenza or try it upon physician recommendation “I would definitely try it once -- it’s all-natural, how is it going to hurt me?” – PHN patient, NY 18 Source: NeurogesX qualitative market research (n=78).
AN PM 10% IM 9% APM 5% 18% RHU 4% P 4% 20% 6% Others 24% FP Source: NDC 6/04 - Prometrics Analysis N Commercialization Strategy • 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 Pain Clinic Office Pain Services 14% 23% 63% Hospital Pain Clinic Source: FIRSTMARK April 2006
2009 2010 2011 2012 Temporary Codes: Improve Ease of Reimbursement/Market Access • Temporary codes (product + procedure) shortly after launch • Permanent Codes 1-2 years post-launch Misc. C-Code (Medicare - Hospital Outpatient ONLY) Qutenza C-Code (Medicare - Hospital Outpatient ONLY) NGX-4010 Reimbursement Qutenza J-Code Misc. J-Code Permanent CPT code for procedure Treatment Procedure Reimbursement Temporary Q or Misc CPT or Category III CPT code for procedure PDUFA Date
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: Next Generation Pain Management Non-Patch Formulation Using Qutenza’s API
NGX-1998: Phase 1 ResultsSimilar Efficacy in Less Time versus Qutenza 20.0 18.0 16.0 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0 • Potential control formulations under evaluation for future trials ENF counts [mean SEM]* ENF Counts (fibers/mm) Control NGX-4010 (60 min) NGX-1998 (25 min) NGX-1998 (15 min) NGX-1998 (5 min) * Preliminary data: N=28 24
Product Pipeline Clinical Program Initiated 2008 NDA Filed and Accepted QUTENZA™ (NGX-4010): PHN Qutenza: HIV-DSP MAA Filed 2007 Qutenza: PDN NGX-1998 Opioid Prodrug Partnering Opportunities NGX-6052 NGX-6100 NGX-9674 Acetaminophen Prodrug Partnering Opportunities NGX-1576
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 hepatoxicity 100 NGX-1576 75 APAP APAP (µg/mL) 50 25 4 3 2 1 Time (hr) 300 APAP APAP 200 Units/L NGX-1576 NGX- 1576 Control 100 Control ALT AST
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
2009 – 2010 Milestones 1H09MAA Decisionfor Qutenza (neuropathic pain) 1H09EUCommercial Partnership 2H09PDUFA for Qutenza (PHN) 2H09Qutenza EU Launch 1H10 Qutenza U.S. Launch 28