Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (April 2008)
26 slides from Vanda Pharmaceuticals's investor presentation, Apr 1, 2008
Slide 1: Vanda Pharmaceuticals Inc. Corporate Overview April 2008
Vanda Pharmaceuticals Inc. Corporate Overview April 2008
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to our financial condition, results from operations and business, and our expectations and beliefs about future events. Actual resu
Slide 3: Vanda Overview
Vanda Overview Late-stage products targeting large, under-served markets: Fiapta(tm) (iloperidone) - schizophrenia (NDA) Tasimelteon (VEC-162) - sleep disorders (Phase III) Tasimelteon - mood disorders (Phase II) Significant near-term milestones: Fiapta(tm) PDUFA date expected July 27, 2008 Tasimelt
Slide 4: Fiapta (iloperidone) (Schizophrenia)
Fiapta(tm) (iloperidone) (Schizophrenia)
Slide 5: Fiapta Status
Fiapta(tm) Status Key short-term milestones: PDUFA date expected July 27, 2008 Currently targeting launch in Q1, 2009 Compelling commercial profile established Commercialization efforts underway pre-PDUFA action
Slide 6: Atypical Antipsychotics Approved Products
Atypical Antipsychotics Approved Products Source: IMS HEALTH National Sales Perspectives (2007), Vanda calculations Approved Products Company US Launch Year 2007 US Revenue ($MM) 2007 US Y-o-Y Growth Seroquel(r) AstraZeneca 1997 3,256 13.2% Risperdal(r) J&J 1994 3,122 11.3% Zyprexa(r) Eli Lilly 1996
Slide 7: Atypical Drug Selection Factors
Question. Please rate each of the statements below using a scale of 1-10 on importance to you when selecting an antipsychotic therapy for your schizophrenia patients. (130 respondents) Risk of prolactin elevation Availability of long-acting formulation Risk of QT prolongation Somnolent effects QD do
Slide 8: Perceptual Map: Driven by Movement and Metabolics
Adverse Lipid Effects Weight Gain Adverse Glucose Effects Onset of EPS Onset of Akathisia Efficacy Source: GfK V2 Qualitative Positioning Study, January 2008. Perceptual Map: Driven by Movement and Metabolics Physicians differentiate atypicals more on side effect profile than on efficacy
Slide 9: Fiapta - Compelling Commercial Profile
FiaptaTM - Compelling Commercial Profile Similar Efficacy Favorable Metabolic Profile Favorable Movement Disorder Profile Geodon(r) Abilify(r) Invega(r) Risperdal(r) Seroquel(r) Zyprexa(r) Fiapta(tm) profile: favorable in movement disorders and metabolics
Slide 10: Key Areas of Launch Preparation
Key Areas of Launch Preparation Launch Preparation Sales Force MSL Managed Care Distribution Groundwork for a successful launch combines pre-PDUFA planning with rapid post-PDUFA execution Marketing
Slide 11: Marketing
Marketing Significant efforts underway Marketing team build-out Messaging and positioning Branding Publication planning and execution Packaging Psychiatric community outreach Conferences
Slide 12: Sales Force
Sales Force Hire VP of sales Territory mapping Plan sales force scenarios Managers/reps: if Vanda owns sales force CSO: if Vanda rents sales force Hire or engage sales force Source: Verispan Deciles Antipsychotic MDs Depression MDs Insomnia MDs 10 721 3,418 3,370 10-8 3,734 18,001 17,381 10-5 14,012
Slide 13: Managed Care
Managed Care IMS, Atypical managed care analysis, Q42006 Vanda believes a small managed care organization can effectively ensure Fiapta(tm) coverage Hire VP of managed care Payer profiling Develop pricing and contracting strategy Plan, engage managed care field force Execute on contracting strategy
Slide 14: Medical Science Liaisons
Medical Science Liaisons Hire Director of MSLs Territory mapping Recruit and deploy MSLs Hire additional MSLs Vanda planned pre-PDUFA activity Vanda planned post-PDUFA activity
Slide 15: Distribution
Distribution Hire 3rd party logistics agency Responsible for getting product to the trade Applying for state licenses Continue outsource strategy Contract manufacturer 3rd Party Logistics Contract packaging Role of 3rd Party Logistics Coordinator National wholesalers Regional wholesalers Specialty d
Slide 16: Vanda Planning for Fiapta Launch Success
Vanda Planning for Fiapta(tm) Launch Success Attractive clinical profile Strong core team in place Significant efforts underway Balancing execution and cash conservation objectives
Slide 17: Tasimelteon (VEC-162) (Sleep and Mood Disorders)
Tasimelteon (VEC-162) (Sleep and Mood Disorders)
Slide 18: Distinct MoA Demonstrated in Wide Range of Indications
Distinct MoA Demonstrated in Wide Range of Indications Balanced melatonin-1, melatonin-2 agonist Sleep induction Sleep maintenance Circadian rhythm advance Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders Seasonal Affective Disorder Major Depression MoA Effect Potenti
Slide 19: Large Market Opportunity in Sleep Disorders
Large Market Opportunity in Sleep Disorders Sleep induction Sleep maintenance Circadian rhythm modulation Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders US prevalence 54 million 18 million Approved drugs/drug classes NBZDs (Ambien(r) CR, Lunesta(r), etc.) BZDs (lora
Slide 20: CRSD an Attractive Market for Tasimelteon
CRSD an Attractive Market for Tasimelteon Circadian Rhythm Sleep Disorders Shift Worker Sleep Disorder Delayed Sleep Phase Syndrome Jet Lag Non-24 Hour Sleep/Wake Cycle U.S. Prevalence (000) 1,500 3,000 13,500 50 Tasimelteon Potential Benefits Disease-modification (CR modulation) Demonstrated effica
Slide 21: Mood Disorders an Attractive Market for Tasimelteon
Mood Disorders an Attractive Market for Tasimelteon Circadian Rhythm- Related Mood Disorders Seasonal Affective Disorder Major Depression U.S. Prevalence (000) 5,800 14,700 Tasimelteon Potential Benefits Disease-modification (CR modulation) LT safety Sleep benefits Source: LEK, 2005
Slide 22: Pending Tasimelteon Phase III Milestone
Pending Tasimelteon Phase III Milestone Objective Safety and efficacy in treatment of patients with chronic insomnia Duration 35 days (including screening) Dosing 20, 50 mg QD Comparator Placebo # of Patients 324 Key Endpoints LPS, WASO, safety Results expected in June, 2008 Phase III transient inso
Slide 23: Substantial Development Program Underway
Substantial Development Program Underway Phase III transient insomnia Completed Phase III chronic insomnia Process refinement Completion expected in 08 Carcinogenicity Vanda anticipates a 2010 NDA for tasimelteon Clinical Preclinical Manufacturing Clinical pharmacology Clinical scale-up In planning
Slide 24: Conclusions
Conclusions
Slide 25: Summary Financials
Summary Financials ($ in millions) 12/31/07 Cash/cash equivalents/ST investments $93.2 ($ in millions) Year ended 12/31/07 Operating Expenses R&D $47.2 G&A 32.8 Loss from Operations (80.0) Net Loss $(74.1) Cash expected to be sufficient to fund operations through Fiapta(tm) PDUFA date and into Q4 20
Slide 26: Major Milestones in 2008
Major Milestones in 2008 Fiapta(tm) APA (May) PDUFA (expected July 27) Tasimelteon Phase III chronic insomnia (expected in June) APSS (June)
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