Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Cowen Healthcare Conference 2010
26 slides from Vanda Pharmaceuticals's conference presentation, Mar 9, 2010
Slide 1: Vanda Pharmaceuticals Inc. Cowen Healthcare Conference
Vanda Pharmaceuticals Inc. Cowen Healthcare Conference March 9, 2010 Mihael H. Polymeropoulos MD CEO
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: Company Summary
Company Summary Vanda Pharmaceuticals (Nasdaq: VNDA) Rockville, MD 22 Employees Established in 2003 IPO 2006
Slide 4: Vanda Historical Stock Performance
Vanda Historical Stock Performance
Slide 5: Pipeline
Pipeline Phase I PhaseII PhaseIII NDA Market Fanapt(tm) (schizophrenia) Iloperidone depot Tasimelteon (CRSD)
Slide 6: Fanapt (iloperidone) (Schizophrenia)
Fanapt(tm) (iloperidone) (Schizophrenia)
Slide 7: Fanapt Overview
Fanapt(tm) Overview Fanapt(tm) (iloperidone) tablets - oral formulation FDA approved in May 2009 for adults with Schizophrenia Iloperidone - depot formulation Phase II Oral formulation launched January 11, 2010 by Novartis in the U.S.
Slide 8: Deal Summary
Deal Summary FDA approved for acute treatment of adult patients with schizophrenia Partnered with Novartis in the U.S. and Canada Vanda received $200 million upfront Eligible to receive up to an additional $265 million in payments tied to commercial and development milestones Low double-digit sales
Slide 9: Schizophrenia: the disease
Schizophrenia: the disease Severe, chronic, and debilitating brain disorder Prevalence: 1% worldwide ( ~2.4 million in the U.S.) Age of onset: 15-35 years Symptoms Positive Negative General Debilitating outcomes Near-universal disability Aggressive behavior High risk of suicide Sources: NAMI, NMA, D
Slide 10: Antipsychotic Market: Summary
Antipsychotic Market: Summary Significant unmet needs remain CATIE study showed 74% discontinue in 18 months, primarily due to safety concerns Protected compound class on federal and private formularies due to disease severity Highly concentrated prescriber base $15+ billion market
Slide 11: Approved Products
Approved Products Company US Launch Year US Patent Expiry Clozaril (r) Novartis 1990 generic Zyprexa(r) Eli Lilly 1996 4/2011 Risperdal(r) J&J 1994 generic Seroquel(r) AstraZeneca 1997 9/2011 Abilify(r) BMS/Otsuka 2002 10/2014 Geodon(r) Pfizer 2001 9/2012 Invega(r) J&J 2007 11/2011 Source: IMS - Wor
Slide 12: Depot Landscape
Depot Landscape Compliance remains a significant unmet need Limited competition Risperdal Consta: $1.3B revenue in 2009 Invega Sustenna: 2009 Launch Zyprexa Relprevv: 2009 Launch
Slide 13: Iloperidone Depot Formulation: Summary
Iloperidone Depot Formulation: Summary Differentiated profile Once every 4 weeks Well tolerated Weight gain/metabolics Movement disorders PK and Phase III studies needed for NDA
Slide 14: Iloperidone IP Summary
Iloperidone IP Summary Fanapt(tm) (oral) NCE (+ HW & pediatric) through mid 2017 Iloperidone depot microspheres US 2023 (allowed) EU 2022 (application) Iloperidone depot crystals US 2022 (application) EU 2022 (allowed)
Slide 15: Tasimelteon (VEC-162) (Circadian Rhythm Sleep Disorders or CRSD)
Tasimelteon (VEC-162) (Circadian Rhythm Sleep Disorders or CRSD)
Slide 16: Tasimelteon Program Overview
Tasimelteon Program Overview 2004: Acquired from BMS Mechanism: MT1, MT2 melatonin receptor agonist Vanda has completed 1 Phase II study and 2 Phase III studies Studies 2101 and 3101 establish tasimelteon as a circadian rhythm regulator
Slide 17: Vanda Clinical Trials to Date
Vanda Clinical Trials to Date Design Outcome Assessments Outcome Assessments Outcome Assessments Design Phase Advance Sleep Onset Sleep Maintenance Phase II Phase II Phase II Phase II Phase II 2101 5-Hour Phase Advance R, DB, PC parallel-group study N=39 5 dose groups Treatment: 3 nights + + + Phase
Slide 18: CRSD Population
CRSD Population 80K 12.6 MM 35.7 MM N24HSWD SWSD/Early Risers DSPD 15.6 MM Jet-Lag Total Population: >65 MM
Slide 19: Non-24-Hour SWD Background
Non24Hour SWD Background Non-24-Hour Sleep Wake Disorder (N24HSWD), a type of Circadian Rhythm Sleep Disorder (CRSD) 65K-95K people in the U.S. Problems with sleep and wakefulness Endogenous circadian rhythm or "body clock" is unable to entrain to a normal 24- hour day. In sighted individuals, the s
Slide 20: Orphan Indication Facts
Orphan Indication Facts Orphan indication granted January 2010 Streamlined development Tax credit / User fees for NDA waived FDA protocol assistance 7 year market exclusivity
Slide 21: Non-24-Hour SWD Draft Clinical Development Plan
Non24Hour SWD Draft Clinical Development Plan Proposed Clinical Development Plan:
Slide 22: Tasimelteon IP Summary
Tasimelteon IP Summary Tasimelteon NCE: December 2017 expiration (2023 including HW+pediatric) VXB-269 (back-up compound) NCE: June 2020 expiration
Slide 23: Finance Summary
Finance Summary
Slide 24: Summary Financials
Summary Financials ($ in millions) 12/31/09 Cash/cash equivalents/ST investments $205.3 ($ in millions) Year Ended 12/31/2009 Revenue Operating Expenses $4.5 COGS 2.9 R&D 13.9 G&A 23.7 Loss from Operations 40.5 Net Loss $36.0 Guidance: Vanda's fixed overhead costs are expected to be approximately $1
Slide 25: Tax Update
Tax Update Deferral for 2010 382 NOL Analysis On-going On-going discussion with IRS
Slide 26: Vanda Pharmaceuticals Inc. Cowen Healthcare Conference
Vanda Pharmaceuticals Inc. Cowen Healthcare Conference March 9, 2010 Mihael H. Polymeropoulos MD CEO
Vanda Pharmaceuticals — Cowen Healthcare Conference 2010 on 6ix