Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (September 2011)
35 slides from Vanda Pharmaceuticals's investor presentation, Sep 8, 2011
Slide 1: Vanda Pharmaceuticals Inc. 2011 Corporate Presentation
Vanda Pharmaceuticals Inc. 2011 Corporate Presentation
Slide 2: Forward-Looking Statement
Forward-Looking Statement Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," or the negative of these ter
Slide 3: Development and Commercial Capabilities Address Unmet Medical Needs
Development and Commercial Capabilities Address Unmet Medical Needs CNS Specialty Company Vanda Company Vision 3
Slide 4: Vanda Investment Highlights
Vanda Investment Highlights First Commercial Product Launched in 2010 in US Late Stage CNS Pipeline Strong Core Capabilities Fanapt(r) Approved in the US for Schizophrenia ROW rollout ongoing Tasimelteon for the Treatment of Sleep & Mood Disorders Phase III: Non-24-Hour Sleep-Wake Disorder (N24SWD)
Slide 5: Vanda Product Pipeline
Vanda Product Pipeline Phase I Phase II Phase III Filing US - Schizophrenia (oral) Long-Acting Injectable N24SWD1 Fanapt(r) Tasimelteon Major Depression Market EU - Schizophrenia (oral) 5 1) Non-24-hour Sleep Wake Disorder
Slide 6: Significant 2011-2012 Milestones
Significant 2011-2012 Milestones Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Fanapt(r) Tasimelteon Oral EU (Filed July 2011) Long-Acting Injectable PK/PD Study Results (2H 2012) ROW - Regulatory Submissions/Partnering (On-going) Initiate PhIIB/III Study in Major Depression (2H 2011) N24HSWD Ph I
Slide 7: Fanapt (iloperidone)
Fanapt® (iloperidone) BS DVYANDA
Slide 8: Fanapt Overview
Fanapt(r) Overview Fanapt(r) oral formulation Fanapt(r) long-acting injectable formulation Fanapt(r) franchise Intellectual Property An atypical antipsychotic agent for the treatment of schizophrenia in adults 8
Slide 9: Fanapt Oral Formulation Status
Fanapt(r) Oral Formulation Status US Clinical Regulatory Status US FDA approval: May 6, 2009 Indication: Schizophrenia in adults US Commercial Status Partnered with Novartis for US and Canada Launched January 2010 On preferred drug list (PDL) or unrestricted in >90% of state formularies 9
Slide 10: Antipsychotic Market Landscape
Antipsychotic Market Landscape FY 2009 US Total Market $14.7B Global Market $23.2B All Antipsychotics1 US Total Market $2.9B Seven Major Markets3 $5.1B Schizophrenia Market2 FY 2009 1 IMS Health Midas Report, December 2010 2 Data Monitor - Forecast Insight: Depression, December 2010 3 US, Japan, Fra
Slide 11: Fanapt U.S. Update
Fanapt(r) U.S. Update Novartis Agreement Vanda receives a low double digit royalty on US & Canada net sales $265M in potential outstanding development and sales based milestones 11 Prescription results1 through Q2 2011 Over 110,000 prescriptions have been written since launch in January 2010 Q2 2011
Slide 12: Fanapt ROW Update
Fanapt(r) ROW Update Filed for Approval Europe Argentina Israel Singapore Australia ROW Partners Mexico - Probiomed Argentina - Biotoscana 12 July 2011 July 2011 May 2011 March 2011 October 2010 Vanda has full commercial rights for Fanapt(r) outside of the U.S. and Canada
Slide 13: Fanapt Long-Acting Injectable
Fanapt(r) Long-Acting Injectable Long-acting Injectable Formulation Once a month formulation to address non-compliance Prior Phase I/II study supports further development Less crowded commercial market as compared to oral market Novartis responsible for development and US/Canada Vanda retained right
Slide 14: Fanapt Long-Acting Injectable: Efficient path to market
Fanapt(r) Long-Acting Injectable Efficient path to market Study Goal: Evaluate the safety and PK profiles of two long- acting formulations Study Profile: Expect single efficacy study to support filings Filing Roles: Novartis files in US/Canada Vanda files in EU/ROW PK/PD Study Phase III Study FDA/EM
Slide 15: Fanapt Franchise Intellectual Property
Fanapt(r) Franchise Intellectual Property Fanapt(r) Oral(1) Mid 2017(2) Approval + 10 Years Microspheres 2023 2022(4) Fanapt(r) Long-acting injectable(3) Crystals 2022 1) New Chemical Entity Patent (NCE) 2) Includes full 5 year Hatch Waxman and assumes 6 month Pediatric extension 3) Formulation pate
Slide 16: Tasimelteon: A Circadian Regulator
Tasimelteon A Circadian Regulator A Circadian Regulator
Slide 17: Tasimelteon - Mechanism of Action
Tasimelteon - Mechanism of Action Unique Molecular Mechanism of Action Melatonin 1 (MT1) agonist Melatonin 2 (MT2) agonist Circadian Regulator Circadian Phase Shift effects Soporific effects Mood restoring effects 17
Slide 18: Tasimelteon - Potential Indications
Tasimelteon - Potential Indications Circadian Rhythm Sleep Disorders Non-24-Hour Sleep-Wake Disorder (N24HSWD) Shift Worker Sleep Disorder Delayed Sleep Phase Disorder Jet Lag Major Depressive Disorder 18
Slide 19: Tasimelteon N24HSWD
Tasimelteon N24HSWD QYANDA
Slide 20: N24HSWD Facts
N24HSWD Facts A Circadian Rhythm Sleep Disorder Affects 65,000 - 95,000 people in the US Occurs almost entirely in blind subjects with no light perception Person affected will "free run" slightly longer than 24 hours without environmental input, causing a phase delay in the body clock each day No ap
Slide 21: Tasimelteon - N24HSWD Clinical Development Plan
Tasimelteon - N24HSWD Clinical Development Plan 2010 H1 H2 2011 2012 H1 H2 H1 H2 2013 H1 H2 3201 - Phase III Efficacy NDA Filing 3203 - Phase III Randomized Withdrawal 3202 - Safety Study 3204 Safety Study 21
Slide 22: Tasimelteon - Phase III Efficacy Study (3201)
Sites 31 Sites: 25 US and 6 Europe Enrollment ~ 100 Design Evaluate efficacy & safety of tasimelteon in patients with N24HSWD Randomized, double-masked 2 dosing arms (placebo, 20 mg tasimelteon) Endpoints Primary Nighttime Total Sleep Time (nTST) Secondary (8 total) Total Daytime Nap Time Effect on
Slide 23: Tasimelteon - N24HSWD Market Opportunity
Tasimelteon - N24HSWD Market Opportunity Worldwide total market potential of up to $500M1 Orphan drug designation granted in the US and the EU Potential to expand into broader CRSD market Shift Work Sleep Disorder Delayed Sleep Phase Syndrome Jet Lag Over 65M US Patients with CRSD1 13M 16M 36M 1Vand
Slide 24: Tasimelteon Major Depressive Disorder
Tasimelteon Major Depressive Disorder Major Depressive Disorder
Slide 25: Tasimelteon - Major Depression Market
Tasimelteon - Major Depression Market Approved Treatments Company US Launch Year 2009 Worldwide Sales ($B)1 Lexapro(r) Forest / Lundbeck 2002 $1.8 Effexor XR(r)/Pristiq(r) Pfizer 1994 $1.7 Cymbalta(r) Eli Lilly 2004 $1.6 Atypical Antipsychotics multiple 2000's $2.0 Other SSRI / SNRI multiple $3.5 To
Slide 26: Circadian Mechanism Suspected in Major Depressive Disorder
Tasimelteon - Major Depressive Disorder Circadian Mechanism Suspected in Major Depressive Disorder Phase advance theory of depression Diurnal variation of symptoms Light therapy in seasonal affective disorder Tasimelteon: Proof of concept - Positive forced swim test Valdoxan(r): MT1/MT2 agonist appr
Slide 27: Tasimelteon - Potential for Superior Profile
Tasimelteon - Potential for Superior Profile Bedtime dosing Immediate effect on circadian rhythm Early onset of action possible Short 2.5 hour half life reduces continuous exposure No sexual side effects / no weight gain No activation / no akathisia Address the mechanism of depression symptoms Treat
Slide 28: Tasimelteon - MDD Clinical Development Plan
Expect to initiate 3301 MDD efficacy study in 2H 2011 Streamlined MDD clinical program Potential to use Ph IIB/III as one of the two pivotal studies Leverage preclinical and clinical safety data from N24HSWD program Two Pivotal Studies plus Safety Study New Drug Application (NDA) Tasimelteon - MDD C
Slide 29: Tasimelteon - MDD Efficacy Study (3301)
Sites 40 Sites Enrollment ~ 500 Design Evaluate efficacy & safety of tasimelteon in patients with MDD Randomized, double-masked 2 dosing arms (placebo, 20 mg tasimelteon) Endpoints Primary Depression Scales (HAMD/MADRS) Secondary Circadian Misalignment Quality of Life Tasimelteon - MDD Efficacy Stud
Slide 30: Tasimelteon - Intellectual Property
Tasimelteon - Intellectual Property Exclusive, Worldwide Rights Acquired from BMS Strong Intellectual Property NCE patent expires in US: December 2017 (2022)1 Data exclusivity in EU: December 20172 Commercial exclusivity in EU: Approval + 10 years Vanda also acquired VXB-269 (follow-on compound) App
Slide 31: Financial Summary
Financial Summary
Slide 32: Financials - 1H 2011 Results
Financials - 1H 2011 Results Licensing Agreement1 $13.1M Royalty Revenue $1.6M Revenue $14.9M Research & Development $10.3M General & Administrative $5.4M Intangible Asset Amortization $0.7M Operating Expense $16.4M Net Loss ($1.2M) Cash $188.4M 1H 2011 1) Licensing agreement of $13.1M reflects the
Slide 33: Financials - Full Year 2011 Guidance
Financials - Full Year 2011 Guidance Research & Development $30M - $34M General & Administrative $10M - $12M Intangible Asset Amortization $1.5M Total Operating Expense $41M - $47M FY 2011 R&D and G&A include $5M - $6M of non-cash stock based compensation 33
Slide 34: Significant 2011-2012 Milestones
Significant 2011-2012 Milestones Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Fanapt(r) Tasimelteon Oral EU (Filed July 2011) Long-Acting Injectable PK/PD Study Results (2H 2012) ROW - Regulatory Submissions/Partnering (On-going) Initiate PhIIB/III Study in Major Depression (2H 2011) N24HSWD Ph I
Slide 35: Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. DVANDA
Vanda Pharmaceuticals — Investor Presentation (September 2011) on 6ix