Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (June 2011)
33 slides from Vanda Pharmaceuticals's investor presentation, Jun 9, 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: Vanda Company Vision
Development and Commercial Capabilities Address Unmet Medical Needs CNS Specialty Company Vanda Company Vision 2
Slide 4: Vanda Investment Highlights
Vanda Investment Highlights First Commercial Product Launched in 2010 in US Late Stage CNS Pipeline Strong Core Capabilities Fanapt ® • 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 • Ph
Slide 5: Vanda Product Pipeline
Vanda Product Pipeline Phase I Phase II Phase III Filing Market Size US — Schizophrenia (oral) Long-Acting Injectable Non-24-Hour Sleep- Wake Disorder ~$12B1 ~$500M2 >$10B3 1Antipsychotic Market — IMS Health National Sales Perspectives 2010 2Vanda Estimate 3 Data Monitor — Forecast Insight: Depressi
Slide 6: Key Milestones 2011-2015
Key Milestones 2011 — 2015 Significant 2011-2012 Milestones Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Fanapt ® Tasimelteon (Oral) EU Filing (2H 2011) Depot PK/PD Study Results (2H 2012) ROW — Regulatory Submissions/Partnering (On-going) Initiate PhIIB/III Study in Major Depression (2H 2011) N2
Slide 7: Fanapt (iloperidone)
Fanapt® (iloperidone) Bia QvArca
Slide 8: Fanapt Overview
Fanapt ® Overview • Fanapt ® oral formulation • Fanapt ® long-acting injectable formulation • Fanapt ® franchise Intellectual Property An atypical antipsychotic agent for the treatment of schizophrenia in adults 6
Slide 9: Fanapt Oral Formulation Status
Fanapt ® 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
Slide 10: Antipsychotic Market Landscape
Key Milestones 2011 — 2015 Antipsychotic Market Landscape FY 2009 US Total Market $14.7B Global Market $23.2B All Antipsychotics1 US Total Market $2.9B $3.0B Seven Major Markets3 $5.1B $5.6B Schizophrenia Market2 FY 2009 FY 2019 Forecast 1 IMS Health Midas Report, December 2010 2 Data Monitor — Fore
Slide 11: Fanapt U.S. Revenue Update
Fanapt ® U.S. Revenue Update $21M $1M $5M $5M $9M Novartis Net Sales ($M) • Vanda receives a low double digit royalty on US & Canada net sales • $265M in potential outstanding development and sales based milestones 9
Slide 12: Fanapt ROW Filing Update
Fanapt ® ROW Filing Update Filed for Approval Israel — Filed 5/17/2011 Singapore — Filed 3/16/2011 Australia — Filed 10/31/2010 Submission in Process Europe — Submission targeted for 2H 2011 Argentina — Submission targeted for 2H 2011 Other Latin America in process 10
Slide 13: Fanapt Long-Acting Injectable
Fanapt ® 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 ret
Slide 14: Fanapt Long-Acting Injectable: Efficient path to market
Fanapt ® Long-Acting Injectable Efficient path to market Study Goal: Evaluate the safety and PK profiles of two longacting 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/EMA F
Slide 15: Fanapt Franchise Intellectual Property
Fanapt ® Franchise Intellectual Property Fanapt ® Oral(1) Mid 2017(2) Approval + 10 Years Microspheres 2023 2022(4) Fanapt ® Long-acting injectable(3) Crystals 2022 1) New Chemical Entity Patent (NCE) 2) Assumes full Hatch Waxman and Pediatric extensions 3) Formulation patent. PK/PD study will enabl
Slide 16: Tasimelteon: A Circadian Regulator
Tasimelteon A Circadian Regulator 24 A Circadian Regulator 24
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 Mood Disorders 14
Slide 18: Tasimelteon Non-24 Hour Sleep / Wake Disorder (N24HSWD)
Tasimelteon Non-24 Hour Sleep / Wake Disorder (N24HSWD) N24HSWD
Slide 19: 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 d
Slide 20: N24HSWD Clinical Development Plan
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 17
Slide 21: Phase III Efficacy Study (3201)
Sites 31 Sites: 25 US and 6 Europe Enrollment ~ 160 Design • Evaluate efficacy & safety of tasimelteon in patients with N24HSWD • Randomized, double-blind • 2 dosing arms (placebo, 20 mg) Endpoints Primary • Nighttime Total Sleep Time (nTST) Secondary (8 total) • Total Daytime Nap Time • Effect on t
Slide 22: N24HSWD Market Opportunity
N24HSWD Market Opportunity • Estimated Worldwide total market ~ $500M1 • Orphan drug designation granted in the US and the EU • Potential to expand into broader CRSD market Shift Work Sleep Disorder Delayed Sleep Phase Syndrome Jet Lag Over 65M US Patients with CRSD1 13M 16M 36M 1Vanda Estimate 19
Slide 23: Tasimelteon Major Depressive Disorder
Tasimelteon MajMoarj oDr eDperpersessisvivee DDiissoorrddeerr
Slide 24: Tasimelteon: Major Depression Market
Tasimelteon: Major Depression Market Approved Treatments Company US Launch Year 2009 Worldwide Sales ($B)1 Lexapro ® Forest / Lundbeck 2002 $1.8 Effexor XR ® /Pristiq ® Pfizer 1994 $1.7 Cymbalta ® Eli Lilly 2004 $1.6 Atypical Antipsychotics multiple 2000’s $2.0 Other SSRI / SNRI multiple $3.5 Totals
Slide 25: Tasimelteon 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: Positive forced swim test • Valdoxan ® : MT1/MT2 agonist approved in
Slide 26: 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
Slide 27: Major Depression 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 3301 MDD Efficacy Study Two Pivotal Studies plus Safety Study New Drug Applica
Slide 28: 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 co
Slide 29: Financial Summary
Financial Summary Qvanda
Slide 30: Financials: Full Year 2010 Results
Key Milestones 2011 — 2015 Financials — Full Year 2010 Results Revenue $35.7M Cost of Sales $2.9M Research & Development $12.3M General & Administrative $10.1M Intangible Asset Amortization $1.5M Operating Expense $26.9M Net Income $7.2M Cash $198.0M FY 2010 Licensing Agreement $26.8M 1 Royalty Reve
Slide 31: Financials: Full Year 2011 Guidance
Key Milestones 2011 — 2015 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 27
Slide 32: Significant 2011-2012 Milestones
Key Milestones 2011 — 2015 Significant 2011-2012 Milestones Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 Fanapt ® Tasimelteon (Oral) EU Filing (2H 2011) Depot PK/PD Study Results (2H 2012) ROW — Regulatory Submissions/Partnering (On-going) Initiate PhIIB/III Study in Major Depression (2H 2011) N2
Slide 33: Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. QYAnnr
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