Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (October 2010)
24 slides from Vanda Pharmaceuticals's investor presentation, Oct 7, 2010
Slide 1: Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. October 7, 2010 Mihael H. Polymeropoulos MD CEO
Slide 2: Forward-Looking Statement
Forward-Looking Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Vanda's financial condition, results from operations and business, and its expectations and beliefs. Forward-looking statements a
Slide 3: Company Summary
Company Summary Focused on the development and commercialization of products for central nervous system disorders First drug, Fanapt(r) (iloperidone), approved by FDA in 2009 for the treatment of schizophrenia and licensed to Novartis for US and Canada Late-stage clinical pipeline Strong cash positi
Slide 4: Pipeline
Phase I Phase II Phase III NDA/MAA Phase I/II Pipeline Market Fanapt(r) (Schizophrenia, US) Iloperidone Depot Tasimelteon (CRSD) Fanapt(r) (Schizophrenia, E.U.
Slide 5: Fanapt (iloperidone)
Fanapt(r) (iloperidone)
Slide 6: Fanapt Overview
Fanapt(r) Overview Atypical antipsychotic approved by FDA in May 2009 for adults with schizophrenia Subsequently licensed to Novartis for marketing in US and Canada Vanda retains commercial rights outside of US and Canada. Commercial launch: January 2010 Novartis has created a dedicated sales force
Slide 7: Novartis Partnership
Novartis Partnership Vanda received $200 million upfront payment Eligible to receive an additional $265 million in milestone payments Low double-digit royalties on sales Territories: US and Canada - Vanda retains rights for both oral and depot formulations outside of the US and Canada Novartis is co
Slide 8: Antipsychotic Market
Antipsychotic Market $15+ billion market (2009) Highly concentrated prescriber base Significant unmet needs remain Protected drug class: CMS-mandated formulary coverage due to disease severity Majority of patients with schizophrenia are covered through Medicaid or Medicare Part D
Slide 9: Fanapt Launch Update
Fanapt(r) Launch Update Physicians have provided positive feedback on Fanapt(r) based upon its safety and efficacy profile Payer access - on the preferred drug list in approximately 70% of states Promotional launch began end of May 2010
Slide 10: Long-Acting iloperidone
Long-Acting iloperidone
Slide 11: Depot Formulation of iloperidone
Depot Formulation of iloperidone Once a month dosing using microsphere technology Drug is well-tolerated in studies to date It is expected that a PK study and one Phase III study is required for NDA filing
Slide 12: Long Acting Antipsychotic Market
Long Acting Antipsychotic Market Compliance remains a significant unmet need in Schizophrenia Limited competition Risperdal Consta: $1.3B revenue in 2009 $1 billion ex-US, $300 million US Invega Sustenna: 2009 launch Zyprexa Relprevv: 2009 launch Well-established market for long-acting entrant
Slide 13: Fanapt Franchise: IP Protection
Fanapt(r) Franchise: IP Protection Fanapt(r) (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 14: Tasimelteon
Tasimelteon
Slide 15: Tasimelteon
Tasimelteon Oral dual melatonin receptor agonist in development for sleep and mood disorders, including Circadian Rhythm Sleep Disorders (CRSD) In Phase III for Non-24 Hour Sleep Wake Disorder (N24HSWD) Licensed from BMS
Slide 16: Tasimelteon Highlights for N24HSWD
Tasimelteon Highlights for N24HSWD Granted orphan drug designation for N24HSWD by FDA No current treatment options available for N24HSWD Long-term health consequences from N24HSWD Relatively small clinical studies with short development timeline
Slide 17: N24HSWD Facts
N24HSWD Facts A type of circadian rhythm sleep disorder Affects 65,000 - 95,000 people in the US Occurs almost entirely in subjects without light perception Person affected will "free run" slightly longer than 24 hours without environmental input, causing a phase delay in his/her body clock each day
Slide 18: N24HSWD Clinical Program
N24HSWD Clinical Program Phase III study underway, results expected late 2011 Placebo-controlled, double-masked study of 160 patients with N24HSWD Study duration 6-9 months Building a patient community to raise awareness for N24HSWD with leading organizations
Slide 19: Prior Tasimelteon Clinical Experience
Prior Tasimelteon Clinical Experience One Phase II and two Phase III clinical studies for insomnia completed, outcomes positive Tasimelteon shown to improve both sleep onset and sleep maintenance in Phase II and III phase advance studies Also shown to improve sleep onset in Phase III study in patien
Slide 20: On-going Trials in N24HSWD
On-going Trials in N24HSWD VP-3201 (efficacy study) 2 arm, 160-patient study 6-month treatment period Primary outcome: Subjective Nighttime Total Sleep Time (nTST) FPFV August 2010 VP-3202 (safety study) Target enrollment, n = 140 12-month treatment period FPFV planned for Q4 2010
Slide 21: CRSD Population in the U.S.
35.7 MM N24HSWD SWSD/Early Risers DSPD 80,000 12.6 MM 15.6 MM Jet-Lag Total Population: >65 MM CRSD Population in the U.S.
Slide 22: Tasimelteon Summary
Tasimelteon Summary Clinical efficacy/safety studies complete Q4 2012 Target NDA filing early 2013 Orphan indication Low R&D spend Significant commercial opportunity
Slide 23: Summary Financials
($ in millions) 06/30/10 Cash/cash equivalents/ST investments $207.1 ($ in millions) Six Months Ended 06/30/10 Revenue Operating Expenses $20.7 COGS 3.6 R&D 4.4 G&A 5.3 Income from Operations 7.4 Tax provision 5.6 Net Income $1.8 TAX UPDATE: Deferral for 2010 - 382 NOL Analysis Ongoing Discussion wi
Slide 24: Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. October 7, 2010 Mihael H. Polymeropoulos MD CEO
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