Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (June 2014)
27 slides from Vanda Pharmaceuticals's investor presentation, Jun 4, 2014
Slide 1: Vanda Pharmaceuticals Inc. 2014 Corporate Presentation
Exhibit 99.1 Vanda Pharmaceuticals Inc. 2014 Corporate Presentation
Slide 2: Forward-Looking Statements
Forward-Looking Statements All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forwar
Slide 3: Vanda Overview
CNS Specialty Company – Focused on unmet medical needs Proven Track Record of Development and Drug Approvals Vanda Overview HETLIOZ™ - FDA approved treatment for Non-24-Hour Sleep-Wake Disorder (Non-24) April 2014 commercial launch in US & full rest of world rights Additional novel commercial and cl
Slide 4: Vanda Product Pipeline
Vanda Product Pipeline Phase I Phase II Phase III NDA / MAA US – Schizophrenia (2) US - Non-24 Fanapt ® HETLIOZ™ Market EU – Schizophrenia Pruritus (1) VLY-686 1. Treatment Resistant Pruritus in Atopic Dermatitis 2. Marketed in the US by Novartis EU - Non-24
Slide 5: HETLIOZ
© Hetlioz °ee@@@@ | (asimelteon 20mg DYANDA
Slide 6: Non-24 Overview
Non-24 Overview • Non-24 is a circadian rhythm disorder that primarily affects the totally blind • Results in misalignment of the sleep-wake cycle to the 24-hour day • Causes serve and chronic impairment in social and occupational functioning • An estimated 80K Americans suffer from Non- (1) ; EU pr
Slide 7: Significant 2014 HETLIOZ Milestones
Significant 2014 HETLIOZ™ Milestones National Non-24 Awareness Campaign initiated (January 2014) FDA approval (1/31/14) HETLIOZ™ commercial launch (4/21/14) 9,500 individuals have responded to the Non-24 Awareness Campaign in the US (6/3/14) EMA accepts HETLIOZ™ Non-24 MAA filing for review (6/3/14)
Slide 8: First FDA Approved Treatment for Non-24
HETLIOZ™ - First FDA Approved Treatment for Non-24 FDA Approval: January 31, 2014 US Commercial Launch: April 21, • Indication: HETLIOZ™ (tasimelteon) 20mg is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) • Common Adverse Events: The most common adverse reactions (incidence
Slide 9: Solutions
HETLIOZ™ Solutions A hub to address patient and physician needs Patient Support • Non-24 disease awareness • HETLIOZ™ information • Insurance benefits verification • Financial assistance programs • Prescription follow-up support • HETLIOZ™ prescribing information • Prescription intake processing • T
Slide 10: Access & Reimbursement
HETLIOZ™ Access & Reimbursement Principle: Ensure patient access to HETLIOZ™ Programs for co-pay assistance Foundation support Patient assistance programs Key Facts: 1. Wholesale acquisition cost Mix of Commercial and Government Payors Financial Assistance Programs in place WAC (1) is $84,231 per ye
Slide 11: U.S. Launch Initiatives
HETLIOZ™ U.S. Launch Initiatives Non-24 Awareness Case Management Significant efforts in the first half of 2014 to increase Non-24 awareness Focus in the second half of 2014 is to help patients obtain proper diagnosis and treatment Advocacy Radio Web TV Education materials to people who opt-in Case
Slide 12: Non-24 Awareness Campaign
Non-24 Awareness Campaign 3,600 ~40% 9,500 individuals from across the US have responded and “Opted-In” to learn more about Non-24 5,900 ~60% Likely Patients Friends & Family/Other
Slide 13: US Launch: June 4, 2014 Update
HETLIOZ™ US Launch: June 4, 2014 Update • Majority of new prescriptions come from patients who have previously responded to the Non-24 Awareness Campaign • Most payors require prior authorization • Formulary decisions expected over the next 6 months • Encouraging uptake to date Prescriptions Written
Slide 14: Launch Campaign
HETLIOZ™ Launch Campaign Its time to treat Non-24 Its time for HETLIOZ™
Slide 15: EMA Filing
HETLIOZ™ EMA Filing • HETLIOZ™ Marketing Authorization Application (MAA) for the treatment of Non-24 was accepted for review under Centralised Procedure in June 2014 • HETLIOZ™ has been granted orphan drug designation for the treatment of Non-24 in the totally blind by the European Commission
Slide 16: Pediatric Non-24
HETLIOZ™ - Pediatric Non-24 • Clinical protocols under development for further EMA and FDA discussions • Pediatric suspension formulation development is underway
Slide 17: Smith-Magenis Syndrome (SMS)
HETLIOZ™ - Smith-Magenis Syndrome (SMS) • Genetic disorder due to chromosome 17p abnormality • Developmental defects, sleep and behavior problems – Inversion of circadian rhythm reported • SMS observational study underway to better characterize the disorder
Slide 18: Intellectual Property
HETLIOZ™ Intellectual Property United States Expiry Date Patent ID Tasimelteon 2017 (2022) Tasimelteon Synthesis Tasimelteon Dose Range 2027 (if issued) Method to Treat in Non-24 2033 (if issued) Method to Diagnose in Non-24 2033 (if issued) US7,754,902 Family PCT/US2007/069411 PCT/US2013/023312 PCT
Slide 19: NK-1R Antagonist VLY-686
NK-1R Antagonist VLY-686
Slide 20: VLY-686 – Treatment Resistant Pruritus
VLY-686 – Treatment Resistant Pruritus Sites / Enrollment Design Endpoints VLY-686 for Treatment Resistant Pruritus in Atopic Dermatitis Phase II Study initiated in Q4 2013 Two sites in Germany Subjects = 68 (enrollment ongoing) • Atopic dermatitis patients with chronic pruritus refractory to conven
Slide 21: Fanapt (iloperidone)
Fanapt ® (iloperidone) An atypical antipsychotic agent for the treatment of schizophrenia in adults
Slide 22: Fanapt Oral Formulation Status
Fanapt ® Oral Formulation Status US & Canada Rest of World Approvals / Partners Mexico - Probiomed Israel - Megapharm EMA application to be re-filed after maintenance study is concluded Vanda has full commercial rights for Fanapt ® outside of the US and Canada Partnered with Novartis 2010 US launch
Slide 23: Other Programs - Intellectual Property
Other Programs - Intellectual Property United States Europe VLY-686 (1) (2029) (2) Approval + Years (3) Fanapt ® Oral (4) 1. Composition of Matter Patent 2. Assumes full 5-year Hatch-Waxman extension in US 3. Eligible for up to 10 years commercial exclusivity in the EU 4. Composition of Matter plus
Slide 24: Financial Results – First Quarter 2014
Financial Results – First Quarter 2014 Licensing Agreement (1) $7.5M Royalty Revenue $1.7M Revenue $9.1M Research & Development (2)(4) $7.3M General & Administrative (3)(4) $27.9M Intangible Asset Amortization $0.6M Operating Expense $35.7M Net Loss ($26.5M) Cash (5) $100.4M Q1 2014 1.Licensing agre
Slide 25: Financials – Full Year 2014 Guidance
Financials – Full Year 2014 Guidance FY 14 Operating Expenses $110M - $120M 1H 14 Operating Expenses $67M - $72M 2H 14 Operating Expenses $43M - $48M Year End Cash (1) $20M - $30M Before HETLIOZ™ income FY 2014 • Total 2014 operating expenses are expected to be between $110 and $120 million. This in
Slide 26: Important Safety Information
HETLIOZ™ Important Safety Information Indication and Important Safety Information About HETLIOZ™ Indication HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Important Safety Information HETLIOZ™ may cause somnolence: After taking HETLIOZ™, patients should limit th
Slide 27: Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc.
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