Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (November 2019)
35 slides from Vanda Pharmaceuticals's investor presentation, November 2019
Slide 1: Corporate 2019 Presentation
CORPORATE 2019 PRESENTATION November 2019
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to, Vanda’s financial guidance for 2019, are “forward-looking statements” under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstan
Slide 3: Strategy for Long-Term Success
Strategy for Long-Term Success Lifecycle management and product optimization Developing and commercializing innovative therapies to address high unmet medical needs & improve the lives of patients Diversified pipeline in Expand into new high-growth niche geographies therapeutic markets 3
Slide 4: Marketed Assets
Marketed Assets Circadian Rhythms Psychiatry US - Non-24 US - Schizophrenia EU - Non-24 ROW - Schizophrenia Distribution partners 4
Slide 5: Clinical Development Pipeline
Clinical Development Pipeline: Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Smith-Magenis Syndrome (SMS) Non-24 Pediatric Delayed Sleep Phase Disorder (DSPD) Bipolar Disorder (Oral tablets) Long Acting Injectable (LAI) PK Study ongoing in preparation for a Ph
Slide 6: Select Research & Development Milestones
Select Research & Development Milestones Tradipitant Gastroparesis - Initiate a Phase III study Q2 2019 Atopic Dermatitis - Initiate a second Phase III study (EPIONE II) Q4 2019 Atopic Dermatitis - Phase III clinical study results (EPIONE) Q1 2020 Motion Sickness - Phase II clinical study re
Slide 7: Tradipitant
Tradipitant Atopic Dermatitis Gastroparesis Motion Sickness
Slide 8: Tradipitant Clinical Development Programs
Tradipitant Clinical Development Programs Innovative approach to treating millions of patients Tradipitant: NK-1R Antagonist The activation of NK-1R by the natural ligand Substance P is thought to be involved in the perception of itch, pain, behavioral stress response, cravings and nausea and vomiti
Slide 9: Tradipitant: Atopic Dermatitis
Tradipitant: Atopic Dermatitis Atopic Dermatitis (AD): US Market Estimated US Prevalence1 • Approximately 9.8M diagnosed and 6.4M drug-treated AD patients2 17,800,000 • Management of pruritus is a key treatment goal for patients3 Atopic Dermatitis: High Unmet Medical Need Atopic Dermatitis Treatment
Slide 10: Tradipitant Phase II Study (2102): Atopic Dermatitis
Tradipitant Phase II Study (2102): Atopic Dermatitis Results reported in September 2017 Tradipitant treated patients showed clinically meaningful improvement in both worst itch and atopic dermatitis severity Favors Tradipitant Favors Placebo Favors Placebo Favors Tradipitant Tradipitant Phase II Stu
Slide 11: Tradipitant Phase III Program: Atopic Dermatitis
Tradipitant Phase III Program: Atopic Dermatitis • 2 Phase III clinical studies: EPIONE and EPIONE II (similar study design) EPIONE 8 weeks double-masked treatment Study Design Tradipitant 85mg BID versus placebo Sites 65 in the United States Enrollment Randomized Subjects = 375 Atopic dermatitis pa
Slide 12: Tradipitant: Gastroparesis
Tradipitant: Gastroparesis Delayed Gastric Gastroparesis: US Market Emptying Up to 600,000 diagnosed1 Symptoms Previous treatments focused on prokinetic MOA (improving delayed gastric emptying): Future treatment focus is on patient reported symptoms: Estimated US Prevalence • metoclopramide Nausea 6
Slide 13: Tradipitant Phase II Study (2301): Gastroparesis
Tradipitant Phase II Study (2301): Gastroparesis Tradipitant has the potential to become a first line treatment for patients with gastroparesis & the first new treatment option in almost 40 years1 Results reported in December 2018 ITT Population (n=141) *For DD-Nausea, DD-% Nausea Free Days, GCSI, P
Slide 14: Tradipitant Phase II Study (2301): Gastroparesis
Tradipitant Phase II Study (2301): Gastroparesis Vomiting subpopulation showed greater improvements in average daily nausea score Subpopulation analysis based on screening vomiting score on GSC-Daily Diary • Vomiting score average > 0 (at least 1 vomiting episode) • 101/141 of patient population (~7
Slide 15: Tradipitant Phase II Study (2301): Complete Responder Analysis
Tradipitant Phase II Study (2301): Gastroparesis Complete Responder Analysis ITT Population Vomiting Population n=141 n=101 36.2% 40 40 p= 0.0013 32.8% p= 0.0001 35 35 % of complete responders 30 30 25 25 20 20 11.7% 15 15 6.9% 10 10 5 5 0 0 Placebo Tradipitant Placebo Tradipitant Complete responder
Slide 16: Tradipitant Phase III Program: Gastroparesis
Tradipitant Phase III Program: Gastroparesis Placebo Controlled Phase III Clinical Study: Enrollment Ongoing Study Design 12 weeks double-masked treatment Sites 40 in the United States Enrollment Randomized Subjects ~ 250 Population Stratified for diabetic or idiopathic gastroparesis Patient Reporte
Slide 17: Tradipitant Phase II Results: Motion Sickness
Tradipitant Phase II Results: Motion Sickness Tradipitant was shown to be effective in preventing Motion Sickness Tradipitant Placebo Difference P-value Motion Sifnos Phase II Study ITT* n=63 n=63 % Vomiting 17.5% 39.7% 22.2% 0.0039 Single day sea travel in the Pacific Ocean Worst MSSS 3.40 3.75 0.3
Slide 18: Circadian Rhythms
Circadian Rhythms
Slide 19: Circadian Rhythms
Circadian Rhythms 1 Drive sales growth for Marketed in the US for the treatment existing indication of Non-24 in adults since 2014 Jet Lag Disorder Smith-Magenis Syndrome 2 Add new indications Non-24 Pediatric Delayed Sleep Phase Disorder Launch in new Marketed in Germany for the treatment 3 of Non-
Slide 20: Non-24 is a Serious Circadian Rhythm Disorder
Non-24 is a Serious Circadian Rhythm Disorder Key demographics Blind individuals Sighted individuals Misaligned circadian with Non-24 with Non-24 timing system ~70% totally blind have Non-241 Non-24 is comorbid with depressive and bipolar disorders3 Prevalence of Non-24 in the general population is
Slide 21: HETLIOZ Net Product Sales
HETLIOZ® Net Product Sales Robust growth since launch Full year 2019 global net product sales guidance of $137 to $143 million1 $150 $137M - $143M $125 $116M HETLIOZ® Net Product Sales $100 $90M (In millions) $75 $72M $50 $44M $25 $13M Guidance $0 2014 2015 2016 2017 2018 2019 1. Results expected in
Slide 22: HETLIOZ European Non-24 Market
HETLIOZ® European Non-24 Market • Approximately 130,000 totally blind individuals in Europe have Non-241 EU Non-24 Market Ongoing Activities • Similar prevalence to US market • Engagement with blind advocacy groups • No approved circadian regulators in EU • Reimbursement & marketing preparations EU
Slide 23: Smith-Magenis Syndrome
Smith-Magenis Syndrome deletion of 17p11.2 • 1/15,000-25,000 births in the U.S.1 • Chromosomal deletion of 17p11.2 • Major physical, developmental & • Rare mutations of the retinoic behavioral features • 5.3/100,000 in Europe2 acid 1 (RAI1) gene Severe sleep disorder: Strongest predictor of No appro
Slide 24: HETLIOZ Smith-Magenis Syndrome
HETLIOZ® Smith-Magenis Syndrome VEC-162-2401 is the largest placebo controlled study ever conducted demonstrating significant sleep improvements in patients with SMS Study results reported in December 2018 HETLIOZ® Placebo Difference Endpoints Description (n=25) (n=25) p-value Subjective Sleep Quali
Slide 25: Jet Lag Disorder Market
Jet Lag Disorder Market US Travelers demographics 80% of US passengers traveling 5-8 Misaligned Circadian Timing System Over 20 million US residents travel to time zones pass through 10 airports2 destinations in Europe, the Middle 35% through JFK and Newark2 78% of transmeridan travelers East and As
Slide 26: HETLIOZ Jet Lag Disorder – JET8 Study
HETLIOZ® Jet Lag Disorder – JET8 Study Phase III study (3107) results were reported in March 2018 The magnitude of the total sleep time benefit of 85 minutes improvement over placebo is significant and clinically meaningful The demonstration of benefits in measurements of next day alertness on both
Slide 27: HETLIOZ Jet Lag Disorder
HETLIOZ® Jet Lag Disorder Vanda received a complete response letter (CRL) from the FDA in August 2019 related to the sNDA of HETLIOZ® for the treatment of Jet Lag Disorder Vanda met with the FDA to discuss the CRL in a Post Action meeting and is determining its next steps Vanda believes the HETLIOZ®
Slide 28: Psychiatry
Psychiatry
Slide 29: Psychiatry
Psychiatry Drive sales growth for Marketed in the US for the treatment 1 existing indication of Schizophrenia since 2010 Clinical activities planned for 2 Add new indications • Bipolar Depression • Long Acting Injectable Launch in new 3 Partnered in select non-US markets geographies 29
Slide 30: Schizophrenia: Fanapt
Schizophrenia: Fanapt® Akathisia Frequently seen with antipsychotics • About 1% of adult population • Patients frequently switch • Up to 25% of patients treated worldwide is diagnosed with antipsychotic treatments due to with some antipsychotics schizophrenia1 side effects2 experience akathisia • Ab
Slide 31: Fanapt Net Product Sales
Fanapt® Net Product Sales Vanda initiated Fanapt® US promotion in April 2015 Full year 2019 global net product sales guidance of $78 to $82 million1 A Fanapt for Schizophrenia DTC pilot is planned for early 2020 $90 $78M - $82M $75M $77M $74M $75 Fanapt® Net Product Sales $66M $60 (In millions) $45
Slide 32: Financials – Results Through September 30, 2019
Financials – Results Through September 30, 2019 9 Months Ended 9/30/2019 HETLIOZ® Net Product Sales $104.4M Fanapt® Net Product Sales $61.9M Total Revenue $166.3M Cost of Goods Sold $18.3M Research & Development $35.6M General & Administrative $92.7M Intangible Asset Amortization $1.1M Operating Exp
Slide 33: Financials – Full Year 2019 Guidance
Financials – Full Year 2019 Guidance1 Vanda expects to achieve the following financial objectives in 2019: Financial Objectives 2019 Guidance Combined net product sales from $215 to $225 million2 both HETLIOZ® and Fanapt® HETLIOZ® net product sales $137 to $143 million2 Fanapt® net product sales $78
Slide 34: For more information on HETLIOZ and FANAPT
For more information on HETLIOZ®, please visit www.HETLIOZ.com For more information on FANAPT®, please visit www.FANAPT.com 34
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