Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (January 2021)
50 slides from Vanda Pharmaceuticals's investor presentation, January 2021
Slide 1: Corporate 2021 Presentation
CORPORATE 2021 PRESENTATION January 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to, Vanda’s financial guidance for 2020, are “forward-looking statements” under the securities laws. Forward-looking statements are based upon current expectations and assumptions that involve risks, chang
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 Products
Marketed Products Circadian Rhythms Psychiatry U.S. - Non-24 U.S. - Schizophrenia U.S. - SMS ROW - Schizophrenia EU - Non-24 Distribution partners 4
Slide 5: Research and Development
~ Research and fii Development
Slide 6: Clinical Development Pipeline
Clinical Development Pipeline: Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Non-24 Pediatric Bipolar Disorder (Oral tablets) Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis Motion Sickness Tradipitant Atopic Dermatitis COVID-19 Pneumo
Slide 7: Tradipitant
Tradipitant 4@
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: Gastroparesis
Gastroparesis 4@
Slide 10: Tradipitant: Gastroparesis
Tradipitant: Gastroparesis Delayed Gastric Gastroparesis: U.S. Market Emptying Up to 600,000 diagnosed¹ Symptoms Previous treatments focused on prokinetic MOA (improving Estimated US Prevalence delayed gastric emptying): Future indication focus is on patient reported symptoms: 6,000,000 (1.8%)² •met
Slide 11: 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 more than 40 years1 Results reported in December 2018, published in Gastroenterology July 2020² 1. Reglan (metoclopramid
Slide 12: Tradipitant Phase II Study (2301): Gastroparesis
Tradipitant Phase II Study (2301): Gastroparesis Results reported in December 2018, published in Gastroenterology July 2020¹ 1. Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H., & Polymeropoulos, M. H. (2020). Efficacy and safety
Slide 13: Tradipitant Phase III Study: Gastroparesis
Tradipitant Phase III Study: 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 ~ 200 Population Stratified for diabetic or idiopathic gastroparesis Patient Reported
Slide 14: Motion Sickness
Motion Sickness 14
Slide 15: Tradipitant Phase II Results: Motion Sickness
Tradipitant Phase II Results: Motion Sickness Results reported in July 2019 Motion Sifnos study results for overall population and for the Calm and Rough Sea sub-populations Motion Sifnos Phase II Study Single day sea travel in the Pacific Ocean Patients with a history of motion sickness 170mg tradi
Slide 16: Tradipitant Phase III Program: Motion Sickness
Tradipitant Phase III Program: Motion Sickness Placebo Controlled Phase III Clinical Study: Initiated 2020 Study Design Single, double-masked treatment Sites 15 in the United States Enrollment Randomized Participants ~ 300 Population Patients with a history of motion sickness Assessments Motion Sick
Slide 17: Atopic Dermatitis
Atopic Dermatitis 17
Slide 18: 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 19: Tradipitant Phase II Study (2102): Atopic Dermatitis
Tradipitant Phase II Study (2102): Atopic Dermatitis Results reported in September 2017 Favors Tradipitant Favors Placebo Favors Placebo Favors Tradipitant Tradipitant Phase II Study (2102) results Results presented at recent scientific and medical meetings including • World Congress on Itch (Octobe
Slide 20: Tradipitant Phase III Study (3101): Atopic Dermatitis
Tradipitant Phase III Study (3101): Atopic Dermatitis Results reported in February 2020 • Tradipitant antipruritic effects not seen in moderate or severe Atopic Dermatitis and the study did not meet its primary endpoint • Tradipitant significantly improved severe itch and nighttime sleep in patients
Slide 21: Tradipitant Phase III Program: Atopic Dermatitis
Tradipitant Phase III Program: Atopic Dermatitis EPIONE 2 8 weeks double-masked treatment Study Design Tradipitant 85mg BID versus placebo Sites 42 in the United States Enrollment Randomized Subjects = 400 total (200 per arm, 1:1 randomization) Atopic dermatitis patients with mild to moderate atopic
Slide 22: COVID-19 Pneumonia
COVID-19 Pneumonia 22
Slide 23: Tradipitant: COVID-19 ARDS & Pneumonia
Tradipitant: COVID-19 Acute Respiratory Distress Syndrome (ARDS) & Pneumonia ODYSSEY Study • The ODYSSEY study is a randomized controlled trial to examine the effectiveness of tradipitant as compared to placebo in COVID-19 patients • The efficacy endpoints include mortality rate, severity of disease
Slide 24: Tradipitant ODYSSEY Study: Interim Analysis
Tradipitant ODYSSEY Study: Interim Analysis Figures A & B: Interim Analysis – Time to 2-or-More Point Improvement (n=62) 24
Slide 25: Circadian Rhythms
| Circadian Rhythms Sp? GEIR ROR Eye: el) i R AAR oA
Slide 26: Circadian Rhythms
Circadian Rhythms Marketed in the U.S. for: Drive sales growth for • Non-24 in adults 1 existing indication • Sleep disturbances in SMS • Adult oral capsules • Pediatric liquid Clinical activities planned for: • Jet Lag Disorder 2 Add new indications • Non-24 Pediatric Marketed in Germany for the tr
Slide 27: Non-24 is a Serious Circadian Rhythm Disorder
Non-24 is a Serious Circadian Rhythm Disorder Blind individuals with Sighted individuals with Misaligned circadian Non-24 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 unclear but appea
Slide 28: HETLIOZ Net Product Sales
HETLIOZ® Net Product Sales Robust growth since launch Full year 2020 global net product sales guidance of $155 to $165 million $155M - $165M HETLIOZ® Net Product Sales (In millions) Guidance 28
Slide 29: Smith-Magenis Syndrome
Smith-Magenis Syndrome SMS Background 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: HETLIOZ® first a
Slide 30: HETLIOZ Smith-Magenis Syndrome
HETLIOZ® Smith-Magenis Syndrome • On December 1, 2020 the U.S. Food and Drug Administration approved HETLIOZ® for the treatment of nighttime sleep disturbances in Smith Magenis Syndrome. HETLIOZ® was also granted an orphan drug designation for SMS. Study VEC-162-2401 results reported in December 201
Slide 31: Jet Lag Disorder Market
Jet Lag Disorder Market U.S. Traveler Demographics Over 20 million US residents travel to 80% of US passengers traveling 5-8 Misaligned Circadian Timing System destinations in Europe, the Middle time zones pass through 10 airports2 78% of transmeridan travelers experience East and Asia each year1 35
Slide 32: HETLIOZ Jet Lag Disorder – JET8 Study
HETLIOZ® Jet Lag Disorder – JET8 Study Study 3107 Results 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 KSS and VAS i
Slide 33: 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 HE
Slide 34: Psychiatry
Psychiatry 34
Slide 35: Psychiatry
Psychiatry Drive sales growth for Marketed in the U.S. for the 1 existing indication treatment of adults with Schizophrenia since 2010 Clinical activities planned for 2 Add new indications • Bipolar I Disorder • Long Acting Injectable • Parkinson’s Disease Psychosis Launch in new 3 Partnered in sele
Slide 36: Schizophrenia: Fanapt
Schizophrenia: Fanapt® Fanapt® Background Akathisia Frequently seen with antipsychotics • About 1% of adult population • Patients frequently switch • Up to 25% of patients treated with worldwide is diagnosed with antipsychotic treatments due to some antipsychotics experience schizophrenia1 side effe
Slide 37: Fanapt Net Product Sales
Fanapt® Net Product Sales Vanda initiated Fanapt® U.S. promotion in April 2015 Full year 2020 global net product sales guidance of $85 to $95 million A Fanapt for Schizophrenia DTC campaign launched in 2020 $85M - $95M Fanapt® Net Product Sales (In millions) Guidance 37
Slide 38: Fanapt Phase III Study: Bipolar I Disorder
Fanapt® Phase III Study: Bipolar I Disorder 4 weeks double-masked treatment followed by 52 week open label Study Design Iloperidone 12-24 mg BID versus placebo Sites 50 in the United States and Europe Enrollment Randomized Subjects = 400 total (200 per arm, 1:1 randomization) Population Adult patien
Slide 39: Fanapt: Long Acting Injectable (LAI)
Fanapt®: Long Acting Injectable (LAI) Single dose: single dose iloperidone long-acting injection Study Design Repeat dose: 24 weeks treatment, four doses iloperidone long-acting injection Sites 3 in the United States Enrollment Randomized Subjects = Up to 37 patients for single dose, up to 24 patien
Slide 40: Parkinson's Disease Psychosis
Parkinson's Disease Psychosis Parkinson’s Disease (PD) Demographics • Parkinson's disease (PD) is a • 930,000 people in the U.S. with Parkinson’s neurodegenerative disorder that affects Disease1 predominately dopaminergic neurons in • Expected to increase to 1.2 million in the U.S. by a specific are
Slide 41: Fanapt Phase II Study: Parkinson's Disease Psychosis
Fanapt® Phase II Study: Parkinson's Disease Psychosis Study Design Two cohorts, open label treatment for up to 4 weeks with optional 52 week extension Sites 4 in the United States Enrollment Randomized Subjects = Up to 24 total (12 per cohort) Population Elderly patients with Parkinson’s disease psy
Slide 42: Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Program
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Program 42
Slide 43: VSJ-110 CFTR Activator
VSJ-110 CFTR Activator VSJ-110 • CFTR activators increase water excretion into the extracellular space they may be beneficial in treating a number of conditions such as dry eye(1,2), cholestasis, constipation3, and some lung conditions such as COPD, among others. • VSJ-110 is a small molecule nanomo
Slide 44: BPO-27 CFTR Inhibitor
BPO-27 CFTR Inhibitor BPO-27 • As CFTR inhibitors decrease water excretion across epithelia, such as where aberrant CFTR activation occurs, they may be useful in the treatment of cholera, traveler's diarrhea1, polycystic kidney disease2, and other conditions of water hyper-excretion. • Chloera Disea
Slide 45: Clinical Development Pipeline
Clinical Development Pipeline: Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Non-24 Pediatric Bipolar Disorder (Oral tablets) Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis Motion Sickness Tradipitant Atopic Dermatitis COVID-19 Pneumo
Slide 46: Financial Results
Financial Results 46
Slide 47: Financials – Results Through September 30, 2020
Financials – Results Through September 30, 2020 9 Months Ended 9/30/2020 HETLIOZ® Net Product Sales $116.5M Fanapt® Net Product Sales $64.0M Total Revenue $180.5M Cost of Goods Sold $17.0M Research & Development $40.7M General & Administrative $104.9M Intangible Asset Amortization $1.1M Operating Ex
Slide 48: Financials – Full Year 2020 Guidance
Financials – Full Year 2020 Guidance¹ Vanda expects to achieve the following financial objectives in 2020: Financial Objectives 2020 Guidance Total Revenues $240 to $260 million HETLIOZ® net product sales $155 to $165 million Fanapt® net product sales $85 to $95 million Year-end 2020 Cash2 Greater t
Slide 49: 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 49
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