Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (September 2021)
53 slides from Vanda Pharmaceuticals's investor presentation, September 2021
Slide 1: 2021 Corporate Presentation
2021 CORPORATE PRESENTATION September 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to, Vanda’s financial guidance for 2021, are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-look
Slide 3: Commercialized Products
Commercialized Products 02 HETLIOZ® oral capsules are approved in Fanapt® is approved in the U.S. the U.S. and Europe for the treatment of for the treatment of adults with Non-24-Hour Sleep-Wake Disorder (Non- schizophrenia. 24). HETLIOZ® oral capsules and HETLIOZ LQ™ liquid formulation are approved
Slide 4: Clinical Development Pipeline
Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Delayed Sleep Phase Disorder (DSPD) Autism Spectrum Disorder (ASD) Non-24 Pediatric Bipolar Disorder Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis Tradipitan
Slide 5: Financial Objectives & Highlights
Financial Objectives & Highlights 2021 Financial Q2 2021 Financial Objectives and Highlights Guidance1 Total revenues $270 to $300 million $67.9 million HETLIOZ® net Total net product sales from HETLIOZ® and product sales $180 to $200 million Fanapt® were $67.9 million in the second quarter of 2021,
Slide 6: 2021 Top Priorities & Milestones
2021 Top Priorities & Milestones SMS Launch Tradipitant for • Growth of HETLIOZ® with the Gastroparesis launch of nighttime sleep 01 02 • Results of Phase III study disturbances in SMS expected later this year, and • Estimated 15,000 patients in NDA filing expected by early the U.S. 2022 • Gastropar
Slide 7: HETLIOZ for Smith-Magenis Syndrome (SMS)
HETLIOZ® for Smith-Magenis Syndrome (SMS) • HETLIOZ® first approved treatment for nighttime sleep disturbances in SMS (December 2020) • Severe sleep disorder is the strongest predictor of maladaptive behavior 15,000 Chromosomal deletion of 17p11.2 Major physical, 1/15,000-25,000 Rare mutations of de
Slide 8: HETLIOZ for Smith-Magenis Syndrome (SMS)
HETLIOZ® for Smith-Magenis Syndrome (SMS) 1. December 2020: FDA approves HETLIOZ® & HETLIOZ LQTM for the treatment of nighttime sleep disturbances in patients with SMS 2. Patients from the ongoing open label clinical study have been contacted and are at different stages of working with their doctors
Slide 9: Research and Development
© Research and fi Development
Slide 10: Clinical Development Pipeline
Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Delayed Sleep Phase Disorder (DSPD) Autism Spectrum Disorder (ASD) Non-24 Pediatric Bipolar Disorder Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis Tradipitan
Slide 11: Tradipitant Programs
Tradipitant Programs 11
Slide 12: Tradipitant Programs
Tradipitant Programs 1 Gastroparesis • Ongoing Phase III, 12-week study of ~200 patients with idiopathic or diabetic gastroparesis • Phase II positive study with results reported in December 2018 and published in the Journal of Gastroenterology in January 2021 2 Motion Sickness • Phase III study on
Slide 13: Gastroparesis
Gastroparesis 13
Slide 14: Tradipitant for Gastroparesis
Tradipitant for Gastroparesis • Phase III study of tradipitant for the treatment of gastroparesis is ongoing, expected to be completed later this year. • Gastroparesis is a significant unmet medical need. • Last treatment approved more than 40 years ago1. 600,000 300,000 6 million diagnosed prescrip
Slide 15: Gastroparesis - Symptoms & Clinical Expression
Gastroparesis - Symptoms & Clinical Expression1 Diabetic or Idiopathic Gastroparesis Chronic Nausea Vomiting Patients with gastroparesis suffer from chronic, severe and Gastroparesis can cause debilitating nausea. vomiting, which can lead to weight loss and hospitalization due to nutritional deficie
Slide 16: Gastroparesis – Phase III Study
Gastroparesis – Phase III Study • Phase III study enrollment complete. • Upon completion of the Phase III study we plan to file an NDA by early 2022. • Expanded Access program is ongoing. Study Design Population Assessments o Patient Reported Daily Diary: o 12 weeks of double-blind o Approximately 2
Slide 17: Gastroparesis – Phase II (2301) Study Results
Gastroparesis – Phase II (2301) Study Results Results reported in December 2018, published in Gastroenterology January 20211 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 18: Gastroparesis – Phase II (2301) Study Results
Gastroparesis – Phase II (2301) Study Results Results reported in December 2018, published in Gastroenterology January 20211 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 19: Gastroparesis – Phase II (2301) Study Results
Gastroparesis – Phase II (2301) Study Results Results reported in December 2018, published in Gastroenterology January 20211 Figure 3 (left): Clinically meaningful responder analyses in the ITT population and baseline vomiting population. A nausea responder was defined as a participant averaging 1 (
Slide 20: Gastroparesis – Phase II (2301) Study Conclusions
Gastroparesis – Phase II (2301) Study Conclusions Results reported in December 2018, published in Gastroenterology January 20211 • Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P = .0099) and a signifi
Slide 21: Motion Sickness
Motion Sickness 21
Slide 22: Tradipitant for Motion Sickness
Tradipitant for Motion Sickness Neurokinin-1 (NK-1) receptor antagonists have the potential to be effective in improving the symptoms of motion sickness, given the involvement of substance P in nauseogenic and emetic pathways and the expression of NK-1 receptors in the gastrointestinal system.1 The
Slide 23: Motion Sickness – Phase II Study Results
Motion Sickness – Phase II Study Results Results reported in July 2019, published in Frontiers in Neurology in September 20201 • Tradipitant was shown to be effective in preventing motion sickness1 • An exploratory analysis was performed to evaluate the effects of tradipitant under “calm” and “rough
Slide 24: Motion Sickness – Phase II Study Results
Motion Sickness – Phase II Study Results Results reported in July 2019, published in Frontiers in Neurology in September 20201 • Tradipitant was shown to be effective in preventing motion sickness1 • An exploratory analysis was performed to evaluate the effects of tradipitant under “calm” and “rough
Slide 25: Atopic Dermatitis (AD)
Atopic Dermatitis (AD) 25
Slide 26: Tradipitant for Atopic Dermatitis (AD)
Tradipitant for Atopic Dermatitis (AD) • Tradipitant has the potential to become a first line pharmacological treatment for patients with pruritus in AD in need of systemic treatment. • Management of pruritus is a key treatment goal for patients.1 • Chronic pruritus, pruritus lasting more than 6 wee
Slide 27: Atopic Dermatitis – Phase II Study Results
Atopic Dermatitis – Phase II Study Results Results reported in September 2017 • Primary endpoint of average itch Visual Analog Scale (VAS) did not show significance due to high placebo effect and lack of sensitivity of this measure • Significant improvements also shown in Clinical Global Impression
Slide 28: Atopic Dermatitis – Phase III Study Results
Atopic Dermatitis – Phase III Study Results Results reported in February 2020, published in the Journal of the European Academy of Dermatology and Venereology in December 20201 •Tradipitant antipruritic effects not seen in moderate or severe AD and the study did not meet its primary endpoint •Tradip
Slide 29: Atopic Dermatitis – Phase III Study Results
Atopic Dermatitis – Phase III Study Results Results reported in February 2020, published in the Journal of the European Academy of Dermatology and Venereology in December 20201 •Tradipitant antipruritic effects not seen in moderate or severe AD and the study did not meet its primary endpoint •Tradip
Slide 30: COVID-19 Pneumonia
COVID-19 Pneumonia 30
Slide 31: Tradipitant for COVID-19 ARDS & Pneumonia
Tradipitant for 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 dise
Slide 32: HETLIOZ Lifecycle Management
HETLIOZ® Lifecycle Management 32
Slide 33: HETLIOZ Lifecycle Management Programs
HETLIOZ® Lifecycle Management Programs 1 Delayed Sleep Phase Disorder • Phase III program initiated 2 Autism Spectrum Disorder • Phase II open label study to be followed by a Phase III randomized, placebo-controlled study 3 Non-24 Pediatric • Phase III clinical program in preparation 4 Jet Lag Disor
Slide 34: Delayed Sleep Phase Disorder (DSPD)
Delayed Sleep Phase Disorder (DSPD) 34
Slide 35: HETLIOZ for Delayed Sleep Phase Disorder (DSPD)
HETLIOZ® for Delayed Sleep Phase Disorder (DSPD) Prevalence ~ 3.3 million adults in the U.S.* The prevalence of delayed sleep-wake phase disorder (DSPD) is highest in adolescents and young adults, with rates estimated between 3.3 and 4.6 percent.1 The prevalence of DSPD in adults is lower, with esti
Slide 36: DSPD Symptoms & Clinical Expression
Delayed Sleep Phase Disorder (DSPD) Symptoms & Clinical Expression Sleep Insufficiency & Delayed Sleep Onset Daytime Impairment Delayed bedtime, combined with conventional Individuals with DSPD habitually go to school/work start times causes significant bed and wake-up significantly later than reduc
Slide 37: Jet Lag Disorder
Jet Lag Disorder 37
Slide 38: HETLIOZ for Jet Lag Disorder
HETLIOZ® for Jet Lag Disorder U.S. Traveler Demographics Over 20 million U.S. 80% of US passengers residents travel to 78% of transmeridian travelers traveling 5-8 time zones destinations in Europe, the experience sleep pass through 10 airports. Middle East and Asia each disturbances.2 35% through J
Slide 39: Jet Lag Disorder – JET8 Study Results
Jet Lag Disorder – JET8 Study Results 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 is meaningful
Slide 40: Jet Lag Disorder – Clinical Program
Jet Lag Disorder – Clinical Program 4 Positive Clinical Studies • 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
Slide 41: Fanapt Lifecycle Management
Fanapt® Lifecycle Management 41
Slide 42: Fanapt Lifecycle Management Programs
Fanapt® Lifecycle Management Programs 1 Bipolar I Disorder • Phase III program ongoing for the acute treatment of Bipolar I disorder with sites in the U.S. and Europe 2 Parkinson’s Disease Psychosis Two studies: 1. Phase II open label study of 2 cohorts 2. Followed by a larger, randomized, placebo-c
Slide 43: Parkinson’s Disease Psychosis
Parkinson’s Disease Psychosis 43
Slide 44: Fanapt for Parkinson’s Disease Psychosis
Fanapt® for Parkinson’s Disease Psychosis ~ 1 million adults Prevalence in the U.S. with 930,000 people in the U.S. with Parkinson’s Parkinson’s Disease1 Disease (PD).1 More than 10 million people worldwide with PD.2 Between 20-40% of people with PD report the experience of hallucinations or delusio
Slide 45: Early Stage Programs
Early Stage Programs 45
Slide 46: Early-Stage Programs
Early-Stage Programs Cystic Fibrosis Transmembrane Conductance Regulators (CFTR) • VSJ 110 – CFTR Activator: VSJ-110 has shown efficacy in a dry eye model¹ and exhibited anti- inflammatory properties in both in vitro and in vivo assays • Ongoing Phase II Conjunctivitis Study investigating anti-infla
Slide 47: Financial Results
Financial Results 47
Slide 48: Financial Objectives & Highlights
Financial Objectives & Highlights 2021 Financial Q2 2021 Financial Objectives and Highlights Guidance1 Total revenues $270 to $300 million $67.9 million HETLIOZ® net Total net product sales from HETLIOZ® and product sales $180 to $200 million Fanapt® were $67.9 million in the second quarter of 2021,
Slide 49: Financials – HETLIOZ Net Product Sales
Financials – HETLIOZ® Net Product Sales • Robust growth since launch • Full year 2021 global net product sales guidance of $180 to $200 million • In December of 2020 HETLIOZ® oral capsules and HETLIOZ LQ™ liquid formulation were approved for the treatment of nighttime sleep disturbances in adults an
Slide 50: Financials – Fanapt Net Product Sales
Financials – Fanapt® Net Product Sales • Vanda initiated Fanapt® U.S. promotion in April 2015 • Full year 2021 global net product sales guidance of $90 to $100 million • A Fanapt® for Schizophrenia DTC campaign launched in 2020 $90-100M $90 $87M $84M $75M $77M $74M $75 $66M Fanapt® Net Product Sales
Slide 51: Financials – Results Through June 30, 2021
Financials – Results Through June 30, 2021 Results Through June 30, 2021 HETLIOZ® Net Product Sales $83.9M Fanapt® Net Product Sales $46.7M Total Revenues $130.6M Cost of Goods Sold $12.6M Research & Development $36.4M Selling, General & Administrative $58.1M Intangible Asset Amortization $0.7M Oper
Slide 52: 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 52
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