Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (January 2024)
45 slides from Vanda Pharmaceuticals's investor presentation, January 2024
Slide 1: 2024 Corporate Presentation
2024 CORPORATE PRESENTATION January 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to statements regarding Vanda’s commercial products, plans and opportunities, as well as statements about Vanda’s products in development and the related clinical development and regulatory timelines and c
Slide 3: Vanda Pharmaceuticals Inc. (VNDA)
Vanda Pharmaceuticals Inc. (VNDA) Vanda is a leading global biopharmaceutical company dedicated to innovating in the service of people’s pursuit of happiness Commercialized Robust pipeline Strong Financial Products Recent regulatory Position HETLIOZ® submissions HETLIOZ LQ® Approx. $490 million Mult
Slide 4: Recent acquisition of PONVORY from Johnson & Johnson Company
Recent acquisition of PONVORY® from Johnson & Johnson Company In December 2023, Vanda acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company, for $100 million. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and H
Slide 5: Commercialized Products
Commercialized Products 02 • HETLIOZ® oral capsules are approved in the U.S. • Fanapt® is approved in the U.S. for the treatment • PONVORY® is indicated for the treatment of and Europe for the treatment of Non-24-Hour of adults with schizophrenia. relapsing forms of multiple sclerosis (MS), to Sleep
Slide 6: Clinical Development Pipeline: Key Milestones
Clinical Development Pipeline: Key Milestones Vanda pursuing FDA approval for the following: Product Indication Fanapt® Bipolar (PDUFA Date: 4/2/2024) HETLIOZ® Insomnia (PDUFA Date: 3/4/2024) Tradipitant Gastroparesis (PDUFA Date: 9/18/2024) Other recent and upcoming clinical and regulatory developm
Slide 7: Strategic Focus
Strategic Focus Increase Advance Consumer revenue pipeline focus Organically through Late / early-stage Increase access and existing products programs affordability for patients Business development Emerging ASO Engage directly with opportunities platform consumer 7
Slide 8: Commercial Priorities & Milestones
Commercial Priorities & Milestones Tradipitant • Continued focus on market for • Retain market share despite • Re-launch in existing • Pursue FDA approval for schizophrenia generic competition through multiple sclerosis (MS) tradipitant in patients with • Pursue FDA approval for focus on patient loy
Slide 9: Fanapt for Schizophrenia
Fanapt® for Schizophrenia: • About 1% of adult population • Patients frequently switch worldwide is diagnosed with antipsychotic treatments due to schizophrenia1 side effects2 • About 3 million people in the U.S. • Side effects include metabolic, live with schizophrenia weight and movement disorders
Slide 10: HETLIOZ for Non-24-Hour Sleep-Wake Disorder (Non-24)
HETLIOZ® for Non-24-Hour Sleep-Wake Disorder (Non-24) 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 popula
Slide 11: HETLIOZ for Smith-Magenis Syndrome (SMS)
HETLIOZ® for Smith-Magenis Syndrome (SMS) • HETLIOZ® first approved treatment for nighttime sleep disturbances in SMS (December 2020) • Pursuing approval in the E.U. market • Severe sleep disorder is the strongest predictor of maladaptive behavior 15,000 Chromosomal deletion of 17p11.2 Major physica
Slide 12: HETLIOZ for Smith-Magenis Syndrome (SMS)
HETLIOZ® for Smith-Magenis Syndrome (SMS) 1. December 2020: FDA approves HETLIOZ® & HETLIOZ LQ® 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 13: Research and Development
Research and Development 13
Slide 14: Late-Stage Clinical Development Pipeline
Late-Stage Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Insomnia Delayed Sleep Phase Disorder (DSPD) Non-24 Pediatric Bipolar I Disorder Long Acting Injectable (LAI) TBD TBD Gastroparesis Tradipitant Motion Sickness Atopic Dermat
Slide 15: HETLIOZ Lifecycle Management
HETLIOZ® Lifecycle Management 15
Slide 16: HETLIOZ Lifecycle Management Programs
HETLIOZ® Lifecycle Management Programs 1 Jet Lag Disorder • Clinical program completed 2 Insomnia • Clinical program completed; sNDA accepted for filing with PDUFA target action date of 3/4/2024 3 Delayed Sleep Phase Disorder • Phase III program initiated 4 Non-24 Pediatric • Phase III clinical prog
Slide 17: Fanapt Lifecycle Management
Fanapt® Lifecycle Management 17
Slide 18: Fanapt Lifecycle Management Programs
Fanapt® Lifecycle Management Programs 1 Bipolar I Disorder • Phase III program complete; positive results announced in December 2022 • Pursuing FDA approval for Fanapt® in the indication of bipolar I disorder in adults; sNDA accepted for filing with PDUFA target action date of 4/2/2024 2 Long Acting
Slide 19: Bipolar I Disorder
Bipolar I Disorder 19
Slide 20: Fanapt for Bipolar I Disorder
Fanapt® for Bipolar I Disorder Results reported in December 2022 ~ 1 million adults • Thein theIII study Phase U.S.enrolled withapproximately 400 volunteers with a history of bipolar I disorder suffering Parkinson’s Disease from a current episode of mania.1 • The primary endpoint was assessed by the
Slide 21: Fanapt for Bipolar I Disorder
Fanapt® for Bipolar I Disorder Results reported in December 2022 ~ 1 million adults in the U.S. with • The secondary endpoints, Clinician Global Impression of Severity (CGI-S) and Clinician Parkinson’s Disease Global Impression 1 of Change (CGI-C), also achieved statistical significance (p=0.0005 an
Slide 22: Tradipitant Programs
Tradipitant Programs 22
Slide 23: Tradipitant Programs
Tradipitant Programs 1 Gastroparesis • Phase III study results reported in February 2022; 12-week study of ~200 patients with idiopathic or diabetic gastroparesis • Phase II positive study with results reported in December 2018 and published in Gastroenterology in January 2021 • Pursuing FDA approva
Slide 24: Gastroparesis
Gastroparesis 24
Slide 25: Tradipitant for Gastroparesis
Tradipitant for Gastroparesis • Completed two clinical studies of tradipitant in gastroparesis. NDA accepted for filing with PDUFA target action date of 9/18/2024. • Gastroparesis is a significant unmet medical need. • Last treatment approved more than 40 years ago1. 600,000 300,000 6 million diagno
Slide 26: 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 27: Tradipitant Gastroparesis Clinical Program
Tradipitant Gastroparesis Clinical Program 1 Phase II Study (VP-VLY-686-2301) • 4-week study of approximately 150 adult patients with diabetic or idiopathic gastroparesis • Tradipitant was shown to be effective in improving nausea and overall symptoms in patients with gastroparesis • Efficacy establ
Slide 28: Gastroparesis – Phase II Study
Gastroparesis – Phase II Study Results reported in December 2018, published in Gastroenterology January 20211 Study Design Population Assessments o 4 weeks of double-blind treatment o Approximately 150 randomized o Patient Reported Daily Diary: followed by optional 8 weeks of subjects Nausea, Vomiti
Slide 29: Gastroparesis – Phase III Study
Gastroparesis – Phase III Study Study is complete and results were reported in February 2022 Study Design Population Assessments o 12 weeks of double-blind o Approximately 200 randomized o Patient Reported Daily Diary: treatment subjects Nausea, Vomiting & Other o 85 mg b.i.d. o Stratified by idiopa
Slide 30: Gastroparesis – Pooled Study Results
Gastroparesis – Pooled Study Results • Vanda completed a pooled analysis of two clinical studies of tradipitant in gastroparesis. • Population of 342 patients with relevant clinical endpoints. • Both studies were large multi-site, randomized, double-blind, placebo-controlled studies • Tradipitant wa
Slide 31: Gastroparesis – Pooled Study Results
Gastroparesis – Pooled Study Results Figure 1 and Table 1 show the results of such pooled analysis of all patients randomized in the two studies (intent to treat population, ITT) and Figure 2 and Table 2 show the results for the same parameters in the population of patients who were judged as compli
Slide 32: Motion Sickness
Motion Sickness 32
Slide 33: 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 34: 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 35: 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 36: Motion Sickness: Phase III Program
Motion Sickness: Phase III Program • Phase III study completed – Positive results in prevention of vomiting • Second Phase III study initiated • Open label safety study started Enrollment Program Timeline o First Phase III Study: o First Phase III results reported in o Randomized: 365 May 2023 o 85
Slide 37: Motion Sickness: Phase III Study
Motion Sickness: Phase III Study • 365 participant study across 34 boat trips in coastal waters of U.S. from November 2021 to April 2023 • Participants randomized 1:1:1 tradipitant 170mg v tradipitant 85mg v placebo 1 hour prior to departure • Approximately 4-hour trips with questionnaires of vomiti
Slide 38: Early-Stage Programs
Early-Stage Programs 38
Slide 39: 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 40: Early-Stage Programs
Early-Stage Programs Antisense Oligonucleotide (ASO) • VCA-894A was granted Orphan Drug Designation for the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within IGHMBP2. • In September 2022, Vanda and OliPass Corporation (OliPass) announced
Slide 41: Financial Results
Financial Results 41
Slide 42: Q3 2023 Financial Highlights
2023 Financial Highlights Q3 2023 Financial Highlights $38.8 million Total net product sales from HETLIOZ® and Fanapt® were $38.8 million in the third quarter of 2023 HETLIOZ® net product sales were Fanapt® net product sales were $17.5 million in the third quarter of $21.3 million in the third quart
Slide 43: Financials – Results Through September 30, 2023
Financials – Results Through September 30, 2023 Results Through September 30, 2023 HETLIOZ® Net Product Sales $79.1M Fanapt® Net Product Sales $68.3M Total Revenues $147.4M Cost of Goods Sold $11.3M Research & Development $52.5M Selling, General & Administrative $89.3M Intangible Asset Amortization
Slide 44: 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 44
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