Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (September 2023)
59 slides from Vanda Pharmaceuticals's investor presentation, September 2023
Slide 1: 2023 Corporate Presentation
2023 CORPORATE PRESENTATION September 2023
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 Upcoming regulatory Position submissions HETLIOZ® Approx. $490 million HETLIOZ LQ® Mu
Slide 4: Commercialized Products
Commercialized Products 02 • HETLIOZ® oral capsules are approved in the U.S. and • Fanapt® is approved in the U.S. for the treatment of adults Europe for the treatment of Non-24-Hour Sleep-Wake with schizophrenia. Disorder (Non-24). • Positive results in the Phase III clinical study of Fanapt® in •
Slide 5: Clinical Development Pipeline
Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Insomnia Delayed Sleep Phase Disorder (DSPD) Autism Spectrum Disorder (ASD) Non-24 Pediatric Bipolar I Disorder Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis
Slide 6: Clinical Development Pipeline: Key Milestones
Clinical Development Pipeline: Key Milestones Vanda pursuing FDA approval over the next year for the following: Product Indication Fanapt® Bipolar HETLIOZ® Insomnia Tradipitant Gastroparesis Other recent clinical and regulatory developments include: Indication Recent Action Motion sickness Positive
Slide 7: 2022 Financial Performance
2022 Financial Performance HETLIOZ® net product sales were $159.7 Full Year 2022 million for the full year 2022 Revenue $254.4 million Fanapt® net product sales were $94.7 million for the full year 2022 Cash as of December 31, 2022 $466.9 million Cash as of June 30, 2023 was $489.4 million 7
Slide 8: Q2 2023 Financial Highlights
2023 Financial Highlights Q2 2023 Financial Highlights $46.1 million Total net product sales from HETLIOZ® and Fanapt® were $46.1 million in the second quarter of 2023 HETLIOZ® net product sales were Fanapt® net product sales were $22.0 million in the second quarter $24.1 million in the second quart
Slide 9: 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 9
Slide 10: Commercial Priorities & Milestones
Commercial Priorities & Milestones Tradipitant • Continued focus on market for • Retain market share despite • Pursue FDA approval for schizophrenia generic competition through tradipitant in patients with • Pursue FDA approval for focus on patient loyalty gastroparesis Fanapt® in the indication of
Slide 11: 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 12: 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 13: 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 14: 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 15: Research and Development
@ Research and Development 4a
Slide 16: Clinical Development Pipeline
Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Jet Lag Disorder Insomnia Delayed Sleep Phase Disorder (DSPD) Autism Spectrum Disorder (ASD) Non-24 Pediatric Bipolar I Disorder Long Acting Injectable (LAI) Parkinson’s Disease Psychosis Gastroparesis
Slide 17: HETLIOZ Lifecycle Management
HETLIOZ® Lifecycle Management 17
Slide 18: HETLIOZ Lifecycle Management Programs
HETLIOZ® Lifecycle Management Programs 1 Jet Lag Disorder • Clinical program completed 2 Insomnia • Clinical program completed 3 Delayed Sleep Phase Disorder • Phase III program initiated 4 Autism Spectrum Disorder • Phase II open label study to be followed by a Phase III randomized, placebo-control
Slide 19: Jet Lag Disorder
Jet Lag Disorder 19
Slide 20: HETLIOZ for Jet Lag Disorder
HETLIOZ® for Jet Lag Disorder U.S. Traveler Demographics Over 20 million U.S. 80% of U.S. 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
Slide 21: 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 22: Jet Lag Disorder – Clinical Program
Jet Lag Disorder – Clinical Program 4 Positive Clinical Studies Study Patients Design Circadian challenge of an 8-hour advance to a subject’s JET8 (3107) 318 usual bedtime Circadian challenge of a 5-hour advance to a subject’s usual JET5 (3101) 411 bedtime A two-phase transatlantic travel study, wit
Slide 23: Delayed Sleep Phase Disorder (DSPD)
Delayed Sleep Phase Disorder (DSPD) 23
Slide 24: 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 25: 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 26: Fanapt Lifecycle Management
Fanapt® Lifecycle Management 26
Slide 27: 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 2 Long Acting Injectable • Pharmacokinetic (PK) study of Fanapt® long-acting injectable for
Slide 28: Bipolar I Disorder
Bipolar I Disorder 28
Slide 29: 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 30: 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 31: Tradipitant Programs
Tradipitant Programs 31
Slide 32: 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 33: Gastroparesis
Gastroparesis 33
Slide 34: Tradipitant for Gastroparesis
Tradipitant for Gastroparesis • Completed two clinical studies of tradipitant in gastroparesis. Pursuing FDA approval for tradipitant in patients with gastroparesis. • Gastroparesis is a significant unmet medical need. • Last treatment approved more than 40 years ago1. 600,000 300,000 6 million diag
Slide 35: 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 36: 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 37: 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 38: 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 39: 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 40: 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 41: Motion Sickness
Motion Sickness 41
Slide 42: 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 43: 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 44: 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 45: Motion Sickness: Phase III Program
Motion Sickness: Phase III Program • Phase III study completed – Positive results in prevention of vomiting • Open label safety study started Enrollment Program Timeline o Randomized: 365 o Phase III results reported in May 2023 o 85 and 170mg tradipitant both met primary endpoint preventing o Conti
Slide 46: 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 47: Atopic Dermatitis (AD)
Atopic Dermatitis (AD) 47
Slide 48: 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 49: 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 50: 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 51: 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 52: Early-Stage Programs
Early-Stage Programs 52
Slide 53: 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 54: 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 55: Financial Results
Financial Results 55
Slide 56: Q2 2023 Financial Highlights
2023 Financial Highlights Q2 2023 Financial Highlights $46.1 million Total net product sales from HETLIOZ® and Fanapt® were $46.1 million in the second quarter of 2023 HETLIOZ® net product sales were Fanapt® net product sales were $22.0 million in the second quarter $24.1 million in the second quart
Slide 57: Financials – Results Through June 30, 2023
Financials – Results Through June 30, 2023 Results Through June 30, 2023 HETLIOZ® Net Product Sales $61.6M Fanapt® Net Product Sales $47.0M Total Revenues $108.6M Cost of Goods Sold $8.3M Research & Development $35.9M Selling, General & Administrative $64.5M Intangible Asset Amortization $0.8M Opera
Slide 58: 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 58
Slide 59: Slide 59
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