Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (October 2024)
35 slides from Vanda Pharmaceuticals's investor presentation, October 2024
Slide 1: 2024 Corporate Presentation
2024 CORPORATE PRESENTATION October 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to, the guidance provided under “2024 Financial Guidance” and statements regarding Vanda’s commercial products, plans and opportunities, as well as statements about Vanda’s products in development and the
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 and upcoming Position Fanapt® regulatory submissions Approx. $388 million HETL
Slide 4: Commercialized Products
Commercialized Products • Fanapt® is approved in the U.S. for the acute • HETLIOZ® oral capsules are approved in the • PONVORY® is indicated for the treatment of treatment of bipolar I disorder in adults and for U.S. and Europe for the treatment of Non-24- relapsing forms of multiple sclerosis (MS),
Slide 5: 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 5
Slide 6: Commercial Priorities & Milestones
Commercial Priorities & Milestones Tradipitant • Commercial launch of Fanapt® • Retain market share despite • Commercial launch in existing • Continue to pursue FDA in acute bipolar I disorder. generic competition through multiple sclerosis (MS) approval for tradipitant in • Continued focus on marke
Slide 7: Research and Development
~ Research and Development q@
Slide 8: Late-Stage Clinical Development Pipeline
Late-Stage Clinical Development Pipeline Product Indication Preclinical Phase I Phase II Phase III Regulatory Long Acting Injectable (LAI) Bipolar I Disorder Milsaperidone Schizophrenia Major Depressive Disorder Jet Lag Disorder Insomnia Pediatric Insomnia Delayed Sleep Phase Disorder (DSPD) Pediatr
Slide 9: HETLIOZ Lifecycle Management
HETLIOZ® Lifecycle Management 9
Slide 10: HETLIOZ Lifecycle Management Programs
HETLIOZ® Lifecycle Management Programs 1 Jet Lag Disorder • Clinical program completed; continuing to pursue FDA approval 2 Insomnia • Clinical program completed; continuing to pursue FDA approval 3 Delayed Sleep Phase Disorder • Phase III program initiated 4 Non-24 Pediatric • Phase III clinical pr
Slide 11: Fanapt Lifecycle Management
Fanapt® Lifecycle Management 11
Slide 12: Fanapt Lifecycle Management Programs
Fanapt® Lifecycle Management Programs 1 Bipolar I Disorder • Phase III program complete; positive results announced in December 2022. • FDA approved Fanapt® in bipolar I disorder in adults in April 2024. 2 Long Acting Injectable • Expect to initiate a Phase III program for the long acting injectable
Slide 13: Tradipitant Programs
Tradipitant Programs 13
Slide 14: Tradipitant Programs
Tradipitant Programs 1 Gastroparesis • Continuing to pursue FDA approval for tradipitant in patients with 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 Dec
Slide 15: Gastroparesis
Gastroparesis 15
Slide 16: Tradipitant for Gastroparesis
Tradipitant for Gastroparesis • Completed two clinical studies of tradipitant in gastroparesis • Gastroparesis is a significant unmet medical need. • Last treatment approved more than 40 years ago1. 600,000 300,000 6 million diagnosed prescriptions people 600,000 people Appx. 300,000 Estimated U.S.
Slide 17: 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 18: 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 19: 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 20: 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 21: 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 22: 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 23: Motion Sickness
Motion Sickness 23
Slide 24: 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 25: Motion Sickness: Phase III Program
Motion Sickness: Phase III Program • First Phase III study completed – Positive results in prevention of vomiting • Second Phase III study completed – Positive results in prevention of vomiting • Open label safety study started Enrollment Program Timeline o First Phase III Study: 365 randomized o Fi
Slide 26: Motion Sickness: First Phase III Study
Motion Sickness: First 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
Slide 27: Motion Sickness: Second Phase III Study
Motion Sickness: Second Phase III Study • 316 participant study across 20 boat trips in coastal waters of U.S. from September 2023 and April 2024 • Participants randomized 1:1:1 tradipitant 170mg v tradipitant 85mg v placebo 1 hour prior to departure • Approximately 4-hour trips with questionnaires
Slide 28: Early-Stage Programs
Early-Stage Programs 28
Slide 29: 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 • Phase II study of VSJ-110 for the treatment of dry eye is ongo
Slide 30: 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 31: Financial Results
Financial Results 31
Slide 32: 2024 Financial Objectives & Highlights
2024 Financial Objectives & Highlights 2024 Financial Q2 2024 Financial Guidance1 Highlights Total revenues $180M - $210M $50.5 million Year-end 2024 $360M - $390M Cash2 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.5 million in the second quarter of 2024 Fanapt® net product s
Slide 33: Financials – Results Through June 30, 2024
Financials – Results Through June 30, 2024 Results Through June 30, 2024 Fanapt® Net Product Sales $43.7M HETLIOZ® Net Product Sales $38.8M PONVORY® Net Product Sales $15.4M Total Revenues $97.9M Cost of Goods Sold $6.2M Research & Development $37.8M Selling, General & Administrative $69.6M Intangib
Slide 34: For more information on HETLIOZ ® , please visit www.HETLIOZ.com For more information on
For more information on HETLIOZ®, please visit www.HETLIOZ.com For more information on Fanapt®, please visit www.FANAPT.com For more information on PONVORY®, please visit www.PONVORYUS.com 34
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