Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (June 2024)
42 slides from Vanda Pharmaceuticals's investor presentation, June 2024
Slide 1: 2024 Corporate Presentation
2024 CORPORATE PRESENTATION June 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 and upcoming Position Fanapt® regulatory submissions Approx. $390 million HETL
Slide 4: Acquisition of PONVORY from Johnson & Johnson Company
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 Health C
Slide 5: Commercialized Products
Commercialized Products • Fanapt® is approved in the U.S. for the acute • HETLIOZ® oral capsules are approved in the U.S. • PONVORY® is indicated for the treatment of treatment of bipolar I disorder in adults and for the and Europe for the treatment of Non-24-Hour relapsing forms of multiple scleros
Slide 6: Clinical Development Pipeline: Key Milestones
Clinical Development Pipeline: Key Milestones Recent and upcoming clinical and regulatory developments include: Product Recent Action Fanapt® FDA approval of Bipolar in April 2024 Milsaperidone NDA expected to be submitted in early-2025 Tradipitant Gastroparesis: PDUFA Date: 9/18/2024 Tradipitant Mo
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 • Commercial launch of Fanapt in • Retain market share despite • Commercial launch in existing • Pursue FDA approval for acute bipolar I disorder. generic competition through multiple sclerosis (MS) tradipitant in patients with • Continued focus on mark
Slide 9: Research and Development
© Research and Development q@
Slide 10: 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 Jet Lag Disorder Insomnia Delayed Sleep Phase Disorder (DSPD) Non-24 Pediatric Psoriasis Ulcerative Colitis Gastro
Slide 11: HETLIOZ Lifecycle Management
HETLIOZ® Lifecycle Management 11
Slide 12: 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 Non-24 Pediatric • Phase III clinical program in preparation 12
Slide 13: Fanapt Lifecycle Management
Fanapt® Lifecycle Management 13
Slide 14: 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 15: Bipolar I Disorder
Bipolar I Disorder 15
Slide 16: 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 17: 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 18: Tradipitant Programs
Tradipitant Programs 18
Slide 19: Tradipitant Programs
Tradipitant Programs 1 Gastroparesis • Pursuing FDA approval for tradipitant in patients with gastroparesis; NDA accepted for filing with PDUFA target action date of 9/18/2024 • Phase III study results reported in February 2022; 12-week study of ~200 patients with idiopathic or diabetic gastroparesi
Slide 20: Gastroparesis
Gastroparesis 20
Slide 21: 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 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: Motion Sickness
Motion Sickness 28
Slide 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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 35: Early-Stage Programs
Early-Stage Programs 35
Slide 36: 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 37: 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. Phase I study expects to enroll patient in mid-2024. • In September 20
Slide 38: Financial Results
Financial Results 38
Slide 39: Q1 2024 Financial Highlights
2024 Financial Highlights Q1 2024 Financial Highlights $47.5 million Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $47.5 million in the first quarter of 2024 Fanapt® net product sales HETLIOZ® net product sales PONVORY® net product were $20.6 million in the first were $20.1 millio
Slide 40: Financials – Results Through March 31, 2024
Financials – Results Through March 31, 2024 Results Through March 31, 2024 Fanapt® Net Product Sales $20.6M HETLIOZ® Net Product Sales $20.1M PONVORY® Net Product Sales $6.8M Total Revenues $47.5M Cost of Goods Sold $3.4M Research & Development $21.2M Selling, General & Administrative $30.1M Intangi
Slide 41: For more information on HETLIOZ, Fanapt, PONVORY
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 41
Slide 42: Slide 42
Vanda Pharmaceuticals — Investor Presentation (June 2024) on 6ix