Vanda Pharmaceuticals Inc. · NASDAQ:VNDA
Vanda Pharmaceuticals — Investor Presentation (January 2016)
30 slides from Vanda Pharmaceuticals's investor presentation, Jan 11, 2016
Slide 1: 2016 Corporate Presentation
2016 CORPORATE PRESENTATION January 2016 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements Various statements in this presentation, including, but not limited to Vanda’s preliminary financial results for the fourth quarter of 2015 and full year 2015, and financial guidance for 2015 and 2016, are “forward-looking statements” under the securities laws. Forward-loo
Slide 3: Strategy for Long-Term Success
Strategy for Long-Term Success Specialty pharmaceuticals Lifecycle management and product optimization Comprehensive customer support and engagement Novel therapies addressing high unmet needs Diversified pipeline in high- growth therapeutic markets
Slide 4: Vanda Timeline and Historical Milestones
Vanda Timeline and Historical Milestones Acquisition of tradipitant Eli Lilly 2012 Acquisition of US and Canadian rights to Fanapt® 2014 Acquisition of iloperidone- Novartis tasimelteon- BMS 2004 IPO 2006 Founded 2003 Fanapt® US Approval Schizophrenia Fanapt® US & Canadian rights out-licensed 2009 H
Slide 5: Marketed Assets
Marketed Assets US - Schizophrenia ROW - Schizophrenia Distribution partners Mexico - Probiomed Israel - Megapharm Circadian Rhythms Psychiatry US - Non-24 EU - Non-24
Slide 6: Clinical Development Pipeline
Clinical Development Pipeline Name Indication Preclinical Phase I Phase II Phase III Regulatory Non-24 Pediatric Smith-Magenis Syndrome (SMS) Jet Lag Vanda expects to initiate a Phase 3 study for each indication during 2016 Schizophrenia US LT Maintenance Schizophrenia EU Bipolar & Long Acting Injec
Slide 7: Circadian Rhythms
» Circadian Rhythms LEAN WO IAG ea
Slide 8: Circadian Rhythms
Circadian Rhythms Smith-Magenis Syndrome Non-24 Pediatrics Marketed in US since April 2014 EU approval in July 2015 Pursuing regulatory approval in select ROW markets Phase I (PK) study planned for Q2 2016 Phase III study planned for H2 2016 Open label Interventional study initiated in Q4 2015 Place
Slide 9: Non-24 is a Serious Circadian Rhythm Disorder
Non-24 is a Serious Circadian Rhythm Disorder Key demographics ~70% totally blind have Non-242 1:4000 in US (~80,000)1 Disrupted nighttime sleep Excessive daytime sleepiness Poor social and occupational functioning Clinical characteristics Misaligned circadian timing system Vanda estimate Dressman e
Slide 10: HETLIOZ US Non-24 Market
HETLIOZ® US Non-24 Market An Innovative Approach to an Orphan Indication Patient Advocacy Non-24 Public Awareness Campaign Case Management Program Healthcare Professional Program Sales Force Program Patient
Slide 11: HETLIOZ Net Product Sales
HETLIOZ® Net Product Sales HETLIOZ® Net Product Sales (In millions) Robust growth since launch Full year 2016 global net product sales guidance of $73 to $78 million Vanda announced preliminary unaudited financial results on 1/11/2016 1
Slide 12: HETLIOZ European Non-24 Market
HETLIOZ® European Non-24 Market Approximately 130,000 totally blind individuals in Europe have Non-241 EU Non-24 Market Pre - Launch Activities Similar prevalence to US market No approved circadian regulators in EU Engagement with blind advocacy groups Reimbursement & marketing preparations 2016 Pri
Slide 13: Smith-Magenis Syndrome Is a Clinically Recognizable Genetic Syndrome
No approved treatment Smith-Magenis Syndrome Is a Clinically Recognizable Genetic Syndrome 1/15,000-25,000 births in the U.S.1 5.3/100,000 in Europe2 Chromosomal deletion of 17p11.2 Rare mutations of the retinoic acid 1 (RAI1) gene Daytime melatonin secretion Orphanet ORPHA number 819. Smith et al.
Slide 14: HETLIOZ Smith-Magenis Syndrome Clinical Program
HETLIOZ® Smith-Magenis Syndrome Clinical Program Confirmed mistiming of melatonin secretion Sleep patterns significantly disrupted Fragmented sleep characterized by short sleep intervals Observational Study Completed in 2015 (N=8) Vanda has begun a Phase III clinical program to explore HETLIOZ® as a
Slide 15: Jet Lag Market
Jet Lag Market US Travelers demographics 50% of travelers leaving the US fly ≥4 time zones1, 80% have disrupted sleep2 26 million passengers/year fly to Europe1 # passengers/year Time zones travelled 4 6 8 10 12 14 16 18 20 22 24 Misaligned Circadian Timing System Clinical Characteristics3 Insomnia
Slide 16: HETLIOZ Jet Lag Clinical Program
HETLIOZ® Jet Lag Clinical Program Simulated Jet Lag (5 time zones) Proof of Concept Study (2101) – 39 patients Phase III Study (3101) – 411 patients Key Conclusions Shifted circadian rhythms on first night (2101) Improved sleep measures: Total sleep time, Time to fall asleep, Sleep maintenance & eff
Slide 17: Psychiatry
Psychiatry
Slide 18: Schizophrenia: Fanapt
Vanda owns global rights for Fanapt® Commercialized in Mexico and Israel through partners Expecting 10 year data exclusivity in Europe Schizophrenia: Fanapt® Patients frequently switch antipsychotic treatments due to side effects2 Side effects include metabolic, weight and movement disorders About 1
Slide 19: Fanapt Net Product Sales
Fanapt® Net Product Sales Vanda initiated Fanapt® US promotion in April 2015 Fanapt® US field sales team expanded to 50 during Q4 2015 Full year 2016 global net product sales guidance of $70 to $75 million Fanapt® Net Product Sales (In millions) Vanda announced preliminary unaudited financial result
Slide 20: Fanapt Oral: Regulatory Activity
Fanapt® Oral: Regulatory Activity Fanapt® Regulatory Activity US sNDA for long term maintenance indication filed in Sept 2015 FDA PDUFA May 2016 EU MAA filed in December 2015 CHMP Opinion expected by end of 2016 EU US
Slide 21: Dermatology
» Dermatology
Slide 22: Chronic Pruritus: Tradipitant (VLY-686)
Chronic Pruritus: Tradipitant (VLY-686) Current treatment options are ineffective Topical, intralesional, or systemic corticosteroids have significant problems with long-term use Antihistamines have low efficacy UV-treatment has problems with long term use and low efficacy Strong preclinical and cli
Slide 23: Patent Portfolio - Key FDA Orange Book Listings
Patent Portfolio - Key FDA Orange Book Listings Name Number US Expiry Type US 5,856,529 20221 NCE US 8,785,492 2033 Method of treatment US 9,060,995 2033 Method of treatment RE 39198 20162 NCE US 9,138,432 2025 Method of treatment US 8,586,610 2027 Method of treatment US 9,157,121 2030 Method of tre
Slide 24: For more information on HETLIOZ®, please visit www.HETLIOZ.com For more information on FANAPT®, please
For more information on HETLIOZ®, please visit www.HETLIOZ.com For more information on FANAPT®, please visit www.FANAPT.com
Slide 25: Financials – 2015 Results
Financials – 2015 Results HETLIOZ® Net Product Sales $29.2M $15.1M $44.3M Fanapt® Net Product Sales $48.9M $16.7M $65.6M Total Revenue $78.1M $31.8M $109.9M Cost of Goods Sold $17.3M Research & Development $20.4M General & Administrative $55.7M Intangible Asset Amortization $10.0M Operating Expense
Slide 26: Financials – Full Year 2015 Guidance
Financials – Full Year 2015 Guidance1 Vanda expects to achieve the following financial objectives in 2015: Total net product sales from HETLIOZ® and Fanapt® of between $100 and $115 million. HETLIOZ® net product sales of between $40 and $45 million. Fanapt® net product sales of between $60 and $70 m
Slide 27: Financials – Full Year 2016 Guidance
Financials – Full Year 2016 Guidance1 Vanda expects to achieve the following financial objectives in 2016: Global net product sales from HETLIOZ® and Fanapt® of between $143 and $153 million. HETLIOZ® global net product sales of between $73 and $78 million. Fanapt® global net product sales of betwee
Slide 28: Non-GAAP Financial Information
Non-GAAP Financial Information Vanda believes that the Non-GAAP financial information provided in this presentation can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. This presen
Slide 29: 2016 Corporate Milestones
2016 Corporate Milestones* HETLIOZ® ¨ Non-24 – Germany product launch Q3 2016 ¨ Pediatric Non-24 Phase III study initiation H2 2016 ¨ SMS placebo controlled Phase III study initiation H2 2016 ¨ Jet Lag Phase III study initiation H2 2016 Fanapt ® ¨ Vanda v. Roxane (NCE & ‘610 Patents) Feb 2016 ¨ PDUF
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