Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (November 2009)
34 slides from Novavax's investor presentation, November 2009
Slide 1: Corporate Presentation November, 2009
Corporate Presentation November, 2009
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical development, product sales, operating expenses, and anticipated milestones are forward-looking st
Slide 3: Introduction
Introduction Novavax is a NASDAQ listed biopharmaceutical company focused on developing novel, highly potent recombinant vaccines Technology platform based on proprietary virus-like particles (VLP’s) Our vision is to be a profitable, stand-alone vaccine company that is aggressively driving towards d
Slide 4: Investment Highlights
Investment Highlights • Proven, proprietary VLP technology delivering blockbuster product candidates with scalable, fast and cost effective manufacturing solution • Innovative funding/commercialization strategy with regional partnerships – Non-dilutive financing for advanced development, production
Slide 5: Table of Contents
Table of Contents • Section 1: VLP Technology Overview • Section 2: Pipeline Products • Section 3: Innovative Financing Strategy • Section 4: Driving Shareholder Value
Slide 6: Section 1: VLP Technology Overview
Section 1: VLP Technology Overview
Slide 7: Recombinant Particle Vaccines are Widely Used
Recombinant Particle Vaccines are Widely Used • Examples of currently marketed recombinant particle vaccines − Hepatitis B vaccines (recombinant) Recombivax® HB (Merck) Engerix® B (GSK) − Human papillomavirus vaccines (recombinant) Gardasil® (Merck) Cervarix® (GSK) Other than live attenuated
Slide 8: Recombinant VLP Vaccines Mimic the Virus
Recombinant VLP Vaccines Mimic the Virus But lack genome for replication VLPs Virions
Slide 9: Manufacturing VLPs in Insect Cell Culture
Manufacturing VLPs in Insect Cell Culture Cell Substrate Infect & Remove Cells, Inactivate Preparation Incubate Purify VLPs Virus Insect Cell Culture-Based Influenza Vaccine Production in Disposable Mfg Systems:
Slide 10: Scale-up Approach for Recombinant Influenza Vaccine Production
Scale-up Approach for Recombinant Influenza Vaccine Production Novavax’s Pilot Plant and Commercial Launch Facility Rockville, MD ~10,000 ft2 (1,000 m2) 1000L Cell Culture Reactor Capacity: 25 – 30 M doses in 6 mo.* 120 days to construct Total Cost $5 million
Slide 11: Section 2: Pipeline Products
Section 2: Pipeline Products
Slide 12: Proprietary Pipeline Targeting Major Markets
Proprietary Pipeline Targeting Major Markets Preclinical Phase I Phase II Phase III Market Pandemic Influenza H1N1 (2009) H5N1 (Avian flu) Seasonal Influenza Respiratory Syncytial Herpes Zoster Completed Planned for next 12 months 12
Slide 13: Novavax Flu VLP Vaccines: Potential Immunological Advantages
Novavax Flu VLP Vaccines: Potential Immunological Advantages Novavax VLPs • Contain 3 immunologically important proteins • HA – neutralizing ab prevents infection − Current flu vaccines consist almost entirely of HA alone • NA – neutralizing ab reduces disease severity • M1 – cell mediated responses
Slide 14: VLP Flu Vaccines are Safe & Immunogenic
VLP Flu Vaccines are Safe & Immunogenic Vaccine Phase I Phase II Phase III Approval Candidate • Two part pivotal trial (n=4,000) Approval / H1N1 • Not required • Stage 1: Preliminary results by Jan 2010 launch (Mexico) (2009 pandemic) in 2010 • Stage 2: Initiation as soon as Dec 2009 • Two Phase II
Slide 15: Pandemic Influenza Vaccine
Pandemic Influenza Vaccine
Slide 16: Pandemic Flu Vaccine Opportunity
Pandemic Flu Vaccine Opportunity • Novavax’s vaccines provide significant advantages for the pandemic influenza market • Response time (first wave) − Rapid response to create custom vaccine against emerging strain − Surge capacity (create massive supply in 6 months) • In-border manufacturing (supply
Slide 17: VLP Technology Responds Fast
VLP Technology Responds Fast (2009 Pandemic H1N1 - Case Study) Task Name Start Finish April 2009 May 2009 24 25 26 27 28 29 30 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 20 Viral genes 1 A/CA/04/09 4/24/09 4/28/09 received from CDC A/CA/04/09 genes 2 4/29/09 5/4/09 cloned Recombinant
Slide 18: Pandemic Flu - How Does Novavax Compare?
Pandemic Flu - How Does Novavax Compare? Product Response Surge Supply Company Capacity Candidate Time Solution In-Border Stockpile VLP (cell) <3 months Yes (cross reactive ) Split (egg) Maybe with > 6 months Stockpile (with or w/o adjuvant) adjuvant MF59-adjuvanted Maybe with > 6 months Stockpile S
Slide 19: Pandemic H1N1 Influenza Vaccine: Next Steps
Pandemic H1N1 Influenza Vaccine: Next Steps • Pivotal clinical trial with our 2009 H1N1 pandemic VLP influenza vaccine in Mexico − High attack rate may enable test for vaccine efficacy _ Two-stage randomized, placebo trial in 4000 subjects _ Final data in Jan. 2010 • Large scale manufacturing demons
Slide 20: Seasonal Influenza Vaccine
Seasonal Influenza Vaccine
Slide 21: Seasonal Influenza Vaccine Opportunity
Seasonal Influenza Vaccine Opportunity • Unmet medical need in the elderly and very young • Annual strain mismatches result in lower efficacy − Novavax’s vaccines address strain drift • Product cost, capital for production capacity − New emerging markets • Significant market opportunity − $6 billion
Slide 22: World Influenza Vaccine Market
World Influcnza Vaccine Market e Supply (6 month production) » 2008 -410 million doses* © 50%* increase in + years « Excess supply e Capacity (12 month production) « Current ~700 million** « Expanding to 1 billion e Pandemic Insufficient surplus capacity 6.2 billion population worldwide 14 million p
Slide 23: Seasonal Influenza Vaccine: Next Steps
Seasonal Influenza Vaccine: Next Steps • Launch a Phase II dose range study in older adults head-to-head with marketed vaccine • Establish complete immunological profile: − Hemagglutinin inhibition antibody (HAI) − Anti neuraminadase antibody response − Cell mediated immune response • Phase III init
Slide 24: Section 3: Innovative Financing Strategy
Section 3: Innovative Financing Strategy
Slide 25: Innovative Funding/Commercial Strategy
Innovative Funding/Commercial Strategy • Our approach: − Work with leaders: GE Healthcare (worldwide) Regional partners (Avimex, ROVI, Cadila) NIH − Leverage partner resources to fund/accelerate development & commercialization in US and internationally − Provide in-country manufacturing and lo
Slide 26: Regional Partnership (Mexico)
Regional Partnership (Mexico) • Alliance with Avimex Laboratories to support clinical trial and potential commercial distribution of the H1N1 vaccine in Mexico • Pivotal trial two-stage randomized, placebo trial in 4,000 subjects for 2009 H1N1 • Stage A of 1,000 subjects evaluating safety, immunogen
Slide 27: Regional Partnerships (Spain & Portugal)
Regional Partnerships (Spain & Portugal) • ROVI Pharmaceuticals (Spain): − Non dilutive funding - Phase III trials of VLP vaccines funded by Spanish Government through ROVI − Potential EU-wide approval with rights largely retained by Novavax Deal enables marketing authorization in entire EU by 201
Slide 28: Section 4: Driving Shareholder Value
Section 4: Driving Shareholder Value
Slide 29: Significant Progress in 2009
Significant Progress in 2009 Significant Milestones: 2009 YTD 1Q 09 Additional data to support differentiated influenza vaccine RSV pre-clinical candidate 2Q 09 Expanded dose range & safety study in healthy adults for seasonal influenza Regional partnership: Cadila (India) Regional partner
Slide 30: Upcoming Milestones
Upcoming Milestones Near-Term Value Drivers 4Q 09 H1N1 Initial data (Mexico) Seasonal Initiate Phase II trial in older adults 1Q 10 H1N1 Final H1N1 data (Mexico) H1N1 Regulatory filing and potential approval (Mexico) Seasonal Phase II data in elderly adults US RFP Expected decision on HH
Slide 31: Current Business & Financial Highlights
Current Business & Financial Highlights* * All figures approximate • Cash and short term investments (6/30/09) $39MM • Current annual cash burn rate $28MM • Total shares outstanding (6/30/09) 91MM • State of the art 51,000 sq. ft research and manufacturing facility located in Rockville, MD • 90 empl
Slide 32: 100+ Years of Vaccine Development Experience
100+ Years of Vaccine Development Experience John Lambert Chairman of the Board 30 years in vaccines, Former President Chiron Vaccines, Former President APMSD (Aventis/Merck joint venture) Rahul Singhvi, ScD, MBA President and CEO 14 years in vaccines (Merck, Novavax) Fred Driscoll VP, CFO & Treasur
Slide 33: Why Invest in Novavax?
Why Invest in Novavax? • Proven, proprietary VLP technology delivering blockbuster product candidates with scale-able, fast and cost effective manufacturing solution • Innovative funding/commercialization strategy with regional partnerships – Non-dilutive financing for advanced development, producti
Slide 34: Creation of Recombinant Influenza VLP Vaccines
Creation of Recombinant Influenza VLP Vaccines • Select proteins important for inducing neutralizing antibody and CMI – Surface hemagglutinin (HA) – Neuraminidase (NA) – Matrix (M1) Genes coding for the Infect cell culture Proteins (HA, NA, M1) HA, NA, and M1 proteins (Sf9) with baculovirus spontane