Novavax, Inc. · NASDAQ:NVAX
Novavax — BIO Investor Forum 2008
26 slides from Novavax's conference presentation, Oct 30, 2008
Slide 1: BIO Investor Forum 2008
BIO Investor Forum 2008 San Francisco, CA 30 October, 2008
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: Creating Tomorrow's Vaccines
Creating Tomorrow's Vaccines Robust vaccine pipeline Positive Phase II results with H5N1 Flu VLP (POC); Seasonal Flu VLP in Phase II Competitive advantage e.g., influenza vaccines (COGS) Reduced Capital Requirement Multiple commercialization options Efficient Manufacturing Solution Scalable Cell Bas
Slide 4: Leveraging the VLP Platform: Strong Pipeline Targeting Major Markets
Completed 2008 Planned Development Leveraging the VLP Platform Discovery Preclinical Phase I Phase II Pandemic Influenza Seasonal Influenza Herpes Zoster Respiratory Syncytial Virus Funded by NIH HIV SARS Strong Pipeline Targeting Major Markets
Slide 5: Key Milestones
Key Milestones Top line data for pandemic flu Phase II trial Commence seasonal flu Phase II trial in healthy adults; report top line results of trial: Q4 2008 Today; RSV announced as previously undisclosed discovery program Commence seasonal Phase II trial in older adults (T- 2009) after analysis of
Slide 6: Novavax Proprietary VLP Technology
Novavax Proprietary VLP Technology Single Protein Crystalline VLP e.g. Gardasil(r) (HPV vaccine) Novavax Enhanced VLP platform e.g. multi-component influenza VLP vaccine Exclusive composition of matter on Target Surface Proteins Patent protection for VLP matrix platforms Lipid Envelope
Slide 7: What Makes Novavax Different
What Makes Novavax Different Contain 3 immunologically important proteins Current flu vaccines consist almost entirely of HA Genetic match to wild-type strains causing influenza in humans HA - neutralizing ab prevents infection NA - neutralizing ab reduces disease severity M1 - cell mediated respons
Slide 8: Pandemic Influenza Vaccine: Positive Phase I/II Results
Proof of concept for VLP technology Safe, well-tolerated and immunogenic at two doses; 230 subjects Significant rise in antibody titers vs. baseline Support development of VLP vaccines against seasonal influenza and other diseases Pandemic Influenza Vaccine: Positive Phase I/II Results
Slide 9: Overview of Pandemic Influenza Phase II Study Design
Overview of Pandemic Influenza Phase II Study Design Stage A: Dose Escalation 2 injections: 15 mcg, 45 mcg, placebo N=70 Results reported December, 2007 Stage B: Dose Ranging 2 injections: 15 mcg, 45 mcg, 90 mcg, or a placebo N=160 Safety and Immunogenicity Results
Slide 10: Immunogenicity: Neutralizing Antibody Responses
Immunogenicity Percentage of subjects with NA titer >1:20 (>4-fold rise in titer) 15 mcg - 72% (CI: 53,86) 45 mcg - 73% (CI: 55,87) 90 mcg - 94% (CI: 80,99) Placebo - 0% Neutralizing Antibody (NA) Responses Against the A/Indonesia Strain After 2 Doses of the H5N1 VLP Vaccine
Slide 11: Pandemic Influenza Vaccine Opportunity
Stockpile, capacity pre-purchase, Domestic vaccine production capacity Pandemic Influenza Vaccine Opportunity Potential Market Worldwide population at risk Vaccine market segments Insufficient worldwide vaccine capacity Global budgets for pandemic preparedness > $13 billion Human infections/deaths c
Slide 12: VLP Approach May Address Gaps in Pandemic Influenza Vaccine Strategy
Issue Progress/Plan Poorly immunogenic antigen H5N1 VLP vaccine demonstrated good immunogenicity at all dose levels tested Response Time > 6 months Strain-matched VLP vaccine can be supplied to market within 12 weeks of strain identification Cell culture based manufacturing Scalable, cell based proc
Slide 13: Seasonal Influenza Opportunity
Seasonal Influenza Opportunity Potential Market Significant patient population each year U.S. continues to expand vaccination recommendations Current vaccines deficient in the most exposed populations $6 Billion by 2013 15 - 60 Million Infected >36,000 Deaths New Pediatric Recommendations Pediatric
Slide 14: Overview of Seasonal Influenza Phase II Study Designs
Overview of Seasonal Influenza Phase II Study Designs Dose Ranging in Healthy Adults 1 injection: 5 mcg, 15 mcg, 30 mcg, or a placebo N=~300 No serious adverse events reported to date Blinded data show different safety profile vs. pandemic vaccine Primary results targeted December, 2008 Dose Ranging
Slide 15: VLP Approach May Address Gaps in Current Seasonal Influenza Vaccines
Issue Progress/Plan Over-supply of current vaccine; Limited effectiveness in elderly, pediatrics Probability of success for differentiation increased with H5N1 vaccine data; dose response observed Phase IIa dose ranging study in healthy adults ongoing Phase IIa dose ranging in Older adults to commen
Slide 16: Seasonal Flu - Window of Opportunity: How Does Novavax Compete?
Seasonal Flu - Window of Opportunity How Does Novavax Compete? Company Differentiation in Elderly Indication for Broad Population (>6 mos) Cell-culture Speed to Market Each Year High dose or intradermal Currently have No No MF59-adj vaccine (not licensed in US) Yes No No Novel Adjuvant (regulatory r
Slide 17: Herpes Zoster (Shingles) Virus Discovery Candidate
Herpes Zoster (Shingles) Virus Discovery Candidate Potential multi-billion dollar market: ACIP recommended for ages 60+; approx 50 million patient market potential in US alone Lifetime risk of disease, 25% - 30% Global opportunity Single vaccine on market ($150/dose): Live, stored at -15°C; must be
Slide 18: Respiratory Syncytial Virus Discovery Candidate
Respiratory Syncytial Virus Discovery Candidate No preventative vaccine currently available Most commonly identified cause of lower respiratory tract infections in young children Certain risk groups such as the elderly >65 years of age and those with cardiovascular disease can develop respiratory tr
Slide 19: Old Manufacturing Solution
Old Manufacturing Solution
Slide 20: New, Efficient Manufacturing Approach
New, Efficient Manufacturing Approach Pre-sterilized, ready to use, disposable equipment Very adaptable to VLP vaccine production Synergies of a single production platform for multiple vaccines
Slide 21: Novavax Manufacturing Advantage
Traditional Approach Novavax Manufacturing High CAPEX Greatly reduced capital costs (~80%) Low yield Higher yields Long time to commissioning/ROI Can cut commissioning time in half Centralized, large factories Distributed manufacturing Single product facility Multiple product facility Novavax Manufa
Slide 22: Flexible Commercialization Strategy
Flexible Commercialization Strategy 10MM dose capacity for seasonal influenza vaccine in place (Rockville, MD) Advanced manufacturing knowledge & capacity is valuable to potential partner (Corporate or Government) Economically viable regional or in-border manufacturing solution (e.g. with GE Healthc
Slide 23: Sound Financial Position
Sound Financial Position NASDAQ: NVAX Shares outstanding: 69 million Current market capitalization (10/28/08): ~$150 million Cash, equivalent and short term (6/30/08): $36 million (+$18M equity round) 2008 burn: ~$8 million/quarter run rate Financing options: Partnering; non-dilutive and equity
Slide 24: 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) Penny Heaton, MD Chief Medical
Slide 25: Why Novavax?
Why Novavax? Proven technology used in vaccine development Strong IP for VLP franchise Strong proof of concept clinical data Broad application of VLPs to multiple virus candidates Unique and efficient manufacturing process Key clinical milestones in near term Potential blockbuster vaccines in discov
Slide 26: BIO Investor Forum 2008
BIO Investor Forum 2008 San Francisco, CA 30 October, 2008