Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (December 2008)
23 slides from Novavax's investor presentation, December 2008
Slide 1: Corporate Presentation
Corporate Presentation December , 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 Broad VLP Platform Technology Robust vaccine pipeline with IP Positive Phase II results with H5N1 Flu VLP (POC); Seasonal Flu VLP in Phase II Scalable Cell Based Manufacturing Competitive advantage (COGS, Reliability) Efficient Manufacturing Solution Reduced Capital Requ
Slide 4: Strong Pipeline Targeting Major Markets
Strong Pipeline Targeting Major Markets Leveraging the VLP Platform Discovery Preclinical Phase I Phase II Pandemic Influenza Seasonal Influenza Herpes Zoster Respiratory Syncytial Virus Funded by NIH HIV SARS Completed 2008 Planned Development
Slide 5: Key Milestones
Key Milestones 3Q 2008 Ongoing Top line data Commence RSV Report Commence Announce for pandemic seasonal flu announced optimized HAI seasonal phase country flu Phase II Phase II trial as assay results for II trial in adults transaction as trial in healthy previously pandemic Phase >65 years of age p
Slide 6: Novavax Proprietary VLP Technology
Novavax Proprietary VLP Technology Exclusive composition of Novavax matter on Target Enhanced VLP Surface Proteins platform Patent protection for VLP matrix Single Protein platforms Crystalline VLP Lipid Envelope e.g. Gardasil® (HPV vaccine) e.g. multi-component influenza VLP vaccine
Slide 7: Pandemic Influenza Vaccine: Positive Phase I/II Results
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
Slide 8: Immunogenicity (Stage B)
Immunogenicity (Stage B) Neutralizing Antibody (NA) Responses Against the A/Indonesia Strain After 2 Doses of the H5N1 VLP Vaccine 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%
Slide 9: Pandemic Influenza Vaccine Opportunity
Pandemic Influenza Vaccine Opportunity Potential Market Global budgets for pandemic preparedness > $13 billion Worldwide population at risk Human infections/deaths continue Asia particularly vulnerable Vaccine market segments Stockpile, capacity pre-purchase, Domestic vaccine production capacity Ins
Slide 10: VLP Approach May Address Gaps in Pandemic Influenza Vaccine Strategy
VLP Approach May Address Gaps in Pandemic Influenza Vaccine Strategy Issue Progress/Plan H5N1 VLP vaccine demonstrated good Poorly immunogenic antigen immunogenicity at all dose levels tested Scalable, cell based process with higher yield: Cell culture based manufacturing economically viable; No
Slide 11: Seasonal Influenza Opportunity
Seasonal Influenza Opportunity Potential Market $6 Billion by 2013 Significant patient population each year 15 - 60 Million Infected >36,000 Deaths U.S. continues to expand vaccination recommendations New Pediatric Recommendations Current vaccines deficient in the most exposed populations Pediatric
Slide 12: Seasonal Flu - How Does Novavax Compete?
Seasonal Flu - How Does Novavax Compete? Company Differentiation Indication for Broad Cell- Speed to Market in Elderly Population (>6 mos) culture Each Year High dose or Currently have No No intradermal MF59-adj vaccine Yes No No (not licensed in US) Novel Adjuvant Yes No No (regulatory risk) No 2 -
Slide 13: Seasonal Influenza Studies
Seasonal Influenza Studies 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 (non-serious adverse events) vs. pandemic vaccine •Primary results targeted December, 2008 Dose
Slide 14: Herpes Zoster (Shingles) Virus
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;
Slide 15: Respiratory Syncytial Virus
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 respirat
Slide 16: Old Manufacturing Solution
Old Manufacturing Solution [HOVAVAS | el
Slide 17: 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 18: Novavax Manufacturing Advantage
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
Slide 19: Flexible Commercialization Strategy
Flexible Commercialization Strategy Direct Product 10MM dose capacity for seasonal influenza Sale vaccine in place (Rockville, MD) Advanced manufacturing knowledge & capacity is Partnering valuable to potential partner (Corporate or Government) Regional Economically viable regional or in-border Manu
Slide 20: Financial Position
Financial Position NASDAQ: NVAX Shares outstanding: 69 million Current market capitalization (10/28/08): ~$150 million Cash, equivalent and short term (9/30/08): $45 million 2008 burn: ~$8 million/quarter run rate Financing options: Partnering; non-dilutive and equity
Slide 21: 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 22: Why Novavax?
Why Novavax? • Proven VLP technology for vaccine development • Strong IP for VLP franchise • Two phase II clinical candidates with strong proof of concept • Broad application of VLPs to multiple virus candidates • Potential blockbuster vaccines in discovery • Scalable manufacturing process with lowe
Slide 23: Corporate Presentation
Corporate Presentation December , 2008