Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (January 2008)
30 slides from Novavax's investor presentation, Jan 14, 2008
Slide 1: Corporate Presentation January 2008
Corporate Presentation January, 2008 Nasdaq: NVAX
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
Slide 3: Discussion Points
Discussion Points The New Novavax New Term Milestones Our Strategy to Succeed VLP/Manufacturing Technology Product Pipeline Team Summary
Slide 4: The New Novavax
The New Novavax Clinical stage vaccine development company based in Rockville, MD NASDAQ: NVAX Shares Outstanding: 62 Million Current Cash (9/30/07): $52 Million Institutional Ownership* 46% Stock Float 90% * as of Sept 30, 2007
Slide 5: Vaccine Market Growth Drivers
Vaccine Market Growth Drivers Existing Vaccine bar graph Worldwide Vaccine Growth (Datamonitor, Kalorama, Novavax) Large, growing markets Expanding government recommendations for immunizations New indications Technological innovations New differentiated products for unmet needs Higher prices/margins
Slide 6: Example of New Vaccines-Market Potential
Disease Unmet Medical Need Potential Market (1) RSV No current vaccine >$1bn VZV 1st Generation product >$1bn S Aureus No current vaccine $1.8bn* Flu Vaccine Elderly differentiated product >$1bn Pneumococcal 1st Generation Product $2.2bn* Mening B No current vaccine $1.8bn* Colorectal No current vac
Slide 7: Our Strategy to Succeed
Our Strategy to Succeed Vaccine Technologies Product Pipeline Management Team
Slide 8: Virus Like Particle (VLP) Vaccine Technology
Basic VLPs Target Surface Proteins Lipid Envelope Novavax VLPs Single Protein Crystalline VLP e.g. Gardasil(r) (HPV vaccine) e.g. Influenza vaccine Virus Like Particle (VLP) Vaccine Technology NOVAVAX Enhanced VLP platform VLP is a proven technology for creating safe and efficacious vaccines
Slide 9: Novavax VLP: Why It Matters
Novavax VLP: Why It Matters VLPs are "decoys", made of proteins presented in the 3-D conformation native to the targeted viruses Induce immune responses similar to natural infection Stimulate multiple arms of the immune system Potential safety advantages: No genetic machinery No adjuvant required Ma
Slide 10: Novavax VLP Intellectual Property
Novavax VLP Intellectual Property Exclusive IP on composition of matter Patent protection for VLP matrix platforms - freedom to operate Leading to...unique methods of exclusive use
Slide 11: Manufacturing Excellence is Key for Success in Vaccines
Manufacturing Excellence is Key for Success in Vaccines Traditional Vaccine VLP Vaccines 70,000 eggs ^ 100 liters
Slide 12: Disposable Manufacturing Solution
Disposable Manufacturing Solution Leads To......... Lower capital costs Shorter commissioning time Improved manufacturing yields & quality (cost/dose) Lower production risks (e.g. contamination) Synergies of a single production platform
Slide 13: Manufacturing Advantages: Plant Build Costs/Space
Manufacturing Advantages Plant Build Costs/Space Facility $150,000,000 Sq ft 145,000 Facility $40,000,000 Sq ft 40,000 NVAX VLPs Egg Based Seasonal Flu Vaccine Example: 100 Million Doses Annual Capacity
Slide 14: Manufacturing Advantages: Higher Yield with VLPs
Manufacturing Advantages Higher Yield with VLP's Traditional Egg Based Yield 34% Yield 48% VLP's 42% Improvement
Slide 15: Influenza Vaccine Production Relative Process Yield
Influenza Vaccine Production Relative Process Yield 15 30 45 90 mcg/dose Relative Yield (Dose/Liter) egg based NVAX insect cell process cell-based 3 4 5 6 0 2 1
Slide 16: Pipeline: Leveraging the VLP Platform
Pipeline: Leveraging the VLP Platform Discovery Preclinical Phase I/IIA Phase IIb/III Pandemic influenza Zoster (Shingles) Undisclosed Seasonal influenza HIV (with UAB) Dengue (with U. Pitt) Funded by NIH E-selectin (with NIH) Funded Programs Funded by DOD
Slide 17: Pandemic Influenza VLP Vaccine Phase I/IIa Stage A Interim Results
Pandemic Influenza VLP Vaccine Phase I/IIa Stage A Interim Results Safety & Dose Ranging Study Initial doses tested: 15 and 45 mcg (70 subjects) Vaccine well tolerated... DSMB approved doses up to 90 mcg ....and immunogenic at both doses At 45 mcg. dose 63% of subjects had neutralizing antibody tite
Slide 18: Implications from Interim Results
Implications from Interim Results Promising recombinant H5N1 vaccine without an adjuvant that induces similar immunogenicity (at 45mcg dose) as licensed vaccine and that can be produced within 12 weeks Higher doses being tested in second stage of study Proof of Concept for Novavax VLP technology Inc
Slide 19: Pandemic Influenza Opportunity
Pandemic Influenza Opportunity "Everything we say before a pandemic will be viewed as alarmist, everything we do after it happens will be insufficient"* Insufficient worldwide vaccine capacity Globally, government budgets for pandemic preparedness exceed $13 Billion USD Market segments include: stoc
Slide 20: Pandemic Influenza Customer Segments
Pandemic Influenza Customer Segments Possible strain mismatch Limited population coverage Replenishment of aged doses Subcontractor supply role to large pharma Long production lead time Cross-border shipments 12 week response time with strain match Domestic infrastructure Long production lead time S
Slide 21: Domestic Infrastructure Segment Detail
Domestic Infrastructure Segment Detail Substantial capacity lacking in most advanced countries All countries lack first wave protection through rapid delivery of a strain matched vaccine Existing Planned AUS USA GE ES JP SWE IND TW ROK IT FR UK NL CA CHN TW BR TH SG RSA IDN Supply Gap> 10bn doses* *
Slide 22: Pandemic Vaccine Competition & Capabilities
Pandemic Vaccine Competition & Capabilities Novavax offers a complete pandemic vaccine solution Attributes Novavax Competition Remarks Efficacy Immunogenicity similar to approved vaccine; others unapproved Safety No Adjuvants, proven technology, No wild type virus Response Time 12 weeks vs 6 months
Slide 23: Novavax Vaccine Value Proposition
Novavax Vaccine Value Proposition = First Wave + Domestic Infrastructure Multiple potential commercial channels Traditional (RFP) and non-traditional (GE) Existing Planned AUS USA GE ES JP SWE IND TW ROK IT FR UK NL CA CHN TW BR TH SG RSA IDN Supply Gap > 10bn doses* * Oliver Wyman/Path - Influenza
Slide 24: Novavax and GE Collaboration: A New Business Model
Novavax and GE Collaboration: A New Business Model Step 1: Co-Market a pandemic influenza vaccine solution, based on Novavax's VLP vaccine and manufacturing platform using GE products, to select international countries Step 2: Execute an agreement with a target country to enable domestic vaccine pro
Slide 25: Seasonal Influenza VLP Vaccine
Seasonal Influenza VLP Vaccine Large, growing market with unmet medical needs US Government plans to expand current vaccine recommendations for vaccination 2010 - 2012 Need for a more immunogenic vaccine in older adults Two Pronged Development Strategy Rapidly develop a non-inferior recombinant prod
Slide 26: Varicella Zoster Virus (VZV) Vaccine
Varicella Zoster Virus (VZV) Vaccine VZV is responsible for over 1 million cases of herpes zoster (shingles) in the US each year Primary complication is post-herpetic neuralgia (PHN), which occurs in ~65% of affected patients Large market with only one vaccine supplier Current vaccine provides ~50%
Slide 27: The Talent And Experience To Succeed
The Talent And Experience To Succeed 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 10 years with Merck vaccines Penny Heaton MD: Chief Medical Officer and VP De
Slide 28: Key 2008 Milestones
Key 2008 Milestones Top line data for Pandemic flu Phase I/IIa trial with final dose Q2 2008 Commence seasonal flu Phase I/IIa trial Q2 2008 Obtain Top line data from seasonal flu Phase I/IIa trial Q3 2008 Obtain initial pre-clinical results for VZV Vaccine Q3 2008 Initiate Divestiture of Legacy Ass
Slide 29: Key Takeaways
Key Takeaways A proven recombinant vaccine approach with a broad platform Focus on products with clear development and regulatory approval pathway Two vaccines (pandemic and seasonal) through Phase IIa by Q3'08 Two novel, high value vaccine programs in early development Cost effective, paradigm chan
Slide 30: NOVAVAX: Creating Tomorrow's Vaccines
NOVAVAX Creating Tomorrow's Vaccines Nasdaq: NVAX