Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (September 2011)
38 slides from Novavax's investor presentation, Sep 8, 2011
Slide 1: Investor Update
Investor Update September 8, 2011
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: Breaking News: Novavax Provides Update on H5N1 Avian Flu
Breaking News: Novavax Provides Update on H5N1 Avian Flu High Priority for HHS $179 million contract focused on Novavax H5N1 technology – Non egg-based vaccine production system – Time to large scale production < 12 weeks from ID of new strain Protection against heterologous challenge in mice
Slide 4: H5N1-Avian Influenza Vaccine Update
H5N1-Avian Influenza Vaccine Update Phase 1/2 Clinical Trial, J. Virol, in press Collaboration with FDA scientists H5N1 (A/Indonesia/05/2005 (Clade 2.1), dose escalation in 150 subjects, 15-90 ug un-adjuvanted vaccine Highlights: Seroconversion rates of 40-61% by HI Serconversion rates o
Slide 5: NOVAVAX Investment Highlights
NOVAVAX Investment Highlights Platform technology delivering proprietary recombinant Virus like Particle (VLP) vaccine candidates Influenza, RSV, Rabies Novasomes, a novel adjuvant Scalable, fast and cost effective vaccine manufacturing Partnering to Create and Capture Value US Government
Slide 6: BARDA Contract
BARDA Contract NOVAVAX Awarded HHS-BARDA Contract Valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology BARDA requirements Recombinant HA-based influenza vaccine Less than 12 weeks production cycle time US based
Slide 7: BARDA Contract
BARDA Contract “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save lives during a pandemic as well as during seasonal flu outbreaks.” – HHS Secr
Slide 8: BARDA Contract
BARDA Contract NOVAVAX Value $179 million 5 year contract Validates NOVAVAX flu program Funds flu program through BLA submission $97 million 3 year base period funds Seasonal phase 2 and 3 clinical trials H5N1 phase 1 and 2 clinical trials NOVAVAX proprietary adjuvant into the clinic
Slide 9: Execution: New Organization
Execution: New Organization Management Changes/Additions Chairman: Jim Young, Ph.D., Former President R&D and co- founder MedImmune CEO: Stan Erck, Former CEO Iomai and Procept (both public), management w/ Integrated Genetics, Baxter CMO: Greg Glenn, M.D., Former CSO/Founder IOMAI, WRAIR VP,
Slide 10: NVAX and Cadila Biologics (CPLB)
NVAX and Cadila Biologics (CPLB) Leveraging our partnership for new products Cadila Pharmaceuticals - Established Indian pharmaceutical company with new biotechnology arm New vaccine manufacturing facility with fill/finish capability VLP production and worldwide commercialization capacity 10
Slide 11: LG Life Sciences Partnership
LG Life Sciences Partnership NOVAVAX Licenses Recombinant VLP Influenza Vaccine to LG Life Sciences for South Korea and Other Countries LGLS is leading provider of biologicals with annual sales of $300+ million Deal includes upfront and milestone payments plus double digit royalties LGLS will
Slide 12: Technology
NOVAVAX Creating Tomorrow's Vaccines 9 TECHNOLOGY alld | Novavax |
Slide 13: Recombinant Nanoparticle Technology
Recombinant Nanoparticle Technology Select key antigens/sequences Genes put into baculovirus Infect insect cells Antigens made as Nanoparticles (VLPs, Micelles) Immunogenic particle with concentrated antigens in native configuration Genes coding for Baculovirus- proteins are put Proteins (
Slide 14: Baculovirus/Insect Cell Derived Nanoparticles: Virus-Like Particles
Baculovirus/Insect Cell Derived Nanoparticles: Virus-Like Particles HA, NA HA, NA Protein Protein RNA Empty Genes M1 M1 Matrix Matrix Influenza Virus H1N1 VLPs HA, NA Proteins M1 Matrix 14
Slide 15: Program Update
NOVAVAX Creating Tomorrow's Vaccines 9 PROGRAM UPDATE al | Novavax |
Slide 16: Influenza Vaccine
NOVAVAX Creating Tomorrow's Vaccines Influenza Vaccine | Novavax |
Slide 17: Clinical Summary: Influenza VLPs
Clinical Summary: Influenza VLPs Phase / Study Initiated Design Status Indication Trivalent 15 μg, 60μg per strain; Phase-IIa / Double blind, vs 15μg per strain Complete NCT01014806 11/2009 seasonal of commercial TIV* (N=480) influenza Adults over 60 - [Safety/immunogenicity study] Phase II / 5 μg,
Slide 18: H1N1 VLP Influenza Vaccine: Clinical Evaluation in Mexico 09-10
H1N1 VLP Influenza Vaccine: Clinical Evaluation in Mexico 2009-10 Two Part Study Part A Safety and Immunogenicity over a dose range 1271 subjects dose at Day 0 and 21 – Placebo, 5, 15 and 45 µg, dose 1:1:1:1 ratio – Day 0, 21, 35 HAI Part B Safety only in expanded number of subjects 3550 s
Slide 19: Seroconversion, Seroprotection, Fold Rise
Seroconversion, Seroprotection, Fold Rise HAI, Seroprotection, Seroconversion and Fold Rise Placebo (N=242) 5µg dose (N=237) 15µg dose (N=244) 45µg dose (n=244) D0 D14 D35 D0 D14 D35 D0 D14 D35 D0 D14 D35 GMT (95% CI) Total 20 24 25 23 88 85 21 141 138 20 174 209 (17-23) (20-28) (21-29) (19-26) (75-
Slide 20: Safety/Immunogenicity Highlights
Safety/Immunogenicity Highlights No related SAEs, dose related local AEs, generally mild. HAI, seroconversion and seroprotection responses robust. FDA seasonal influenza licensure criteria met at all doses, after a single dose: Serconversion for 5µg: 48.3% (95% CI 41.7-54.9%) vs LB CI 40%
Slide 21: Next Steps for Flu Vaccine Program
Next Steps for Flu Vaccine Program Seasonal Large scale production leading to Phase 3 Trials 1,000 subject Phase 2 dose-ranging, dose-confirmation trial 4Q 2011 – Data 1H 2012 Phase 3 trial targeted 2013 BLA Submission targeted 2014 Pandemic H5N1 Phase 1 trials to evaluate H5N1 VLP wit
Slide 22: Respiratory Syncytial Virus
RESPIRATORY SYNCYTIAL VIRUS 22
Slide 23: Respiratory Synctial Virus RSV
Respiratory Synctial Virus RSV Major new target for vaccine developers Infects all children by age 2 years Is the leading cause of bronchiolitis and pneumonia in infants <1 year of age 75,000 to 125,000 hospitalizations annually (in US) A leading cause of pneumonia in older adults 14,000
Slide 24: Infant RSV Hospitalization Rates
Infant RSV Hospitalization Rates Fryzek et al, 2011 24
Slide 25: Cotton Rat Lung Histopathology Post RSV Challenge
Cotton Rat Lung Histopathology Post RSV Challenge A. Vaccine (1 µg +alum)-RSV challenged B. Vaccine (6 µg +alum)-RSV challenged C. Vaccine (30 µg +alum)-RSV challenged D. Control-RSV challenged E. Formalin Inactivated Virus: RSV challenged F. Normal 25
Slide 26: Cotton Rat Lung Histopathology Post RSV Challenge
Cotton Rat Lung Histopathology Post RSV Challenge A. Vaccine (1 µg +alum)-RSV challenged B. Vaccine (6 µg +alum)-RSV challenged C. Vaccine (30 µg +alum)-RSV challenged D. Control-RSV challenged E. Formalin Inactivated Virus: RSV challenged F. Normal 26
Slide 27: Cotton Rat Lung Histopathology Post RSV Challenge
Cotton Rat Lung Histopathology Post RSV Challenge A. Vaccine (1 µg +alum)-RSV challenged B. Vaccine (6 µg +alum)-RSV challenged C. Vaccine (30 µg +alum)-RSV challenged D. Control-RSV challenged E. Formalin Inactivated Virus: RSV challenged F. Normal Disease Exacerbation 27
Slide 28: Cotton Rat Lung Histopathology Post RSV Challenge
Cotton Rat Lung Histopathology Post RSV Challenge A. Vaccine (1 µg +alum)-RSV challenged B. Vaccine (6 µg +alum)-RSV challenged C. Vaccine (30 µg +alum)-RSV challenged D. Control-RSV challenged E. Formalin Inactivated Virus: RSV challenged F. Normal RSV F Vaccine protective: A,B,C vs D No disease ex
Slide 29: Cotton Rat Lung Histopathology Post RSV Challenge
Cotton Rat Lung Histopathology Post RSV Challenge A. Vaccine (1 µg +alum)-RSV challenged B. Vaccine (6 µg +alum)-RSV challenged C. Vaccine (30 µg +alum)-RSV challenged D. Control-RSV challenged E. Formalin Inactivated Virus: RSV challenged F. Normal RSV F Vaccine protective: A,B,C vs D No disease ex
Slide 30: RSV F Vaccine Phase 1 Study
RSV F Vaccine Phase 1 Study Amended Phase 1 Safety & Immunogenicity in Healthy Adults (N=150, 6 Cohorts) Healthy adults, 18-19, male and female 20 per active group with 5 placebo Two Immunizations on Day 1 & 30 Dose-escalation with Safety Monitoring Committee between dosage levels 5, 15,
Slide 31: Rabies
NOVAVAX Creating Tomorrow's Vaccines 9% Rabies om if | Novavax |
Slide 32: Rabies: Building a Pipeline w/ CPLB
Rabies: Building a Pipeline w/ CPLB Rabies Virus Rabies G Protein BV/SF9 Micellular VLP Vaccine 32
Slide 33: Rabies Virus, Unmet Need and Vaccine
Rabies Virus, Unmet Need and Vaccine • Global problem, fatal disease • 50,000 annual deaths in India • Compliance with 5 dose post-exposure vaccine regimen difficult • Vaccine expensive, unstable, frequent short supply Novavax CONFIDENTIAL
Slide 34: Rabies G Protein Vaccine: Neutralizing Antibodies by Day
Neutralizing Antibodies by Day 10 after 2 Dose G Protein Vaccine Rabies G protein Vaccine: Neutralizing Antibodies 3.5 Rabipur (0,3) Rabies VLP 4ug (d 0,3) 3 Rabies VLP 4uG (0,3) Rabies VLP 4ug (d 0,7) Rabipur (0,5) Rabies VLP 4uG (0,5) 2.5 Target Product Profile Rabipur (0,7) Rabies VLP 4ug (d 0,5)
Slide 35: Creating Value with Partnerships
Creating Value with Partnerships
Slide 36: Value Creation Through Partnerships
Value Creation Through Partnerships India Korea CPL LG Life Biologics Sciences Clinical Data U.S. BARDA Manufacturing Capacity Pharma Upfront Milestones and Royalties Regional Market Access Product Development Funding NOVAVAX Has Created Value in Non-dilutive Manner and Retained Commercial
Slide 37: Upcoming News Events
Upcoming News Events Event RSV-Phase 1 First Patient in (FPI) BARDA Award LG South Korea Deal Phase 2 Seasonal Flu Trial – FPI RSV-Phase 1 Top-line Data Phase 1 Pandemic Flu Trial – FPI Phase 1 Pandemic Flu with NOVAVAX Adjuvant – FPI 37
Slide 38: Current Business & Financial Highlights
Current Business & Financial Highlights* Cash and short term investments (6/30/11) $22M Projected cash burn rate <$22M Total shares outstanding (6/30/11) ~115M State of the art 51,000 ft2 research and manufacturing facility located in Rockville, MD 103 employees Top Shareholders Wellington, Cadila