Novavax, Inc. · NASDAQ:NVAX
Novavax — Citi 12th Annual Biotech Conference 2017
35 slides from Novavax's conference presentation, Sep 7, 2017
Slide 1: Citi 12th Annual Biotech Conference
Citi 12th Annual Biotech Conference September 7, 2017
Slide 2: Safe harbor statement
Safe harbor statement Certain information, particularly information relating to future performance and other business matters, including expectations regarding clinical development, market opportunities and anticipated milestones constitute forward- looking statements within the meaning of the Priva
Slide 3: Novavax Targets: Influenza and RSV, the leading causes of respiratory tract infection
Novavax Targets: Influenza and RSV, the leading causes of respiratory tract infection RSV RSV remains a major unmet medical need in both children and older adults and a vaccine is an ideal solution Novavax is the leader in RSV vaccine development Novavax RSV F Vaccine is a multi-billion dollar
Slide 4: RSV F Vaccine Phase 3 Trial Infants via Maternal Immunization
` RSV F Vaccine Phase 3 Trial Infants via Maternal Immunization
Slide 5: Phase 3 RSV F Vaccine For Infants Via Maternal Immunization Addresses Significant Unmet Medical Need
Novavax Phase 3 RSV F Vaccine For Infants Via Maternal Immunization Addresses Significant Unmet Medical Need • RSV is the most common cause of lower respiratory tract infections among young • RSV is largely a disease of healthy, full-term children infants • RSV is the leading cause of hospitalizatio
Slide 6: Maternal Immunization: Building on a Proven Strategy
Maternal Immunization: Building on a Proven Strategy Building on Proven Strategy • Growing acceptance of maternal vaccination for flu and pertussis among HCPs and mothers • American College of Obstetrics and Gynecology conducts CME-accredited webinar: “Respiratory Syncytial Virus: The Need for a Mat
Slide 7: Novavax Has Conducted a Number of Successful Phase 2 Trials with RSV F Vaccine
Novavax Has Conducted a Number of Successful Phase 2 Trials with RSV F Vaccine Women of child-bearing age • Safety and immunogenicity confirmed in dose selection trials • Demonstration of ~50% reduction of RSV infections in vaccine groups in two trials in two separate seasons Pregnant women • Vaccin
Slide 8: Phase 3 RSV F Vaccine for Infants via Maternal Immunization Trial: Goals and Design
Phase 3 RSV F Vaccine for Infants via Maternal Immunization Trial: Goals and Design Primary Determine the efficacy of maternal immunization with the RSV F Objective Vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with objective measures of medical significance of LRTI throug
Slide 9: The Phase 3 Prepare Trial has Entered its Third Year
The Phase 3 Prepare™ Trial has Entered its Third Year Global infrastructure has been established to drive enrollment and surveillance Recruitment and surveillance are going well and indicate trial feasibility Global Season 1: 16 sites in 5 countries Global Season 2: 46 sites in 7 countries Global Se
Slide 10: Protecting Infants from RSV via Maternal Immunization
Protecting Infants from RSV via Maternal Immunization • Global footprint has grown from 16 sites in 5 countries in first season of enrollment to 80 sites in 11 countries in third season • Interim analysis occurs at 4,600 vaccinees • Requires a minimum of 3,000 vaccinees • Expect to trigger unblindin
Slide 11: Annual burden of RSV disease in infants 0-6 months affects those most at risk
Annual burden of RSV disease in infants 0-6 months of 1.9m infections affects those most at risk • Potential U.S. market: ~4 million pregnancies/year ~34,000 Hospital Admissions2 ~109,000 ~263,000 ER Visits2 Outpatient Visits2 1.9M Infections1 ~31 Deaths3 Values represent estimated annual rates. 11
Slide 12: Nanoparticle influenza vaccine with Matrix-M (NanoFlu)
` Nanoparticle influenza vaccine with Matrix-M™ (NanoFlu) 12
Slide 13: Influenza Market is Large, and Growing, with Little Product Differentiation
Influenza (Flu) Market is Large, and Growing, with Little Product Differentiation • Effectiveness of current licensed flu vaccines is inconsistent, and in some years, not effective at all • Pricing is generally commodity-like, the exception being Fluzone HD and, recently, FluAd, both for the older a
Slide 14: NanoFlu Target Product Profile
NanoFlu Target Product Profile Point of Market Entry Older Adults (65 years and older) HAI and Microneutralization titers equal to Immunogenicity Profile (or better than) the best-selling vaccine in older adults (Fluzone® High Dose) Broadly Neutralizing Better neutralization against drifted strains
Slide 15: A Significant Percentage of Older Adults get Vaccinated for Influenza
A Significant Percentage of Older Adults get Vaccinated for Influenza • Current influenza immunization rates in North America: Vaccination rate Year USA (U.S. CDC) 66.7% 2014/15 Canada (Statistics Canada)1 64.1% 2014 Total (pop. wt. avg.) 66.4% • CDC aims to have at least 100 Effectiveness of Licens
Slide 16: Influenza Vaccine Market Landscape
Influenza Vaccine Market Landscape • Approximately $3.1B in 2015 in the 7 major markets1,2 • Growing to $4.3B by 20252 • EU5 market is expected to grow by 70% and reaching almost $1B in sales by 20252 • Current average influenza vaccination rate of older adults in EU5 is 57% • Strong growth since 20
Slide 17: Novavax' Nanoparticle Influenza Vaccine candidate (NanoFlu)
Novavax’ Nanoparticle Influenza Vaccine candidate (NanoFlu) • Novavax NanoFlu preclinical data demonstrate a superior, differentiated immunogenicity and efficacy profile based on those established models and markers, potentially addressing deficiencies of current flu vaccines • Flu has established p
Slide 18: Influenza Virus - Primary Vaccine Target: Hemagglutinin
Influenza Virus - Primary Vaccine Target: Hemagglutinin • Receptor binding region is the target for HA Protein Structure antibodies that prevent virus binding to cells. These antibodies are highly strain- specific and dominate the immune response. • Antibodies to receptor binding site can be detecte
Slide 19: Flu Program Data Published in Vaccine
Flu Program Data Published in Vaccine Full publication is available on Novavax website or at: http://www.sciencedirect.com/science/article/pii/S0264410X17310885 19
Slide 20: Preclinical Study Design - Ferret Immunogenicity & Challenge Study
Preclinical Study Design - Ferret Immunogenicity & Challenge Study Virus Challenge Group Immunization Blood Draw Influenza A/H3N2 Placebo NanoFlu 15µg/HA + 50µg Matrix Days 21 and Day 49 Days 0 and 21 Fluzone® HD 42 60µg/HA Fluzone® 15µg/HA A H3N2: current strain, matched to vaccine Challenge Virus
Slide 21: Ferret Immunogenicity & Challenge Study
Ferret Immunogenicity & Challenge Study Novavax Fluzone HD Fluzone Quadrivalent NanoFlu A/Michigan (H1N1) A/California (H1N1) A/HongKong (H3N2) B/Brisbane B/Phuket 21
Slide 22: NanoFlu Induced Superior Hemagglutination Inhibition Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Hemagglutination Inhibition (HAI) Day 42 Antibody Responses A/Michigan (H1N1) A /M ic h ig a n /4 5 /2 0 1 5 A/California (H1N1) A /C a lifo r n ia /0 7 /2 0 0 9 512 2048 1024 256 512 128 256 H A I T ite r H A I T ite r 64 128 32 64 32 16 16 8 LO D 8 LO D 4 4
Slide 23: NanoFlu Induced Superior Hemagglutination Inhibition Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Hemagglutination Inhibition (HAI) Day 42 Antibody Responses A/Michigan (H1N1) A /M ic h ig a n /4 5 /2 0 1 5 A/California (H1N1) A /C a lifo r n ia /0 7 /2 0 0 9 512 2048 1024 256 512 128 256 H A I T ite r H A I T ite r 64 128 32 64 32 16 16 8 LO D 8 LO D 4 4
Slide 24: NanoFlu Induced Superior Microneutralizing Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Microneutralizing (MN) Day 42 Antibody Responses A/Michigan (H1N1) A/California (H1N1) 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu + Matrix M Matrix M A/Hong Kong (H3N2) B/Brisbane 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu +
Slide 25: NanoFlu Induced Superior Microneutralizing Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Microneutralizing (MN) Day 42 Antibody Responses A/Michigan (H1N1) A/California (H1N1) 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu + Matrix M Matrix M A/Hong Kong (H3N2) B/Brisbane 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + Matrix M N
Slide 26: NanoFlu Induced Broadly Neutralizing Antibodies against Drifted A(H3N2) Viruses
Immunogenicity: NanoFlu Vaccine Induced Broadly Neutralizing Antibodies against Drifted A(H3N2) Influenza Viruses 4096 NNanoFlu IV + M + a Matrix tr ix M M FFluzone l u z o n eHD H D M N T ite r s (L o g 2 ) 1024 Fluzone F lu z o n e Q IV 256 64 16 50% 4 5 4 1 7 3 9 4 /0 2 /0 9 2 /1 /0 /1 /9 /1 /0 /
Slide 27: NanoFlu Superior in Protecting Ferrets Challenged with Matched and Drifted H3N2
NanoFlu Vaccine was Superior in Protecting Ferrets Challenged with Matched and 10-year Drifted H3N2 (unmatched) Strain A/Hong Kong/4801/2014 (H3N2)–like A /H o n g K o n g /4 8 0 1 /2 0 1 4 ( H 3 N 2 ) A/Brisbane/10/2007 (H3N2)-like A /B r is b a n e /1 0 /2 0 0 7 ) H 3 N 2 ) - lik e A/Alaska/140/20
Slide 28: NanoFlu Product Development Strategy
NanoFlu Product Development Strategy Seasonal, older adult vaccine candidate in head-to-head trial • 4Q 2017: Data from Phase 1/2 trial designed to show product differences from current market leader • 1Q 2018: End of Phase 2 meeting expected, potential for accelerated approval • 4Q 2018: Pivotal im
Slide 29: RSV F Vaccine in Older Adults (E205)
` RSV F Vaccine in Older Adults (E205)
Slide 30: Recently Announced E-205 Vaccine/Adjuvant Study Conclusions
Recently Announced E-205 Vaccine/Adjuvant Study Conclusions Adjuvant effects • The adjuvants meaningfully increased immunity in measures generally associated with effective immunity • Anti-F and PCA • MN titers • Avidity of antibodies to neutralizing epitopes • Memory B cell and CD4+ T cells specifi
Slide 31: Path Forward for Older Adult Vaccine
Path Forward for Older Adult Vaccine • Building on E-205 data, RSV F Vaccine will be formulated with adjuvant for older adults • Two pathways to licensure: 1. Conduct a Phase 2 efficacy trial in a highly susceptible population • A profound vaccine effect was demonstrated in both our Phase 2 and Phas
Slide 32: Impact of Vaccine on COPD Exacerbations
Impact of Vaccine on COPD Exacerbations Post-hoc Analyses of Hospitalizations for All Cause COPD Exacerbations in E-201 and E-301 Data from the Safety Database E301 Day 0-182 Placebo Vaccine VE% 95% CI p value COPD hospitalization rate in all 23/5935 (0.39%) 9/5921 (0.15%) 60.8% 15.2—81.9 0.017 subj
Slide 33: COPD Hospitalizations in E-301
COPD Hospitalizations in E-301 All-Cause COPD Exacerbation Hospitalization-Free Survival in E-301 1 Proportion of Population Free of COPD 0.9995 0.999 0.9985 Exacerbation 0.998 0.9975 Active 0.997 Placebo 0.9965 0.996 0.9955 0.995 0 50 100 150 200 250 300 350 Days From Treatment 33
Slide 34: Summary of COPD Opportunity
Summary of COPD Opportunity A significant market opportunity exists with COPD, ~ $1.5 billion globally Prevention of acute exacerbations of COPD with the RSV F Vaccine would have a significant impact on the clinical and economic burden of COPD in the United States 1. Centers for Disease Control and
Slide 35: Upcoming Flu and RSV Milestones
Upcoming Flu and RSV Milestones Novavax is the leader in RSV vaccine development • Phase 3 program for RSV maternal immunization supported by Bill & Melinda Gates Foundation grant of $89 million • Interim data analysis in 2018 Differentiated NanoFlu program • Data from Phase 1/2 trial in 4Q 2017 • E