Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (September 2021)
71 slides from Novavax's investor presentation, September 2021
Slide 1: Corporate Overview and Investor Deck
CORPORATE OVERVIEW AND INVESTOR DECK Nasdaq: NVAX | September 2021
Slide 2: Safe Harbor Statement
Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine product candidates, timing of future regulatory filings and actions, anticipated manufacturing capacity, the readiness
Slide 3: Novavax at-a-Glance
Novavax at-a-Glance 90% 10+ years Overall Efficacy in of Nanoparticle Vaccine Development PREVENT-19 Phase 3 Trial 93% $2+ billion Efficacy Against the Predominantly in Funding Secured to Date Circulating VoC and VoI 150 million 100% Doses per Month Manufacturing Efficacy Against Moderate Capacity b
Slide 4: Significant Progress in 2021
Significant Progress in 2021 Filed regulatory submissions for EUA of NVX-CoV2373, in partnership with Serum Institute of India (Serum Institute) Confirmed high levels of efficacy in PREVENT-19 Phase 3 trial Announced positive data from 6-month booster study for NVX-CoV2373 Entered into APA with GAVI
Slide 5: Table of Contents
Table of Contents Section Page Introduction 6 COVID-19 Clinical Trial Information 9 Booster Study 37 NVX-CoV2373 Regulatory Pathway 51 NanoFlu™ and Combination Vaccine Programs 53 Strategic Development of COVID-19 Vaccines 56 NVX-CoV2373 Manufacturing & Distribution 60 Clinical Development Conducted
Slide 6: Introduction
Introduction novavax.com 6
Slide 7: NVX-CoV2373 Vaccine Design
NVX-CoV2373 Vaccine Design SARS-CoV-2 Spike gene Final vaccine Matrix-M™ inserted into insect virus Vaccine nanoparticles are mixed with adjuvant a Matrix-M™ adjuvant to create full-length, stabilized Spike gene is ready-to-use NVX-CoV2373 vaccine. engineered into baculovirus, | Viral RNA a aly aA N
Slide 8: NVX-CoV2373 Highlighted in Recent Peer-Reviewed Publications
NVX-CoV2373 Highlighted in Recent Peer-Reviewed Publications The picture can't be displayed. novavax.com 8
Slide 9: COVID-19 Clinical Trial Information
COVID-19 Clinical Trial Information novavax.com 9
Slide 10: NVX-CoV2373 Clinical Development Program
NVX-CoV2373 Clinical Development Program Phase 3 N=29,960 § Licensure-enabling safety in US population US & Mexico § Licensure-enabling efficacy in US populations § Licensure-enabling safety data Phase 3 N=15,203 § Licensure-enabling efficacy data United Kingdom § Safety of co-administration with in
Slide 11: Key Takeaways from NVX-CoV2373 Clinical Trials
Key Takeaways from NVX-CoV2373 Clinical Trials Efficacy ü Efficacy confirmed against original COVID-19 and variant strains 4 Clinical Trials Conducted ü 100% efficacy against moderate and Across 4 Continents severe disease Immunogenicity 50,000+ Participants Enrolled in Clinical Trials ü Robust immu
Slide 12: PREVENT-19
PREVENT-19 Phase 3 United States and Mexico novavax.com 12
Slide 13: PREVENT-19 Phase 3 Trial Design
PREVENT-19 Phase 3 Trial Design Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety 5µg + 50µg Matrix-M adjuvant Placebo 2 injections, 21 days apart 29,960 2 injections, 21 days apart R n = ~20,000 Adults 2:1 >18 years Placebo 5µg + 50µg Matrix-M adj
Slide 14: 90% Overall Vaccine Efficacy
90% Overall Vaccine Efficacy 1.8% Placebo Event Rate 1.6% 1.4% Vaccine and placebo rates separate prior to dose 2 (day 21). 1.2% No evidence of waning efficacy 1.0% through day 98. 0.8% NVX-CoV2373 0.6% 0.4% 0.2% 0.0% 0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 Days fr
Slide 15: 93% Efficacy Against Predominantly Circulating Variants of Interest and Concern
93% Efficacy Against Predominantly Circulating Variants of Interest and Variants of Concern VoI/VoC represented 82% of cases 9 (17%) VoI/VoC 35 (65%) Variants of Interest VE = 92.6% Variants of Concern 0 10 20 30 0 10 20 30 B.1.526 6 (13.6%) B.1.1.7 VE = 93.6% (post-hoc) 28 (63.6%) B.1.526-1 1 (2.3%
Slide 16: Serious and Severe Events: Infrequent and Balanced
Serious and Severe Events: Infrequent and Balanced Safety summary through crossover (n=25,981) NVX-CoV2373 Any Adverse Event (AE) Placebo Any Medically Attended AE An AE is any event reported, whether or not related to vaccine. Serious AE No single adverse event term was reported by Any Severe AE mo
Slide 17: Favorable Reactogenicity Profile
Favorable Reactogenicity Profile Local: Pain and Tenderness most common, £ 3 days duration Systemic: Fatigue, Headache and Muscle Pain, £ 2 days duration Local Systemic Dose 1 Any Grade Grade 3+ Any Grade Grade 3+ 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60%
Slide 18: Final Analysis: High Overall Efficacy
Final Analysis: High Overall Efficacy NVX-CoV2373 Placebo (n=17,312)* (n=8,125)* Total 14 63 Mild 14 49 Moderate 0 10 Severe 0 4 90.4% Vaccine Efficacy (95% CI: 82.9, 94.6) • Primary efficacy statistical criteria achieved with lower bound of 95% CI >30 • 82% of cases caused by Variants of Interest (
Slide 19: 100% Efficacy Against Variants Not Considered VoI/VoC
100% Efficacy Against Variants Not Considered Variants of Interest/Concern Protection against variants more closely matched to prototype NVX-CoV2373 Placebo (n=17,312)* (n=8,125)* Total 0 10 Mild 0 7 Moderate 0 2 Severe 0 1 100% Vaccine Efficacy (95% CI: 80.8, 100) Pre-specified key secondary endpoi
Slide 20: High Efficacy Against Variants of Interest & Concern
High Efficacy Against Variants of Interest & Variants of Concern NVX-CoV2373 Placebo (n=17,312)* (n=8,125)* Total 6 38 Mild 6 29 Moderate 0 7 Severe 0 2 92.6% Vaccine Efficacy (95% CI: 83.6, 96.7) Efficacy updated in post-hoc analyses. Sequence not available for 23 cases: 21 mild (8 in vaccine, 13 i
Slide 21: 100% Efficacy Against Moderate or Severe Disease
100% Efficacy Against Moderate or Severe Disease NVX-CoV2373 Placebo (n=17,312)* (n=8,125)* Total 0 14 Moderate 0 10 Severe 0 4 100% Vaccine Efficacy (95% CI: 87.0, 100) • Pre-specified secondary endpoint • Post-hoc analysis for Severe disease only: VE = 100% (95% CI: 35, 100) • An additional 6 COVI
Slide 22: High Efficacy in High-Risk Population
High Efficacy in High-Risk Population NVX-CoV2373 Placebo (n=16,493)* (n=7,723)* Total 13 62 91.0% Vaccine Efficacy (95% CI: 83.6, 95.0) High Risk defined as: • ≥65 years of age • <65 years of age with obesity, chronic kidney disease, chronic lung disease, cardiovascular disease, Type 2 diabetes • L
Slide 23: PREVENT-19 Phase 3 Pediatric Expansion
PREVENT-19 Phase 3 Pediatric Expansion Randomized, observer-blinded, placebo-controlled trial evaluating safety, efficacy and effectiveness April 2021 First Dose 5 µg + 50 µg Matrix-M adjuvant (2 injections: Day 0 and Day 21) 2,248 n = ~1,500 June 2021 Adolescents R Enrollment Complete 2:1 12-17 yea
Slide 24: PREVENT-19 Pivotal Phase 3 Trial Summary
PREVENT-19 Pivotal Phase 3 Trial Summary 29,960 119 Sites Adult Crossover Participants Enrolled 113 in U.S. & 6 in Mexico Completed Consistent, High Efficacy Reasserted Among Circulating Variants Favorable Safety Profile Overall efficacy with cases 90.4% predominantly VoI/VoC ü Vaccine generally wel
Slide 25: Phase 3 United Kingdom
Phase 3 United Kingdom novavax.com 25
Slide 26: 89% Overall Vaccine Efficacy
Phase 3 89% Overall Vaccine Efficacy UK 2.5% Event Rate Placebo 2.0% 1.5% 1.0% NVX-CoV2373 0.5% 0.0% 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 Days from first vaccination = case Heath et al. 2021; DOI: 10.1056/NEJMoa2107659 novavax.com 26
Slide 27: Safety Events Were Infrequent and Balanced
Phase 3 Safety Events Were Infrequent and Balanced UK Summary of events1 through Day 7 after Dose 1 & 2 (n=15,139) NVX-CoV2373 MAAEs Placebo 2 Any Severe AEs Events were infrequent and balanced between vaccine Any Serious AEs and placebo groups. 4 AESIs related to COVID 1. Events occurring after rec
Slide 28: Local Symptoms: Majority None or Mild
Phase 3 Local Symptoms: Majority “None” or “Mild” UK Mild Moderate Severe Life Threatening Dose 1 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Any local symptom Any localPlacebo symptom NVX-CoV2373 Any local symptom Any local symptom Tenderness Tend
Slide 29: Systemic Symptoms: Majority None or Mild
Phase 3 Systemic Symptoms: Majority “None” or “Mild” UK Mild Moderate Severe Life Threatening Dose 1 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Any systemic symptom Placebo Any systemic symptom NVX-CoV2373 Any systemic symptom Any systemic symptom
Slide 30: NVX-CoV2373 Well-Tolerated when Administered with Influenza Vaccine
NVX-CoV2373 Well-Tolerated Phase 3 UK when Administered with Influenza Vaccine Participants received influenza vaccine or placebo with first dose of NVX-CoV2373 (n=431) Mild Moderate 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Placebo NVX-CoV2373 Vaccine Efficacy Preserved Any local NVX CoV2373
Slide 31: UK Phase 3 Trial Summary
Phase 3 UK Phase 3 Trial Summary UK 15,203 Adult Crossover Participants Enrolled Completed Primary Efficacy Demonstrated Endpoint Achieved Favorable Safety Profile 90% Overall efficacy ü Safety events were infrequent and balanced 96% Efficacy against original COVID-19 between vaccine and placebo gro
Slide 32: Consistent Efficacy Across Phase 3 Studies
Consistent Efficacy Across Phase 3 Studies UK Phase 3 PREVENT-19 Overall Efficacy 89.7% 90.4% “Matched” Strain Efficacy 96.4% 100% Prototype (Non-VoI/VoC) 93.6% Alpha (B.1.1.7) Efficacy Against Variants 86.3% Alpha (B.1.1.7) 92.6% VoI/VoC NS Efficacy Against Severe Disease (all 5 severe cases 100% i
Slide 33: Phase 2b Trial South Africa
Phase 2b Trial South Africa novavax.com 33
Slide 34: South Africa Phase 2b Trial Summary
Phase 2b South Africa Phase 2b Trial Summary South Africa Conducted in a context of greater than 90% variant virus 4,422 Adult Crossover with Participants Enrolled Boosting Ongoing Primary Efficacy Demonstrated Endpoint Achieved Favorable Safety Profile 49% Efficacy in overall trial population ü Gen
Slide 35: Phase 1/2 Trial United States & Australia
Phase 1/2 Trial United States & Australia novavax.com 35
Slide 36: Robust Immune Response
Robust Immune Response Phase 1/2 US & Australia 2 doses + Matrix-M adjuvant 100,000 2 doses: 5µg + Matrix-M Antibody levels at 6 adjuvant months are within the 2 doses: 25µg + Matrix-M adjuvant range of recently recovered patients 10,000 Convalescent Sera Anti-Spike IgG (Log10EU/mL) 1 dose: 25µg + M
Slide 37: Booster Study
Booster Study United States & Australia novavax.com 37
Slide 38: Phase 2 Study Ongoing: Examining Third Dose
Phase 2 Study Ongoing: Examining Third Dose Day 189 boost complete, immune responses evaluated on Day 217 USA & Australia — N=1,288 | Adults aged 18-84 years (n=583; 60-84 years) Placebo 5 µg + Matrix-M 5 µg + Matrix-M 25 µg + Matrix-M 25 µg + Matrix-M n=255 n=258 n=256 n=259 n=255 Day 0 5 µg + 5 µg
Slide 39: Adverse Event Rates Comparable with Low Rates of Severe and Serious Events
Adverse Event Rates Comparable with Low Rates of Severe and Serious Adverse Events Day 217 Safety Summary (5µg/5µg/5µg arm, all ages) After Dose 1 0% 20% 40% 60% 80% 100% AEs Severe AEs MAAEs After Dose 3 SAEs 0% 20% 40% 60% 80% 100% Discontinued AEs PIMMCs Severe AEs After Dose 2 MAAEs SAEs 0% 20%
Slide 40: Local Symptoms: Favorable Profile is Consistent
Local Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 2 days, except erythema (2.5 days) novavax.com 40
Slide 41: Systemic Symptoms: Favorable Profile is Consistent
Systemic Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 1 day, except muscle pain (2 days) novavax.com 41
Slide 42: Robust Anti-Spike IgG Responses
Robust Anti-Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 1,000,000 202,406 100,000 41,621 Titers increased ~4.6- Anti-Spike IgG (Log10EU/mL) fold compared to peak 11,514 response seen after 10,000 primary vaccination 5,943 series. 1,000 745 106 Placebo 100 Day Day 0 7 21 28 35
Slide 43: Consistent Anti-Spike IgG Responses
Consistent Anti-Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 1,000,000 Anti-spike IgG titers Ages 18-59 increased ~3.9-fold in Overall adults aged 18-59. Ages 60-84 100,000 Anti-spike IgG titers Anti-Spike IgG (Log10EU/mL) increased ~5.4-fold in adults aged 60-84. 10,000 1,000
Slide 44: Robust Beta Anti-Spike IgG Responses
Robust Beta Anti-Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 1,000,000 169,770 100,000 Beta IgG Anti-Spike IgG (Log10EU/mL) 10,000 4,413 1,000 Placebo 100 Day Day 0 7 21 28 35 49 105 189 217 novavax.com 44
Slide 45: Increased Wild Type Neutralization Responses
Increased Wild Type Neutralization Responses Vaccination on Day 0 & 21 and boost on Day 189 10,000 6,039 WT neutralization titers 1,581 increased ~4.3-fold IC<50% Wild Type Virus Neutralization (Log10) compared to peak 1,000 response seen after primary vaccination series. Neutralization titers 100 i
Slide 46: Boosted Anti-spike IgG Responses Greater Than Phase 3
Boosted Anti-spike IgG Responses Greater Than Observed in Phase 3 Studies UK Phase 3 Efficacy PREVENT-19 Efficacy Prototype: 96% Non-VoI/VoC: 100% B.1.1.7: 86% VoI/VoC: 93% B.1.1.7: 94% 1,000,000 3.7-4.4x Anti-Spike IgG (EU/mL, Log10) 100,000 10,000 1,000 UK Ph3 Day 35 PREVENT-19 Day 35 US/AU Ph2 Da
Slide 47: Boosted Microneutralization Responses Greater Than Phase 3
Boosted Microneutralization Responses Greater Than Observed in Phase 3 Studies UK Phase 3 Efficacy PREVENT-19 Efficacy Prototype: 96% Non-VoI/VoC: 100% B.1.1.7: 86% VoI/VoC: 93% B.1.1.7: 94% 100,000 Wild Type Virus Neutralization (Log10) 10,000 4.6-5.5x 1,000 100 UK Ph3 Day 35 PREVENT-19 Day 35 US/A
Slide 48: High Functional hACE2 Responses Against All Variants After Boosting
After Boosting, All Participants Developed High Levels of Functional hACE2 Responses Against All Variants Post-boost consistency suggests maturation of immune response (n=29) 10,000 Ancestral 10,000 Alpha 10,000 Beta 10,000 Delta 6x increase 10.8x increase 6.6x increase 8.1x increase 1,000 average 1
Slide 49: Use of NVX-CoV2373 in a Boosting Campaign
Use of NVX-CoV2373 in a Boosting Campaign A single dose of NVX-CoV2373 at 6 months significantly increases immune responses: • Wild-type Neutralization and Anti-Spike IgG levels up >4x over peak primary vaccination response • Increased functional hACE-2 immune response against variants: • Delta (B.1
Slide 50: Emerging Shift Toward Booster Doses
Emerging Shift Toward Booster Doses NVX-CoV2373 Positioned to be Booster of Choice Data from Phase 2 Homologous Booster Study in U.S. & Emerging Booster Policy Australia Supports NVX-CoV2373’s Ability to Boost Recommendations • A single dose of NVX-CoV2373 at 6 months significantly increases immune
Slide 51: NVX-CoV2373 Regulatory Pathway
NVX-CoV2373 Regulatory Pathway novavax.com 51
Slide 52: Filings for Authorization Underway with Additional Filings Expected in 2H 2021
Filings for Authorization Underway with Additional Filings Expected in 2H 2021 TODAY Drugs Controller Indonesia General of India a The Philippines • Regulatory submissions filed for EUA* with India, World Health Organization Indonesia, Philippines (WHO) • Expect to complete rolling European UK Medic
Slide 53: NanoFlu and Combination Vaccine Programs
NanoFlu and Combination Vaccine Programs novavax.com 53
Slide 54: NanoFlu Addresses the Need for Greater and Broader Immune Responses
NanoFlu Addresses the Need for Greater and Broader Immune Responses Recombinant nanoparticle technology and Matrix-M adjuvant Next-generation flu vaccine for improved protection Provides broader Eliminates egg-adaptive Enhances immune protection against strain changes that response to generate antig
Slide 55: COVID-NanoFlu Combination Vaccine Development
COVID-NanoFlu Combination Vaccine Development A transformative innovation to fight both illnesses Clinical Proof of Concept May 2021 Announced positive ü UK Phase 3 co-administration sub-study completed preclinical data* ü Demonstrated viability of simultaneous COVID-19 and influenza vaccination Pre
Slide 56: Strategic Development of COVID-19 Vaccines
Strategic Development of COVID-19 Vaccines novavax.com 56
Slide 57: Variant Strain Vaccine Development
Variant Strain Vaccine Development Complementary Studies of rS-B.1.351 Ongoing development for new • Compared immunization with NVX-CoV2373 or constructs against emerging strains rS-B.1.351 alone, in combination or as Study 1 heterologous prime boost Preclinical • rS-B.1.351 was highly immunogenic a
Slide 58: Response in Baboons Immunized 1 Year Ago
Response in Baboons Immunized 1 Year Ago Boost: 3µg rS-B.1.351 + 50µg Matrix-M adjuvant Prime/Boost Boost Original strain Variant strain Dose 1 Dose 2 Dose 1 Dose 2 10000000 1000000 Geometric mean of 1, 5 or 25µg NVX-CoV2373 7 days after dose + 50µg Matrix-M adjuvant 100000 Anti-rS IgG Titer EC50 Ge
Slide 59: ACE2 Receptor Inhibition Increases After Boost at Year 1
Ace2 Receptor Inhibition Increases After Boost at 1 Year Boost: 3µg rS-B.1.351 + 50µg Matrix-M adjuvant US-WU1 (Original) B.1.351 Spike Spike Inhibition Inhibition 10000 10000 Priming Regimen 50% Receptor Inhibition Titer 50% Receptor Inhibition Titer 1000 1000 Geometric mean of 1, 5 or 25µg NVX-CoV
Slide 60: NVX-CoV2373 Manufacturing & Distribution
NVX-CoV2373 Manufacturing & Distribution novavax.com 60
Slide 61: Practical Benefits Enabling Efficient Distribution
Practical Benefits Enabling Efficient Distribution Presentation • 10-dose vials Transportation & Storage • Stable at 2 to 8°C Administration • Ready to use • Well-characterized technology Large Global Capacity platform; Dose-sparing novavax.com 61
Slide 62: Global Supply Chain Established
Global Supply Chain Established Capacity of approx. 150 million* doses per month starting by end of 4Q 2021 PolyPeptide Group AGC Biologics Biologics Jubilant Manufacturing Novavax AB HollisterStier Centre GSK Par Sterile FujiFilm UK SK AGC Products Novavax CZ Bioscience Biologics Novavax Biofabri H
Slide 63: Agreements Executed for NVX-CoV2373
Agreements Executed for NVX-CoV2373 Ensuring fair and equitable global access Gavi / COVAX Facility Commitment to US Government • Finalized APA with Gavi • NVAX to provide 350 million doses • Doses committed to US ~1.1 billion • Serum Institute to provide 110 million government in relation to doses
Slide 64: Clinical Development Conducted by Partners
Clinical Development Conducted by Partners novavax.com 64
Slide 65: NVX-CoV2373 Clinical Development Conducted by Partners
NVX-CoV2373 Clinical Development Conducted by Partners Phase 1/2 • Evaluating immunogenicity and safety of NVX- n = 200 Enrollment Complete Sponsored by Takeda Japan CoV2373 ≥ 20 years Phase 2/3 • Evaluating immunogenicity and safety of NVX- n = 1,600 Enrollment Complete Sponsored by Serum Institute
Slide 66: Malaria Vaccine Candidates / Matrix-M Adjuvant Collaborations
Malaria Vaccine Candidates / Matrix-M Adjuvant Collaborations R21 R0.6C with Matrix-M Adjuvant with Matrix-M Adjuvant Phase 2b Africa Preclinical Study n = 450 5-17 months Complete Data Published • Demonstrated greater than 80% reduction of transmission of parasite that causes malaria • Data publish
Slide 67: Upcoming Milestones
Upcoming Milestones novavax.com 67
Slide 68: Key Upcoming Milestones
Key Upcoming Milestones Protection against Highly adaptable Strong stability Favorable safety variants platform profile profile By end of 2021 • Expect to complete regulatory filings for emergency authorization with the MHRA, WHO, EMA, FDA, New Zealand Medsafe, Health Canada and Australian Therapeut
Slide 69: Pipeline Overview
Pipeline Overview novavax.com 69
Slide 70: Near-Term Vaccine Pipeline
Near-Term Vaccine Pipeline Significant Opportunities for Future Development Clinical Development Conducted by Novavax Therapeutic Area Name Preclinical Phase 1 Phase 2 Phase 3 Marketed NVX-CoV2373 (Booster) Coronavirus Variant Strain (Monovalent and / or Bivalent) NanoFlu Seasonal Influenza (Older A
Slide 71: novavax.com ir@novavax.com
21 Firstfield Road Gaithersburg, MD 20878 United States novavax.com ir@novavax.com novavax.com 71