Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (January 2022)
22 slides from Novavax's investor presentation, Jan 10, 2022
Slide 1: Corporate Overview and Investor Deck
CORPORATE OVERVIEW AND INVESTOR DECK NASDAQ: NVAX | JANUARY 10TH, 2022 © 2022 NOVAVAX. All rights reserved. 1
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, COVID-NanoFluTM combination vaccine, Omicron-specific vaccine, and other Novavax vaccine product candida
Slide 3: Our Significant Momentum
OUR SIGNIFICANT MOMENTUM © 2022 NOVAVAX. All rights reserved. 3
Slide 4: Novavax At-A-Glance
NOVAVAX AT-A-GLANCE HIGH EFFICACY FOR NVX-CoV2373 >6 BILLION LIVES IN MARKETS WITH 90% overall • 100% against moderate & severe disease REGULATORY AUTHORIZATION Across 170+ countries around the globe STRONG RESPONSE TO VARIANTS ~2 BILLION DOSES COMMITTED 93% against VoI/VoC • Cross-protection agains
Slide 5: NVX-CoV2373 Addresses the Evolving Pandemic
NVX-CoV2373 ADDRESSES THE EVOLVING PANDEMIC NVX-CoV2373 VACCINE DESIGN Well-Tolerated with High Efficacy Significant Global Capacity • Innovative vaccine nanoparticles based on recombinant protein technology • Full-length SARS-CoV-2 Spike Ease of Distribution & Administration • Formulated with uniqu
Slide 6: Multiple Emergency Use Authorizations Received
MULTIPLE EMERGENCY USE AUTHORIZATIONS RECEIVED Status of global regulatory filings COVOVAXTM / NUVAXOVIDTM AUTHORIZATIONS RECEIVED REGULATORY SUBMISSIONS COMPLETED EULs from World Health CMA from European Commission US FDA** Japan’s Ministry of UK Medicines and Organization for both Health, Labour a
Slide 7: Global Market Opportunities for NVX-CoV2373
GLOBAL MARKET OPPORTUNITIES FOR NVX-CoV2373 PRIMARY VACCINATION BOOSTER VACCINATION Addressing vaccine hesitancy Need for robust protection, including through best-in-class efficacy based against variants, driving continued on well-understood technology demand for boosters PEDIATRIC VACCINATION EQUI
Slide 8: Significant Global Market Opportunity for NVX-CoV2373
SIGNIFICANT GLOBAL MARKET OPPORTUNITY FOR NVX-CoV2373 TO SUPPLY PRIMARY, BOOSTER AND PEDIATRIC VACCINATIONS Primary Booster Pediatric Vaccination* Vaccination** Vaccination (12-17) High-Income Countries ~4.8 Billion Total Dose Demand Upper-Middle Income Countries*** Lower-Middle Income and Low- ~6.8
Slide 9: ~2 Billion Doses of NVX-CoV2373 Committed Globally
~2 BILLION DOSES OF NVX-CoV2373 COMMITTED GLOBALLY Ensuring fair and equitable global access GAVI / COVAX FACILITY COMMITMENT TO US GOVERNMENT • APA with Gavi • NVAX to provide 350 million doses ~1.1 Billion • Serum Institute to provide 750 million 110 Million Doses committed to US government as Dos
Slide 10: Manufacturing Infrastructure Supports Global Demand for NVX-CoV2373
MANUFACTURING INFRASTRUCTURE SUPPORTS GLOBAL DEMAND FOR NVX-CoV2373 Antigen Production ✓ Significant bioreactor capacity at multiple sites ✓ Additional sites to be added to harmonized regulatory file Sites: Novavax CZ • Serum Institute • SK bioscience • Takeda • Biofabri • Biologics Manufacturing Ce
Slide 11: Clinical & Regulatory Overview
CLINICAL & REGULATORY OVERVIEW © 2022 NOVAVAX. All rights reserved. 11
Slide 12: Expanding Label and Policy Indications
EXPANDING LABEL AND POLICY INDICATIONS Additional clinical data being developed to support expanded recommendations for NVX-CoV2373 Strategic Approach • Receive regulatory authorizations in additional markets Primary • Distribute doses to ensure broad, equitable access Vaccination • Collect addition
Slide 13: Consistent Efficacy Across Phase 3 Studies
CONSISTENT EFFICACY ACROSS PHASE 3 STUDIES Primary Vaccination UK Phase 3 PREVENT-19 N=15,203 N=29,960 Overall Efficacy 89.7% 90.4% “Matched”/ Prototype 96.4% 100% Efficacy Prototype (Non-VoI/VoC) 86.3% 93.6% Alpha (B.1.1.7) Efficacy Against Variants Alpha (B.1.1.7) 92.6% All VoI/VoC NS Efficacy Aga
Slide 14: Robust Data to Support NVX-CoV2373 as a Booster
ROBUST DATA TO SUPPORT NVX-CoV2373 Booster Vaccination AS A BOOSTER Additional data expected from ongoing studies in 2022 Homologous Ongoing Studies Phase 2 U.S. & Australia PREVENT-19 • Functional inhibition increased 6x (prototype) to 19.9x (Omicron) compared to peak responses following 2-dose pri
Slide 15: Variant-Specific Responses Induced, With Significant IgG Increase After 6-Month Boost
VARIANT-SPECIFIC RESPONSES INDUCED, WITH SIGNIFICANT IgG INCREASE AFTER 6-MONTH BOOST Booster Vaccination 100% seroconversion after 2 doses against all tested variants 1,000,000 Fold increase 5.4x 6.5x 11.1x 9.7x 9.3x Prototype efficacy of * Anti-Spike IgG GMT and 96-100% in U.S./Mexico Alpha effica
Slide 16: Functional Inhibition of hACE2 Against Variants Increased After 6-Month Boost
FUNCTIONAL INHIBITION OF hACE2 AGAINST VARIANTS INCREASED AFTER 6-MONTH BOOST Booster Vaccination Magnitude of immune responses for all variants was greater than the peak observed after 2 doses 100% seroconversion against all variants after 6-month boost 1,000 Fold increase 6x 10.8x 6.6x 8.1x 19.9x
Slide 17: Pediatric Expansion to Support Regulatory Submission in 1Q 2022
PEDIATRIC EXPANSION TO SUPPORT Pediatric Vaccination REGULATORY SUBMISSION IN 1Q 2022 April 2021 June 2021 October 2021 Expected 1Q 2022 First dose Completed Completed blinded Complete regulatory filing enrollment crossover for pediatric indication (12 – 17 years) • 2,248 adolescents After 2 doses:
Slide 18: Omicron Vaccine Development Underway
OMICRON VACCINE December 2021 DEVELOPMENT • Initiated development of Omicron-specific vaccine UNDERWAY • Demonstrated cross-reactive immune responses against Omicron variant from two-dose primary Approach demonstrates ability to rapidly regimen of NVX-CoV2373 develop and scale strain change • Initia
Slide 19: Leader in COVID, NanoFlu and Combination Vaccine Development
September 2021 • Initiated Phase 1/2 clinical trial of combination vaccine • Safety, immunogenicity, and dose finding LEADER IN COVID, NANOFLUTM AND COMBINATION October 2021 • Completed enrollment of Phase 1/2 clinical trial VACCINE DEVELOPMENT • ~640 adults 50 – 70 years of age A transformative inn
Slide 20: Near-Term Vaccine Pipeline
NEAR-TERM VACCINE PIPELINE Significant opportunities for future development DISEASE PRODUCT PRECLINICAL PHASE 1 PHASE 2 PHASE 3 AUTHORIZED NVX-CoV2373* Matrix-M Coronavirus Omicron Variant Strain (Potential licensure pathway via Matrix-M strain change) NanoFlu Seasonal Influenza Matrix-M (Older Adul
Slide 21: Key Upcoming Milestones
KEY UPCOMING MILESTONES NVX-CoV2373 Primary Vaccination • Receive regulatory authorizations in additional markets • Distribute doses in authorized geographies • File for EUA with the U.S. FDA Boosting Vaccination • Initiate additional boosting studies • Pursue boosting label indications and policy r
Slide 22: novavax.com ir@novavax.com
21 Firstfield Road Gaithersburg, MD 20878 United States novavax.com ir@novavax.com © 2022 NOVAVAX. All rights reserved. 22