Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (April 2021)
33 slides from Novavax's investor presentation, April 2021
Slide 1: Corporate Overview and Investor Deck
CORPORATE OVERVIEW AND INVESTOR DECK Nasdaq: NVAX | April 2021
Slide 2: 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 Private Securities Litigatio
Slide 3: Novavax at-a-Glance
Novavax at-a-Glance 10+ years $2+ billion of Nanoparticle Vaccine Development in Funding Secured to Date 2+ billion 50,000+ Doses of Annual Participants Enrolled in Manufacturing Capacity* COVID-19 Clinical Trials 96% ~800 Efficacy Demonstrated Employees Globally Against Original COVID-19 Strain * W
Slide 4: Recent Progress Leading to Significant Opportunity
Recent Progress Leading to Significant Opportunity Unique COVID-19 vaccine developed and advanced through multiple pivotal trials Demonstrated efficacy against original COVID strain and two prominent variants Established global supply chain of 2 billion potential annual doses of NVX-CoV2373 at full
Slide 5: NVX-CoV2373 Progress Built Upon Years of Vaccine Research
NVX-CoV2373 Progress Built Upon Years of Vaccine Research novavax.com 5
Slide 6: Recombinant Nanoparticle Technology Platform and Matrix-M Combined
Recombinant Nanoparticle Technology Platform and Matrix-M™ Combined to Create Vaccines That Address Global Public Health Threats Coronavirus uses Spike Recombinant Spike Matrix-M adjuvant helps Recombinant nanoparticle protein to attach and protein nanoparticles stimulate a robust, protective and Ma
Slide 7: NVX-CoV2373: Stabilized Prefusion SARS-CoV-2 Spike Glycoprotein + Matrix-M
NVX-CoV2373: A full-length, stabilized prefusion SARS-CoV-2 spike (S) glycoprotein + Matrix-M™ • Full-length, native conformation Spike protein trimer configured in a nanoparticle • Formulated with Matrix-M adjuvant • Highly immunogenic • Spike protein is a validated Transmission Electron Microscopy
Slide 8: Technology and Programs Highlighted in Peer-Reviewed Publications in 2020
Novavax Technology and Programs Highlighted in Peer-Reviewed Publications in 2020 novavax.com 8
Slide 9: NVX-CoV2373 Clinical Development Overview
NVX-CoV2373 Clinical Development Overview novavax.com 9
Slide 10: NVX-CoV2373 Clinical Development Overview
NVX-CoV2373 Clinical Development Overview PHASE PHASE PHASE PHASE 1-2 3 2b 3 US & AUSTRALIA UNITED KINGDOM SOUTH AFRICA US & MEXICO (PREVENT-19) n = 131 n = 15,203 n = 4,404 n ~ 30,000 Phase 1 18-59 years 18-84 years 18-65 years ≥18 years Enrollment Complete (n=400 co-admin with flu vaccine) (n=245
Slide 11: Key Takeaways from Clinical Trials
Key Takeaways from Clinical Trials • 96% VE against original COVID-19 Primary • 86% VE against B.1.1.7 variant (first described in UK) Endpoints • 51% VE against B.1.351 variant* (first described Achieved in South Africa) • Favorable preliminary safety profile * In 95% of HIV-negative study populati
Slide 12: Phase 1/2 Published in NEJM
Phase 1/2 Published in NEJM CONCLUSIONS: • Reassuring safety profile and well-tolerated • Induced desirable immunologic phenotype in both arms of the immune system • High levels of neutralizing antibody • Induction of Th1-biased (effector-memory) cellular immune response novavax.com 12
Slide 13: Phase 1/2 Doses + Matrix-M at Day 35: Robust Antibody Response
Phase 1/2 2 Doses + Matrix-M™ at Day 35: Robust Antibody Response 100,000 10,000 Convalescent Sera Anti-Spike IgG (Log10EU/mL) 1,000 100 Placebo 25µg 25µg + Matrix-M 5µg + Matrix-M 25µg + Matrix-M Placebo 25µg Placebo 5µg + Matrix-M 25µg + Matrix-M Keech, C. et al. DOI: 10.1056/NEJMoa2026920 novavax
Slide 14: Phase 1/2 Doses + Matrix-M: Robust Immune Response
Phase 1/2 2 Doses + Matrix-M™: Robust Immune Response 100,000 2 doses: 5µg + Matrix-M Antibody levels at 6 months are within the 2 doses: 25µg + Matrix-M range of recently recovered patients 10,000 Convalescent Sera Anti-Spike IgG (Log10EU/mL) 1 dose: 25µg + Matrix-M 1,000 Placebo 100 DayDay DayDayD
Slide 15: Phase 2 in US/Australia: 6-Month Boost
Phase 2 in US/Australia: 6-Month Boost • Select participants in the 5µg dose cohorts are receiving booster doses • Two treatment groups are being boosted at 6 months: Group 1: received 5µg on day 0 • Randomized to received 5µg vs placebo at day 186 Group 2: received 5µg on day 0 and day 21 • Ran
Slide 16: Key Takeaways from Phase 3 Study in the UK
Key Takeaways from Phase 3 Study in the UK • 96% efficacy against original COVID-19 Primary Endpoint • 86% efficacy against B.1.1.7 variant Achieved: (first described in UK) 90% Overall Efficacy • Favorable preliminary safety profile • 100% protection against severe disease novavax.com 16
Slide 17: Key Takeaways from Phase 2b Study in South Africa
Key Takeaways from Phase 2b Study in South Africa • 55% efficacy in HIV-negative population (95% of study participants) Primary Efficacy • Cross-protection against B.1.351 Endpoint Achieved: escape variant, accounting for 93% of 49% in Overall Trial sequenced cases Population • 100% protection again
Slide 18: PREVENT-19 Phase 3 Trial Fully Enrolled
PREVENT-19 Phase 3 Trial Fully Enrolled Interim Data Expected in 2Q 2021 Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety 5 µg + 50 µg Matrix-M™ (2 injections: Day 0 and Day 21) ~30K n = ~20,000 Adults R 2:1 >18 years Placebo (2 injections: Day 0
Slide 19: PREVENT-19 Phase 3 Update
PREVENT-19 Phase 3 Update WA MT ME ND OR MN VT NH ID SD WI NY MA MI CT WY ~30K participants enrolled IA PA NE NV NJ IL OH DC IN UT CA CO KS MO WV VA 20% Latin American • 12% African American • KY NC 6% Native American • 5% Asian American • 13% Older Adults OK AZ TN AR NM SC MS AL GA Blinded crossove
Slide 20: Pathway to Regulatory Approvals
Pathway to Regulatory Approvals • Rolling reviews in various markets • Ongoing discussions with FDA through submissions to open IND • Filings for authorization in UK and US expected in 2Q 2021 US Food and Drug Administration UK Medicines and Healthcare Australian Therapeutic Goods products Regulator
Slide 21: Variant Vaccines Under Development Against Emerging COVID-19 Variants
Variant Vaccines Already Under Development Against Emerging COVID-19 Variants Optimal vaccine for all regions may need to address / contain alternate strains Development underway for new constructs against emerging strains, using both variant and bivalent approaches • Ongoing evaluation in animal mo
Slide 22: NVX-CoV2373 Manufacturing & Distribution
NVX-CoV2373 Manufacturing & Distribution novavax.com 22
Slide 23: 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 23
Slide 24: Global Supply Chain Established
Global Supply Chain Established Annual capacity of over 2 billion* doses starting in 2021 PolyPeptide Group AGC Biologics Biologics Jubilant Manufacturing Novavax AB HollisterStier Centre GSK FujiFilm Par Pharma Novavax CZ SK AGC UK Novavax Bioscience Biologics Biofabri HQ MD Takeda PolyPeptide Baxt
Slide 25: Agreements Executed for NVX-CoV2373
Agreements Executed for NVX-CoV2373 Ensuring fair and equitable global access Gavi / COVAX Facility Commitment to US Government • Ensuring fair and equitable access to low-, middle- and Doses committed to US ~1.1 billion high-income countries 110 million Government in relation to doses • NVAX and Se
Slide 26: NanoFlu Program
NanoFlu™ Program novavax.com 26
Slide 27: 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 antigenic changes to strains and response to generat
Slide 28: NanoFlu Program
NanoFlu™ Program March 2020 Successfully completed pivotal Phase 3 clinical trial October 2020 Formed dedicated team to advance NanoFlu through licensure November 2020 Published Phase 2 data in Clinical Infectious Diseases • Committed to NanoFlu regulatory approval Today • Exploring combinations wit
Slide 29: Summary
Summary novavax.com 29
Slide 30: Significant Milestones in 2021
Significant Milestones in 2021 Further establish NVX-CoV2373’s unique profile: additional efficacy/safety data and populations anticipated from ongoing clinical trials Execute on global manufacturing and distribution plans, transitioning into profitable commercial-scale organization Seek authorizati
Slide 31: Pipeline Overview
Pipeline Overview novavax.com 31
Slide 32: Robust Vaccine Pipeline, Demonstrating Significant Opportunities
Robust Vaccine Pipeline, Demonstrating Significant Opportunities for Future Development Therapeutic Area Name Preclinical Phase 1 Phase 2 Phase 3 Marketed NVX-CoV2373 Coronavirus Variant Strain (Booster and / or Bivalent) NanoFlu Seasonal Influenza (Older Adults) (Pre-BLA) NanoFlu / NVX-CoV2373 Comb
Slide 33: novavax.com [email protected]
21 Firstfield Road Gaithersburg, MD 20878 United States novavax.com [email protected] novavax.com 33