Second Quarter 2021 Financial Results and Operational Highlights Nasdaq: NVAX | August 5th, 2021 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 of our global supply chain and future availability of NVX-CoV2373 at a global scale constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act.
Forward-looking statements may generally contain words such as “believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “intend,” “indicate,” “plan,” “project,” “expect,” “should,” “would,” or “assume” or variations of such words or other words with similar meanings. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time and may cause actual results to differ materially from the results discussed in the forward-looking statements.
These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, SafeSafe HarborHarbor governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission, which are available at www.sec.gov and StatementStatement www.novavax.com.
Forward-looking statements are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance.
Current results may not be predictive of future results.
You should not place considerable reliance on forward-looking statements which speak only as of the date hereof.
The Company does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law.
Matrix-M and NanoFlu are trademarks of Novavax, Inc.
novavax.com 2 Significant Progress in 2Q 2021
Filed regulatory submissions for EUA of NVX-CoV2373, in partnership with Serum Institute of India
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 and finalized terms of APA with the European Commission to expand global reach
Confirmed manufacturing guidance: Capacity of 100M doses per month by the end of Q3 and 150M doses per month by the end of Q4
novavax.com 3 NVX-CoV2373 Clinical Development Program
§ Established dose level in younger and older adults PHASE 1-2 N=131 Phase 1 § Confirmed need for adjuvant and 2 dose schedule US & Australia N=1,288 Phase 2 § Defined immunologic phenotype
Keech et al. NEJM 02 September 2020 § Described preliminary safety profile § Evaluated preliminary efficacy PHASE 2b N = 4,422 § Defined safety profile South Africa § HIV+ subgroup Shinde et al. NEJM 20 May 2021 § Licensure-enabling safety data PHASE 3 N = 15,203 § Licensure-enabling efficacy data United Kingdom § Safety of co-administration with influenza vaccine Heath et al. NEJM 30 June 2021
§ Licensure-enabling safety in US population PHASE 3 N = 29,960 US & Mexico § Licensure-enabling efficacy in US populations
novavax.com 4 PREVENT-19 Phase 3 Trial Design
Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety
5 µg + 50 µg Matrix-M™ adjuvant Placebo (2 injections: Day 0 and Day 21) 30,000 2 injections 21 days apart R n = ~20,000 Adults 2:1 >18 years Placebo 5 µg + 50 µg Matrix-M™ adjuvant (2 injections: Day 0 and Day 21) 2 injections 21 days apart n = ~10,000
Study expanded to include adolescents 12-18 years of age (n = 2,248) Dosing complete and follow-up for safety, immunogenicity and efficacy ongoing Blinded cross-over planned for week of August 9, 2021
novavax.com 5 90% Overall Vaccine Efficacy from 7 Days After Second Dose
novavax.com 6 Disease Severity by Sequence-Confirmed Variants* Red: Variant of Concern Orange: Variant of Interest Green: Not VOC or VOI NVX-CoV2373 Placebo (n=17,312) (n=8,140) Total 14 63 Vaccine Efficacy (primary) (4) B.1.1.7 UK (20) B.1.1.7 UK • 90.4% (95% CI: 82.9; 94.6) (1) B.1.351 South Africa (1) B.1.351 South Africa (2) B.1.526 New York (2) P.1 Japan / Brazil (7) No Sequence (1) B.1.429 USA/California Non-VoI/VoC (key secondary) (5) B.1.526 USA/New York • 100% (95% CI: 85.8; 100) Mild (1) B.1.617.1 India (1) P.2 Brazil Disease (4) B.1/1.1/1.1.316/1.1.519 Severe/Moderate (secondary) (1) B.1.2 (2) B.1.243 • 100% (95% CI: 87; 100) (2) B.1.311 (1) B.1.596 (8) No Sequence VoI/VoC (exploratory) • 92.6% (95% CI: 83.6; 96.7) Moderate (6) B.1.1.7 UK 0 (2) B.1.429 USA/California Disease (2) B.1.2 B.1.1.7 (post-hoc) (1) B.1.1.7 UK Severe (1) B.1.526 USA/New York • 93.6% (95% CI: 81.7; 97.8) 0 Disease (1) B.1.2 (1) No Sequence • Based on US CDC classification • Includes post-hoc sequences
novavax.com 7 UK Phase 3 Trial Design
Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety
5 µg + 50 µg Matrix-M™ adjuvant Placebo (2 injections: Day 0 and Day 21) 2 injections 21 days apart 15,000 n = ~7,500 Adults R >18 years 1:1 Placebo 25% > age 65 5 µg + 50 µg Matrix-M™ adjuvant (2 injections: Day 0 and Day 21) 2 injections 21 days apart n = ~7,500
All crossover vaccinations have completed
novavax.com 8 89% Overall Vaccine Efficacy from 7 Days After Second Dose
novavax.com 9 NVX-CoV2373 Well-Tolerated when Administered with Influenza Vaccine Participants received influenza vaccine or placebo with first dose of NVX-C0V2373 (n=431)
LOCAL SYSTEMIC Influenza HAI and seroconversion
Grade 0 Grade 1 Grade 2 Grade 3 Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 responses preserved with 100% coadministration.
80% NVX-CoV2373 efficacy trend 60% preserved when co-administered
40% with influenza vaccine: • NVX-CoV2373 efficacy: 20% 89.7% (95%CI: 80.2; 94.6)
0% • NVX-CoV2373 + flu efficacy: Plc Plc 87.5% (95%CI: -0.2; 98.4) NVX NVX Dose 1 NVX Dose 1 NVX Dose Plc + flu+ Dose 1 Plc Plc + flu Dose 1 Dose flu + Plc NVX Dose1 NVX + flu NVX + flu Dose 1 Dose flu NVX + Any Solicited Local AEs Any Solicited Systemic AEs
Vaccination 1
https://www.medrxiv.org/content/10.1101/2021.06.09.21258556v1 novavax.com 10 Influenza HAI Responses Preserved with Co-administration
Quadrivalent cell-culture influenza vaccine, age 18-64 Trivalent adjuvanted influenza vaccine, age >64
n=201 NVX-CoV2373 + influenza; n=201 placebo + influenza n=16 NVX-CoV2373 + influenza; n=13 placebo + influenza
novavax.com 11 Consistency in Efficacy Across Phase 3 Studies
Efficacy demonstrated in 2 independent Phase 3 studies • UK Phase 3 (N=15,000): Vaccine efficacy = 89.7% • US/Mexico Phase 3 (N=30,000): Vaccine efficacy = 90.4%
“Matched” strain efficacy • UK Phase 3: Prototype efficacy = 96.4% • US/Mexico Phase 3: Non-variants of Interest/Concern efficacy = 100%
Efficacy against variants • UK Phase 3: Alpha (B.1.1.7) efficacy = 86.3% • US/Mexico Phase 3: Alpha (B.1.1.7) efficacy = 93.6% • US/Mexico Phase 3: Variants of Interest/Concern efficacy = 92.6%
Efficacy against severe disease • UK Phase 3: efficacy = NS (all 5 severe cases in placebo group) • US/Mexico Phase 3: efficacy = 100%
novavax.com 12 South Africa Phase 2b Trial Design
Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety
5 µg + 50 µg Matrix-M™ adjuvant 1 injection Placebo AND (2 injections: Day 0 and Day 21) 1 injection 5 µg + 50 µg Matrix-M™ 4,400 n = ~2,200 adjuvant 21 days apart Adults R 18-65 years 1:1 Placebo (n=245 HIV+) 5 µg + 50 µg Matrix-M™ adjuvant (2 injections: Day 0 and Day 21) 2 injections 21 days apart n = ~2,200
All crossover and boost vaccinations have started
novavax.com 13 Phase 2 Study Design and Status 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
5 µg + 5 µg + 25 µg + Day 0 Placebo 25 µg + Matrix-M Matrix-M Matrix-M Matrix-M
5 µg + 25 µg + Day 21 Placebo Placebo Placebo Matrix-M Matrix-M
5ug + 5ug + Day 189 Placebo Placebo Placebo Placebo Placebo Matrix-M Matrix-M
Additional boosting planned on Day 357
novavax.com 14 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% 40% 60% 80% 100% Discontinued AEs PIMMCs Severe AEs MAAEs SAEs Discontinued PIMMCs
novavax.com 15 Local Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 2 days, except erythema (2.5 days)
novavax.com 16 Systemic Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 1 day, except muscle pain (2 days)
novavax.com 17 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- fold compared to peak EU/mL)
10 11,514 response seen after 10,000 primary vaccination 5,943 series. Spike IgG (Log IgG Spike - Anti 1,000 745
106 Placebo 100 Day Day 0 7 21 28 35 49 105 189 217
novavax.com 18 Consistent Anti-Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189
1,000,000
Anti-spike IgG titers increased ~3.9-fold in Ages 18-59 adults aged 18-59. Overall Ages 60-84 100,000 Anti-spike IgG titers increased ~5.4-fold in EU/mL)
10 adults aged 60-84. 10,000 Spike IgG (Log IgG Spike - Anti 1,000
Placebo 100 Day Day 0 7 21 28 35 49 105 189 217
novavax.com 19 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 EU/mL) 10
10,000
4,413 Spike IgG (Log IgG Spike - Anti 1,000
Placebo 100 Day Day 0 7 21 28 35 49 105 189 217
novavax.com 20 Increased Wild Type Neutralization Responses Vaccination on Day 0 & 21 and boost on Day 189
10,000 6,039
WT neutralization titers
) increased ~4.3-fold
10 1,581 compared to peak 1,000 response seen after primary vaccination series.
Neutralization titers 100 increased ~3.7-fold in 65 adults aged 18-59 & ~4.7-fold in adults 33 aged 60-84. IC<50% Wild Type Virus Neutralization (Log Neutralization Virus Type Wild IC<50%
10 10 Day Day 0 7 21 28 35 49 105 189 217
novavax.com 21 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 )
10 3.7-4.4x
100,000
10,000 Spike IgG (EU/mL, Log IgG (EU/mL, Spike - Anti
1,000 UK Ph3 Day 35 PREVENT-19 Day 35 US/AU Ph2 Day 217 IgG Responses with 95% CI novavax.com 22 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 ) 10
10,000 4.6-5.5x
1,000 Wild Type Virus Neutralization (Log 100 UK Ph3 Day 35 PREVENT-19 Day 35 US/AU Ph2 Day 217
Microneutralization Responses with 95% CI novavax.com 23 Functional hACE2 Inhibition Responses Increased for All Variants with a Single Booster Dose of NVX-CoV2373 Post-boost consistency suggests maturation of immune response
Fold 6x 6.6x 10.8x 8.1x Increase
Assays performed by Novavax Discovery novavax.com 24 NVX-CoV2373 Clinical Summary
In 2 independent Phase 3 studies, high levels of vaccine efficacy: • UK Phase 3 (N=15,000): 89.7% • US/Mexico Phase 3 (N=30,000): 90.4%
Both Phase 3 studies demonstrated strong efficacy against variants: • UK Phase 3 - Alpha (B.1.1.7): 86.3% • US/Mexico Phase 3 - Alpha (B.1.1.7): 93.6% • US/Mexico Phase 3 - All Variants of Interest/Concern: 92.6%
novavax.com 25 NVX-CoV2373 Clinical Summary
A single dose of NVX-CoV2373 at 6 months significantly increases immune responses: • Wild-type Neutralization and Anti-Spike IgG levels up 4.3 to 4.6-fold over peak primary vaccination response • Functional hACE-2 immune response detected against alpha, beta and delta: • Delta: 6.6-fold increase from peak • Beta: 10.8-fold increase from peak • Alpha: 8.8-fold increase from peak
These data support the use of our vaccine in a boosting campaign.
Immune responses were not significantly perturbed through co-administration with flu vaccine – both can be co-administered in an annual vaccination campaign.
novavax.com 26 Advance Purchase Agreement Updates
novavax.com 27 Regulatory Updates
novavax.com 28 Manufacturing Updates
novavax.com 29 2Q 2021 Financial Results
Reported revenue of $298 million related to development activities for NVX-CoV2373
Received $1.1 billion of upfront payments associated with APAs
Ended quarter with strong cash position of $2.1 billion
novavax.com 30 Overview of Strategic Priorities
novavax.com 31 novavax.com 32