Novavax, Inc. · NASDAQ:NVAX
Novavax — Q2 2021 Earnings Presentation
32 slides from Novavax's earnings presentation, Aug 5, 2021
Slide 1: Second Quarter 2021 Financial Results and Operational Highlights
Second Quarter 2021 Financial Results and Operational Highlights Nasdaq: NVAX | August 5th, 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: Significant Progress in 2Q 2021
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
Slide 4: NVX-CoV2373 Clinical Development Program
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 pr
Slide 5: PREVENT-19 Phase 3 Trial Design
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 Mat
Slide 6: 90% Overall Vaccine Efficacy from 7 Days After Second Dose
90% Overall Vaccine Efficacy from 7 Days After Second Dose novavax.com 6
Slide 7: Disease Severity by Sequence-Confirmed Variants
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
Slide 8: UK Phase 3 Trial Design
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 25% > age 65 Placebo 5 µg + 50 µg
Slide 9: 89% Overall Vaccine Efficacy from 7 Days After Second Dose
89% Overall Vaccine Efficacy from 7 Days After Second Dose novavax.com 9
Slide 10: NVX-CoV2373 Well-Tolerated when Administered with Influenza Vaccine
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 wi
Slide 11: Influenza HAI Responses Preserved with Co-administration
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
Slide 12: Consistency in Efficacy Across Phase 3 Studies
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
Slide 13: South Africa Phase 2b Trial Design
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 adjuvant 21 days apart n = ~2,200
Slide 14: Phase 2 Study Design and Status
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 Day 0 5 µg + 5 µg + 25 µg + 2
Slide 15: Adverse Event Rates Comparable with Low Rates of Severe and Serious Adverse 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 16: 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 16
Slide 17: 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 17
Slide 18: 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 19: 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 20: 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 20
Slide 21: 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 22: Boosted Anti-spike IgG Responses Greater Than Observed in Phase 3 Studies
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 23: Boosted Microneutralization Responses Greater Than Observed in Phase 3 Studies
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 24: Functional hACE2 Inhibition Responses Increased for All Variants
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
Slide 25: NVX-CoV2373 Clinical Summary
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 (
Slide 26: NVX-CoV2373 Clinical Summary
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: •
Slide 27: Advance Purchase Agreement Updates
Advance Purchase Agreement Updates novavax.com 27
Slide 28: Regulatory Updates
Regulatory Updates novavax.com 28
Slide 29: Manufacturing Updates
Manufacturing Updates novavax.com 29
Slide 30: 2Q 2021 Financial Results
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
Slide 31: Overview of Strategic Priorities
Overview of Strategic Priorities novavax.com 31
Slide 32: novavax.com
NOVAVAX Creating Tomorrow's Vaccines Today NOVAVAX novavax.com ‘Creating Tomorrow’ Vaccines Today