Novavax, Inc. · NASDAQ:NVAX
Novavax — 15th Annual Needham Healthcare Conference (2016)
32 slides from Novavax's conference presentation, Apr 29, 2016
Slide 1: 15th Annual Needham Healthcare Conference
15th Annual Needham Healthcare Conference
Slide 2: Safe harbor statement
Safe harbor statement Certain information contained herein, particularly information relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical development, product sales, operating expenses, our
Slide 3: Novavax discovers, develops and commercializes groundbreaking nanoparticle vaccines
Novavax discovers, develops and commercializes groundbreaking nanoparticle vaccines Proprietary vaccine technology platform for efficient production of a new class of highly immunogenic nanoparticles addressing urgent unmet, medical needs Robust pipeline targeting large market opportunities and
Slide 4: Robust pipeline with late stage products target large commercial opportunities
Robust pipeline with late stage products target large commercial opportunities Preclinical Phase 1 Phase 2 Phase 3 RSV Older Adults (60+) Infants (Maternal Immunization) Pediatrics (6 mos – 5 yrs) Influenza Quadrivalent Seasonal Pandemic (H7N9 + Matrix-MTM) New Product Opportunities Ebola + Matrix-M
Slide 5: Novavax nanoparticle vaccines represent a new paradigm
Novavax nanoparticle vaccines represent a new paradigm Nanoparticle vaccine efficacy proven in clinical trials Nanoparticle RSV F Vaccine efficacious in older adults technology platform Groundbreaking proof-of-principle and Fast Track targets antigens with designation in RSV maternal immunizat
Slide 6: Novavax Corporate Strategy
Novavax Corporate Strategy Leverage proprietary nanoparticle vaccine technology to build a global infectious disease Focus near term company development on commercialization of Target development on large market RSV F Vaccine for opportunities Older Adults Collaborate on emerging infectious di
Slide 7: RSV incidence and burden in major markets
RSV incidence and burden in major markets Infections/Year: ~37 M Total Cost Burden: ~$88 B US EU5 ASIA (UK, Italy, France, Spain, Germany) (Japan, South Korea, Taiwan) ~15 M ~14 M ~8 M Infections/Year Infections/ Year Infections/Year ~$5 B ~$3 B ~$1.4 B Direct Cost Burden Direct Cost Burden Direct C
Slide 8: Unmet need is acute in our 3 target populations
While RSV is a lower respiratory tract infection that impacts all individuals, unmet need is acute in our 3 target populations Novavax RSV Older Adult & Maternal vaccines have first-to-market potential Older Adults Infants via Maternal Pediatrics All adults 60 years of age Immunization Children and
Slide 9: RSV F Vaccine: Older Adults
RSV F Vaccine Older Adults 9
Slide 10: RSV burden of disease is comparable to influenza and pneumococcus
RSV burden of disease is comparable to influenza and pneumococcus Burden of Disease for RSV, Influenza, and Pneumococcus in US Adults 65 and Older RSV Influenza Pneumococcus Deaths Hospitalizations # of infections RSV Influenza* Pneumococcus # of Infections 2,540,000 2,883,052 1,286,556 Hospitalizat
Slide 11: 2015 UK study concludes burden of RSV may be higher than influenza
2015 UK study concludes burden of RSV may be higher than influenza Conclusions from UK based study: Burden of RSV in primary care higher than that of influenza Hospitalizations and deaths attributable to RSV approach or exceed those from influenza Little variation in the burden from season to
Slide 12: Novavax novel RSV F Vaccine demonstrates breakthrough efficacy
Novavax novel RSV F Vaccine demonstrates breakthrough efficacy RSV F-Protein Site I Clinical Trial Achievements First to demonstrate efficacy in any population Site IV Breakthrough efficacy in older adults Breakthrough proof-of-principle in maternal immunization Well-tolerated in seven clini
Slide 13: Older Adults: P2 Study Objectives
RSV F Vaccine Older Adults: P2 Study Objectives One of the largest prospective epidemiologic RSV trials conducted in older adults Primary Secondary Exploratory • Epidemiology trial • Evaluate amplitude of • Estimate efficacy of PCA and vaccine on all • Describe the incidence microneutralizing sympto
Slide 14: P2 Older Adults: Durable 4.8-fold increase in anti-F antibody response
P2 RSV F Vaccine Older Adults: Durable 4.8-fold1 increase in anti-F antibody response Seroresponse in >93% of subjects2 6000 135 ug RSV F Vaccine 5000 Anti-F IgG GMEU1 (95% CI) 4000 3000 2000 Placebo 1000 0 0 10 20 30 40 50 60 Days 1 geometric mean rise relative to Day 0 2% of group with EU >95th pe
Slide 15: P2 Older Adults: Durable 5.2-fold increase in PCA response
P2 RSV F Vaccine Older Adults: Durable 5.2-fold1 increase in PCA response Seroresponse in >96% of subjects2 120 100 135 ug RSV F Vaccine PCA GMC 1 (µg/mL) 80 60 40 Placebo 20 0 0 10 20 30 40 50 60 Days 1 geometric mean rise relative to Day 0 2 % of group with EU >95th percentile of the placebo group
Slide 16: P2 Older Adults: Early and durable protection from RSV infection
P2 RSV F Vaccine Older Adults: Early and durable protection from RSV infection RT-PCR confirmed RSV Events Product-Limit Survival Estimate Log-Rank test or equality over strata; p=0.039 1.00 Proportion of Group With No RSV Infection 0.98 135 ug RSV F Vaccine 0.96 Placebo 0.94 0.92 p=0.039 October 31
Slide 17: P2 Older Adults: Efficacy analogous to Prevnar
P2 RSV F Vaccine Older Adults: Efficacy analogous to Prevnar 13 RSV F Vaccine Number of Symptoms # Vaccine vs Placebo Vaccine and Signs Reported* Subjects (N = 1,600) P-value Efficacy Any symptomatic RSV 23 vs 39 41% 0.041 At least 3 LRTI signs and symptoms 5 vs 14 64% 0.047 (ad hoc) At least 4 LRTI
Slide 18: Older Adults: P3 Trial Resolve enrolled 4Q15 ahead of RSV season
RSV F Vaccine Older Adults: P3 Trial Resolve™ enrolled 4Q15 ahead of RSV season Significant near-term commercial opportunity Timeline Primary Trial Objective Trial Design • P3 initiated Nov 2015 • Prevention of • Older adults, ages < 30 days after end-of- moderate-severe RSV- 60+ P2 FDA meetings ass
Slide 19: Older Adults: Pathway to licensure
RSV F Vaccine Older Adults: Pathway to licensure August 2015: FDA End of Nov 2015: Dec 2015: Phase 3 File BLA FDA Launch Positive Phase 2 Initiated Completed Data in Approval Phase 2 Data Meeting Phase 3 Trial Enrollment Older and in Older in Older Adults Licensure Adults Adults Q3 2015 Q4 2015 Q3 2
Slide 20: RSV F Vaccine: Infants via Maternal Immunization
RSV F Vaccine Infants via Maternal Immunization 20
Slide 21: Protection of Young Infants via Maternal Immunization
Protection of Young Infants via Maternal Immunization Protection via transplacental transport of mother’s antibodies into baby’s blood is effective against flu, whooping cough: At full term, baby has >100% of mother’s antibody levels CDC recommends Tdap vaccine in 3rd trimester of every pregna
Slide 22: P2 Maternal Immunization: Study Objectives
P2 Maternal Immunization: Study Objectives Primary Secondary Trial Objective • Mothers: Describe safety of the • Mothers: Evaluate amplitude and RSV F vaccine through delivery and duration of anti-F IgG, PCA and RSV 6 months post-delivery A/B microneutralizing antibody • Infants: Describe safety thr
Slide 23: P2 Infants: Placental Antibody Transfer
P2 Infants: Placental Antibody Transfer Delivered <30 days Delivered >30 days Antibody Source post vaccination post vaccination All (N = 21*) (N = 7*) (N = 14*) Cord 7,227 8,659 8,153 Anti-F IgG Mothers 12,979 6,993 8,594 Ratio 0.6 1.2 0.9 Cord 177 195 189 PCA Mothers 303 178 213 Ratio 0.6 1.1 0.9 C
Slide 24: Maternal vaccine induces competitive antibodies to broadly neutralizing epitopes
Maternal RSV F Vaccine induces competitive antibodies to broadly neutralizing epitopes I, II, and IV 1024 mAb 1112 (Site I) mAb 1269 (Site I) PCA (Site II) mAb 1243 (Site IV) 512 RSV mAb competitive ELISA titer (50% inhibition) 256 128 64 32 16 8 4 Mother Cord Mother Cord Mother Cord Mother Cord Mot
Slide 25: P2 Maternal Immunization: Summary
P2 Maternal Immunization: Summary Vaccine was well-tolerated Response to RSV F Vaccine in pregnant women replicated immune response in non-pregnant women Robust anti-F, PCA and neutralizing antibody transfer observed with 110-120% of mothers antibody levels in infants Maternal antibody peaks
Slide 26: Infants via Maternal Immunization: Global P3 Trial Prepare launched 4Q15
RSV F Vaccine Infants via Maternal Immunization: Global P3 Trial Prepare™ launched 4Q 15 RSV is most common cause of infant hospitalizations in the U.S. Timeline Trial Objectives Trial Design • P3 initiated Dec 2015 • Primary: Prevention of • Pregnant women in 3rd < 30 days after lower respiratory t
Slide 27: Four key findings support Novavax' RSV F Vaccine program
Four key findings support Novavax’ RSV F Vaccine program Finding 1: Protection from RSV challenge in animal models Cotton Rats Baboons Finding 2: Vaccine reduces serologic evidence of RSV infection in two studies of women of childbearing age ~50% reduction in infection rate Finding 3: Vaccine
Slide 28: Robust pipeline with late stage products target large commercial opportunities
Robust pipeline with late stage products target large commercial opportunities Phase 1 Phase 2 Phase 3 NIH, MedImmune P Live-attenuated Multiple candidates Particle-based Novavax RSV F P Novavax OA Vaccine RSV F Vaccine Novavax M RSV F Vaccine GSK M GSK Subunit RSV F + adjuvant RSV F Protein M Immun
Slide 29: Influenza Clinical Update
Influenza Clinical Update 29
Slide 30: Influenza clinical program demonstrating enhanced efficacy in multiple applications
Influenza clinical program demonstrating enhanced efficacy in multiple applications Seasonal Influenza Pandemic Influenza Combination Program / Product Quadrivalent Pandemic (H7N9 + Respiratory (RSV + Flu) Seasonal Matrix-MTM) Development Phase 2 Phase 2 Preclinical Stage Study P2 Positive P2 Positi
Slide 31: 2016 Calendar
2016 Calendar 2016 Phase 3 pivotal RSV F Vaccine in Older Adults • Data, 3rd quarter Phase 2 RSV F Vaccine Rollover Trial in Older Adults • Data, 2nd half Combination Respiratory in Healthy Adults • Trial initiation, 1st half 2017 31
Slide 32: Investment summary
Investment summary Only RSV vaccine to demonstrate protection in any population • Two P3 candidates with significant market opportunities • De-risked P3 lead candidate with 3Q16 clinical data readout that addresses older adult market representing $28 billion cost burden • Groundbreaking proof-of-pri
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