Novavax, Inc. · NASDAQ:NVAX
Novavax — J.P. Morgan Healthcare Conference January 2018
30 slides from Novavax's conference presentation, Jan 8, 2018
Slide 1: J.P. Morgan Healthcare Conference January 2018
` J.P. Morgan Healthcare Conference January 2018
Slide 2: Safe harbor statement
2 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 Litig
Slide 3: Novavax Priority Targets: RSV for IVM; Flu for OA
3 RSV Vaccine for Infants Via Maternal Immunization (IVM) x RSV remains a major unmet medical need for newborns in their first 6 months of life x Novavax has the only RSV vaccine in Phase 3 clinical trial x Informational analysis of Phase 3 successful; indicates vaccine is efficacious x Interim effi
Slide 4: Status of Phase 3 RSV IVM Clinical Trial
Status of Phase 3 RSV IVM Clinical Trial 4
Slide 5: Primary Endpoints for Phase 3 Clinical Trial
5 • Clinical trial utilizes a group sequential design • Primary endpoint: medically - significant RSV lower respiratory tract infection (LRTI) • Presence of RSV detected by RT - PCR during a continuous illness episode, AND • At least one manifestation of LRTI (cough, nasal flaring, lower chest wall
Slide 6: Phase 3 IVM Clinical Trial Is Ongoing Worldwide
6 • Currently completing enrollment in Global Year 3 and beginning enrollment in Global Year 4 • ~ 80 sites in 11 countries • United States, United Kingdom, Spain, South Africa, Australia, New Zealand, Argentina, Mexico, India, Philippines, Bangladesh Phase 3 IVM Clinical Trial Is Ongoing Worldwide
Slide 7: Review of Phase 3 Informational Analysis
Review of Phase 3 Informational Analysis 7
Slide 8: Rationale for Informational Analysis
8 • Novavax performed an informational analysis in Q4 2017 • In a multi - year Phase 3 trial, Novavax wanted to ensure that the ongoing investment in the program was justified based on a high probability of a commercially - viable determination of efficacy • Targeted an efficacy threshold against th
Slide 9: Informational Analysis
9 • December 2017: Data Safety Monitoring Board statistician performed this unblinded analysis and communicated that RSV F Vaccine successfully met this criteria • Received yes/no answer, Novavax remains blinded Informational Analysis
Slide 10: Phase 3 Outcome De-risked by Successful Informational Analysis
Phase 3 Outcome De - risked by Successful Informational Analysis 100% 0% Vaccine Efficacy (VE) Against Primary Endpoint Informational Analysis Result 1,307 Enrollees A ssumes 2:1 randomization Data from the informational analysis indicate an observed vaccine efficacy in the range of 42 - 100% 40 %
Slide 11: Next Steps after Informational Analysis
11 Based on the positive informational analysis, we are focusing on: • Continuing enhanced enrollment efforts to drive to interim analysis • Designing clinical lot consistency trial • Completing preparation for PPQ campaigns • Extending two - year drug product stability in vials; one - year in PFS •
Slide 12: Plan for Upcoming Interim Analysis
Plan for Upcoming Interim Analysis 12
Slide 13: Overview of Interim Analysis
13 ~4,600 mothers treated by 2Q 2018 • Exact number dependent on actual randomization • 2:1 randomization • FDA requires ≥ 3,000 active vaccinees for safety and efficacy 3,000+ active infants born Interim analysis completed by 4Q 2018/1Q 2019 • Conducted by DSMB; NVAX remains blinded BLA filing by 4
Slide 14: Commercial Opportunity for Maternal RSV Vaccine
Commercial Opportunity for Maternal RSV Vaccine 14
Slide 15: RSV incidence in key markets in newborns
4 6 8 0 2 1 3 5 7 9 Taiwan Total 0.5 0.6 RSV incidence in 9 key markets in newborns from birth to 6 months of age (2014) Millions of addressable patients U.S. UK 0.4 0.5 0.7 Germany France Italy 1.0 Spain Japan South Korea 3.7 0.8 0.2 8.4 RSV has a large addressable population, with ~8.4M incident n
Slide 16: Annual direct burden of infant RSV exceeds ~$1.8B
The annual direct burden of infant RSV exceeds ~$1.8B in select geographies, driven largely by hospitalization and inpatient costs for acute care 0 1 2 3 4 5 6 Total Infant RSV disease burden by country (2014) Billions of USD SK TW U.S. JP 2.7 2.1 0.5 0.2 0.0 5.6 Direct burden Indirect burden ● The
Slide 17: Global peak revenues > $1.5B
17 • U.S. market > $750M in peak revenues • ROW market approximates U.S. market • Global peak revenues > $1.5B Global Peak Revenues > $ 1.5B US Market Model 3.9M births in U.S. annually 95% infants born after mother treated (28 – 36 wks g.a .) 80 - 90% immunization rate after ACIP recommendation > $
Slide 18: Maternal Immunization: Building on a Proven Strategy
Maternal Immunization: Building on a Proven Strategy 18 Building on Proven Strategy • Growing acceptance of maternal vaccination for flu and pertussis among HCPs and mothers • American College of Obstetrics and Gynecology conducts CME - accredited webinar: “Respiratory Syncytial Virus: The Need for
Slide 19: Summary
Summary 19
Slide 20: Summary
20 • Informational analysis indicates RSV F Vaccine is efficacious • First positive Phase 3 efficacy indication for an RSV vaccine • Phase 3 enrollment to yield pivotal efficacy data by 4Q 2018/1Q 2019 • Expected to be first licensed RSV vaccine • Global peak revenue estimated to be >$ 1.5B Summary
Slide 21: Nanoparticle Influenza Vaccine with Matrix-M (NanoFlu)
Nanoparticle Influenza V accine with Matrix - M™ (NanoFlu) 21
Slide 22: Nanoparticle Influenza Vaccine (NanoFlu)
22 Influenza (Flu ) market snapshot x Efficacy of seasonal flu vaccines is inconsistent and usually less than 50% x Older adults vaccine efficacy is lower than healthy younger adults x Sanofi HD, based on published data, has not sufficiently improved the outcomes x Annual flu vaccination is universa
Slide 23: A significant percentage of older adults are vaccinated for influenza
23 A significant p ercentage of older a dults are vaccinated for influenza Source: CDC, L.E.K . and Company research and analysis • Current older adult influenza immunization rates in U.S. and Canada: • CDC aims to have at least 90% of adults aged 65 or older receive an annual flu shot by 2020 -20 0
Slide 24: The need for new and better influenza vaccines
The need for new and better influenza vaccines
Slide 25: Growing awareness about shortcomings of egg-based flu vaccines
25 • A November 29, 2017 editorial in the New England Journal of Medicine detailed public health concerns related to the poor efficacy of existing seasonal influenza vaccines that is due, in part, to changes or drift in genes that encode the HA protein, leading to low vaccine efficacy • Based on pro
Slide 26: Flu program data published in Vaccine
26 Flu program d ata p ublished in Vaccine Full publication is available on Novavax website and at : http://www.sciencedirect.com/science/article/pii/S0264410X17310885
Slide 27: Immunogenicity: NanoFlu induced broadly neutralizing antibodies
27 4 16 64 256 1024 4096 5 0 % M N T i t e r s ( L o g 2 ) NIV + Matrix M Fluzone HD Fluzone QIV A / H o n g K o n g / 4 8 0 1 / 1 4 A / S w i t z e r l a n d / 9 7 5 1 5 2 9 3 / 1 3 A / T e x a s / 5 0 / 1 2 A / V i c t o r i a / 3 6 1 / 1 1 A / P e r t h / 1 6 / 0 9 A / B r i s b a n e / 1 0 / 0 7
Slide 28: Phase 1/2 trial of NanoFlu Vaccine initiated in Older Adults
• Primary objective: assess safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to licensed vaccine ( Fluzone ® High - Dose) • 330 healthy older adults; 110 per group • Evaluate immune response by microneutralization assays • Contrast immune response to egg based ver
Slide 29: Novavax Priority Targets: RSV for IVM; Flu for OA
29 RSV Vaccine for Infants Via Maternal Immunization (IVM) x RSV remains a major unmet medical need for newborns in their first 6 months of life x Novavax has the only RSV vaccine in Phase 3 clinical trial x Informational analysis of Phase 3 successful; indicates vaccine is efficacious x Interim eff
Slide 30: Discussion
Discussion NOVAVAX | errr nciney
Novavax — J.P. Morgan Healthcare Conference January 2018 on 6ix