Novavax, Inc. · NASDAQ:NVAX
Novavax — Q2 2017 Earnings Presentation
29 slides from Novavax's earnings presentation, Aug 8, 2017
Slide 1: Introduction
` Introduction Stanley C. Erck August 8, 2017 President & CEO
Slide 2: Safe harbor statement
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 Priva
Slide 3: Agenda
Agenda Introduction Stanley C. Erck, President and CEO Novavax Financial Update Buck Phillips, Senior Vice President, CFO and Treasurer Novavax Nanoparticle Influenza Vaccine James F. Cummings, M.D., Vice President, (NanoFlu) Clinical Development Summary and Q&A Stanley C. Erck, President and CEO 3
Slide 4: Financial Update
` Financial Update Buck Phillips Chief Financial Officer, Treasurer 4
Slide 5: Influenza Introduction
Influenza Introduction ` Stanley C. Erck President and CEO 5
Slide 6: July 24th RSV Update Webcast: Findings
July 24th RSV Update Webcast: Findings Phase 3 Prepare™ Trial – Accelerating, 80 sites across 11 countries Vaccine Construct - Our prefusogenic RSV F antigen works Adjuvant Formulation and Regimen - We know how to make it even better Phase 2 and Phase 3 Efficacy Results - We identified a significant
Slide 7: Today's focus will be on Novavax' Nanoparticle Influenza Vaccine candidate (NanoFlu)
Today’s focus will be on Novavax’ Nanoparticle Influenza Vaccine candidate (NanoFlu) Novavax is a leader in nanoparticle vaccine development • Flu is a large global market with significant future growth potential representing a multi billion dollar opportunity for a new vaccine that demonstrates sup
Slide 8: Influenza and RSV are the leading causes of respiratory tract infection
Influenza and RSV are the leading causes of respiratory tract infection and impact all individuals with a high burden in major markets Burden of Disease for RSV, Influenza, and Pneumococcus in US Adults 65 and Older RSV Influenza Pneumococcus Deaths Hospitalizations # of infections RSV Influenza* Pn
Slide 9: A significant percentage of older adults get vaccinated for influenza
A significant percentage of older adults get vaccinated for influenza • Current influenza immunization rates in North America: Vaccination rate Year USA (U.S. CDC) 66.7% 2014/15 Canada (Statistics Canada)1 64.1% 2014 Total (pop. wt. avg.) 66.4% • CDC aims to have at least 100 Effectiveness of Licens
Slide 10: Influenza vaccine market competitive landscape
Influenza vaccine market competitive landscape • Approximately $3.1B in 2015 in the 7 major markets1,2 • Growing to $4.3B by 20252 • Strong growth since 2005/2006 • 2010 ACIP recommendation for universal vaccination in U.S. • US remains the largest market with ~59% of major market sales2 • EU5 marke
Slide 11: Why do we need new and better influenza vaccines
Why do we need new and better influenza vaccines 11
Slide 12: NanoFlu Target Product Profile
NanoFlu Target Product Profile Point of Market Entry Older Adults (65 years and older) HAI and Microneutralization titers better than Immunogenicity Profile or equal to the best-selling vaccine in older adults (Fluzone® High Dose) Broadly Neutralizing Better protection against drifted strains Capabi
Slide 13: Influenza Nanoparticle Vaccine
Influenza Nanoparticle ` Vaccine James F. Cummings, M.D. Vice President, Clinical Development 13
Slide 14: Influenza Virus - Primary Vaccine Target: Hemagglutinin
Influenza Virus - Primary Vaccine Target: Hemagglutinin HA Protein Structure Hemagglutinin (HA) Neuraminidase (NA) 14
Slide 15: Influenza Virus - Primary Vaccine Target: Hemagglutinin
Influenza Virus - Primary Vaccine Target: Hemagglutinin • Receptor binding region is the target for HA Protein Structure antibodies that prevent virus binding to cells. These antibodies are highly strain- specific and dominate the immune response. • Antibodies to receptor binding site can be detecte
Slide 16: Novavax NanoFlu Vaccine - Strain specific recombinant Hemagglutinin Nanoparticles
Novavax NanoFlu Vaccine - Strain specific recombinant Hemagglutinin Nanoparticles PS80 PS80 10nm Influenza A/Hong Kong/4801/2014 (H3N2) Hemagglutinin: Stable Multiple HA Trimer – PS80 Detergent Nanoparticles 16
Slide 17: NanoFlu Vaccine Preclinical Goals
NanoFlu Vaccine Preclinical Goals • Evaluate seasonal HA-based nanoparticle influenza vaccine (NanoFlu Vaccine), adjuvanted with Matrix-M, in ferret model to assess vaccine immunogenicity and protective efficacy • Compare immunogenicity of adjuvanted NanoFlu Vaccine with two leading commercial 2016-
Slide 18: Preclinical Study Design - Ferret Immunogenicity & Challenge Study
Preclinical Study Design - Ferret Immunogenicity & Challenge Study Virus Challenge Group Immunization Blood Draw Influenza A/H3N2 Placebo NanoFlu 15µg/HA + 50µg Matrix Days 21 and Day 49 Days 0 and 21 Fluzone® HD 42 60µg/HA Fluzone® 15µg/HA A H3N2: current strain, matched to vaccine Challenge Virus
Slide 19: Ferret Immunogenicity & Challenge Study
Ferret Immunogenicity & Challenge Study Novavax Fluzone HD Fluzone Quadrivalent NanoFlu A/Michigan (H1N1) A/California (H1N1) A/HongKong (H3N2) B/Brisbane B/Phuket 19
Slide 20: Immunogenicity: NanoFlu Induced Superior HAI Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Hemagglutination Inhibition (HAI) Day 42 Antibody Responses A/Michigan (H1N1) A /M ic h ig a n /4 5 /2 0 1 5 A/California (H1N1) A /C a lifo r n ia /0 7 /2 0 0 9 512 2048 1024 256 512 128 256 H A I T ite r H A I T ite r 64 128 32 64 32 16 16 8 LO D 8 LO D 4 4
Slide 21: Immunogenicity: NanoFlu Induced Superior HAI Titers - A/Michigan and A/California (H1N1)
Immunogenicity: NanoFlu Induced Superior HAI Titers - A/Michigan and A/California (H1N1) Day 42 A/Michigan HAI Titers Day 42 A/California HAI Titers (matched ) (unmatched ) NanoFlu NanoFlu + NanoFlu++ Matrix Matrix M MatrixMM Day 42 Michigan HAI Titers Day 42 California HAI Titers NanoFlu Fluzone Na
Slide 22: Immunogenicity: NanoFlu Induced Superior Microneutralizing Day 42 Antibody Responses
Immunogenicity: NanoFlu Induced Superior Microneutralizing (MN) Day 42 Antibody Responses A/Michigan (H1N1) A/California (H1N1) 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu + Matrix M Matrix M A/Hong Kong (H3N2) B/Brisbane 50% MN Titers (Log2) 50% MN Titers (Log2) NanoFlu + NanoFlu +
Slide 23: NanoFlu Induced Broadly Neutralizing Antibodies against Drifted A(H3N2) Viruses
Immunogenicity: NanoFlu Vaccine Induced Broadly Neutralizing Antibodies against Drifted A(H3N2) Influenza Viruses 4096 NNanoFlu IV + M + a Matrix tr ix M M FFluzone l u z o n eHD H D M N T ite r s (L o g 2 ) 1024 Fluzone F lu z o n e Q IV 256 64 16 50% 4 5 4 1 7 3 9 4 /0 2 /0 9 2 /1 /0 /1 /9 /1 /0 /
Slide 24: NanoFlu Superior in Protecting Ferrets Challenged with Matched and Drifted H3N2
NanoFlu Vaccine was Superior in Protecting Ferrets Challenged with Matched and 10-year Drifted H3N2 (unmatched) Strain A/Hong Kong/4801/2014 (H3N2)–like A /H o n g K o n g /4 8 0 1 /2 0 1 4 (H 3 N 2 )-lik e A/Brisbane/10/2007 (H3N2)-like A /B r is b a n e /1 0 /2 0 0 7 ( H 3 N 2 ) -lik e A/Alaska/14
Slide 25: Novavax Nanoparticle Influenza Vaccine (NanoFlu) Summary
Novavax Nanoparticle Influenza Vaccine (NanoFlu) Summary: • Nanoparticle influenza vaccine (NanoFlu) vaccine: high yields, purity, potency, and stability • Ferret model • NanoFlu induced HAI and MN antibodies and protection superior to Fluzone HD • NanoFlu provided superior protection against both m
Slide 26: Summary
` Summary Stanley C. Erck President and CEO 26
Slide 27: NanoFlu Licensing Strategy
NanoFlu Licensing Strategy • Phase 1/2 clinical trial • FSI September 2017 • Compare HAI and MN responses of NanoFlu to Fluzone HD, and ability to induce broadly neutralizing antibodies to both matched and drifted (unmatched) strains • Immunogenicity data in 4Q 2017, leading to… • End of Phase 2 mee
Slide 28: Milestone Timeline
Milestone Timeline 2017 2018 Q3 Q4 Q1 Q2 Q3 Q4 RSV F Vaccine Infants via Maternal Phase 3 Global enrollment ongoing Immunization Phase 2 Data Phase 2 RSV F Vaccine Positive Older Adults immunogenicity Efficacy & safety readout Older Adults Nanoparticle IND Phase 1/2 FDA Pivotal Immunogenicity Initia
Slide 29: Wrap up
Wrap up 29