Novavax, Inc. · NASDAQ:NVAX
Novavax — Q1 2024 Earnings Presentation
33 slides from Novavax's earnings presentation, May 10, 2024
Slide 1: First quarter 2024 financial results & operational highlights
First quarter 2024 financial results & operational highlights Nasdaq: NVAX | May 10th, 2024 © 2024 NOVAVAX. All rights reserved. 1
Slide 2: Cautionary note regarding forward-looking statements
Cautionary note regarding forward-looking statements This presentation includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “pro
Slide 3: Q1 2024 Earnings call Agenda
Q1 2024 Earnings call Agenda Erika Schultz Welcome Senior Director, Investor Relations Introduction & John C. Jacobs Sanofi Agreement President and Chief Executive Officer John Trizzino Commercial Updates President and Chief Operating Officer Filip Dubovsky, MD Research and Development President, Re
Slide 4: Novavax and Sanofi collaboration and licensing agreement summary
Novavax and Sanofi collaboration and licensing agreement summary This agreement is a further validation of our technology platform and provides significant opportunity to drive value creation and benefit global public health A multi-billion dollar potential across upfronts, equity investment, milest
Slide 5: Novavax and Sanofi collaboration and licensing agreement summary (2)
Novavax and Sanofi collaboration and licensing agreement summary (2) Summary of financial terms Eligible for payments of up to ~$1.3 billion via upfront, equity investment and COVID-19 related milestones plus royalties Q2 Upfront payment $500M Equity Investment ~$70M Equity investment of ~$70M Payme
Slide 6: Novavax and Sanofi collaboration and licensing agreement summary (3)
Novavax and Sanofi collaboration and licensing agreement summary (3) Summary of financial terms Eligible for payments for new vaccine candidate plus royalties New vaccines Candidate selection & clinical milestones (*) $10M New vaccines with Matrix-MTH: Eligible Matrix-MTM Launch & sales milestones $
Slide 7: 2024 Near-term priorities
2024 Near-term priorities Priority #1 Priority #2 Priority #3 Priority #4 Prioritize the Continue to expand Prepare to initiate an Deliver an updated successful transition and diversify organic additional cost product for the 2024- tojdsfm our new opportunities, and reduction program 2025 vaccinatio
Slide 8: Commercial Updates
Commercial SECTION Updates © 2024 NOVAVAX. All rights reserved. 8
Slide 9: Setting the stage for a stronger U.S. commercial performance in 2024+
Setting the stage for a stronger U.S. commercial performance in 2024+ 2024-2025 Vaccination Season Goals Product Presentation Single-dose pre-filled syringe Timing of Product at Distribution Targeting August 2024 Centers Ready to be Shipped National and Regional Retail Market Access Large IDNs and H
Slide 10: COVID-19 commercial execution in rest of world in 2024+
COVID-19 commercial execution in rest of world in 2024+ Europe Australia, New Zealand and Canada • Entering commercial market for first-time • Preparing for National Immunization Program and retail model in Australia and New Zealand • Delivering unit-dose presentation • Secured NACI recommendation i
Slide 11: Research and Development
Research and SECTION Development © 2024 NOVAVAX. All rights reserved. 11
Slide 12: Research and development overview
Research and development overview 2024-2025 • WHO and EMA concur on use of JN.1 for 2024-2025 season Strain • Novavax JN.1 vaccine candidate induces broad neutralizing response in non-human primates Change • Commercial manufacture in pre-filled syringes and unit dose vials is ongoing CIC & • Phase 3
Slide 13: 2024-2025 Strain Change
• WHO and EMA concur on use of JN.1 for 2024- 2024-2025 Strain 2025 season Change • Novavax JN.1 vaccine candidate induces broad neutralizing response in non-human primates • Commercial manufacture in pre-filled syringe and unit dose vials is ongoing © 2024 NOVAVAX. All rights reserved. 13
Slide 14: JN.1 vaccine induces robust neutralizing response in XBB.1.5 vaccinated macaques
JN.1 vaccine induces robust neutralizing response against JN.1 and JN.1 subvariants in XBB.1.5 vaccinated Macaques Commercial manufacture of JN.1 vaccine in pre-filled syringe is ongoing All Macaques vaccinated with XBB.1.5 on day 1,21 and 211 and boosted with JB.1 on day 246 All vaccines contain 5u
Slide 15: COVID-Influenza Combination and Stand-Alone Seasonal Influenza Program
COVID-Influenza- • Phase 3a study modified to evaluate both CIC Combination and and stand-alone seasonal influenza vaccines Stand-Alone • Phase 3a and both lot-to-lot manufacturing consistency studies on track for 4Q 2024 Seasonal Influenza • Data for decision-making/partnering available Program 2Q2
Slide 16: Influenza-Combination (CIC) and Stand-Alone-Influenza (tNIV) in ≥ 60 yo
Clinical program has been modified to seek licensure for both COVID- Influenza-Combination (CIC) and Stand-Alone-Influenza (tNIV) in ≥ 60 yo Designed to achieve accelerated approval endpoints for both products with no change to timelines Phase 3a Study Design Phase 3a on track for 2H2024 • Immunolog
Slide 17: Pre-clinical RSV Vaccine Candidate
Pre-clinical RSV • Novavax RSV vaccine induces high levels of antibody against site 0, II, IV, V and P27 neutralizing Vaccine epitopes Candidate • Nanoparticle RSV vaccine robust RSVA and RSVAB neutralizing responses © 2024 NOVAVAX. All rights reserved. 17
Slide 18: Competitive binning of neutralizing mAbs on Novavax and GSK RSVPreF antigen
Competitive binning of neutralizing mAbs on Novavax and GSK RSVPreF antigen NVX RSVF + Matrix induces high levels of antibodies against a broad array of neutralizing epitopes Competitive Binning on Novavax RSVF Antigen Competitive Binning on GSK RSVPreF Antigen NVX RSVF + Matrix GSK RSVPreF + AS01E
Slide 19: RSV A and RSV B neutralization in mice
RSV A and RSV B neutralization in mice NVX RSVF + Matrix induces robust RSV A and RSV B neutralization responses RSVA Neutralization RSVB Neutralization Day 39 Day 39 2 18 >6-fold✱ difference 2 16 2 16 2 14 ✱ >3-fold difference RSVA Neutralization Titer RSVA Neutralization Titer (EC50, GMT, 95%CI) 2
Slide 20: Mucosal Vaccination
Mucosal • Intranasal formulations have been developed that consist of nanoparticle antigens and Matrix-M Vaccination adjuvant • In mice these vaccines induce high levels of mucosal IgA and boost the serum neutralizing response © 2024 NOVAVAX. All rights reserved. 20
Slide 21: Mucosal IgA response in bronchoalveolar lavage fluid following XBB.1.5 boost
Mucosal IgA response in bronchoalveolar lavage fluid following XBB.1.5 boost Mucosal IgA responses increased following Intranasal boost BAL- Anti-XBB.1.5 IgA Responses 4 Primary : Anti-rS IgA (OD@1:2 Dilution) Bivalent BA.5 3 (Median) 2 1 0 D21 Novavax (IM) Novavax (IN) Boost : XBB.1.5 rS+ Matrix-M
Slide 22: Serum and BAL XBB.1.5 neutralization response following XBB.1.5 boost
Serum and BAL XBB.1.5 neutralization response following XBB.1.5 boost Intranasal vaccination boosts serum and mucosal neutralizing responses Serum XBB.1.5 XBB.1.5 pseudovirus Pseudovirus neutralization Neutralization MucosalXBB.1.5 XBB.1.5 pseudovirus Pseudovirus neutralization Neutralization 2 16 2
Slide 23: Novel MatrixNanoParticle Development
• Novel MatrixNanoParticle (MNP) has been developed that directly links antigens to Matrix Novel • MatrixNanoParticle (MNP) vaccine candidates MatrixNanoParticle can be delivered by intramuscular and intranasal route in animal models Development • One dose of avian H5N1 MNP vaccine induces high leve
Slide 24: Novel MatrixNanoParticles link antigen directly to Matrix adjuvant
Novel MatrixNanoParticles link antigen directly to Matrix adjuvant Potential MatrixNanoParticle Characteristics • Larger particle may facilitate APC recognition and phagocytosis • Increased antigen density may increase APC activation • Antigen/adjuvant co-delivery into endosome may facilitate access
Slide 25: Single dose of intramuscular and intranasal H5N1 MatrixNanoParticle vaccine in rhesus macaques
Single dose of intramuscular and intranasal H5N1 MatrixNanoParticle vaccine induce robust serum neutralizing response in rhesus macaques Pseudovirus Neutralization Titer 262144 Pseudovirus Neutralization Titer 262144 65536 GMT=5,860 65536 (pVN50, Mean, 95% CI) (pVN50, Mean, 95% CI) 16384 16384 A/AW/
Slide 26: Financial Results
SECTION Financial Results © 2024 NOVAVAX. All rights reserved. 26
Slide 27: Key financial themes for Q1 2024
Key financial themes for Q1 2024 Q1 2024 Financial Results Operating Expenses Cash, APAs & Sanofi Agreement • Total Revenue: $94 million • Q1 2024 – 50% reduction to R&D • Combined Cash & A/R of $517 o Product sales primarily driven and SG&A as compared to prior million (3/31/2024) by APA deliveries
Slide 28: Q1 financial results
Q1 financial results ~50% decrease to R&D + SG&A spend Q1 2024 - $179M Q1 2023 - $360M © 2024 NOVAVAX. All rights reserved. 28
Slide 29: R&D and SG&A expense trends & 2024 guidance
R&D and SG&A expense trends & 2024 guidance Creating a more lean and agile Combined Annual R&D and SG&A Expense organization • Reduced workforce by 30% compared to $1.7B the first quarter of 2023 ~$1B reduction Midpoint compared to FY 2022 • Targeting FY 2024 R&D and SG&A $1.2B expenses of $700 - $7
Slide 30: 2024 Liability management
2024 Liability management Current Liabilities ~$1.7B in Current Liabilities addressed since 2022 $2.5B Reduced current liabilities by $831 million in the first quarter of 2024 including the impact of the settlements with GAVI and Fujifilm $1.6B $0.8B 1 12/31/2022 12/31/2023 3/31/2024 1. Other Curren
Slide 31: Full year 2024 financial guidance
Full year 2024 financial guidance Prior Updated $ in millions (as of February 28, 2024) (as of May 10, 2024) Combined Revenue & Sanofi Agreement Payments $800 - $1,000 $970 - $1,170 Total Revenue1,2 $800 - $1,000 $400 - $600 Initial Sanofi Agreement Payments3 ~$570 Combined R&D and SG&A $700 - $800
Slide 32: Closing Remarks
Closing Remarks © 2024 NOVAVAX. All rights reserved. 32
Slide 33: Q&A
Q&A © 2024 NOVAVAX. All rights reserved. 33