Novavax, Inc. · NASDAQ:NVAX

Novavax — Q1 2023 Earnings Presentation

29 slides from Novavax's earnings presentation, May 9, 2023

  1. Slide 1: First quarter 2023 financial results & operational highlights

    First quarter 2023 financial results & operational highlights Nasdaq: NVAX | May 9th, 2023 © 2023 NOVAVAX. All rights reserved. 1

  2. 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

  3. Slide 3: Non-GAAP financial measures

    Non-GAAP financial measures The Company has used a non-GAAP financial measure in this presentation, which is R&D and SG&A expense, excluding one-time restructuring charges including a restructuring charge related to employee severance and benefit costs of $10 million to $15 million and additional an

  4. Slide 4: Q1 2023 Earnings call agenda

    Q1 2023 Earnings call Agenda Welcome Erika Schultz Senior Director, Investor Relations John C. Jacobs Introduction President and Chief Executive Officer COVID Variant Strain Filip Dubovsky, MD Development & Pipeline President, Research and Development John Trizzino Commercial Updates EVP, Chief Comm

  5. Slide 5: Recent progress across near-term priorities

    Recent progress across near-term priorities Priority #1 Priority #2 Priority #3 Deliver a competitive Reduce our rate of Leverage our product for the spend, manage our technology platform, jdsfm 2023 fall upcoming cash flow, and our capabilities, and vaccination season evolve our scale & our portfol

  6. Slide 6: COVID Variant Strain Development

    1 COVID Variant Strain SECTION Development © 2023 NOVAVAX. All rights reserved. 6

  7. Slide 7: Vaccine candidates in variant development platform

    Vaccine candidates in variant development platform Pre-clinical Master Virus Seed Large Scale GMP Clinical Studies Immunogenicity Production Manufacture Wuhan P P P P BA.1 P P P P BA.2 P BA.2.12.1 P BA.5 P P P In Process BQ.1 P BQ.1.1 P P BF.7 P CH.1.1 P P BN.1 P XBB P XBB.1 P XBB.1.16 In Process In

  8. Slide 8: Study 311: Part 2 confirms strain change approach for future vaccine approvals

    Study 311: Part 2 Confirms strain change approach for future vaccine approvals Study 311: Part 1 Study 311: Part 2 Results announced November 2022 Ongoing • Evaluated NVX-CoV2373, BA.1 vaccine • Evaluating NVX-CoV2373, BA.5 vaccine candidate, and bivalent BA.1 + Prototype candidate, and bivalent BA.

  9. Slide 9: COVID-Influenza Combination and Stand-alone Influenza Vaccines

    COVID-Influenza 2 Combination and SECTION Stand-alone Influenza Vaccines © 2023 NOVAVAX. All rights reserved. 9

  10. Slide 10: COVID-Influenza Combination and stand-alone influenza vaccine candidates

    COVID-Influenza Combination (CIC) and stand-alone influenza vaccine candidates Stand-alone Influenza Vaccine COVID-Influenza Combination (CIC) Vaccine Combines stand-alone Quadrivalent vaccine influenza vaccine and with four influenza NVX-CoV2373 in single Hemagglutinin (HA) genes formulation + + Ma

  11. Slide 11: CIC Phase 2, Part 1: Design

    CIC Phase 2, Part 1: Design Study Design Day 0 OBJECTIVES Vaccine Group N HA per Matrix-M, rS, µg Strain, µg µg u Assess safety and reactogenicity of various COVID- CIC Vaccine Formulations (qNIV + prototype SARS-CoV-2) Influenza combination (CIC) and qNIV formulations. A 75 30 15 50 B 75 30 15 75 u

  12. Slide 12: Summary of safety

    Summary of safety Data collected through Day 21 Both the stand-alone influenza vaccine and the combination vaccine had reassuring preliminary safety profiles that were clinically indistinguishable from the comparators • No AESI or PIMMC in any vaccine arm • Few SAEs, none treatment-related • Unsolic

  13. Slide 13: Novavax stand-alone influenza vaccine compared to licensed influenza vaccine

    Novavax stand-alone influenza vaccine compared to licensed influenza vaccine Key comparators to inform advanced development 3 dosage levels 75 µg Influenza Matrix-M adjuvant Hemagglutinin Influenza Stand-alone 3 formulations Comparators Licensed High Dose IIV4-HD Licensed Adjuvanted aIIV4 © 2023 NOV

  14. Slide 14: Stand-alone influenza GMT non-inferior for all strains for Fluzone HD and FLUAD

    Stand-alone influenza GMT non-inferior for all strains for Fluzone HD and FLUAD Baseline adjusted wild type HAI for qNIV compared to licensed influenza vaccines 44-89%* improved responses for H1N1 and H3N2 which cause majority of disease 12% 31%* 250 44%* 44%* 89%* 56%* 200 Adjusted GMT with 95% CI

  15. Slide 15: COVID-Influenza Combination vaccine compared to Nuvaxovid and licensed influenza vaccines

    COVID-Influenza Combination vaccine compared to Nuvaxovid and licensed influenza vaccines Key comparators to inform advanced development 3 dosage levels 3 dosage levels 50 & 75µg SARS-CoV-2 Influenza Matrix-M Spike Protein Hemagglutinin adjuvant COVID-Influenza Combination 11 formulations Comparator

  16. Slide 16: Combination vaccine immune responses comparable to individual COVID and influenza vaccines

    Combination vaccine immune responses are comparable to individual COVID and influenza vaccines Select CIC formulations compared to authorized Nuvaxovid and licensed influenza vaccines 100,000 200 150 Adjusted HAI GMT Adjusted MN GMT 10,000 Adjusted GMEU 1,000 with 95% CI with 95% CI with 95% CI 100

  17. Slide 17: Approximately 30% increase with highest dose COVID vaccine compared to Nuvaxovid

    Approximately 30%* increase observed with highest dose COVID vaccine compared to authorized Nuvaxovid Anti-S IgG and neutralization responses for High-Dose COVID vaccine 128,000 98,356 6,400 88,417 91,680 80,527 64,000 3,105 3,176 3,200 2,686 2,370 32,000 Adjusted IgG GMEU 1,600 Adjusted MN GMT with

  18. Slide 18: CIC Phase 2: Preliminary observations

    CIC Phase 2: Preliminary observations Stand-alone Influenza vaccine • Preliminary safety profile reassuring with reactogenicity comparable to Fluzone HD and FLUAD • HAI* responses 31-56% higher for all four strains compared to FLUAD • HAI* responses 44-89% higher for A strains compared to Fluzone HD

  19. Slide 19: Commercial Updates

    3 Commercial SECTION Updates © 2023 NOVAVAX. All rights reserved. 19

  20. Slide 20: Long-term market opportunity expected for COVID

    Long-term market opportunity expected for COVID Transition to more traditional commercial market underway in priority markets >$15B Projected annual global market size over time1 Transition from pandemic to endemic COVID U.S. ~$7B ROW market size Remainder COVID of total Ongoing need for ~100M vacci

  21. Slide 21: U.S. commercial readiness efforts for 2023 fall vaccination season

    U.S. commercial readiness efforts for 2023 fall vaccination season Preparing for commercial market utilizing existing influenza vaccine logistics and go-to-market infrastructure Discussions with all major retail pharmacies nationwide Educating healthcare providers (HCPs) and pharmacists about our CO

  22. Slide 22: Financial Results

    4 SECTION Financial Results © 2023 NOVAVAX. All rights reserved. 22

  23. Slide 23: Q1 2023 Financial results

    Q1 2023 Financial results Combined R&D and SG&A Expense Trend Q1 2023 Overview • Reduction to combined R&D and $479M SG&A expense to $360 million o Decreased by $120 million & $420M 25% compared to Q1 2022 $360M o Decreased by $60 million & 14% compared to Q4 2022 • Total revenue of $81 million • Re

  24. Slide 24: Q1 2023 Financial results

    Q1 2023 Financial results ($ in millions, except per share amounts) Q1 2023 Q1 2022 Product sales 1 $ (7) $ 586 Grants 87 99 Royalties & other 1 19 Total revenue 81 704 Cost of sales 34 15 Research & development 247 383 Selling, general & administrative 113 96 Total expenses 394 495 Income (loss) fr

  25. Slide 25: 2023 Liability management

    2023 Liability management Current Liabilities Progress Current Liabilities • Reduced current liabilities outstanding as of 3/31/2023 by $541 million $2.5B • In April 2023, addressed additional $140 million including: $1.9B o $27 million payment to resolve the Par arbitration, and o $113 million paym

  26. Slide 26: Global restructuring and cost reduction initiative

    Global restructuring and cost reduction initiative Combined Annual R&D and SG&A Expense Cost Footprint Restructuring Targeting a 40% - 50% $1.7B reduction in 2024 vs. 2022 • An approximately 25% reduction to global workforce $1.3B - $1.4B1 • Focused investment in COVID program Below $1B • Reduction

  27. Slide 27: Full year 2023 financial guidance

    Full year 2023 financial guidance Revenue Other Financial Considerations Total Revenue1 Between $1.4 billion and $1.6 billion • Approximately $800 million in APA orders secured for 2023 based on Grant Revenue Between $340 million and $360 million committed delivery schedules, subject to updated vari

  28. Slide 28: Closing Remarks

    Closing Remarks © 2023 NOVAVAX. All rights reserved. 28

  29. Slide 29: Q&A

    Q&A © 2023 NOVAVAX. All rights reserved. 29

Novavax — Q1 2023 Earnings Presentation on 6ix