Novavax, Inc. · NASDAQ:NVAX
Novavax — Q3 2024 Earnings Presentation
26 slides from Novavax's earnings presentation, Nov 12, 2024
Slide 1: Third quarter 2024 financial results & operational highlights
Third quarter 2024 financial results & operational highlights Nasdaq: NVAX | November 12th, 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: Non-GAAP financial measures
Non-GAAP financial measures The Company has used a non-GAAP financial measure in this presentation, which is adjusted combined R&D and SG&A expenses, net of Sanofi reimbursement costs under the Sanofi Agreement. Non-GAAP financial measures refer to financial information adjusted from financial measu
Slide 4: Q3 2024 Earnings call agenda
Q3 2024 Earnings call Agenda Luis Sanay Welcome Vice President, Investor Relations John C. Jacobs Introduction President and Chief Executive Officer John Trizzino Operating Updates President and Chief Operating Officer Robert Walker, MD Research and Development Senior Vice President, Chief Medical O
Slide 5: Novavax value framework
Novavax value framework Four pillars of potential value creation based on a validated technology platform Value Driver #1 Value Driver #2 Value Driver #3 Value Driver #4 Sanofi partnership Late-stage Leverage our Emerging, early- jdsfm pipeline proven stage pipeline technology platform to drive addi
Slide 6: 2024 Near-term priorities
2024 Near-term priorities Priority #1 Priority #2 Priority #3 Priority #4 Prioritize the Expand early-stage Further reduce Deliver an updated successful execution pipeline, advance combined R&D and vaccine for the of ourjdsfm partnership CIC and flu SG&A expenses 2024-2025 with Sanofi programs. Purs
Slide 7: Operating Updates
Operating SECTION Updates © 2024 NOVAVAX. All rights reserved. 7
Slide 8: U.S. COVID-19 2024-2025 commercial market
U.S. COVID-19 2024-2025 commercial market Focused on improved performance in the largest market Received authorization at the start of the season Pre-filled syringe product presentation Available in over 30,000 locations, including grocers and independent pharmacies Higher visibility of Novavax on v
Slide 9: U.S. COVID-19 2024-2025 Season: Early highlights
U.S. COVID-19 2024-2025 Season: Early highlights Establishing a solid foundation Focused Commercial Approach • Maintained a competitive position against mRNA vaccines in select settings • Achieved ~70% market share in a regional retailer • Targeted marketing campaign, with 53% of Nuvaxovid claims co
Slide 10: Ex-US COVID-19 commercial operations
Ex-US COVID-19 commercial operations Positioned for successful transition of commercial lead to Sanofi Europe APA Markets • Approval received for updated COVID-19 • Prioritizing completion of our APAs vaccine • Focused commercial efforts Continue to work closely with Sanofi in preparation for seamle
Slide 11: Research & Development
Research & SECTION Development © 2024 NOVAVAX. All rights reserved. 11
Slide 12: Research & development overview
Research & development overview 2024-2025 CIC and Expanding Internal COVID-19 jdsfm influenza potential preclinical vaccine program opportunities pipeline for Matrix-M © 2024 NOVAVAX. All rights reserved. 12
Slide 13: COVID-19 Vaccine 2024-2025
Value Driver #1 • Emergency Use Authorization granted by FDA on 2024-2025 August 30th • Pre-filled syringes available across the U.S. by COVID-19 September 13th Vaccine • Non-clinical studies continue to demonstrate that Novavax updated vaccine induces broad neutralizing responses, including against
Slide 14: Pseudovirus Neutralization
Novavax JN.1 vaccine induces broad cross neutralization to variants including KP.3.1.1 and XEC Single JN.1 vaccine dose in XBB.1.5 vaccine primed and boosted rhesus macaques GMFR 40.3 20.0 30.2 32.0 19.9 22.3 14.7 16.0 31.9 24.1 29.5 13.2 29.1 43.2 4,240 5,081 3,423 4,106 10,000 2,891 3,027 2,932 3,
Slide 15: COVID-19-Influenza-Combination and Seasonal Influenza Program
Value Driver #2 COVID-19-Influenza- • Clinical hold removed by FDA Combination and • Safety event from previous phase 2 study reviewed in detail Seasonal Influenza • All clinical hold issues satisfactorily addressed Program • Plan to start Phase 3 trial as soon as possible © 2024 NOVAVAX. All rights
Slide 16: CIC vaccine updated Phase 3 trial design
COVID-19-Influenza-Combination vaccine updated Phase 3 trial design FDA aligned with one Phase 3 trial for both CIC and seasonal influenza vaccines • Phase 2 CIC data support noninferior Participants to be randomized to one of four arms: immunogenicity • During Pre IND process, FDA aligned with one
Slide 17: Opportunities for Matrix-M in vaccine development
Value Opportunities for Matrix-M in vaccine development Driver #3 Matrix-M Adjuvant Attributes1,2,3 • Increased magnitude and breadth of antibody response • Induces polyfunctional T-cells • Supports FcR-mediated responses • Antigen-sparing • Favorable safety and reactogenicity profile • Improve upon
Slide 18: Early-stage pipeline and innovation expansion opportunities
We are identifying early-stage pipeline and innovation expansion opportunities as part of our R&D strategy to support long-term growth Early Pipeline Opportunities RSV Combinations/Pandemic Flu COVID-19 • Focus on exploring RSV- containing combinations – Flu characterization of candidate ongoing CIC
Slide 19: Financial Results
SECTION Financial Results © 2024 NOVAVAX. All rights reserved. 19
Slide 20: Key financial themes for Q3 2024
Key financial themes for Q3 2024 Q3 2024 Financial Results Operating Expenses Cash2 & APAs • Total Revenue: ~$85 million • Q3 2024 – R&D and SG&A expense • Combined Cash & A/R of ~$1 billion o $38 million Product sales of $158 million (9/30/2024) o $46 million Licensing, royalties o 26% reduction co
Slide 21: Q3 2024 financial results
Q3 2024 financial results ($ in millions, except per share amounts) Q3 2024 Q3 2023 Product sales $ 38 $ 2 $36M higher product sales Licensing, royalties, and other 46 20 compared to Q3 2023 Grants - 165 Total revenue 85 187 Cost of sales 61 99 Research and development 87 106 26% reduction in R&D +
Slide 22: Continuing to significantly reduce operating footprint and expenses
Continuing to significantly reduce operating footprint and expenses Creating a more lean and agile Combined Annual R&D and SG&A Expense organization $1.7B ~$1.4B & 80% • Targeting FY 2024 combined R&D and reduction compared $1.2B to FY 2022 SG&A expenses of $700 - $750 million • Prepared to initiate
Slide 23: Full year 2024 financial guidance
Full year 2024 financial guidance Prior Updated $ in millions (as of Aug. 8, 2024) (as of Nov. 12, 2024) Total Revenue $700 - $800 $650 - $700 Product Sales1 $275 - $375 $175 - $225 Licensing, Royalties and Other Revenue2 $425 $475 Combined R&D and SG&A $700 - $750 $700 - $750 Guidance Notes 1. Full
Slide 24: Sanofi Agreement Economics & Financial Reporting
Sanofi Agreement Economics & Financial Reporting Expected Payment Type Event Timing* Line Item Amount ($M) Related To $500 M Upfront payment received in Q2 2024 Upfront Payment and License, Royalties Q2 2024 $500 o $391M recognized in Q2 2024 Equity Investment & Other o $109M amortized over the perf
Slide 25: Closing Remarks
Closing Remarks © 2024 NOVAVAX. All rights reserved. 25
Slide 26: Q&A
Q&A © 2024 NOVAVAX. All rights reserved. 26