Novavax, Inc. · NASDAQ:NVAX
Novavax — Q2 2024 Earnings Presentation
29 slides from Novavax's earnings presentation, Aug 8, 2024
Slide 1: Second quarter 2024 financial results & operational highlights
Second quarter 2024 financial results & operational highlights Nasdaq: NVAX | August 8th, 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: Q2 2024 Earnings call Agenda
Q2 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 Robert Walker, MD Research and Development Senior Vice Pr
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 New, early-stage jdsfm pipeline proven pipeline technology platform to drive additional
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, initiate combined R&D and product for the 2024- ofjdsfm our new Phase 3 CIC and flu. SG&A expenses 2025 vaccination partnership
Slide 7: Operating Updates
Operating SECTION Updates © 2024 NOVAVAX. All rights reserved. 7
Slide 8: U.S. COVID market '24/'25 season readiness
U.S. COVID market ‘24/’25 season readiness Novavax COVID vaccine prepared for delivery: JN.1 strain │ PFS presentation Retail primary focus with resources and dollars 8 major retailers signed, new contracts for 2024-2025 season expand customer access Improved consumer access via retail schedulers ©
Slide 9: Americas product profile for 2024-2025 vaccination season
Americas product profile for 2024-2025 vaccination season Successfully addresses customer needs 2024-25 Vaccination Season Product Presentation Pre-filled syringe FDA Authorization EUA Authorization Status BLA in process Variant Updated JN.1 Approval Status FDA confirmed Label Expansion Ages 12+ und
Slide 10: Contracting for 2024-2025 vaccination season
Contracting for 2024-2025 vaccination season Targeting represents >90% of ‘23/’24 season National Chains • Major retail chains signed* o Novavax on schedulers in most major retailers • Established relationships with Regional Grocers Regional Chains, Grocers & and Independent Pharmacies Merchandisers
Slide 11: EU commercial readiness and APA transition plans 2024
EU commercial readiness and APA transition plans 2024 Europe APAs • Focusing on key countries: • Pandemic need for market APAs concluded • Italy • Poland • Germany • Transition to commercial or tender markets • EMA marketing authorizations expected by focused on high value, high demand markets start
Slide 12: Research and Development
Research and SECTION Development © 2024 NOVAVAX. All rights reserved. 12
Slide 13: Research and development overview
Research and development overview 2024-2025 CIC and Expanding Internal COVID jdsfmstrain influenza potential preclinical change program opportunities pipeline for Matrix-M © 2024 NOVAVAX. All rights reserved. 13
Slide 14: 2024-2025 Strain Change
Value Drive #1 • CDC recommends universal vaccination with 2024-2025 Strain updated vaccine • JN.1 vaccine regulatory packages submitted to FDA Change and EMA in June 2024 • Pre-filled syringes on track to be in U.S. warehouses starting in August 2024 • Novavax updated vaccine induces broad neutrali
Slide 15: Pseudovirus Neutralization
Novavax JN.1 vaccine induces broad cross neutralization to variants Value Drive #1 including KP.3 and KP.3.1.1 Single JN.1 vaccine dose in XBB.1.5 vaccine primed and boosted rhesus macaques Antigenic 5,081 3,423 Variant Units 2,891 4,106 10,000 3,481 JN.1 - 3,189 2,469 2,931 Pseudovirus Neutralizati
Slide 16: COVID-Influenza-Combination and Stand-Alone
Value Drive #2 COVID-Influenza- • Phase 3 immunogenicity study for both vaccines Combination and on-track for 2024 start Stand-Alone • Top-line data readout targeted for middle of 2025 • Preparing for enabling partner to advance to BLA Seasonal Influenza filing and commercialization Program © 2024 N
Slide 17: COVID-Influenza-Combination vaccine development on track
COVID-Influenza-Combination vaccine development on track Value Drive #2 FDA aligned with one Phase 3 study for both CIC and seasonal influenza vaccines Phase 2 CIC data support safety and noninferior Phase 3 on-track for 2024 start immunogenicity • FDA aligned with one Phase 3 study for both CIC and
Slide 18: Matrix-M can be leveraged to improve existing vaccines
Value Matrix-M can be leveraged to improve existing vaccines Drive #3 HAI responses increased when Matrix-M given with licensed egg-derived inactivated influenza vaccine (IIV) Mice vaccinated on days 0 and 21, HAI measured Competition binning: A/Darwin/6/21 HA at day 35 Competition binning : A/Darwi
Slide 19: Matrix-M can improve bacterial polysaccharide vaccines
Value Attributes of Matrix-M can be leveraged to improve bacterial Drive #3 polysaccharide vaccines Anti-pneumococcal antibodies and OPK increased when Matrix-M given with pneumococcal vaccine Anti-Pneumococcal IgG Opsonophagocytic Killing (OPK) Anti- Pneumococal Vaccine IgG 8.3 Fold- Rise Serotype
Slide 20: RSV F and H5N1 vaccine candidates moving forward
Value RSV F and H5N1 vaccine candidates moving forward Drive #4 • Nanoparticle RSV vaccine induces higher RSV A and RSV B neutralizing responses vs. AS01E adjuvanted vaccine in nonclinical studies, with high levels of antibody directed against site 0, II, IV, V and P27 neutralizing epitopes • One do
Slide 21: Financial Results
SECTION Financial Results © 2024 NOVAVAX. All rights reserved. 21
Slide 22: Key financial themes for Q2 2024
Key financial themes for Q2 2024 Q2 2024 Financial Results Operating Expenses Cash2 & Sanofi Agreement • Total Revenue: $415 million • Q2 2024 – R&D and SG&A expense • Combined Cash & A/R of ~$1.1 o $391 million GAAP revenue o 34% reduction compared to billion (6/30/2024) recognition for the $500 mi
Slide 23: Q2 2024 financial results
Q2 2024 financial results 34% decrease to R&D + SG&A spend Q2 2024 - $208M Q2 2023 - $313M 43% decrease to R&D + SG&A spend excluding Sanofi transaction costs of ~$31M © 2024 NOVAVAX. All rights reserved. 23
Slide 24: Sanofi partnership provides multi-billion dollar potential
Sanofi partnership provides multi-billion dollar potential across upfronts, equity investment, milestones and royalties Further validation of our technology platform and provides significant opportunity to drive value creation and benefit global public health jdsfm Co-exclusive license Sole license
Slide 25: Sanofi partnership summary of financial terms
Sanofi partnership provides multi-billion dollar potential (con’t) Summary of financial terms Upfront, Equity Investment, Milestones & Royalties Upfront payment $500 million Q2 2024 Payments Equity investment ~$70 million Total Q2 2024 Payments ~$570 million Nuvaxovid Milestones $350 million COVID-1
Slide 26: 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 27: Full year 2024 financial guidance
Full year 2024 financial guidance Reflects revenue recognition of Sanofi payment Prior Updated $ in millions (as of May 10, 2024) (as of August 8, 2024) Combined Revenue & Sanofi $970 - $1,170 Total Revenue $700 - $800 Agreement Payments Total Revenue1 $400 - $600 Product Sales3 $275 - $375 Licensin
Slide 28: Closing Remarks
Closing Remarks © 2024 NOVAVAX. All rights reserved. 28
Slide 29: Q&A
Q&A © 2024 NOVAVAX. All rights reserved. 29