Novavax Reports Third Quarter 2023 Financial Results and Operational Highlights

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced its financial results and operational highlights for the third quarter ended September 30, 2023.

“We are proud of the progress we made over the last quarter to deliver the only protein-based non-mRNA vaccine option in the U.S. and have worked to provide broad access across retail pharmacies and healthcare offices,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “With the delayed start of respiratory vaccinations, we believe we have yet to reach the midpoint of the vaccination season and, with early and encouraging signs of demand for our vaccine, we believe there remains opportunity to deliver doses and grow our share. This reinforces our belief that the long-term COVID-19 market represents a sustainable opportunity for Novavax in the years to come.”

“As previously stated, one of our key objectives is to strengthen the financial stability of the company. We are currently exceeding the targeted reductions announced earlier in the year and did so while launching our updated vaccine. To more efficiently scale our business, we are prepared to initiate additional cost reductions to further reduce expenses in 2024 by over $300 million, while continuing to maintain our key capabilities and our ability to bring forward a combination vaccine.”

Third Quarter 2023 and Recent Highlights

During the third quarter, Novavax continued to make progress on its three key priorities for 2023.

Priority #1: Deliver an Updated COVID-19 Vaccine for the Upcoming 2023 Fall Vaccination Season

U.S. Market: Novavax received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in October for its updated COVID-19 vaccine and is executing its commercial strategy to maximize access for consumers who want a protein-based non-mRNA vaccine option.

• Expect U.S. 2023-2024 season COVID-19 vaccine demand of between 30 and 50 million doses, with potential for significant November and December vaccinations given current trends and later start as compared to 2022
  
  
• Secured broad access to the Company’s updated vaccine through major pharmacies, clinics and government programs
  • Novavax’s vaccine is available at approximately 14,000 pharmacy locations, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid and Stop & Shop

Global Markets: Received approval in Europe for the Company’s updated COVID-19 vaccine in individuals aged 12 and older

• Advanced regulatory filings against existing APAs for Australia, Canada, New Zealand, Singapore and Taiwan

Priority #2: Reduce Rate of Spend, Manage Cash Flow and Evolve Scale and Structure

Novavax has made significant progress on its commitment to improve its financial position while maintaining the capabilities to support long-term value creation.

• Reduced current liabilities by $128 million during the third quarter of 2023 and by approximately $1 billion as of September 30, 2023
  
  
• Reduced year-to-date operating expenses through the third quarter of 2023 by $950 million or 47%, as compared to 2022
  
  
• On track to exceed the previously announced global restructuring and cost reduction plan for 2023 by over $100 million for combined Research and Development (R&D) and Selling, General, and Administrative (SG&A) expenses
  
  
• Prepared to initiate additional cost reductions to further reshape the size and scope of global operations beyond previously stated cost reduction targets by over $300 million

Priority #3: Leverage Technology Platform, Capabilities, and Portfolio of Assets to Drive Additional Value Beyond Nuvaxovid™

Novavax remains focused on leveraging its technology platform to drive long-term growth and protect global health.

• Expect to initiate a pivotal Phase 3 trial for COVID-19-Influenza Combination (CIC) vaccine candidate in the second half of 2024, with potential for accelerated approval and launch as early as 2026
  
  
• Advanced partnerships with Matrix-M adjuvant technology
  • R21/Matrix-M vaccine received recommendation from the World Health Organization; launch expected in 2024

Third Quarter 2023 Financial Results

• Total revenue for the third quarter of 2023 was $187 million, compared to $735 million in the same period in 2022. Third quarter 2023 grant revenue of $165 million benefited from milestone achievements related to U.S. market preparedness and progress on clinical projects. Third quarter 2023 royalty and other revenue includes $12 million in Matrix-M sales to our collaboration partner in support of launch preparations for the R21/Matrix-M malaria vaccine.
  
  
• Cost of sales for the third quarter of 2023 were $99 million, compared to $435 million in the same period in 2022. Third quarter 2023 cost of sales includes $82 million related to excess, obsolete or expired inventory and losses on firm purchase commitments as compared to $249 million in the same period in 2022. Third quarter 2023 cost of sales also includes a $22 million benefit related to certain negotiated reductions to previously recognized firm purchase commitments.
  
  
• R&D expenses for the third quarter of 2023 were $106 million, compared to $304 million in the same period in 2022. The decrease was primarily due to reduction in clinical and manufacturing spend and a $58 million benefit associated with the negotiated settlement of manufacturing liabilities recorded in the third quarter of 2023.
  
  
• SG&A expenses for the third quarter of 2023 were $107 million, compared to $123 million for the same period in 2022. The decrease was primarily due to certain cost containment measures to reduce operating spend
  
  
• Net loss for the third quarter 2023 was $131 million, compared to a net loss of $169 million in the same period in 2022.
  
  
• Cash, cash equivalents and restricted cash were $666 million as of September 30, 2023, compared to $518 million as of June 30, 2023, and $1.3 billion as of December 31, 2022. Through sales of Novavax common stock pursuant to at-the-market offerings during the third quarter of 2023, Novavax raised net proceeds of $143 million.

Financial Framework

Novavax is updating its Full Year 2023 guidance and providing First Quarter 2024 total revenue guidance:

For updated total revenue guidance, we have included combined FY 2023 and Q1 2024 total revenue to reflect the full delivery timing and revenue recognition of sales associated with the 2023-2024 vaccination season. Consistent with 2023, we originally expected no product sales revenue in the first quarter of 2024. Due to the delayed start to and expectation for a longer season in the U.S., we expect some portion of revenue recognition will extend into the first quarter of 2024. In addition, outside of the U.S., some portion of APA dose deliveries may extend into the first quarter of 2024.

Novavax is prepared to initiate an additional cost reduction program to reduce 2024 expenses by over $300 million:

Intend to further reshape the size and scope of global business operations beyond previously announced 2024 targets to align with the COVID-19 market opportunity.

• • Anticipate reducing 2024 R&D and SG&A expenses by over $200 million compared to prior targets to reflect $750 million or lower spend for 2024, representing a greater than 50% reduction compared to 2022.
  • In addition, anticipate reducing supply network costs by over $100 million as we continue to rationalize our manufacturing footprint.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. Focused on the world’s most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.com and LinkedIn for more information.