Novavax, Inc. Q2 FY2025 earnings call

Key Points

• Optimizing Sanofi Partnership: Received $175 million milestone for Nuvaxovid BLA approval in U.S., completed commercial activities transition to Sanofi in U.S. for '25, '26 seasons. Sanofi developing combination vaccines with Nuvaxovid, eligible for milestones and royalties.
• Enhancing Partnerships and Leveraging Technology: Optimized Takeda partnership in Japan, R21 Matrix-M malaria vaccine has rolled out in 12 African countries with over 20 million doses sold. Advanced Matrix-M adjuvant with material transfer agreements with 3 pharma companies, discussed business partnerships. Positive data from CIC and standalone flu vaccine candidates in June.
• Advancing Technology Platform and Pipeline: Focused pipeline on infectious disease vaccines, exploring Matrix-M in oncology. Using capital-efficient model, AI-driven insights for candidate development. Preclinical progress in RSV combination, C. difficile, and VZV programs.

In the second quarter of 2025, Novavax reported total revenue of $239 million. Product sales were $11 million, consisting of $13 million from supply sales and negative $2 million from Nuvaxovid product sales due to closeout of U.S. market activities. Licensing, royalties, and other revenue were $229 million, with $199 million from Sanofi and $27 million from Takeda. Supply sales were primarily from adjuvant sales to license partners, and year-to-date sales of the R21 Matrix-M malaria vaccine reached 14 million doses, exceeding the full year 2024 sales of 6 million doses.

Forward-Looking Statements

• Updated 2025 financial guidance for combined R&D and SG&A expenses to $495 million to $545 million including PMC study. Multiyear targets for 2026 and 2027: $350 million and $250 million net of partner reimbursements. Adjusted total revenue expected to be between $1 billion and $1.050 billion in 2025. Aim to achieve non-GAAP profitability as early as 2027 depending on partner performance.

Risks

• Forward-looking statements subject to risks and uncertainties causing actual results to differ from projections, including factors in Form 10-K and 10-Q. Risks related to regulatory approvals, partner performance affecting revenue and profitability, and uncertainties in clinical trial outcomes.

Q: Regarding 2025, 2026 COVID season supply, will Novavax file for approval for this season's vaccine and when will supply be ready?

A: Novavax had BLA approval for JN.1, working to improve shelf-life profile for fall season, regulatory filings focused on that improvement.

Q: Comments on interest level and progress of CIC and flu partnership discussion?

A: In conversation with multiple potential partners, strong commentary from Sanofi on combination assets, data from CIC trial strengthened safety and immunogenicity database but registrational trial would be undertaken by partner when partnership occurs.

Q: Confidence in positive efficacy data from post-marketing Phase IV trial and interim analysis?

A: Post-marketing commitment study to start as soon as end of 2025, will generate data in subsequent quarters, Sanofi reimbursement covers incremental study costs.

Q: Evaluating or open to acquiring or in-licensing clinical stage candidates?

A: Focused on external partnering and internal development of pipeline, technology platform has utility across multiple modalities and potential in oncology, focused on unlocking value through technology platform.