Novavax, Inc. Q3 FY2025 earnings call

Corporate Strategy

• Focused on driving growth and value by strengthening existing partnerships, building new collaborations, and advancing R&D innovation.

Partnerships

• With Sanofi: Achieved all 2025 milestones, securing $225 million, including $50 million from marketing authorization transfers in the U.S. and EU; Sanofi took lead commercial responsibility for Nuvaxovid in the U.S. and select markets. Also, Sanofi explored Matrix-M adjuvant in pandemic flu vaccine.
• With Takeda: Renegotiated agreement to enhance revenue from Nuvaxovid in Japan.

R&D Progress

• Early-stage pipeline programs for C. diff, shingles, RSV combination, pandemic flu, and Matrix-M in oncology. Matrix-M adjuvant showed promise in pandemic flu vaccine.

Financial Strength

• Consolidated Maryland campus, bringing in $60 million cash and $230 million cost avoidance; ended Q3 with $812 million in cash and accounts receivable.

Total revenue for the third quarter of 2025 was $70 million. Product sales, which included COVID vaccine and Matrix-M supply sales to license partners, amounted to $13 million, representing 18.57% of total revenue. Licensing royalties and other revenue, primarily from the Sanofi agreement, totaled $57 million, making up 81.43% of total revenue.

Financial Guidance

• Reaffirmed 2025 combined R&D and SG&A expenses midpoint at $520 million, narrowing range to $505M-$535M. Non-GAAP net of partner reimbursement expected at $450M midpoint.
• Raised 2025 adjusted total revenue framework to $1.040B-$1.060B, up $25M midpoint.
• Target to achieve non-GAAP profitability as early as 2028, relying on milestones midterm and growing licensing/royalty revenue long-term.

Forward-looking statements subject to risks and uncertainties, including partner execution, regulatory outcomes, and market dynamics. Risks detailed in Form 10-K and 10-Q filings with the SEC.

Q: How do you see the 2025 COVID season as compared to last year?

A: The COVID season in 2025 started 1 week late, with Rxs down about 20% compared to last year, and the U.S. label aligning more with global markets.

Q: What's the cadence of time lines and milestones for Matrix-M use with potential partners?

A: Partners evaluate early experiments in labs; results can lead to formal arrangements in the near term, not years down the road.

Q: Can you provide color on the $75 million milestone for 2026?

A: The $75 million milestone in 2026 relates to completion of manufacturing tech transfer with Sanofi, supporting their commercialization and clinical efforts.

Q: What are the risks to achieving non-GAAP profitability by 2028?

A: Risks include successful development and regulatory approval of Sanofi's CIC program, Sanofi's commercial execution, and potential delays in new business development agreements.