NOVAVAX INC Q1 FY2025 earnings call

New Growth Strategy

• Moved from focusing on COVID-19 vaccine commercialization to optimizing partnerships and expanding via R&D innovation, organic portfolio expansion, and new collaborations.

Partnerships

• Key priorities include optimizing the partnership with Sanofi, leveraging the tech platform to drive additional partnerships, and advancing the tech platform and early-stage pipeline.

R&D Updates

• Initiated 4 early-stage programs (H5N1, RSV combinations, shingles, C. difficile) after rigorous prioritization. Progressed late-stage COVID-19, Flu, and CIC programs. Explored Matrix-M adjuvant's potential across vaccine platforms and pathogens, with data showing milder reactogenicity vs mRNA vaccines.

Novavax reported total revenue of $667 million in the first quarter of 2025. Product sales amounted to $622 million, with $603 million related to the termination of the Canada and New Zealand APA agreements. Nuvaxovid product sales were $5 million, and supply sales were $14 million. Licensing, royalties and other revenue totaled $45 million.

• Reiterated full-year 2025 combined R&D and SG&A expenses guidance of $475 million to $525 million.
• Raised 2025 revenue framework to between $975 million and $1,025 million.
• Aim to achieve non-GAAP profitability as early as 2027.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from projections, as detailed in the Form 10-K and subsequent Form 10-Qs filed with the SEC.

Q: Regarding the APA revenues recognized this quarter, how much is cash today versus cash in the future?

A: The $603 million from the Canada and New Zealand APA revenue recognition is noncash; the cash was received in prior years and retained through the termination of the agreements.

Q: What is the target profile for the midyear data readout of the CIC program?

A: Looking for immunogenicity and safety data to help design a subsequent pivotal trial for partnering purposes.

Q: Is the post-marketing clinical trial requirement specific to Novavax's BLA filing?

A: Working diligently with the FDA on the post-marketing commitment, which is understood to come after approval and not specific to other COVID-19 vaccines' filings.