Novavax — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $68 million, a 3% decrease compared to $70 million in Q3 2025.
• Product sales were $26 million in Q3 2026, a 91% increase year-over-year from $13 million in Q3 2025, driven by supply sales of Nuvaxovid to Sanofi and Matrix-M to license partners.
• Licensing, royalties, and other revenue was $43 million in Q3 2026, a 25% decrease from $57 million in Q3 2025, primarily due to a $42 million reduction in R&D reimbursement revenue as Sanofi clinical support nears completion.
• Cost of sales was $23 million in Q3 2026 compared to $21 million in Q3 2025.
• R&D expenses were $52 million in Q3 2026, a 47% decrease from $98 million in Q3 2025; Non-GAAP R&D expenses decreased 7% year-over-year.
• SG&A expenses were $24 million in Q3 2026, a 25% decrease from $32 million in Q3 2025.
• Net loss was $31 million in Q3 2026 compared to a net loss of $202 million in Q3 2025.
• Cash, cash equivalents, marketable securities, and restricted cash totaled $627 million as of September 30, 2026, down from $751 million as of December 31, 2025.
• Long-term debt was $292.1 million as of September 30, 2026, compared to $244.2 million as of December 31, 2025.

Guidance and Future Outlook:

• Raised full-year 2026 Non-GAAP Adjusted Total Revenue guidance to a midpoint of $400 million (range $385–$415 million), up from the previous range of $235–$275 million.
• Improved full-year 2026 GAAP Combined R&D and SG&A expense guidance to a midpoint of $385 million (range $375–$395 million), up from the previous range of $370–$410 million.
• Non-GAAP Combined R&D and SG&A expenses guidance remains at a midpoint of $325 million (range $315–$335 million).
• Sanofi confirmed intent to initiate a U.S. Phase 3 influenza-COVID-19 combination vaccine (CIC) trial in 2027 to support U.S. approval.
• The C. difficile vaccine program is anticipated to advance into the clinic as early as 2027.
• Manufacturing technology transfer to Sanofi for Nuvaxovid is expected to be completed in mid-2027.

Business Segments and Product Lines:

• Sanofi initiated a Phase 3 influenza-COVID-19 combination vaccine trial in Europe in October 2026, triggering a $125 million milestone payment to Novavax.
• Novavax is eligible for an additional $225 million milestone upon a U.S. commercial launch of a CIC vaccine following successful completion of clinical and FDA regulatory requirements by Sanofi.
• Novavax is eligible for royalties in the high single digits to sub-teens on Sanofi's global net sales for CIC products.
• A $75 million milestone payment is eligible upon completion of Nuvaxovid manufacturing technology transfer to Sanofi in mid-2027.
• Commercial partners received approvals for the XFG-adapted Nuvaxovid formulation in major markets including the U.S., EU, and Japan in August 2026.
• Sanofi initiated commercial activities for the 2026–2027 COVID-19 vaccination season in the U.S. and select international markets.
• Takeda initiated commercial activities for the 2026–2027 COVID-19 vaccination season in Japan.
• Novavax is eligible for royalties in the high teens to low twenties percent on Sanofi's global net sales for Nuvaxovid.
• Novavax is eligible for an annual milestone payment and mid-to-high teens percentage of Takeda's net sales in Japan.
• Multiple experiments with Matrix-M are underway in infectious disease targets and oncology models.

Market and Competitive Landscape:

• Sanofi is expanding Nuvaxovid's reach through physician engagement, pharmacy activation, and direct-to-consumer outreach.
• Novavax transitioned lead commercial responsibility of Nuvaxovid to Sanofi beginning with the 2025-2026 COVID-19 vaccination season for select markets.
• Novavax presented preclinical data for its C. diff program showing robust immune responses and protection in lethal challenge models at the 9th International C. Difficile Symposium in September 2026.

Risks and Challenges:

• Risks include partner Sanofi's ability to maintain full FDA licensure or foreign regulatory approvals for Nuvaxovid.
• Challenges related to the partnership with Sanofi, including collaboration on post-marketing commitments and pursuing additional partnership opportunities.
• Dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling of Nuvaxovid.
• Potential delays in clinical trials, regulatory filings, or manufacturing and distribution by partners.
• Risks associated with legislative, regulatory, or policy changes affecting vaccine funding, reimbursement, and mandates.
• Potential challenges in achieving commercial adoption and market acceptance of partner vaccines.
• Risks related to meeting contractual requirements, including potential refunds of upfront payments or reduced future payments.

Management Commentary and Tone:

• CEO John C. Jacobs stated the company continued to execute across all three pillars of its strategy: partnering technology, targeted R&D innovation, and a lean operating model.
• Management highlighted the reduction of expenses and operation with financial discipline while advancing the C. difficile candidate and exploring oncology applications.
• The company expressed a belief that its strategy can build a robust and profitable Novavax with multiple partners, diversified revenue streams, and a meaningful impact on global health.

Other Key Points:

• Novavax earned a $125 million milestone payment in October 2026 triggered by the initiation of Sanofi's Phase 3 CIC trial in Europe.
• The press release includes a reconciliation of GAAP to Non-GAAP financial results, showing Non-GAAP R&D expenses of $48.7 million and Non-GAAP Combined R&D and SG&A expenses of $72.3 million for Q3 2026.
• Adjusted Total Revenue is a Non-GAAP measure excluding Sanofi Supply Sales, Sanofi Royalties, and future Sanofi Milestones.
• Novavax is unable to reconcile forward-looking Non-GAAP revenue measures to GAAP measures without unreasonable effort due to reliance on partner sales forecasts.