Novavax (NVAX) Q2 FY26 earnings call: guidance and Q&A

Can you provide color on Sanofi's seasonal supply and the market opportunity for Nuvaxovid? Also, what needs to be aligned for the Phase III combo vaccine trial, and what is the international market opportunity?

Management highlighted the COVID market as significant ($5B-$7B) and expressed excitement for Sanofi's commercial efforts, including direct-to-consumer advertising and retail partnerships. They confirmed Sanofi's intent to be an early mover in the combo vaccine market and their advanced discussions with regulators for Phase III timing, noting the positive momentum from recent regulatory approvals for other flu vaccines.

“We're really happy and looking forward to seeing their impact of their commercial consumer -- direct-to-consumer program to roll it out this year.”

asked by Nabeel Nissar · answered by James Kelly

What are the potential clinical trial design details for the C. diff vaccine Phase I, including endpoints? Also, is funding for Phase II/III C. diff costs embedded in the 2028 operating expense framework?

The Phase I trial design for C. diff will be a standard dose escalation to characterize safety. Management confirmed that funding capacity for advanced development, potentially as early as 2028, has been contemplated within their forward-looking guidance range for expenses.

“the answer to funding capacity is yes, we have contemplated the ability to keep programs, exciting programs like C. diff moving in our forward-looking guidance.”

asked by Unknown Analyst · answered by James Kelly

How much of the 2026 COVID vaccine uptake depends on contract wins versus physician/patient-driven uptake, including DTC outreach? Also, regarding C. diff, what preclinical data supports mucosal immunity, and is it being developed as an injection?

Management stated that the U.S. COVID market is consumer and retail-driven (85%+ through retail), making Sanofi's DTC advertising and retail contracts crucial. They noted Sanofi's methodical, long-term investment approach. For C. diff, preclinical models show evidence of mucosal immunity, but human studies will be needed for confirmation. It is being developed as an injection.

“We're looking at 85% or more of decision-making or shots coming through the retail market. And this is why this direct-to-consumer advertising by Sanofi this year, emphasizing not just exceptional efficacy, but also great tolerability profile, we think, is exceptionally important.”

asked by Pete Stavropoulos · answered by James Kelly

Will there be better line of sight on Sanofi supply sales for 2026 revenue guidance, or will this be easier next year? Has strain selection happened for Nuvaxovid, and is the company prepared to scale manufacturing?

Management stated they cannot guide for Sanofi and do not speak on their behalf regarding strain selection, but noted Sanofi is well-prepared for the season. They confirmed the Nuvaxovid vaccine matches the strain selection of U.S. and other regulators and that doses are on track for delivery to Sanofi.

“The vaccine that Sanofi will be distributing in the U.S. and beyond is -- matches the strain selection of the U.S. and other regulators.”

asked by Alec Stranahan · answered by Robert Walker

Is the C. diff vaccine a treatment or prophylactic, and for whom? For oncology vaccines, do partners want Matrix-M as is, or are they experimenting with its components? Is Novavax close to the final adjuvant for oncology?

For C. diff, the general philosophy is prophylactic, but the database is still developing. For oncology, Novavax believes Matrix-M as it stands has potential and is exploring it deeply, while also looking at other approaches to expand its utility. They are encouraged by early data and the interest from a top 10 pharma company in immuno-oncology.

“We believe Matrix-M in and of itself as it stands today has potential in that arena, and we're exploring deeply its potential there.”

asked by Thomas Shrader · answered by John Jacobs

Given recent leadership changes at Sanofi and portfolio review, what tangible steps give confidence that the combo vaccine remains a strategic priority? Are there internal decision points before Phase III starts?

Management stated they are seeing more engagement from Sanofi, not less, despite leadership changes. They emphasized that any public comments about Sanofi's intentions, such as being an early mover in the combo vaccine market and advanced regulatory discussions, are provided and approved by Sanofi themselves, indicating strong commitment.

“When we do make a comment like we have about Sanofi's commitment about their intention to be one of the first in the KI combination arena market in the U.S. and that they're in late-stage discussions with regulators, those words are signed off on by our partner.”

asked by Unknown Analyst · answered by John Jacobs

What are the implications of the mRNA flu label and regulatory progress for Phase III combo vaccine design? Any updates on the Pfizer partnership? How has the evaluation of 30+ fields progressed, and what are the timelines for licensing?

The recent FDA activity for flu vaccines is encouraging for progression in the seasonal respiratory virus space. The Pfizer partnership continues to progress well, with Novavax upholding its commitments. For the 30+ exploration fields, progress is exciting, but timelines vary by partner and indication, making specific guidance difficult.

“For the second part of the question regarding the Pfizer partnership, we continue to collaborate with Pfizer and uphold our commitments based upon the license agreement that we have with Pfizer.”

asked by Mayank Mamtani · answered by Elaine O'Hara