NVAX

Pipeline and Technology Progress

• The C. diff vaccine candidate is in early development, with preclinical data showing preliminary evidence of potential mucosal immunity, and a Phase 1 trial planned that will follow standard dose escalation protocols focused on characterizing safety.
• The company's adjuvant Matrix-M is currently being explored for oncology applications: Novavax is conducting internal research across multiple oncology targets and has entered a new collaboration with a top 10 global oncology pharma company via a materials transfer agreement (MTA) to test Matrix-M across various oncology targets. Management believes the current formulation of Matrix-M has meaningful potential in oncology, and is also exploring modified approaches to broaden its utility across infectious disease and oncology.
• Novavax has a preclinical shingles (VZV) vaccine candidate in early development, with plans to partner the program once a lead candidate is confirmed.
• The company holds 30+ ongoing evaluation partnerships for Matrix-M spanning infectious disease and oncology, with each partner progressing at different timelines based on their individual experimentation plans.

Commercial Partnership Updates

• Sanofi is leading the full 2026 commercial launch of Nevaxavit (Novavax's COVID vaccine) globally, with launches planned in the U.S., Canada, Germany, the UK and other markets, and has secured contracts with all major U.S. retail pharmacy providers.
• Sanofi is prioritizing direct-to-consumer advertising for Nevaxavit to highlight its efficacy and tolerability profile, consistent with its strategy for its market-leading flu vaccine business.
• Sanofi remains committed to advancing the combination COVID-flu vaccine candidate, with increased engagement from Sanofi leadership after recent organizational changes, and is in late-stage regulatory discussions to initiate development. The combination vaccine targets a large combined global market for COVID and flu vaccination.
• Novavax's existing partnership with Pfizer remains active and progressing per the terms of the license agreement.

• Costs for potential Phase 2 and Phase 3 development of the C. diff vaccine, which could start as early as 2028, are already incorporated into the 2028 operating expense guidance range provided by the company.
• Novavax does not provide revenue guidance for 2026 or beyond that relies on Sanofi's commercial sales performance of Nevaxavit, and cannot speak on behalf of its partner's commercial or regulatory plans.
• The company does not guide on the timing of Sanofi's initiation of the combination COVID-flu vaccine Phase 3 trial, which is identified as a key future value creation catalyst for Novavax.

No financial segment performance data (absolute revenue or revenue contribution percentages) for any product segments was provided in the excerpted earning call transcript.

No explicit discussion of material business risks, financial underperformance, or operational failures was included in the excerpted earning call transcript.

Q: What details can you share about the Phase 1 trial design for your C. diff vaccine, including endpoints, and have you budgeted for potential Phase 2/3 costs in your 2028 operating expense framework?

A: Management does not disclose detailed Phase 1 trial design at this stage, but confirms the trial will follow standard dose escalation protocols focused on characterizing vaccine safety to support further advanced development. The company confirms C. diff development costs through potential Phase 2/3 initiation as early as 2028 fall within the existing 2028 operating expense guidance range.

Q: Following recent leadership changes and a portfolio review at Sanofi, what evidence confirms Sanofi still prioritizes the combination COVID-flu vaccine, and is a 2026 Phase 2/3 trial start still the base case?

A: Management states that despite Sanofi's organizational changes, the company has seen increased behind-the-scenes engagement from Sanofi on the combination vaccine program, and public comments about Sanofi's commitment shared by Novavax are pre-approved by Sanofi. Novavax does not guide on the timing of Sanofi's trial initiation, but confirms advancing the combination vaccine (which targets a large combined market) would be a major value creation catalyst for Novavax.

Q: Is the C. diff vaccine a prophylactic or therapeutic product, and what update can you share on Matrix-M's development for oncology vaccines?

A: The C. diff vaccine is in early development, and the company is currently focused on developing it as a prophylactic preventive vaccine while keeping all options open as more data is generated. For oncology, Novavax is conducting internal Matrix-M research across multiple targets, has secured a new collaboration with a top 10 oncology pharma to explore Matrix-M, and is encouraged by early unpublished data; management believes the current core Matrix-M formulation already has potential in oncology, and is also exploring modified formulations to expand its utility.

Q: Will Novavax update 2026 revenue guidance after seeing early Nevaxavit uptake data this fall, and has the 2026 fall COVID strain selection been confirmed?

A: Novavax cannot provide guidance for Sanofi's commercial sales performance, and does not plan to issue guidance based on Sanofi's performance for 2026 or beyond at this time. Management confirms the Nevaxavit dose that Sanofi will distribute matches the strain selection recommendations of U.S. and global regulators, and Novavax is on track to supply the required doses to Sanofi for the fall season.