Novavax (NVAX) Jefferies London Healthcare Conference 2024 summary

Strategic partnerships and technology platform

• Entered a licensing agreement with Sanofi, granting rights to the COVID vaccine and combinations with Sanofi's flu vaccine, aiming to leverage Sanofi's commercial strength for broader market reach.

• Focused on developing proprietary flu and COVID-flu combo vaccines, with plans to initiate phase III trials soon and seek additional partnerships.

• Actively pursuing more transactions to license Matrix-M adjuvant to other vaccine makers, enhancing existing or failed vaccines.

• Emphasizing capital efficiency by reducing costs and maintaining a disciplined approach to both partnerships and internal development.

COVID vaccine market performance and transition

• Achieved 3% U.S. COVID vaccine market share this year, up from last year, aided by timely market entry and prefilled syringe format.

• Limited shelf life (three months) hindered pre-booking by pharmacies, impacting market share; expects to resolve with longer stability data for next year.

• Sanofi to take over commercial launch next year, expected to improve market share with better shelf life and distribution.

• Transitioning commercial activities to Sanofi, with most material work concluding by December; focus shifts to supporting Sanofi's launch.

• Cost structure reduction aligns with the transition, supporting a leaner operation.

COVID-flu combination and clinical development

• Sanofi will lead development of their own COVID-flu combo, while internal proprietary combo is preparing for phase III after a brief clinical hold was lifted.

• Phase III will use immunogenicity endpoints to demonstrate non-inferiority to market leaders in the over-65 population.

• No additional safety monitoring required after FDA review; ongoing protocol adjustments based on FDA recommendations.

• Timeline for phase III initiation and readout will shift based on actual start date, aiming for dosing completion by mid-February in the Southern Hemisphere.

• Anticipates key catalysts from Sanofi's launch and phase III readouts in the coming year.