Novavax's Corporate Strategy - Novavax is shifting its business model to focus on R&D and diversified partnerships[7, 8] - The company aims to drive value through in-house early-stage R&D and strategic partnerships[6, 9] - Novavax is establishing a lean operating model to drive shareholder value[59] Sanofi Partnership - Sanofi made a minority equity investment (less than 5%) in Novavax[16] - Novavax received a $500 million upfront payment from Sanofi in Q2 2024, with $424 million recognized in 2024 and $76 million amortized through 2026[18] - Novavax is eligible for up to $700 million in milestones from Sanofi[18] COVID-19 and Influenza Vaccines - COVID-19 hospitalization rates are approximately 4 times higher than those for influenza[20] - COVID-19 vaccine coverage rates are less than half of influenza vaccine rates among US adults 18+ in the 2023-24 season (22% vs 45%)[22, 23] - Nuvaxovid recipients experienced approximately 39% fewer symptoms compared to mRNA vaccine recipients[25] Matrix-M Adjuvant and Partnerships - Novavax is eligible to receive up to $200 million in launch and sales milestones plus mid-single digit royalties under the Matrix-M license agreement[19] - Novavax's COVID-Influenza Combination (CIC) vaccine and stand-alone flu vaccines are in Phase 3 trials, with initial cohort data showing robust immune responses and good tolerability[45, 54]

Core Viewpoint - Moderna's shares fell nearly 8% after the company voluntarily withdrew its regulatory filing for mRNA-1083, a combination vaccine for influenza and COVID, following consultation with the FDA [1] Group 1: Regulatory Developments - The withdrawal of the filing was anticipated as the FDA had previously requested additional Phase 3 flu efficacy data [2] - Moderna plans to resubmit the filing later this year after obtaining efficacy data from the ongoing Phase III study of its seasonal influenza vaccine, mRNA-1010, with interim data expected this summer [3] Group 2: FDA Guidance - The FDA recently issued new guidance requiring COVID vaccine manufacturers to conduct randomized, placebo-controlled studies to demonstrate the real-world benefits of yearly COVID vaccine boosters for individuals under 65 [4] Group 3: Clinical Data - The initial FDA filing for mRNA-1083 was based on Phase III study data showing it elicited higher immune responses against influenza and COVID compared to standalone vaccines [5] Group 4: Market Performance - Year-to-date, Moderna's shares have decreased by 38%, contrasting with a 4% decline in the industry [6] Group 5: Competitive Landscape - Other companies, including Novavax, Pfizer, and Sanofi, are also developing COVID-flu combination vaccines [8] - Novavax is conducting a late-stage study comparing its combination vaccine's immunogenicity and safety against separate vaccines, with initial data expected later this year [9] - Pfizer faced setbacks in its combination vaccine program and is currently evaluating adjustments to improve immune responses [10][11] - Sanofi has received fast-track designation from the FDA for two of its experimental combination vaccines, currently in Phase I/II studies [12]