Novavax(NVAX) - 2024 Q4 - Annual Results

COVID-19 Vaccine Developments - Novavax achieved approximately 70% market share in a regional retailer for its COVID-19 vaccine during the 2024-2025 season[26] - The company reported a 50 million milestone from Sanofi related to a COVID-19 pediatric trial[21] - Novavax's COVID-19 vaccine induces broad neutralizing responses across all tested variants, indicating acceptable coverage against currently circulating variants[26] - The partnership with Sanofi includes a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide[24] - Novavax's COVID-19 vaccine was launched in multiple markets, with a focus on driving value through R&D and diversified partnerships[16] - Novavax's late-stage pipeline includes a Phase 3 trial for a combination influenza and COVID-19 vaccine initiated in December 2024, with an initial cohort of approximately 2,000 participants[32][36] - The U.S. COVID-19 BLA PDUF is expected to be a significant focus in the near future[75] Financial Performance and Projections - Novavax's preliminary financial data for the year ended December 31, 2024, is still being finalized and may differ materially from actual results[7] - Novavax anticipates combined R&D and SG&A expenses of 700 million to $750 million for FY 2024, with a portion expected to be reimbursed by Sanofi[66] - Full year 2024 product sales guidance includes approximately$100 million in APA dose deliveries in 1H 2024 and $125 million in commercial market sales in 2H 2024[70] - Full year 2024 licensing, royalties, and other revenue guidance includes$450 million from the Sanofi agreement upfront payment and $25 million in royalty and other revenue from partner-related activities[70] - Current liabilities have decreased by over$1.3 billion since the end of 2022, including a settlement with Gavi[71] - The sale of the CZ manufacturing facility to Novo Nordisk generated $200 million in non-dilutive capital and annual cost reductions of approximately$80 million[71] Partnerships and Collaborations - The Sanofi partnership is expected to create multiple revenue streams and enhance access to Novavax's technology[24] - Sanofi partnership includes a $500 million upfront payment received in Q2 2024, with additional milestone payments totaling$700 million expected through 2026[28] - The company expects to receive ~$450 million in reimbursements from Sanofi for FY 2025, net of expected expenses[68] - The company is pursuing partnerships for its differentiated combination influenza vaccine candidates targeting older adults[37] - The company reported a significant interest in partnering or out-licensing its Matrix-M adjuvant technology[30] Research and Development - The company is focused on a lean operating model to drive shareholder value and has a diversified vaccine pipeline including COVID-19 and influenza candidates[12] - Novavax's technology platform is based on a recombinant protein-based nanoparticle, which is clinically proven and adaptable for combination vaccines[14] - Novavax's Matrix-M™ adjuvant shows promise in enhancing immune responses and is being explored for use in new vaccine formulations[46][47] - Novavax's H5N1 avian pandemic influenza vaccine candidate is currently undergoing preclinical evaluation, with the ability to pivot to new strains as they emerge[42] - The company anticipates advancements in its early-stage pipeline and enhanced partnerships in the coming years[75] Milestones and Future Outlook - Key milestones for 2025 include additional Sanofi-related milestones and data from late-stage assets[75] - Data from the initial cohort in the influenza Phase 3 trial is anticipated in 2025[76]