Novavax(US:NVAX)2024-02-28 16:00Financial Data and Key Metrics Changes - For the full year 2023, total revenue was $984 million, consistent with guidance, with product sales of $531 million, including $251 million in Q4 2023 [62][75][104] - Total operating expenses were reduced by over $1.1 billion in 2023, exceeding savings targets by $150 million [59][105] - Current liabilities were reduced by $825 million during 2023, with an additional reduction of over $500 million expected from the Gavi settlement in 2024 [77][79] Business Line Data and Key Metrics Changes - Over 90% of product sales in 2023 came from APA sales in Europe, Australia, and New Zealand, with the remainder from the U.S., Canada, Singapore, Korea, and Taiwan [62][75] - The U.S. market saw product sales for the 2023-2024 season expected to be below $25 million, significantly lower than prior targets [104][137] Market Data and Key Metrics Changes - In the U.S., the company achieved up to 10% market share in retail outlets when on an even playing field, indicating potential for growth in 2024 [51][30] - The company is focusing on the 65-plus segment, which had a vaccination rate of 42% last season, as a key target for promotional efforts [63] Company Strategy and Development Direction - The company aims to deliver an updated product for the 2024-2025 fall vaccination season, focusing on broader retail availability and early market entry [49][50] - A key priority is to independently launch the Phase 3 trial of the COVID-flu combination vaccine, with a potential launch in 2026 [49][140] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to achieve agreed-upon endpoints for accelerated approval pathways, supported by strong immune response data [42][88] - The company is optimistic about its positioning for success in 2024, having recalibrated its focus on retail and streamlined operations [35][61] Other Important Information - The company has over $1 billion in outstanding APA contract value, with deliveries planned through 2026, positioning it well for future revenue [143] - The Gavi settlement allows for the spreading of remaining liabilities over five years, improving cash flow predictability [14][106] Q&A Session Summary Question: Can you clarify the source of the $100 million in Q1? - The $100 million guidance for Q1 2024 is primarily from APA sales to Europe delivered in January, with expectations for Australia and New Zealand deliveries pending regulatory approval [112][113] Question: What is the expected revenue from the U.S. for the non-APA portion? - The non-APA revenue guidance for 2024 is projected to be $300 million to $400 million, with a significant portion expected from the U.S. market [107][132] Question: What are the remaining hurdles for BLA approval? - The company is working closely with regulatory teams to ensure timely submission and is confident in the data being provided for BLA approval [151]