Financial Data and Key Metrics Changes - Q1 revenues were $100 million, with a net loss of $1 billion, reflecting the seasonal nature of the respiratory vaccine business [6][12] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - R&D expenses decreased by 19% year over year to $856 million, driven by lower clinical development spending [14][19] - SG&A expenses were $212 million, down 23% year over year, reflecting broad-based cost reductions [15] Business Line Data and Key Metrics Changes - Net product sales were $86 million, primarily from COVID vaccine sales, with the U.S. accounting for about one-third of total sales [12][13] - Total revenue for the quarter was $108 million, a decrease of 35% year over year [13] - Cost of sales was $90 million, representing 104% of net product sales, up from 58% in the prior year [14] Market Data and Key Metrics Changes - Lower vaccination rates were observed compared to Q1 last year, indicating a transition of COVID into routine seasonal vaccination patterns [13] - The company expects total revenue in 2025 to be in the range of $1.5 billion to $2.5 billion, with first-half sales of approximately $200 million [17] Company Strategy and Development Direction - The company is focused on three priorities: expanding markets for commercial products, advancing its pipeline to drive sales growth, and executing with financial discipline [7][39] - The oncology portfolio is being expanded with the Checkpoint Medicine program, and the company aims to drive sales for approved products [8][39] - A commitment to achieve a breakeven target on a cash cost basis by 2028 has been established, with plans for significant cost reductions by 2027 [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in the upcoming fall season, despite the competitive market environment [52] - The company remains engaged with the FDA and anticipates continued productive exchanges regarding its product approvals [51] - The management is optimistic about the potential for new product approvals and the impact on sales growth [41][42] Other Important Information - The company plans to reduce annual GAAP expenses by over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The Phase III FRU program has exceeded the required number of case accruals for an interim vaccine efficacy analysis [9] Q&A Session Summary Question: Comments on FDA interactions and potential risks to the vaccine business outlook - Management noted that interactions with the FDA have been productive and ongoing, with a focus on providing necessary data for product reviews [51][52] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable, pending event accruals [56][58] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38%, and they are focused on managing working capital effectively [100][101] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis, stating that they will conduct the analysis once the season is over [105]