Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $72.4 million, a significant increase from $6.4 million in Q3 2024, primarily driven by a BARDA contract awarded in June 2024 [16] - The company ended Q3 2025 with cash, cash equivalents, and investments totaling $28.8 million, with an expected cash runway extending into Q2 2027 due to the recent partnership with Dynavax [16] Business Line Data and Key Metrics Changes - The COVID-19 clinical program has seen a major partnership with Dynavax, which includes an upfront license fee of $25 million and potential future payments totaling up to $700 million [4][5] - The norovirus program reported positive phase I results, showing a 25-fold increase in GII.4 fecal IgA response and a 10-fold increase in GI.1 fecal IgA response over baseline [14][15] Market Data and Key Metrics Changes - The company acknowledges the ongoing prevalence of COVID-19 and the need for new solutions, indicating a sizable market opportunity despite a decrease in vaccination rates [35] - Norovirus remains a significant health concern, with an economic cost exceeding $10 billion in the U.S., highlighting the urgent need for effective vaccines [9] Company Strategy and Development Direction - The partnership with Dynavax is seen as a major milestone, validating the potential of the oral vaccine platform and providing critical non-dilutive capital [5][8] - The company aims to advance its pipeline of vaccines, including norovirus, flu, and HPV, while actively seeking strategic partnerships [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaboration with Dynavax, emphasizing its importance for advancing the COVID-19 program and the overall potential of the oral vaccine platform [17] - The company remains committed to securing partnerships for its other vaccine candidates, including norovirus, and anticipates initiating the next clinical trial in 2026 [10][16] Other Important Information - The company is focused on maintaining a strong cash position while exploring non-dilutive funding options and managing expenses prudently [16] - The next scheduled update will be during a webcasted fireside chat on November 18, where further questions from stockholders will be addressed [18] Q&A Session Summary Question: Why did Dynavax decide to reach a deal now instead of waiting for data from the Sentinel cohort? - Management indicated that the partnership was based on the scientific potential of the platform and the good fit between the companies, rather than solely on clinical data [22][23] Question: Can the company start the phase 2b trial for norovirus by itself with the additional funding? - Management expressed excitement about the validation from Dynavax and indicated ongoing discussions with potential partners for all assets, including norovirus [26][28] Question: How does the company view the current COVID season compared to last year? - Management noted that while fewer people are taking COVID shots, there remains a good market opportunity for oral vaccines, which offer advantages over traditional methods [35]

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]

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 [7] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - Net product sales were $86 million, primarily driven by COVID vaccine sales, with total revenue for the quarter at $108 million, a 35% decrease year over year [13][16] - R&D expenses were $856 million, a 19% decrease year over year, while SG&A expenses were $212 million, down 23% year over year [14][15] Business Line Data and Key Metrics Changes - The U.S. accounted for about one-third of total sales, with lower vaccination rates compared to Q1 last year due to the transition of COVID into routine seasonal vaccination patterns [12][13] - Cost of sales represented 104% of net product sales this quarter, up from 58% in the prior year, driven by lower volume and revenue mix [14] - The oncology portfolio was expanded with the Checkpoint Medicine program, which is expected to drive future sales growth [10][26] Market Data and Key Metrics Changes - The company received approvals for its vaccines in multiple international markets, including Australia, Taiwan, the UK, and Switzerland, enhancing its competitive position [9] - The company anticipates a total addressable market of over $30 billion for its upcoming product approvals [40] Company Strategy and Development Direction - The company is focused on three priorities: driving sales for approved products, advancing its late-stage pipeline, and delivering cost efficiency across the business [39] - The company plans to achieve significant cost reductions, targeting a cash cost of approximately $4.2 billion by 2027 to meet its breakeven target by 2028 [21][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in light of recent data showing high efficacy rates for their updated vaccine [53] - The company remains engaged with the FDA and continues to have productive exchanges regarding its ongoing product reviews [52] Other Important Information - The company is planning a total reduction in annual GAAP expenses of over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The company is actively monitoring for additional cases of Guillain-Barré syndrome (GBS) in its trials and has lifted the clinical hold on its norovirus study [92] 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 that they continue to see a need for COVID vaccination, especially among older Americans [52][53] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable based on historical event rates [57] Question: COVID strain selection process moving forward - The strain selection process will depend on guidance from regulatory bodies, with updates expected within the next month [75] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38% and that inventory levels are being managed by customers [100] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis but indicated that a large number of cases are expected [105]