James M. Mock
Thanks, Stéphane, and hello, everyone. Today, I'll cover our second quarter financial results. our updated 2025 full year outlook and share our strategy to achieve our 2027 operating cost targets. Let's begin with our second quarter financial results on Slide 7. Net product sales were $114 million, primarily driven by COVID vaccine sales. The U.S. accounted for approximately 80% of sales this quarter with the remainder from international markets. While product sales declined 38% compared to the second quarter of 2024, sales were slightly above our expectations due to a stronger-than-expected U.S. spring booster season. We also recorded $28 million in other revenue, bringing total revenue to the quarter to $142 million. The year-over-year decline in other revenue was primarily driven by a $30 million upfront licensing payment that was recognized in the second quarter of last year. Cost of sales for the quarter was $119 million, which was relatively flat compared to $115 million last year. It represented 105% of net product sales this quarter, up from 62% in the prior year, driven primarily by lower volume. R&D expenses were $700 million in the second quarter, down 43% from last year. The decline was primarily driven by the wind down of our respiratory trials and lower clinical manufacturing costs. We also had year-over-year reductions in preclinical and external service costs, reflecting ongoing portfolio prioritization and productivity efforts. Last year's results also included an expense for a priority review voucher. SG&A expenses were $230 million for the quarter, down 14% year-over-year. The decrease reflects broad-based cost reductions across external services, personnel and commercial activities as we continue to streamline operations and manage expenses with discipline. Our income tax provision for the quarter was immaterial, consistent with the prior year. We continue to maintain a global valuation allowance against the majority of our deferred tax assets. which limits our ability to recognize tax benefits for the quarter. Net loss for the quarter was $825 million, a $454 million improvement compared to a $1.3 billion loss in the second quarter of 2024. Loss per share was $2.13, an improvement from a loss of $3.33 in 2024. We ended Q2 with cash and investments of $7.5 billion, down from $8.4 billion at the end of Q1. The decrease was primarily driven by the operating loss for the quarter. Moving to Slide 8, I will share our updated 2025 financial framework. For total revenue, we are updating our 2025 projected revenue range to $1.5 billion to $2.2 billion, reflecting a $300 million reduction at the high end. This change is primarily due to a timing shift of U.K. COVID shipments from the second half of 2025 into the first quarter of 2026. The timing shift for the U.K. shipments is due to the government's use of their fiscal year minimum purchase -- product purchase for the spring campaign in 2026. So our deliveries will now deliver in 1Q 2026. This represents the vast majority of the $300 million impact. Importantly, the timing shift does not impact the total value of our long-term multiyear contract with the U.K. government. Our updated revenue range continues to reflect the uncertainties in vaccination rates the competitive market environment, the size of the RSV market and timing of licensure of our factories and product approvals in Australia and Canada. On a geographic basis, we are updating U.S. product sales -- we are expecting U.S. product sales of $1.0 billion to $1.5 billion, international product sales of $0.4 billion to $0.6 billion and other revenues of approximately $100 million, where the majority is international. For U.S. product sales of $1.0 billion to $1.5 billion, the high end of the range assumes flat year-over-year performance after adjusting for last year's $200 million prior period return reserve reversal. The low end of the range factors the potential combined impacts from lower vaccination rates and competitive market pressures. For international product sales of $0.4 billion to $0.6 billion, the low end of the range is mainly from secured contracts, while the high end factors in incremental revenue from active tenders. The range now also reflects the shift in shipments for the U.K. from the second half of 2025 to the first quarter of 2026. For other revenues of $100 million, we've already recognized $50 million in the first half of the year and expect a similar amount in the second half. The majority of the revenue is associated with our new manufacturing sites but also includes some grant, collaboration, licensing and royalty revenue. The split of our 3Q and 4Q revenue mix will be dependent on timing of regulatory approvals across the world, and the number of days available to ship in the third quarter. We expect the revenue split of 40% to 50% in Q3 with the balance in Q4. Our cost of sales estimate of $1.2 billion remains unchanged and reflects year-over-year improvements in manufacturing efficiency, offset by increased costs associated with the go-live of our new international manufacturing sites. Newly introduced tariffs are not expected to have a material impact on our cost of sales. We continue to monitor changes to global tariffs. We are lowering our R&D expense forecast from $4.1 billion to a range of $3.6 billion to $3.8 billion due to Phase III trial wind- downs, continued portfolio prioritization and productivity. Our revised R&D guidance projects an increase in the second half versus the first half, driven by the seasonality of vaccine spend as well as studies in support of regulatory approvals. SG&A expenses are still expected to be $1.1 billion. Similar to last year, we expect higher SG&A expenses in the second half of the year, primarily due to commercial-related activity but also due to severance charges associated with the workforce reduction we announced yesterday. We expect taxes to be negligible in 2025. Our capital expenditures projection has been lowered from $400 million down to $300 million due to our continued prioritization and efficiency gains. We still expect to end 2025 with approximately $6 billion in cash and investments. Moving to Slide 9. As discussed on last quarter's call, we are planning a total reduction in annual GAAP operating expenses of over $6 billion from $11 billion in 2023 to $5 billion or less in 2027. On a cash cost basis, which excludes stock-based compensation, depreciation and amortization, we are decreasing annual operating expenses from $8.9 billion in 2023 to our midpoint target of $4.2 billion in 2027, which is a reduction of over 50%. Our revised 2025 GAAP operating expense range is now $5.9 billion to $6.1 billion, a $400 million reduction at the midpoint from our previous guidance of $6.4 billion. This updated guidance puts us on track to achieve the first $5 billion of our overall $6 billion reduction in annual GAAP expenses in 2 years. Our updated 2025 guidance includes $0.9 billion of noncash expenses from stock-based compensation, depreciation and amortization. Excluding those noncash items, we now project a 2025 cash cost of approximately $5.1 billion. At the midpoint of the range, a $400 million reduction from our previous cash cost estimate of $5.5 billion. The strong progress in cost reductions to date has been a company-wide effort. While we continue to drive additional cost reductions in all areas, the largest source of future reductions will come from R&D, which represents over 60% of our cost base. On the next slide, I want to share our strategy to achieve our 2027 operating expense targets in more detail. On Slide 10, you can see our GAAP and cash cost targets for 2025 versus 2027. At the midpoint of our ranges, we are targeting a $1.1 billion GAAP cost reduction from $6 billion in '25 to $4.9 billion in '27 and a $900 million cash cost reduction from $5.1 billion in '25 to $4.2 billion in '27. There are 4 primary drivers to achieve this goal, which are all relatively evenly split in impact. First, a reduction in R&D expenses from the completion of our large Phase III trials. We are already seeing the impact of the completion of most of our respiratory trials in 2025, and we'll start to see future cost savings by 2027 from the completion of our Phase III trials for CMB and norovirus. This includes both direct trial costs as well as reductions in clinical manufacturing and other related overheads. These cost reductions will be partially offset by select investments in the pipeline such as our oncology portfolio. Second, we will continue to drive manufacturing efficiencies, which will impact both cost of sales and R&D. We have already made strong progress over the past few years to optimize our manufacturing footprint from endemic level demand of our COVID vaccine. We expect to drive additional savings through process improvements as well as reductions in future inventory write-downs. For example, in 2024, we had $0.5 billion of inventory write-downs, which we are actively driving to reduce in 2025 and beyond. Third, we continue to drive procurement savings. Some of the savings from the renegotiated contracts already taken place will not be fully realized until 2026. Additionally, we have a strong pipeline of new savings initiatives. Fourth, we announced a workforce restructuring yesterday that impacts approximately 10% of our employees and will lower our employee base to under 5,000 by the end of the year versus 5,800 at the beginning of the year. Headcount reductions are always difficult decisions as they impact valued colleagues who have contributed meaningfully to our mission. However, these actions are necessary to reshape our capabilities and align to our long-term operating cost structure. In summary, in just 2 years, the team has made tremendous progress towards our 4-year roughly $5 billion cash cost reduction plan. By the end of 2025, we have taken nearly $4 billion of cost out of the business and have an achievable plan to remove another $1 billion over the next 2 years. We remain committed to breaking even on a cash cost basis in 2028 and will adjust spending as necessary. With that, I will now turn the call over to Stephen.