A：The primary driver of year-over-year revenue growth for Moderna in the first quarter was a significant increase in revenues, mainly due to the full realization of a long-term strategic partnership with the UK Government.

A：The impact of the litigation settlement on Moderna's financial results for the first quarter was a reported net loss of $1.5 billion due to the previously announced settlement, which was excluded from the net loss figure provided. Cost of sales included a $878 million charge related to the settlement.

A：A new phase III clinical trial for non small cell lung cancer for patients with stage 1 disease was initiated. The trial is the first phase 3 study evaluating a vaccine in a monotherapy arm in early-stage disease. An oral presentation at the upcoming ASCO meeting will cover the prior year update of the phase 1b trial in metastatic melanoma. Additionally, new clinical data for MRI 4359, currently in phase 2 for patients in stage 4 disease, was presented at the AACR meeting.

A：The expected revenue range for the second quarter is between $50 and $100 million, evenly split between US and international markets, which would bring the first half revenue to approximately $440 to $490 million. The revenue growth is attributed to strong international performance, primarily from deliveries under long-term strategic partnerships.

A：The cost of sales for the quarter was $955 million, which includes $878 million related to a litigation settlement with Arbus and Genova. Excluding this item, cost of sales was $77 million, a 14% year-over-year decline on a non-GAAP basis, driven by reduced unutilized capacity costs, losses on purchase commitments, and inventory write-downs, partially offset by higher sales volume.

A：The net loss for the quarter was $1.30 per share, compared to a loss of $1.00 per share in the prior year. The decrease per share is primarily driven by the litigation settlement. Excluding this item, the net loss would have been $0.500 billion, or $1.18 per share, down significantly versus the prior year.

A：Modern ended the first quarter with cash and investments of $7.5 billion, compared to $8.1 billion at the end of 2025. The decrease was primarily driven by operating losses as Moderna continued to invest in R&D and advance its pipeline.

A：The company's commercial spend is expected to be more heavily weighted to the second half of the year due to the seasonality of its commercial business.

A：The company expects to end 2026 with between $4.5 to $5 billion of cash and investments.

A：The multi-year growth strategy is anchored in geographic expansion and continued advancement of the product pipeline, aiming for 10% revenue growth by 2026, supported by long-term strategic partnerships in the United Kingdom, Canada, and Australia, and the continued growth of their mRNA vaccine.

A：Recent regulatory approvals include the European Union authorizing an expanded indication for an influenza vaccine for individuals 12 and older and adults 50 and above, and setting a date for the U.S. FDA's PDUFA. These approvals are expected to contribute to revenue growth starting in 2027.

A：The oncology programs include expanding the Phase 3 study of Intis Marin, advancing studies in non-squamous cell lung cancer, and initiating another Phase 3 study in non-squamous cell lung cancer. Progress includes multiple late-stage studies fully enrolled and awaiting interim readouts, as well as Phase I studies in pancreatic and gastric cancers.

A：The PA (Propionic acidemia) program is fully enrolled in its potentially registrational study. The MMA program's start has been deferred until after receiving pivotal data from the PA program later in 2026.

A：The company continues to expect up to 10% revenue growth and aims to deliver an adjusted cash cost target of approximately $4.2 billion. They are focused on AI reinvention across the company and expect other approvals for their products in additional geographies. Key focus areas in oncology include data for Intis Marin and Mrna 4359, and waiting for phase 2 data for other programs.

A：The FDA's review is expected to continue through to the PDUFA date on August 5, during which the company will work hard to address any questions that may arise. The company's senior leadership, including the CEO and other executives, is not typically involved in these reviews; they are conducted by the review staff within the office of vaccinestaff. The company has been in back-and-forth communications with the office of vaccinestaff and does not expect the new acting director to influence the review outcome. The company looks forward to engaging with the leadership broadly across its portfolio.

A：The phase 3 trial for the adjuvant melanoma is being powered based on phase 2 data, which showed a strong hazard ratio. Although the trial's powering assumptions have not been disclosed, the company believes the trial is very well powered to show success with a similar hazard ratio to the phase 2 data. The company is looking for a range of outcomes that could indicate success, including overall survival data that might be better than expected, even if the relative survival (RFS) is not. The company feels well powered for the upcoming interim analysis and looks forward to potential success in either the interim or subsequent analyses.

A：The company has not disclosed the specific timing for data from the RCC and bladder cancer studies, as these studies are event-driven and the timing is dependent on the occurrence of certain events. However, the company is excited about the potential performance of the drug across different tumor types, particularly in RCC, where there is an opportunity for significant improvement. Since the trials are event-driven, the company is blinded and will not know the results until a sufficient number of events occur for a proper analysis. The company hopes to have results within this year or early next year. Good data would likely demonstrate a meaningful clinical benefit, potentially warranting a move towards a phase 3 pivotal study or a quicker progression through earlier stages of study.

A：The company has not provided any statistical guidance for the phase three interim analysis for Int. However, they have indicated that they are proceeding with the interim analysis because they believe there is a chance of success, which could be demonstrated by a relatively early look at the data. The hazard ratio for the current phase is not the same as in the previous phase 2; there have been some differences in the populations, but a significant result between the first and second interim analyses is still possible. The company is excited about the data and is optimistic about the first interim, but they acknowledge that even if it is not successful, there is still potential in the second and final analyses. The company has reserved 'alpha' for these potential outcomes, emphasizing the potential commercial importance of these results.

A：The potential outcomes of the RCC study include improvement in real estate survival, with a hazard ratio of 0.72, suggesting substantial room for improvement even if it is not at the maximum possible effect. The study has about 300 participants, which is about twice as large as the adjuvant melanoma study. The study has potential registrational significance, meaning it could lead to a lower statistical threshold for declaring a strong result. The focus is on preserving the study's potential for registration if a strong signal for the drug's efficacy is found.

A：The key unknown in the timing of the RCC study is the trigger for conducting an analysis based on events. The Data Safety Monitoring Board (DSMB) will review the results and advise whether to declare an early success, remain blinded, or consider alternative utility outcomes. The decision to run a phase 3 study will be based on these recommendations and the need for either a quick analysis if a strong signal is present or a more powered study if further investigation is needed.

A：The stage of cancer diagnosis, especially stage 1, affects potential revenue recognition between the speaker's company and their partner because it influences the timing and nature of product sales. Cancer is diagnosed relatively late, but with better screening tools like low-dose computed tomography (LDCT) for lung cancer, there's an increasing number of earlier stage diagnoses. This shift towards earlier detection aligns with the revenue recognition process, as sales of the product are expected to start higher initially and decrease as the cost of goods sold comes down with increased production efficiency. The revenue will be shared based on the company's percentage of profit from the product sales.

A：There are significant opportunities for early-stage cancer detection in lung cancer, primarily through screening with low-dose computed tomography (LDCT). This has led to an increase in early-stage diagnoses, with a rise of almost a third in stage 1 and stage 2 diagnoses over the last decade. The U.S. has seen a commensurate decrease in later-stage diagnoses. Early detection is crucial as it can lead to better treatment outcomes and potentially reduce the number of stage 3 and 4 diagnoses. The goal is to demonstrate a benefit-risk profile that can justify earlier intervention and impact the number of advanced-stage diagnoses.

A：In the adjuvant setting, studies are looking into alternative IO combinations. Although initial focus was not on IO combinations due to associated toxicity, the company's partner Merck is interested in exploring subsequent value in alternative IO combinations. There is ongoing work in this area, including one-to-two agent combinations with other agents like vaccines in the off context, which are being assessed for potential benefits in specific populations.

A：Norovirus infections can lead to profound dehydration and significant exacerbations of underlying medical diseases, which can result in hospitalization and deaths, especially among those over the age of 75 or with comorbidities. Therefore, reducing such burdens would be value-creating for the healthcare system.

A：Overall survival benefit is critical for Intrap of O 1 as demonstrating relapse-free survival (RFS) has been a good predictor of survival and correlates with progression-free survival (PFS). The company has released data on RFS, Dmfs, and an OS trend from a phase I study and plans to present five-year updates at an upcoming conference. The phase 3 data will include the observation of OS, and phase 2 data will follow suit over time.

A：Q2 revenues were largely driven by COVID, with an expectation that RSV will not be a significant growth driver in 2026. Projected revenue split is about a 50/50 mix between the US and international markets. The anticipated revenue for the year is $1 billion, with $400 million from outside the US and $100 million from the US. The company expects some amount of decline, and the revenue guidance for the year is up 10%.

A：Moderna focuses on building an impactful platform for mRNA modalities to enable the development of various medicines using the same technology components. They are investing heavily in expanding new modalities and have been acquiring companies and engaging with science worldwide to increase their portfolio. The company does not have a pipeline problem but an abundance of products, and they are prioritizing those that can be developed quickly to return to breakeven while maintaining discipline on costs.

A：Moderna's commercialization strategy for the COVID-19 vaccine includes initially focusing on securing market access, pricing, and reimbursement across major markets in Europe. The company aims to help healthcare systems understand the economic value proposition of a combined flu and COVID-19 vaccine. While not expecting revenue in the year of approval, Moderna hopes to achieve a successful launch in 2027 in the initial markets with pricing and access, potentially reaching a more significant uplift in 2028. They aim to capture a substantial share of the respiratory vaccine market, supported by real-world effectiveness data, to deliver benefits to patients, payers, and healthcare systems.