The paragraph is an introduction to Moderna's First Quarter 2025 Conference Call, where company representatives will discuss financial results and business updates. Lavina Talukdar, Head of Investor Relations, introduces the call and states that Stephane Bancel (CEO), Stephen Hoge (President), and Jamey Mock (CFO) will be the main speakers. The call will include forward-looking statements with associated risk factors. Stephane Bancel begins the presentation by noting that Q1 revenues were $0.1 billion with a $1 billion loss, aligning with expectations due to the seasonal nature of the respiratory vaccine business.

In the second paragraph of the article, it is reported that the company concluded the quarter with $8.4 billion in cash and investments, while also achieving a 19% reduction in combined costs for sales, R&D, and SG&A compared to the previous year. The company has made progress in its three primary goals: expanding markets for commercial products, advancing its pipeline for sales growth and diversification, and maintaining financial discipline. Key achievements include winning a tender opportunity for a COVID vaccine business in Europe and securing approvals for mRESVIA in various countries. The company is expanding its oncology portfolio and advancing its Phase 3 flu program. It is also making progress with its INT program and managing expenses effectively. The paragraph concludes with a transition to remarks from Jamey Mock.

The article discusses the company's financial results for the first quarter, highlighting net product sales of $86 million primarily from COVID vaccines, with a third coming from the U.S. and the rest from international markets. Total revenue for the quarter was $108 million, a 35% decrease from the previous year, but in line with expectations due to seasonal vaccine sales and lower vaccination rates. The cost of sales was $90 million, a decrease from the previous year due to lower sales volume. R&D expenses dropped by 19% to $856 million, mainly due to reduced spending on respiratory programs, while SG&A expenses decreased by 23% to $212 million thanks to cost-cutting measures. An income tax provision of $7 million was recorded, similar to the previous year, due to a valuation allowance on deferred tax assets.

The article discusses Moderna's financial performance and outlook. In the recent quarter, the company reported a net loss of $1 billion, an improvement from the previous year's $1.2 billion loss. Loss per share also improved, and the company ended the quarter with $8.4 billion in cash and investments, down from $9.5 billion, primarily due to operating losses. Looking ahead to 2025, Moderna maintains its revenue guidance of $1.5 to $2.5 billion, with early sales reflecting the seasonality of its respiratory vaccine business. However, new product revenue isn't factored into this guidance due to uncertainties in product approvals. The cost of sales is expected to be $1.2 billion, with improvements in manufacturing and upcoming site operations in Australia, Canada, and the U.K. The company notes that new global tariffs haven't significantly impacted its operations, as the U.S. drug substance manufacturing occurs domestically.

The company plans to outline new plants in Australia, Canada, and the U.K. by 2025 and reports that material sourced from China is not significant to its total cost. In 2025, R&D expenses are expected to be around $4.1 billion, and SG&A expenses approximately $1.1 billion, with an emphasis on efficiency and commercial execution. Although pleased with early cost reductions, the company is not updating its full-year guidance yet but expects minimal taxes and $400 million in capital expenditures. They aim to end 2025 with $6 billion in cash and investments and plan $1.4 billion to $1.7 billion in cost reductions by 2027 to achieve a 2028 breakeven target. The 2026 GAAP operating expense forecast is reduced to $5.4 billion to $5.7 billion, with cash costs around $4.7 billion. For 2027, they plan further GAAP expense reductions to $4.7 billion to $5 billion and a cash cost of $4.2 billion.

The paragraph outlines a plan to reduce annual GAAP expenses by over $6 billion from 2023 to 2027, representing a 55% decrease. In 2024, the company achieved $4 billion in expense reductions, primarily by restructuring their manufacturing operations for COVID vaccine production and reducing SG&A and R&D costs. Future cost reductions will mainly come from R&D due to completing Phase 3 trials and achieving procurement savings. The company is optimistic about meeting future cost targets as they continue to identify savings opportunities and have been experiencing significant year-over-year declines in R&D and SG&A expenses. Stephane Bancel then transitions the discussion to review the current pipeline.

The company has filed for regulatory approvals for three programs: a next-generation COVID vaccine (mRNA-1283), an RSV vaccine for high-risk adults (mRNA-1345), and a flu plus COVID combination vaccine for those aged 50 and over (mRNA-1083). They have decided to deprioritize the combination vaccine for younger adults (aged 18-49) and focus on older adults. Additionally, they are advancing their oncology pipeline with the Checkpoint program, targeting regulatory filings for this and six other programs by 2028. The COVID vaccine and RSV vaccine have PDUFA dates set for May 31 and June 12, respectively. However, the flu COVID combination vaccine faces an extended review timeline into 2026 due to additional flu vaccine efficacy data requirements from the FDA.

The paragraph provides updates on several vaccine and therapeutic development programs. The mRNA-1010 flu vaccine is in Phase 3, with enough cases for an interim efficacy analysis expected by summer. The mRNA-1647 CMV vaccine shows lasting antibody response three years post-vaccination, highlighting its potential as an important public health tool. Recruitment for its Phase 3 efficacy study is ongoing. The FDA has lifted the clinical hold on the Phase 3 norovirus trial, now fully enrolled in the Northern Hemisphere, with approval targeted for 2026 or 2027, depending on case accrual. The PA program for rare diseases is in a registrational study, anticipating approval in 2027.

The article discusses advancements in the company's medical initiatives, highlighting the finalized registrational study design with the FDA for methylmalonic acidemia (MMA), with a trial set for 2025 and potential approval by 2028. The company is also making significant progress in its oncology portfolio, specifically in individualized neoantigen therapy and a Checkpoint program. Collaborating with Merck, they have several late-stage studies, including Phase 3 trials in melanoma and non-small cell lung cancer, as well as Phase 2 trials in bladder and renal cell carcinoma. They are expanding their intismarin program to earlier stages, with a new Phase 2 study in non-muscle invasive bladder cancer. Encouraged by early results, they are prioritizing the Checkpoint program in metastatic melanoma and lung cancer, and progressing two novel cancer antigen therapies, including mRNA-4106 for directing immune responses against tumor antigens.

The article discusses the development and evaluation of new cancer therapies, specifically focusing on a Phase 1 study for solid tumors and the Checkpoint program, mRNA-4359. The study aims to assess safety, pharmacodynamics, immunogenicity, and efficacy, particularly for mRNA-4203's role in enhancing T-cell therapy. mRNA-4359 is designed to enhance the immune system's ability to recognize and attack tumor cells through mRNA-based cancer antigens targeting PD-L1 and IDO. The Checkpoint program is being tested in a Phase 1/2 clinical study for first-line metastatic non-small cell lung cancer and melanoma, in combination with KEYTRUDA, to determine its safety, tolerability, and efficacy. Key endpoints include objective response rate, disease control rate, duration of response, and progression-free survival, alongside evaluating T-cell profile changes.

The paragraph discusses a company's strategic priorities and recent developments. They shared early Phase 1a data for a study at a medical congress in late 2024 and plan to present Phase 1b data later this year. Encouraged by initial results, they aim to expand their cancer treatment, Checkpoint, into additional indications. Stephen Hoge outlines three strategic priorities: driving sales of approved products, focusing on late-stage pipeline for growth and diversification, and achieving cost efficiency. The company plans to drive sales of its Spikevax and mRESVIA vaccines and expects 10 product approvals targeting a market of over $30 billion. Approvals for some products, like the Flu plus COVID vaccine and Norovirus, are anticipated by 2026-2027. Checkpoint AMC is added to their pipeline, with other approvals expected by 2027-2028. They emphasize cost discipline achieved in 2024 and 2025.

The company is confident in its ability to streamline its operations from 2025 through 2027, with a 2027 cash cost target of $4.2 billion, aiding in achieving a cash breakeven target by 2025. Milestones for 10 product test programs are anticipated, including regulatory decisions for free products in 2024 and approvals for COVID and flu combination vaccines by 2026. The company awaits final results of its Phase 3 CMV vaccine study in 2025 and has exceeded goals for its flu efficacy study. Oncology trials are ongoing, with durability data expected next year. The addition of the Checkpoint AMT team is promising, and data will be shared later this year. Restructuring studies for PA and MMA are underway. Overall, they express gratitude for their team's progress and cost-reduction efforts.

In the paragraph, Stephane Bancel addresses a question regarding the extended timeline for vaccine approval, now expected in 2026, due to the FDA's requirement for Phase 3 flu efficacy data. He explains that the flu study, involving 40,000 participants, will provide a comprehensive readout soon. This data is essential for assessing the value of their flu component in the flu-COVID combination vaccine. While the COVID component's efficacy was already demonstrated, the flu data review will be integrated into the combination vaccine study. This necessitates extending the review timeline as they await positive results before submitting them to the current BLA for the mRNA-1083 program. Bancel also notes that their interactions with the FDA across various submissions continue as usual.

The paragraph discusses the ongoing efforts and collaborations regarding the company's various programs, including the 1283 program and the RSV program. The company is also preparing for updates in seasonal compositions, particularly in the flu and COVID combination space. It emphasizes the need for COVID vaccinations, noting that many deaths, especially among older adults with risk factors, occurred during peak winter months among unvaccinated individuals. The paragraph highlights the effectiveness of updated vaccines, citing a Danish study showing high prevention rates for death and hospitalization. The company aims to ensure their products are accessible globally for the upcoming fall season to contribute significantly to public health. The paragraph concludes with a transition to a new question from an analyst.

Stephen Hoge discusses the timeline and expectations for several trials. He confirms that the Phase 3 melanoma study reached its target enrollment in September 2024, with a potential efficacy analysis in 2026, although this depends on event accrual. Updates on other indications, such as non-small cell lung cancer, have not been provided yet. The renal cell carcinoma Phase 2 study is fully enrolled and could yield results sooner, as events accumulate quickly in that population. There's potential for expansion into monotherapy, but specific plans will be announced later. Hoge concludes by expressing optimism regarding the Checkpoint initiative.

The paragraph discusses the current status of a medical program in its Phase 1b study, which is being evaluated for its synergistic effects with antibody checkpoints. The speaker mentions progress in non-small cell cancer and metastatic indications, and plans to explore more histologies in the future. An unidentified analyst thanks the speaker and asks about the 1283 program’s review. Stephen Hoge responds, stating that interactions with the FDA have been constructive and positive, and they remain confident in meeting the existing PDUFA date, despite recent developments in other programs such as Novavax.

The paragraph is part of a discussion about the potential impact of a reported policy change requiring vaccine trials to be conducted against a placebo. Diana, an unidentified analyst, asks whether this would affect enrollment in vaccine trials, particularly for respiratory vaccines like COVID-19 and newer ones. Stephen Hoge, responding to the question, states that their vaccine trials, including those for COVID-19, RSV, CMV, and norovirus, are already conducted as placebo-controlled studies in some stages, especially early development or in specific populations like children. He emphasizes that adapting to any new requirements will depend on FDA and HHS guidance, and that their company will cooperate to ensure they meet regulatory and public health needs.

The paragraph is part of a Q&A session during an earnings call or briefing. An analyst, Chris, asks about the process for selecting COVID-19 strains for vaccines, given regulatory uncertainties. Stephen Hoge responds, explaining that the decision is largely up to global regulators like WHO, EMA, and the FDA. They decide whether updates to vaccine strains are needed each year, similar to how flu strains are updated. Although evolving COVID strains are being tracked that might justify updates, the final decision will come from these regulators. The expectation is to hear from them within a month about their requirements for vaccine updates. Another analyst, Cory Kasimov, then shifts the discussion to a flu-COVID combination and asks about the timing and whether they need to refile with updated flu efficacy data.

The paragraph is part of a discussion involving Stephen Hoge and Cory Kasimov about the submission process for a biologics license application (BLA) to the FDA. Hoge explains that the submission of flu efficacy data could be done as an amendment or might require a broader update of the BLA submission, potentially delaying the process. The approach will depend on consultations with the FDA. Meanwhile, Kasimov acknowledges other existing data in the file and the progress being made with it. The conversation then shifts to Courtney Breen's question about new cost-cutting measures announced, inquiring about the specific milestones or changes in expectations that led to these measures, highlighting previous statements regarding top line signals as a basis for such changes.

The paragraph discusses the company's focus on cost-cutting measures and achieving a breakeven point by 2028. They are currently involved in several Phase 3 trials for various vaccines, which are expected to complete by 2027. Although they hadn't provided guidance for 2027 before, they have now extended their expectations to include it. Their strategy for cost reduction focuses on managing the cost base, aiming to lower cash costs to $4 billion by 2028. This will be achieved through ongoing cost efficiency programs, exploring procurement opportunities, and leveraging digital tools. Despite an uncertain environment, they remain confident in their ability to execute their plan and meet the breakeven target.

In this transcript segment, Dick Gottfred asks about the source of a Guillain-Barré Syndrome (GBS) case related to a norovirus vaccine trial and whether there have been additional cases in either hemisphere. Stephen Hoge responds by confirming that the clinical hold on the trial has been lifted and updated informed consent materials have been provided. He notes that no new GBS cases have occurred, which is positive but not surprising given the rarity of the condition. Hoge explains that determining causality for the GBS case might not be possible, as such cases can occur in the general population, especially among older adults. He emphasizes the importance of monitoring the frequency of such adverse events and ensuring that trial participants are informed.

The paragraph discusses updates on a Phase III norovirus study and monitors for additional cases of GBS while emphasizing optimism in advancing their enrollment after being off clinical hold. There's mention of promising evidence in TCR clonal response and vaccine efficacy, as presented at ASCO. Gena Wang from Barclays asks about concerns regarding US COVID revenue being only a fraction of Pfizer's, and Jamey Mock responds by indicating they are looking at script data, suggesting a focus on prescription and market data to assess revenue performance. The second question about flu vaccine interim data in Summer 2025 was not fully captured and needs repeating.

The paragraph features a discussion involving Stephen Hoge and Gena Wang about market share and script data. They note a 38% market share in script data for the first part of the year, relating it to a normalized $1.5 billion revenue. Hoge mentions changes in customer inventory management affecting the market. Gena Wang asks about data related to a flu vaccine expected in 2025, but Hoge states they haven't provided guidance on that yet. The conversation shifts to a Q&A with questions related to comments made at a recent ACIP meeting regarding CMV durability data, implementation challenges, and potential changes in COVID vaccine recommendations. An unidentified analyst poses these questions during the call.

In the paragraph, Jamey Mock discusses the company's progress on developing a CMV vaccine, emphasizing the importance of long-term durability of immune responses, ideally lasting five to ten years. The current data suggests strong durability, as antibody titers remain stable after two to three years. Comparisons are drawn to a related EBV program, which also shows promising durability and viral suppression. Mock expresses optimism about the CMV vaccine platform and its efficacy. Constructive discussions with the ACIP highlighted the need for a CMV vaccine and while durability was a topic, they believe they have addressed it adequately. Also mentioned is the company's role in providing data to public health officials regarding COVID so they can make informed decisions on product use.

The paragraph discusses the application of risk-based decisions for COVID-19 vaccinations, noting that older adults and those with risk factors are prioritized due to their higher risk of severe outcomes. It highlights that a significant portion of Americans under 64 also have risk factors. The text supports allowing individuals to choose vaccination for self-protection against COVID-19, especially considering ongoing deaths. It mentions the decision to deprioritize investment in a vaccine study for younger adults (18-49) and redirect funds towards oncology research. This shift reflects strategic focus on older and high-risk populations while advancing oncology innovations. Stephane Bancel adds that this decision has important strategic implications.

In the given paragraph, the discussion revolves around the importance of the respiratory medical franchise and the reduction of R&D costs post-Phase 3 trials, which allows the business to generate cash flow without further manufacturing investment. The company is strategically reallocating capital towards oncology and is excited about their programs, especially with Merck co-funding efforts. This enables quick adaptation to clinical data in areas like Checkpoint inhibitors. An analyst, identified as Shelby, asks about the political landscape affecting vaccines, specifically touching on RFK's claims about multi-antigen vaccines. Stephen Hoge responds by stating that questions regarding RFK's statements would need to be directed to him personally, and emphasizes the company's focus on products that have demonstrated efficacy and are likely to be evaluated on their risk-benefit profiles rather than political factors.

The paragraph discusses the company's commitment to providing data to support the benefits of their single and multi-antigen products, including vaccines for CMV and EBV. They emphasize their ongoing collaboration with the FDA and the ACIP CDC working groups for product recommendations, ensuring a comprehensive risk-benefit analysis. The company expresses confidence in their data and the potential of their next-generation COVID vaccine, highlighted by a large, multiyear randomized study involving 11,000 participants. They affirm the importance of presenting data objectively for regulatory review and indicate consistent progress, with no changes in business operations in the year's first half.

The paragraph concludes a call by expressing gratitude to participants, emphasizing the focus on executing the strategy, and looking forward to future communication. The operator then ends the presentation, inviting participants to disconnect and wishing them a good day.

This summary was generated with AI and may contain some inaccuracies.