The paragraph introduces the Moderna Fourth Quarter 2024 Conference Call, with participants in listen-only mode initially, followed by a question-and-answer session. Lavina Talukdar leads the call, discussing Moderna's financial results and business updates for the fourth quarter and full year 2024, as well as mentioning key speakers Stephane Bancel, Jamey Mock, and Stephen Hoge. The call includes forward-looking statements and highlights risks that could affect outcomes. Stephane Bancel begins the review, revealing that Moderna earned $3.2 billion in revenue for 2024, achieved cost savings of $2.6 billion, but also reported a loss of $3.6 billion.

The company ended 2024 with $9.5 billion in cash and investments, exceeding its $9 billion target, due to effective management of operating and capital expenditures. It announced a focus on 10 high-value programs with potential approvals in the next three years, aiming to drive sales growth beyond COVID-related products. These programs include various vaccines and treatments in respiratory, rare diseases, and oncology. The company became a multi-product entity with the approval of mRESVIA, alongside Spikevax. Significant progress was reported in its pipeline, with positive Phase 3 results in respiratory vaccines and FDA filings for new vaccines. Phase 1/2 progress was noted in norovirus and other vaccines, while oncology and rare disease programs showed promising data. Jamey Mock will discuss the financial results for Q4 and the full year 2024.

In the provided paragraph, the company outlines its 2025 financial framework and reviews its commercial performance for the fourth quarter of 2024. Net product sales for that period totaled $0.9 billion, with $0.2 billion in the US and $0.7 billion internationally. For the entire year, sales reached $3.1 billion, aligning with the lower end of their revised guidance. US sales benefited from a $0.2 billion favorable adjustment due to a prior return reserve reversal, but underlying sales volume declined because of lower vaccination rates, reduced market share, and increased competition. International sales were $1.4 billion, with $400 million from non-recurring advanced purchase agreements. Most sales came from Spikevax, while the new product, mRESVIA, had $25 million in sales. The company expects long-term growth in the RSV market. Total revenue for the fourth quarter was $966 million, a 66% decrease from the previous year, mainly due to an earlier COVID vaccine launch in the US and reduced international sales as advanced purchase agreements are phased out.

In the quarter, the cost of sales totaled $739 million, including significant expenses such as $45 million in royalties, $193 million in inventory write-downs, and a $238 million non-cash charge from terminating a contract manufacturing agreement. Despite a $190 million year-over-year decrease, lower product sales volumes led cost of sales to account for 79% of product sales, which would have been 53% without the resizing charge. R&D expenses were $1.1 billion, down 20% from the previous year due to lower costs in certain vaccine programs, although there was increased investment in norovirus and INT programs. SG&A expenses decreased 25% to $351 million, attributed to cost management efforts. An income tax benefit of $64 million was recognized, but consistent with the past, it wasn't material due to a global valuation allowance. The quarter ended with a net loss of $1.1 billion, compared to a net income of $217 million the prior year, and a loss per share of $2.91. Cash and investments increased to $9.5 billion, primarily from accounts receivable collections.

The paragraph outlines the full year 2024 financial results for a company, reporting a total revenue of $3.2 billion—a 53% decline from 2023 due to decreased product sales. Other revenue sources, such as grants and royalties, generated $127 million. Cost of sales amounted to $1.5 billion or 47% of net product sales, with improved efficiency lowering manufacturing costs. R&D expenses were reduced by 6% to $4.5 billion due to decreased clinical trial and manufacturing costs, despite purchasing two priority review vouchers. SG&A expenses decreased by 24% to $1.2 billion, benefiting from disciplined cost management and enhanced operational efficiency through digital technology and AI. The company recorded a $46 million income tax benefit versus a $772 million expense in 2023, influenced by a global valuation allowance on deferred tax assets. The net loss for 2024 was $3.6 billion, improving from a $4.7 billion loss in 2023, with a loss per share of $9.28 compared to $12.33 previously.

The paragraph highlights a significant reduction in operating expenses for 2024, with a decline of $3.9 billion on a GAAP basis, primarily driven by factors such as manufacturing resizing and increased digital tool usage. After excluding resizing charges and non-cash costs, the cash costs decreased by $2.6 billion from 2023. For 2025, the company plans to project GAAP expenses at $6.4 billion, with $5.5 billion cash costs after exemptions, which indicates a $1 billion reduction from their previous 2024 projection. The company is committed to further efficiency improvements, with a planned additional expense reduction of $0.5 billion in 2026 to support future product launches.

The paragraph outlines financial projections and expectations for 2025. Total revenue is anticipated to be between $1.5 billion and $2.5 billion, with early-year sales reflecting the seasonal nature of the respiratory vaccine business. The guidance factors in uncertainties like vaccination rates and competitive pressures, without including potential new product revenues. Cost of sales is expected to be $1.2 billion, with R&D expenses at $4.1 billion due to continued investment in the pipeline. SG&A expenses are projected at $1.1 billion, focusing on efficiency. Capital expenditures are forecasted at $0.4 billion, adjusting for a shift in spend from 2024 to 2025. The company expects negligible taxes for the year and anticipates ending 2025 with $6 billion in cash and investments. Overall, 2024 focused on financial discipline, positioning the company well for 2025.

The paragraph outlines the company's commitment to managing costs and investing in future growth, focusing on ten prioritized programs over the next three years. They have filed for approval for three key vaccines: a next-gen COVID vaccine, an RSV vaccine for high-risk adults, and a flu-COVID combination vaccine for people aged 50 and older. Updates include positive Phase 3 data for these vaccines, with impending approval dates in the United States. They are also conducting a Phase 3 efficacy study for their standalone flu vaccine, mRNA-1010, to meet potential approval requirements.

The paragraph discusses the progress and challenges in various vaccine and treatment studies. It mentions optimism for the flu vaccine efficacy analysis by the end of the current season. The CMV vaccine study did not meet early efficacy criteria, but final results are expected later this year. The norovirus vaccine Phase 3 study is on FDA clinical hold due to a case of Guillain-Barre syndrome, but timelines remain unaffected. In oncology, several late-stage studies are being conducted with Merck, including one for adjuvant melanoma fully enrolled in Phase 3. Other studies involve non-small cell lung cancer and trials for bladder and renal cancer. In rare diseases, a registrational study for Propionic acidemia is underway, and a study for Methylmalonic acidemia is planned for 2025. The overall priority for 2025 is to drive sales of approved products.

The paragraph outlines three main priorities for the company. The first priority is to enhance the use of Spikevax and mRESVIA vaccines, with expectations of a stronger market position and expanded approvals by 2025. The second priority focuses on obtaining up to 10 product approvals in the next two years, targeting a market worth over $30 billion. The third priority is to achieve cost efficiencies, demonstrated by a recent $2.6 billion reduction in 2024, and further plans to reduce cash costs to $5.5 billion in 2025 and $5 billion in 2026, aiming to reach breakeven on a cash-cost basis by 2028. Additionally, the company is set to achieve significant milestones in its methylmalonic acidemia test products and anticipates the final results of its CMV Phase 3 study in 2025.

The paragraph discusses ongoing developments in a company's mRNA platform, highlighting its progress with vaccines and studies. Flu and norovirus vaccines are in Phase 3 studies, while data collection depends on case accrual. Other studies, like INT adjuvant melanoma and MMA, are underway. The company is focused on maximizing the impact of mRNA medicines, with a strong portfolio including two approved products and multiple Phase 3 studies. It emphasizes financial discipline and cost reduction efforts. During a Q&A, Ellie Merle from UBS inquires about R&D spending flexibility and the clinical hold on a norovirus vaccine due to a GBS case. Jamey Mock reassures that there is room for R&D spending cuts, projecting a reduction from $4.8 billion to $3.6-$3.7 billion by 2027.

The paragraph discusses the company's current spending on clinical trials, primarily focused on respiratory trials, which are expected to decrease over the next two years. Additional Phase 3 trials in latent disease and oncology are also anticipated to be reduced. There is flexibility beyond the $3.6 billion budget, and further adjustments could be made if necessary. Stephen Hoge explains that Guillain-Barré Syndrome (GBS) occurs naturally and has been recorded among study participants, leading to a pause in activities to prioritize patient safety. Consequently, the FDA has placed the study on hold while reviewing the updated information and study documents.

The paragraph discusses the progress and expectations for two clinical trials. For the Norovirus study, all participants were enrolled and dosed before a case emerged, so no impact on the study's conduct or timeline is expected. Regarding a clinical hold by the FDA, they need time to review submitted materials, and any questions will be addressed. For the CMV trial, cases continue to accumulate, and despite being blinded to interim analysis, the final readout is still anticipated in 2025. The occurrence of a Guillain-Barré syndrome (GBS) case in the Norovirus study is not unexpected and has been documented, minimizing its impact on the trial.

In the article paragraph, Stephen Hoge addresses questions from Michael Yee about the timing and progress of two studies: the INT cancer vaccine and the Norovirus vaccine. Regarding the INT cancer vaccine, Hoge notes that the timing of the results depends on the actual event accrual rate in the Phase 3 study and acknowledges that 2026 is a possible timeframe for data availability, though it could be earlier or later depending on events. On the Norovirus vaccine, he explains that while the Northern Hemisphere study completed enrollment, understanding the timing will depend on hitting the event rate and the company's planning around the Southern Hemisphere enrollment.

The paragraph discusses the progress of a Norovirus study, noting that the majority of participants have been enrolled and dosed in the Northern Hemisphere. Although additional participants from the Southern Hemisphere are desired for broader epidemiological data, they may not be necessary if current enrollment is sufficient for demonstrating efficacy. The study's success hinges on obtaining enough Norovirus cases to reach the efficacy endpoint. Michael Yee expresses understanding, and Salveen Richter from Goldman Sachs inquires about the clinical criteria for the Norovirus program and potential data updates beyond melanoma studies. Stephen Hoge responds, emphasizing the goal of significantly reducing moderate-to-severe gastrointestinal symptoms, especially in high-risk groups, and mentions exploring secondary endpoints like hospitalization and healthcare service usage.

The paragraph discusses a company's progress on a vaccine development program. They have not yet disclosed their target product profile or powering assumptions for interim analyses, aiming for a meaningful reduction in moderate to severe acute gastroenteritis and future updates. They are anticipating Phase 3 readouts for adjuvant melanoma and other cancers including bladder and renal cell carcinoma. The company confirms no cases of Guillain-Barré Syndrome (GBS) with their RSV and COVID vaccines so far. They have filed for approval of a COVID-flu combo vaccine and have demonstrated efficacy for the COVID component, satisfying that requirement, while further details on vaccine efficacy are anticipated.

The paragraph discusses the status of flu and CMV vaccine trials. It highlights that Phase 3 trials for flu and combo vaccines have shown good safety and immunogenicity but efficacy for the flu component hasn't been demonstrated yet; there is optimism about the results due to a robust flu season in the Northern Hemisphere. Concerning the CMV vaccine, despite not meeting early efficacy criteria at the interim, it is still possible for efficacy to be demonstrated in the final analysis due to the initial low power and wide confidence intervals. The analysis remains blinded, and outcomes are anticipated with more cases.

The paragraph is an excerpt from a conference call transcript, where Luca Issi from RBC Capital asks questions about the company's interactions with political figures and about the Norovirus vaccine study. Stephane Bancel mentions working productively with the Trump administration and anticipates collaborating with the new team once confirmed by the Senate. Regarding the Norovirus study, Stephen Hoge explains that around 20,000 participants have been enrolled recently, and he addresses a query about the timing and causality of a Guillain-Barré Syndrome (GBS) case related to the vaccine, although specific details about the timing are not provided.

The paragraph discusses the rapid enrollment during the current Norovirus season and the cautious communication approach being taken with participants, investigators, and regulators due to some extremely rare events. It's highlighted that these events are difficult to attribute to a specific cause, and despite thorough investigation and reporting, a definitive answer may not be found. Respect for confidentiality is emphasized. The conversation then shifts to financial matters, where Jamey Mock clarifies that no changes have been made to the expense guidance. This includes distinguishing between GAAP costs, which include stock-based compensation and depreciation, and cash costs, which exclude these items. The guidance figures for cash costs from 2023 to 2026 are provided, indicating a decreasing trend.

In this paragraph, an unidentified analyst asks Stephen Hoge for more details about the reduction in metabolic decompensation events (MDEs) in a Propionic Acidemia (PA) clinical trial. Hoge explains that they've observed a significant decrease in MDEs, which will serve as the pivotal endpoint for the study's registration phase. As the trial progresses, they will compare MDE rates before and after treatment to support drug approval for PA. Following this, Courtney Breen from Bernstein shifts the conversation to discuss issues with inventory write-downs related to producing seasonal vaccines, such as COVID, flu, and RSV, and seeks insight into the future prospects in this market.

The paragraph discusses efforts to optimize inventory and manufacturing processes to reduce write-downs and excess capacity costs. Jamey Mock responds to Courtney's inquiry by explaining that despite significant reductions, the company faced $500 million in inventory write-downs and $100 million in unutilized manufacturing capacity in 2024. He notes that this is partly due to holding excessive raw materials based on projected demand. The company has reduced its inventory levels to under $300 million, aiming for improvements in this area. Additionally, they experienced overproduction due to overestimated sales, resulting in excess capacity. The focus moving forward is on better aligning production with actual demand, highlighted by terminating an unneeded contract manufacturing agreement.

The paragraph focuses on a discussion during a conference call or investor meeting where participants are asking questions regarding various topics. Stephen Hoge responds to a question from Edward Tenthoff about the Vertex Cystic Fibrosis program, explaining that they are collaborating with Vertex, who is conducting the clinical trial. The trial has moved from the single-ascending dose phase to the multiple-ascending dose phase, which involves patients receiving regular treatment to assess effectiveness on respiratory measures and addressing CF in patients unable to use small-molecule correctors. A readout from this phase is expected soon, with Vertex anticipated to provide updates on the timing. Edward Tenthoff and Jessica Fye, both analysts, are acknowledged in the conversation with further questions to Stephen Hoge.

Stephen Hoge addresses multiple topics in the paragraph. Regarding the Norovirus study, he expresses confidence that there will be no delays enrolling in the Southern Hemisphere and notes that prior enrollment of over 20,000 participants in the Northern Hemisphere should mitigate any potential impacts. On the CMV study, Hoge mentions that case accrual is proceeding steadily and that they anticipate a final analysis possibly by mid-2025, maintaining their earlier timeline prediction. Lastly, the need for vaccine efficacy data from the Phase 3 flu trial for the 1083 COVID-flu filing's approval remains an uncertainty with the FDA. No specific details about the COVID vaccine and RSV markets are provided.

The paragraph discusses the uncertainties and expectations surrounding the review process and market predictions for a flu-COVID combination product. Regulatory review questions are being addressed, particularly concerning the flu efficacy readout, which significantly impacts the overall review. Financial projections for 2024 are provided, with the US market estimated at $1.7 billion (or $1.5 billion after adjustments) and international markets at $1.4 billion, factoring in advanced purchase agreements. High-end financial expectations assume stability in market share and vaccination rates, with minimal increases in RSV. In contrast, low-end projections assume a significant decrease in both market share and vaccination rates in the US.

The paragraph involves a discussion between Jamey Mock and Simon Baker regarding company finances and trial expenditures. Jamey clarifies to Simon that a mentioned 50% spending pertains to the company's trial expenses, as detailed in their 10-K report, and not the overall R&D spend. Simon also inquires about the flu-COVID combo vaccine's approval process and the timing of potential regulatory data requests, questioning whether an early request would affect the approval timeline or risk receiving a complete response in the US, necessitating a refile. Jamey acknowledges the query, providing insight into trial allocations and related costs.

The speaker discusses their engagement in multiple regulatory processes across various regions and mentions the potential dependency on efficacy data from the 1010 study for approval of a combination product. The timing of the data readout and its influence on the regulatory review process is uncertain, and any delays or unfavorable results could affect the approval timeline. The speaker highlights ongoing discussions with regulators and notes a possible dependency on this data for approval in some areas. Simon Baker acknowledges this information, and the conversation shifts to Myles Minter, who inquires about a potential ACIP recommendation review for RSV vaccines and its impact on revenue guidance. Stephen Hoge responds, stating they are working closely with public health officials on the matter.

The paragraph discusses a company's efforts to gain approval for an RSV vaccine for high-risk populations aged 18 to 59, indicating that they are awaiting approval and hope to expand the recommendations to cover these groups. Jamey Mock mentions the company's growth in RSV, but notes that their 2025 guidance does not include potential new product approvals, such as the next-gen COVID vaccine or expanded RSV indications. Tim Anderson from Bank of America questions why the revenue guidance does not include the next-gen COVID product, considering the PDUFA date is approaching and COVID vaccines are well-established. He suggests that political changes might introduce uncertainty in approval. He also raises a question about the FDA's decision to place a norovirus program on clinical hold despite full enrollment.

The paragraph discusses the company's cautious approach to financial guidance for 2024, avoiding including revenue from unapproved products. Stephen Hoge mentions they have learned from past experiences and recognize the variability in product approval. Jamey Mock addresses a clinical hold on a Norovirus study, emphasizing proactive communication with investigators and regulators. He explains that the FDA's review is prudent and doesn't impact current study conduct in the Northern Hemisphere, where they already have 20,000 participants. The company aims to answer the FDA's questions and move forward without reinitiating enrollment. Transparency isn't the issue, as communication has been proactive.

The paragraph indicates the conclusion of a conference call. After a Q&A session, the operator thanks the participants and hands over to Stephane Bancel for closing remarks. Stephane expresses gratitude to the attendees, mentions anticipation of future discussions, and wishes everyone a good day. The operator then formally ends the presentation, allowing participants to disconnect.

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