Moderna Inc. (NASDAQ:MRNA) on Friday reported a fourth-quarter loss of $2.11, beating the expected loss of $2.59, lower than a loss of $2.91 a year ago.The COVID-19 vaccine maker reported quarterly sales of $678 million, topping the expected $626.097 million.Total revenue was on the higher end of the company's prior expectations and was driven primarily by COVID vaccine sales.Product sales were $264 million in the U.S. and $381 million in international markets. Fourth quarter revenue decreased 30% year over ...

分组1 - Moderna reported a quarterly loss of $2.11 per share, better than the Zacks Consensus Estimate of a loss of $2.6, and an improvement from a loss of $2.5 per share a year ago, resulting in an earnings surprise of +18.75% [1] - The company achieved revenues of $678 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 2.81%, although this represents a decline from year-ago revenues of $966 million [2] - Moderna has outperformed the S&P 500, with shares increasing by about 36% since the beginning of the year, while the S&P 500 has declined by 0.2% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$2.14 on revenues of $254.87 million, and for the current fiscal year, it is -$6.70 on revenues of $2.09 billion [7] - The Medical - Biomedical and Genetics industry, to which Moderna belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Moderna Stock Pops On Fourth-Ouarter Report, But Can It Overcome Recent FDA Setbacks? | Investor's Business DailyBREAKING: [Core CPI Inflation Falls To 2.5%. Lowest Since 2021 --- Moderna (MRNA) stock popped Friday after the company reported better-than-expected fourth-quarter sales and reiterated its guidance for 10% sales growth in 2026. But the company was mum on the prospects for it to hit breakeven in 2028. Earlier this week, the Food and Drug Administration refused to review Moderna's experimental flu ...

Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of the COVID vaccine Spikevax and mNEXSPIKE [4][10] - Operating expenses decreased by $2.2 billion, or 30% year-over-year, reflecting significant cost management efforts [4] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - Cash and investments at the end of 2025 totaled $8.1 billion, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE becoming the leading product in the U.S. shortly after its launch [7] - Total revenue for the fourth quarter was $700 million, with $300 million from the U.S. and $400 million from international markets [10] - U.S. revenue for the full year was $1.2 billion, while international revenue was $700 million [10] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, particularly with mNEXSPIKE [11] - Internationally, the company achieved revenue at the higher end of expectations, driven by operational performance and vaccination rates [11] Company Strategy and Development Direction - The company aims for up to 10% revenue growth in 2026, primarily from international markets and local manufacturing in the U.K. and Australia [15][16] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated launch of multiple vaccines in Europe by 2027 [20][22] - The company is focused on expanding its oncology pipeline and expects significant clinical milestones in 2026 [32] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting challenges in the regulatory environment [5] - The company remains optimistic about its growth potential, citing strong momentum heading into 2026 with multiple levers for revenue growth [19][33] - Management emphasized the importance of cost discipline and the adoption of AI tools to improve productivity [33] Other Important Information - The company announced a five-year strategic agreement with the government of Mexico for respiratory vaccine supply [7] - A new Chief Development Officer, Dr. David Berman, was appointed to enhance the oncology pipeline [9] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management noted that the flu filing is under review in Europe, Canada, and Australia, with the U.S. refile pending a Type A meeting with the FDA [37] - The INT program for adjuvant melanoma is event-driven, with data expected this year [41] Question: Thoughts on flu and COVID combination vaccine refile - The company is awaiting feedback from the FDA on what is needed to refile the mRNA-1010 program [45] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [46] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market share in Europe, with mNEXSPIKE expected to be competitive [54] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [57]

Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of its COVID vaccine Spikevax and mNEXSPIKE [4][10] - Operating expenses decreased by $2.2 billion, or 30% year-over-year, reflecting significant cost management efforts [4] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - Cash and investments at year-end totaled $8.1 billion, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE quickly becoming the leading product in the U.S. [7] - Total revenue for the fourth quarter was $700 million, with $300 million from the U.S. and $400 million from international markets [10] - The U.S. revenue for the full year was $1.2 billion, while international revenue was $700 million [10] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, particularly with mNEXSPIKE capturing 24% of the total U.S. retail market [11][25] - Internationally, revenue performance was driven by operational efficiency and vaccination rates meeting expectations [10] Company Strategy and Development Direction - The company aims for up to 10% revenue growth in 2026, primarily from international markets and local manufacturing in the U.K. and Australia [15][16] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated launch of multiple vaccines in 2027 [20][22] - The company is focused on expanding its oncology pipeline and expects significant clinical milestones in 2026 [32] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting regulatory uncertainty as a challenge for innovation [5] - The company remains optimistic about its growth trajectory, citing strong momentum and multiple levers for revenue growth [19][33] Other Important Information - The company has completed enrollment in several late-stage oncology studies and anticipates data readouts in 2026 [28][32] - A new Chief Development Officer has joined the company, expected to enhance the oncology pipeline [9] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management is pleased with the flu filing progress in Europe and Canada, with the U.S. refile dependent on the Type A meeting with the FDA [36] - The INT program for adjuvant melanoma is event-driven, with data expected this year [40] Question: Thoughts on flu and COVID combination vaccine re-filing - The company is awaiting feedback from the FDA on what is needed for re-filing the mRNA-1010 program [43] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [45] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market than the current $700 million estimate, with mNEXSPIKE expected to capture significant share [52] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [55][57] Question: Higher-than-expected cash balance explanation - The cash balance exceeded expectations due to lower cash costs and strong working capital performance [60] Question: Details on the adjuvant phase 3 melanoma study and Norovirus confidence - The adjuvant melanoma study includes interim analyses, with the first expected this year [65] - The Norovirus vaccine is targeting older adults, with a different approach than previous studies [68]

Financial Data and Key Metrics Changes - In 2025, the company reported revenues of $1.9 billion, primarily driven by sales of its COVID vaccine Spikevax and mNEXSPIKE [5][11] - Operating expenses decreased by $2.2 billion, or 30%, compared to the previous year [5] - The net loss for the year was $2.8 billion, an improvement from a net loss of $3.6 billion in 2024 [14] - The company ended the year with $8.1 billion in cash and investments, down from $9.5 billion at the end of 2024 [14][15] Business Line Data and Key Metrics Changes - The company had three products on the market in 2025: Spikevax, mNEXSPIKE, and mRESVIA, with mNEXSPIKE quickly becoming the leading product in the U.S. [7] - For the fourth quarter, total revenue was $700 million, with $300 million from the U.S. and $400 million from international markets [11] - The U.S. revenue totaled $1.2 billion for the full year, while international revenue was $700 million [11] Market Data and Key Metrics Changes - In the U.S., despite a decline in overall COVID market demand, the company maintained strong market share in the retail channel, supported by the successful launch of mNEXSPIKE [12] - Internationally, operational performance and vaccination rates exceeded expectations, contributing to revenue growth [11] Company Strategy and Development Direction - The company aims for total revenue growth of up to 10% in 2026, primarily driven by international markets and local manufacturing agreements in the U.K. and Australia [15][16] - The company plans to launch mNEXSPIKE and its combination flu-COVID vaccine in Europe by the 2027 winter season, expanding its market share [20][21] - Strategic partnerships in Latin America and Asia Pacific are expected to drive growth, alongside the anticipated approval of its flu vaccine in multiple countries [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the FDA's refusal to file letter regarding the flu program, highlighting the challenges posed by regulatory uncertainty [6] - The company remains optimistic about its pipeline and expects continued clinical momentum, particularly in oncology and infectious disease programs [32][33] Other Important Information - The company has completed enrollment in several late-stage cancer studies and anticipates data readouts in 2026 [9][28] - A new Chief Development Officer, Dr. David Berman, will join the company, bringing extensive experience in clinical-stage immunotherapies [10] Q&A Session Summary Question: Implications of flu RTF on cash flow break-even guidance and INT program timing - Management noted that the flu filing is under review in Europe, Canada, and Australia, with the U.S. refile pending a Type A meeting with the FDA [36][37] - The INT program for adjuvant melanoma is event-driven, with data expected this year [42] Question: Thoughts on flu and COVID combination vaccine refile - The company is awaiting feedback from the FDA on what is needed to refile the mRNA-1010 program, with a comprehensive data set already submitted [45][47] - The phase III study for mRNA-1010 showed superior efficacy compared to standard vaccines [49][50] Question: European COVID vaccination market and flu vaccine strain selection - The company anticipates a larger market share in Europe, with mNEXSPIKE expected to be competitive [56][58] - Discussions on better strain matching for flu vaccines are ongoing, with strong support from international regulators [59][61]

Core Insights - Moderna (MRNA.US) has several key events to watch in 2026, including financial performance, vaccine approvals, and clinical data releases Financial Performance - The company plans to release its Q4 and full-year 2025 financial report on February 13, 2026 [2] Project Advancements - In the seasonal vaccine sector, the independent flu vaccine mRNA-1010 is expected to receive regulatory approval in multiple regions in 2026 [3] - The RSV vaccine mRESVIA is anticipated to have Phase III clinical trial data available in 2026 [3] Product Development Progress - In oncology, the personalized cancer vaccine mRNA-4157, developed in collaboration with Merck, may announce Phase III clinical trial data in 2026 [4] - The company's independently developed cancer vaccine mRNA-4359 is expected to have potential Phase II clinical data released in 2026 [4] - Ongoing Phase II/III clinical trials for indications such as non-small cell lung cancer will continue [4] Rare Disease Initiatives - The therapy mRNA-3927 for propionic acidemia has achieved target enrollment for its registration study, with data expected in 2026 [5] - The clinical Phase III study for the norovirus vaccine mRNA-1403 will undergo interim analysis in 2026 [5]

Core Insights - Moderna reported Q4 revenue of $678 million, surpassing estimates of $663 million, while total sales fell 29% year-over-year due to declining COVID vaccine demand [1] - The company significantly reduced annual operating expenses by $2.2 billion, exceeding cost-reduction targets, and narrowed its quarterly loss by 26% year-over-year [1] - The FDA declined to review Moderna's flu vaccine application, delaying diversification efforts beyond COVID vaccines, which negatively impacted share prices [1] Financial Performance - Q4 revenue was $678 million, compared to a loss of $2.11 per share, better than the expected loss of $2.64 [1] - Full-year 2025 revenue was $1.94 billion, down 40% from $3.24 billion in 2024, with a reduced net loss of $2.82 billion from $3.56 billion [1] - The company held $8.1 billion in cash and investments at year-end 2025, after drawing $600 million from its credit facility [2] Cost Management - R&D spending in Q4 decreased by 31% to $775 million as the company wound down Phase 3 respiratory programs [1] - The operational efficiency achieved through cost discipline is highlighted as a significant achievement for the quarter [1] Market Dynamics - International product sales reached $381 million, surpassing U.S. sales of $264 million, indicating a strategic shift towards markets with better vaccine adoption [1] - The company secured international partnerships, including a five-year agreement with Mexico for up to 10 million COVID-19 vaccine doses [1] Regulatory Challenges - The FDA issued a Refusal-to-File letter for Moderna's flu vaccine, delaying its U.S. market entry but maintaining potential revenue from international markets [1] - Despite the setback, the company maintains that it will not impact its 2026 financial guidance [1] Future Outlook - Management projects revenue growth of up to 10% in 2026, estimating approximately $2.13 billion in sales with a balanced split between U.S. and international markets [1] - The company is advancing multiple oncology programs and rare disease therapeutics, with significant data readouts expected in 2026 [2] Valuation Considerations - Moderna's market capitalization stands at $15.67 billion, trading at 7x trailing sales despite ongoing losses [2] - Analysts have a consensus price target of $38.40, with mixed ratings reflecting the company's transition challenges [2]

Fourth Quarter 2025 Financial Results This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2026 financial framework, including up to ten percent revenue growth and further cost reductions in 2026; Moderna's year-end cash balance; Moderna's multi-year revenue growth strategy; Moderna's expectations regarding durable growth supported by strategic agreements and global approvals; M ...

Core Viewpoint - Moderna continues to target a 10% revenue growth for the year, indicating a positive outlook despite recent financial performance [1] Financial Performance - The company's fourth-quarter loss has narrowed compared to the same period last year, suggesting improvements in financial health [1]