Core Insights - Moderna reported a loss of $2.11 per share in Q4 2025, which is an improvement compared to the Zacks Consensus Estimate of a loss of $2.60 and a loss of $2.91 in the same quarter last year [1][6] - Total revenues for the quarter were $678 million, exceeding the Zacks Consensus Estimate of $659.5 million, but reflecting a 30% decline year over year due to lower net product sales [1][3] - Year-to-date, Moderna's stock has increased by 26%, outperforming the industry growth of 18% [1] Financial Performance - Overall product sales decreased by 31% year over year to $645 million, primarily due to reduced sales volume of COVID-19 vaccines [3] - The company generated $33 million from grants, collaborations, licensing, and royalty revenues, marking an 18% increase year over year [4] - For the full year 2025, Moderna's total revenues were $1.94 billion, down 40% year over year, with a loss of $7.26 per share, which is an improvement from a loss of $9.28 per share in the previous year [7] Cost Management - Selling, general and administrative (SG&A) expenses were $308 million, down 12% year over year due to reductions in consulting and external services [5] - Research and development (R&D) expenses decreased by 31% to $775 million, reflecting prioritization and efficiency in clinical development [5] Future Guidance - Moderna expects total revenues to grow by up to 10% in 2026 compared to 2025 levels, with a revenue split nearly equal between domestic and international operations [8] - The company is targeting operating expenses of approximately $4.9 billion, including $3 billion for R&D and $1 billion for SG&A [8] - Capital expenditure is projected to be between $0.2 billion and $0.3 billion [8] - Moderna anticipates ending 2026 with cash and cash equivalents between $5.5 billion and $6.0 billion [9] Pipeline Developments - Moderna is developing over 30 mRNA-based investigational candidates across various clinical stages, including a late-stage study for a norovirus vaccine [10] - The company faced a setback when the FDA refused to review its filing for a seasonal flu vaccine due to inadequacies in the supporting study [11] - An important candidate in the pipeline is intismeran autogene, a personalized cancer therapy being evaluated in collaboration with Merck across multiple pivotal studies [12][13]

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 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]

Core Insights - Moderna experienced significant growth during the early pandemic due to its rapid development of a coronavirus vaccine, with stock prices soaring over 700% and peak vaccine sales exceeding $18 billion in 2022 [1][2] - As demand for coronavirus vaccines declined, the company shifted its focus towards cost-cutting and developing a seasonal vaccine portfolio, including opportunities in oncology and rare disease therapeutics [2][9] - Recent setbacks include the U.S. FDA's decision not to review Moderna's flu vaccine application, leading to a more than 3% drop in stock price [3][4] Company Developments - Moderna's mRNA technology has been pivotal in its success, allowing the company to produce two coronavirus vaccines, Spikevax and mNEXSPIKE, both adapted for the 2025-2026 season, along with a respiratory syncytial virus (RSV) vaccine [7][8] - The company aims to launch its flu vaccine, mRNA-1010, in the global market for the 2027-2028 flu season, which is a critical component of its growth strategy [8] - Despite a recent failure of its cytomegalovirus (CMV) vaccine candidate in a phase 3 trial, Moderna continues to advance its oncology candidates and early-stage programs for rare diseases, planning to reinvest revenue from seasonal vaccines into these initiatives [9]

Core Insights - The fourth-quarter earnings season is ongoing, with major pharmaceutical companies set to announce their results, including AstraZeneca, Incyte, Gilead Sciences, Vertex Pharmaceuticals, and Moderna [1] Industry Overview - Several large pharmaceutical companies such as Johnson & Johnson, Lilly, AbbVie, Biogen, Merck, and Amgen reported better-than-expected fourth-quarter results, surpassing estimates for both earnings and revenues. In contrast, Novartis and Sanofi had mixed results, with earnings exceeding estimates but revenues falling short [2] - As of February 4, 40% of companies in the Medical sector, representing 73.9% of the sector's market capitalization, reported quarterly earnings. Among these, 87.5% exceeded earnings estimates, and 75% surpassed revenue estimates. Year-over-year, earnings increased by 3.3%, while revenues rose by 9.5%. Overall, fourth-quarter earnings for the Medical sector are expected to decline by 1.5%, while sales are projected to increase by 9.1% compared to the previous year [3] Company-Specific Insights AstraZeneca - AstraZeneca's performance has been mixed, with earnings beating estimates in two of the last four quarters, meeting once, and missing once, resulting in an average surprise of 3.81%. The consensus estimate for fourth-quarter sales is $15.78 billion, with earnings expected at $2.18 per share [5] - Key medicines, particularly cancer drugs and diabetes medicine, are expected to drive fourth-quarter sales, supported by strong demand trends [7] - AstraZeneca is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [8] Incyte - Incyte has a mixed history of earnings surprises, beating estimates in three of the last four quarters, with an average surprise of 14.35%. The consensus estimate for fourth-quarter sales is $1.35 billion, with earnings expected at $1.94 per share [9] - Strong sales of Jakafi and expected growth in Opzelura sales are likely to contribute to revenue growth in the fourth quarter [11][12] - Incyte is also set to report its fourth-quarter and full-year 2025 earnings on February 10 [12] Gilead Sciences - Gilead Sciences has a mixed earnings surprise history, beating estimates in three of the last four quarters, with an average surprise of 7.80%. The consensus estimate for fourth-quarter sales is $7.57 billion, with earnings expected at $1.83 per share [13] - Increased sales from Biktarvy and Descovy, along with growth in the Liver Disease portfolio, are anticipated to drive top-line growth [14] - Gilead is scheduled to report its fourth-quarter and full-year 2025 results on February 10 [15] Vertex Pharmaceuticals - Vertex has a mixed earnings surprise history, beating estimates in two of the last four quarters, with an average surprise of 2.01%. The consensus estimate for fourth-quarter sales is $3.17 billion, with earnings expected at $5.07 per share [16] - Revenue growth is likely to be driven by higher sales of its cystic fibrosis medicine, Trikafta, and contributions from newer drugs [18] - Vertex is set to report its fourth-quarter and full-year 2025 results on February 12 [19] Moderna - Moderna has a strong earnings surprise history, beating estimates in all of the last four quarters, with an average surprise of 31.45%. The consensus estimate for fourth-quarter sales is $661.4 million, with expected earnings showing a loss of $2.60 per share [20] - Revenue is expected to be primarily driven by sales of COVID-19 vaccines, although demand has declined recently [22] - Moderna is scheduled to report its fourth-quarter and full-year 2025 earnings on February 13 [23]

Core Insights - Moderna is expected to exceed expectations in its fourth-quarter and full-year 2025 results, with earnings having previously beaten estimates by 76.28% in the last quarter [1] - The Zacks Consensus Estimate for sales is $661.4 million, with an anticipated loss of $2.60 per share [1] Product Portfolio and Sales Expectations - Moderna has three marketed products: two COVID-19 vaccines (Spikevax and mNexspike) and an RSV vaccine (mResvia), with overall product sales estimated at $627 million, primarily driven by COVID-19 vaccines [2] - Minimal sales are expected from the RSV vaccine due to strong competition from GSK and Pfizer [3] Pipeline Developments - A key candidate in Moderna's pipeline is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, showing promising results in a mid-stage study for high-risk melanoma [4] - Intismeran is currently being evaluated in three pivotal phase III studies, with additional mid-stage studies for other cancer types [5] - Investors are keen on updates regarding the progress of intismeran and other pipeline candidates [5] Combination Vaccine and Regulatory Updates - Moderna's mRNA-1083, a COVID-19/influenza combination vaccine, is on track for FDA resubmission after addressing efficacy data concerns [6] - Positive late-stage data for the standalone flu shot, mRNA-1010, supports the efficacy of the combination vaccine [6] Earnings Performance and Stock Movement - Moderna has consistently beaten earnings estimates over the past four quarters, with an average surprise of 31.45% [7] - Over the past year, Moderna's shares have increased by nearly 29%, compared to the industry's 39% growth [8] Earnings Prediction - The model predicts an earnings beat for Moderna, with an Earnings ESP of +3.16% and a more accurate estimate of a loss of $2.52 per share compared to the consensus estimate of a loss of $2.60 [11][12]

Core Viewpoint - Moderna is facing a $5 billion patent-infringement lawsuit regarding its COVID-19 vaccine, Spikevax, which allegedly infringes on lipid nanoparticle technology patented by Genevant Sciences and Arbutus Biopharma [1]. Legal Proceedings - U.S. District Judge Joshua D. Wolson denied Moderna's request for summary judgment, allowing the jury to decide on the patent infringement claims [1]. - The judge emphasized the importance of patent law, stating that copying inventions is not permissible, even with expedited vaccine development under "Operation Warp Speed" [2]. Technical Aspects of the Case - The lawsuit centers on the delivery mechanism of the vaccine, specifically how Messenger RNA (mRNA) is protected by lipid nanoparticles, which are claimed to be patented by the plaintiffs [3]. - Arbutus Biopharma asserts that their research involved identifying specific "molar ratios" of lipids necessary for the vaccine's safety and efficacy [3]. Government Immunity Defense - Moderna's defense strategy included invoking section 1498, which protects government contractors from patent infringement lawsuits, arguing that the vaccine was developed under a federal program [4]. - However, the judge ruled that section 1498 applies only if the product was intended for the government itself, not the general public, which could expose Moderna to $5 billion in damages [5]. Patent Validity and Infringement - The jury will also evaluate the scientific validity of the patent claims and the concept of "literal infringement," with the judge allowing certain technical requests regarding how patent infringement can be established [6].

Moderna's Chief Medical Officer Jacqueline Miller, who led the development of the company's mRNA-based COVID-19 vaccine Spikevax, will step down effective March 2, the vaccine maker said on Friday. ...