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]

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 ...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration. The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for a ...

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 - Moderna's mRESVIA vaccine generated $2 million in sales and is approved for adults aged 60 and older in 40 countries, with additional approval for high-risk adults aged 18 to 59 in 31 countries [1] - Total revenue for the third quarter was reported at $1 billion, primarily driven by COVID vaccine sales of $971 million, including $781 million in the U.S. and $190 million internationally [2] - The company anticipates full-year U.S. revenue between $1 billion and $1.3 billion, reflecting ongoing volatility in vaccination trends [5] Financial Performance - Total product sales reached $973 million, with additional revenue of $43 million from collaborations and grants [2] - Moderna reported a net loss of $200 million due to decreased revenue, despite ending the quarter with $6.6 billion in cash and investments [5] - Analysts expect a GAAP loss of $2.60 per share for Q4, with revenue projected to fall by 37% to $623.9 million [8] Pipeline and Future Growth - Moderna has three approved products, with two programs reporting positive Phase 3 results and five additional candidates in clinical studies [6] - The company is developing a seasonal flu vaccine candidate, mRNA-1010, and a flu-plus-COVID combination vaccine, mRNA-1083, with regulatory filings expected before January 2026 [6] - Moderna is also expanding into oncology and rare diseases, with multiple late-stage studies underway in partnership with Merck [7] Market Position and Analyst Ratings - MRNA stock has risen 40% year-to-date but is down 25% from its 52-week high of $55.20 [3] - Analysts rate MRNA stock as a consensus "Hold," with two analysts rating it as a "Strong Buy" and one as a "Moderate Sell" [10] - The average target price for MRNA shares is $37.35, with a high price estimate suggesting potential upside of 228% over the next 12 months [10]

Group 1 - Moderna Inc. has secured a five-year loan of $1.5 billion from Ares Management Corp, with plans to draw $600 million upfront and retain optional access to an additional $400 million through November 2027 and $500 million through November 2028 [1][2][3] - The loan provides Moderna with flexibility to fund business development opportunities or manage risk, as the company targets up to 10% revenue growth in 2026 following a significant decline in revenue from $18.4 billion in 2022 to an expected $1.6 to $2 billion in 2025 [2][3] - Projected revenue growth for 2026 is contingent upon partnerships in the UK, Canada, and Australia, as well as US demand for its next-generation COVID vaccine, mNEXSPIKE, with further growth anticipated in 2027 and 2028 from new product rollouts [3] Group 2 - Moderna is a biotechnology company that provides messenger RNA medicines in the US, Europe, and internationally, although there are opinions suggesting that certain AI stocks may offer greater upside potential with less downside risk [4]

Summary of Moderna's Analyst Day Company Overview - **Company**: Moderna - **Focus**: mRNA medicine, particularly in seasonal vaccines and oncology therapeutics Key Points Seasonal Vaccine Franchise - **Current Status**: Three approved products, with positive phase three results in flu and flu plus COVID vaccines [1][2] - **Market Opportunity**: - 250 million people aged 65 and above in OECD countries, with 90 million in Europe [2][3] - High burden of disease with up to 1 million hospitalizations annually in the U.S. [3][4] - **Technological Advantage**: mRNA technology allows for late strain selection, enhancing vaccine effectiveness [5] - **Manufacturing Flexibility**: Ability to switch between products quickly, optimizing production based on demand [6][44] Growth Drivers - **Geographic Expansion**: - Partnerships in the U.K., Canada, and Australia, with a focus on long-term contracts [17][18] - Anticipated revenue from these partnerships, with $0.2 billion expected in the first quarter [18] - **Product Launches**: - mNEXSPIKE has captured 23% of total retail shots, with nearly a third in the 65+ age group [20] - Upcoming launches include flu, COVID combination vaccines, and norovirus [22][31] - **Market Size**: - The respiratory vaccine market is projected to be $1.8 billion in 2024, with significant growth expected in RSV and flu vaccines [22][26] Financial Outlook - **Revenue Guidance**: Narrowed to $1.6 billion-$2 billion for 2025, with $1 billion-$1.3 billion from the U.S. and $600 million-$700 million from international markets [66] - **Cost Management**: R&D costs for respiratory diseases expected to decrease as large phase three trials conclude [10] - **Operating Margin Improvement**: Growth in top-line revenue, improved gross margins, and lower R&D costs anticipated [11] Oncology and Rare Diseases - **Investment Focus**: Capital generated from the vaccine franchise will be reinvested into oncology and rare disease therapeutics [12][36] - **Upcoming Products**: - Intismeran expected to launch in 2027, with potential for significant impact [12][35] - Other promising products in the pipeline include treatments for melanoma and EBV [12][36] Manufacturing Strategy - **Efficiency Improvements**: - Transition from multiple CMOs to a more streamlined manufacturing process, enhancing speed and cost efficiency [39][40] - New facilities in Canada, the U.K., and Australia to support global supply [42][50] - **Quality Control**: Maintaining high quality with a 100% success rate in drug substance manufacturing [55] Future Outlook - **Long-term Growth**: Sustained sales growth expected due to a diversified product portfolio and strategic partnerships [13][36] - **Technological Integration**: Use of AI and robotics to enhance manufacturing efficiency and reduce costs [64] Additional Insights - **Market Entry Strategy**: Plans to enter the European market in 2027, leveraging the end of pandemic-era contracts [23][24] - **Strategic Partnerships**: Ongoing discussions for partnerships in Latin America and Asia-Pacific to expand market access [25] This summary encapsulates the key insights from Moderna's Analyst Day, highlighting the company's strategic focus on seasonal vaccines, growth opportunities in oncology, and advancements in manufacturing efficiency.