Core Insights - Moderna Inc. reported a significant year-over-year decline in third-quarter revenue, dropping 45% to $1.02 billion, although this figure exceeded Wall Street expectations of $829.1 million [1] - The company experienced a per-share loss of $0.51, which was better than the anticipated loss of $2.21, primarily due to a substantial reduction in operating expenses [2] - The decline in revenue was influenced by falling infection rates and changes in vaccination guidance from the CDC, which recommended that COVID-19 shots be administered only after shared decision-making with healthcare providers [3] Financial Performance - Quarterly revenue fell to $1.02 billion, a 45% decrease year-over-year, but surpassed the Bloomberg consensus estimate of $829.1 million [1] - The per-share loss of $0.51 was narrower than the expected loss of $2.21, aided by reduced operating expenses [2] - Full-year revenue expectations have been adjusted to a range of $1.6 billion to $2.0 billion, down from a previous forecast of $1.5 billion to $2.2 billion [4] Market Context - Moderna, like its peers in the vaccine market, is facing challenges due to decreased infection rates and evolving vaccination guidelines [3] - The timing of the CDC's announcement regarding vaccination recommendations has been cited as a contributing factor to the decline in U.S. revenue [4]

Financial Performance - For Q3 2025, the company reported net product sales of $973 million, a decrease of 46% compared to $1.8 billion in Q3 2024[115] - The net loss per share for Q3 2025 was $(0.51), contrasting with a net income per share of $0.03 in Q3 2024[115] - Total revenue for Q3 2025 decreased by $846 million, or 45%, to $1,016 million compared to Q3 2024[130] - Net product sales for Q3 2025 were $973 million, down $847 million, or 47%, from $1,820 million in Q3 2024[130] - Net loss for Q3 2025 was $200 million, compared to a net income of $13 million in Q3 2024, representing a decline of $213 million[130] - Interest income for Q3 2025 decreased by $30 million, or 29%, totaling $73 million compared to $103 million in Q3 2024[141] - The company expects a decline in net product sales for the full year 2025 due to lower expected vaccination rates and increased market competition[131] - The company incurred a net loss of $2.0 billion for the nine months ended September 30, 2025, following net losses of $3.6 billion and $4.7 billion for the years 2024 and 2023, respectively[156] Research and Development - The company has a pipeline of 30 development candidates across 40 programs, with 37 currently in clinical studies[110] - The Phase 3 trial for the investigational CMV vaccine (mRNA-1647) did not meet its primary efficacy endpoint, leading to the discontinuation of the congenital CMV clinical development program[119] - The company anticipates significant future capital requirements for ongoing research and development activities, including new vaccine candidates and digital capabilities[157] Product Approvals and Developments - The company has received approval for the 2025-2026 formula of Spikevax in 40 countries and for mNEXSPIKE in the U.S. for adults aged 65 and older[111] - mRESVIA has been approved for adults aged 60 and older in 40 countries, and for individuals aged 18 to 59 at increased risk in 31 of those countries[112] - The 2025-2026 formula of Spikevax generated over an 8-fold increase in LP.8.1-neutralizing antibodies in at-risk individuals aged 12-64 and all adults 65 and older[119] - The 2025-2026 formula of mNEXSPIKE generated over a 16-fold increase in LP.8.1-neutralizing antibodies in the same age groups[119] - The company plans to complete submissions for approval of its seasonal flu vaccine (mRNA-1010) by January 2026[119] Operational Metrics - Cash, cash equivalents, and investments decreased by $2.9 billion, or 30%, to $6.6 billion as of September 30, 2025, primarily due to a net cash outflow from operating activities of $2.8 billion[144] - Working capital decreased by $1.0 billion, or 17%, to $4.9 billion as of September 30, 2025, primarily due to a decrease in cash and current investments[145] - Net cash used in operating activities was $2.8 billion for the nine months ended September 30, 2025, consisting of a net loss of $2.0 billion and non-cash adjustments of $519 million[150] - Net cash provided by investing activities was $2.0 billion for the nine months ended September 30, 2025, driven by proceeds from maturities and sales of marketable securities of $6.4 billion[153] - Net cash provided by financing activities decreased by $47 million, or 80%, to $12 million for the nine months ended September 30, 2025, primarily due to a decrease in proceeds from issuance of common stock[155] Deferred Revenue - As of September 30, 2025, the company had deferred revenue of $144 million related to product sales, with $79 million expected to be realized in less than one year[128] - As of September 30, 2025, the company had $144 million in deferred revenue related to product sales[149] Cost Management - Research and development expenses for Q3 2025 decreased by $336 million, or 30%, totaling $801 million compared to $1,137 million in Q3 2024[135] - Selling, general and administrative expenses for Q3 2025 decreased by $13 million, or 5%, totaling $268 million compared to $281 million in Q3 2024[138] - Cost of sales for Q3 2025 was $207 million, a decrease of $307 million, or 60%, compared to $514 million in Q3 2024[133] - Total other income (expense), net improved to $4 million for the nine months ended September 30, 2025, compared to a total expense of $58 million in 2024, driven by lower equity investment losses and reduced interest expense[142] Manufacturing Capabilities - The mRNA manufacturing facilities in Australia and the UK became operational in Q3 2025, supporting domestic mRNA manufacturing and pandemic preparedness[113] - The company launched commercial sales of its RSV vaccine, mRESVIA, in Q3 2024 and expects limited contribution to total product sales in 2025[131]

Core Insights - Moderna reported a loss of $0.51 per share in Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $2.15, compared to an EPS of $0.03 in the same period last year [1][10] - Total revenues for the quarter were $1.02 billion, exceeding the Zacks Consensus Estimate of $860 million, but representing a 45% decline year over year due to lower net product sales [1][10] Revenue Breakdown - Moderna has three marketed vaccines: Spikevax, mNexspike, and mResvia. Product sales fell nearly 47% year over year to $973 million [2] - Sales from COVID-19 vaccines amounted to $971 million, down 46% year over year, attributed to lower vaccination rates and the transition of COVID-19 to a seasonal market [2] - mResvia sales were only $2 million, significantly below the estimated $30 million, and down 80% year over year due to competition from GSK's Arexvy and Pfizer's Abrysvo [3] Operating Costs and Efficiency - SG&A expenses decreased by 5% year over year to $268 million, primarily due to cuts in consulting and external services [5] - R&D expenses were reduced by 30% to $801 million, reflecting a focus on efficiency and prioritization of clinical development [5] Guidance and Outlook - Moderna revised its total revenue guidance for 2025 to a range of $1.6-$2.0 billion, down from $1.5-$2.2 billion [6] - The company also lowered its R&D expense guidance to $3.3-$3.4 billion, from a previous estimate of $3.6-$3.8 billion, while maintaining SG&A and capital expenditure guidance at approximately $1.1 billion and $0.3 billion, respectively [7] Market Reaction - Shares of Moderna rose by 10% in pre-market trading, likely due to the company's cost-cutting measures and improved liquidity outlook, now projected to be between $6.5-$7.0 billion by year-end 2025 [8] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, including a personalized cancer therapy in collaboration with Merck [12][16] - The company discontinued development of mRNA-1647 for CMV prevention after failing to meet primary efficacy endpoints but continues to study it in mid-stage trials for bone marrow transplant patients [13] - Positive results from a phase III study for mRNA-1010, a standalone influenza vaccine, have led to plans for regulatory submissions in early 2026 [14] - The company is also working on mRNA-1083, a combination vaccine for COVID-19 and influenza, and is awaiting further guidance from the FDA [15]

Core Insights - Moderna Inc. reported a third-quarter loss of $0.51, significantly better than the expected loss of $2.02, and a reversal from a profit of $0.03 a year ago [1] - The company achieved quarterly sales of $1.02 billion, exceeding expectations of $886.54 million, although this represents a 45% decline from $1.9 billion year-over-year, primarily due to a 47% decrease in net product sales related to COVID vaccine sales [2] Financial Performance - Q3 2025 COVID vaccine sales amounted to $971 million, with $781 million from the U.S. and $190 million from international markets, while sales from the RSV vaccine totaled $2 million [4] - The cost of sales decreased by 60% year-over-year to $207 million, attributed to fewer inventory write-downs and lower manufacturing capacity utilization [5] - R&D expenses were reported at $801 million, a 30% decrease from the previous year, due to prioritization of investments and more efficient clinical trials [5] Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and investments totaling $6.6 billion, down from $7.5 billion as of June 30, 2025, mainly due to seasonal impacts on working capital [6] Guidance and Outlook - Moderna narrowed its fiscal year sales guidance to between $1.6 billion and $2 billion, compared to the consensus of $1.899 billion [7] - The projected cost of sales for 2025 is expected to be between $0.8 billion and $0.9 billion, down from $1.2 billion, while R&D expenses are projected at $3.3 billion to $3.4 billion, lowered from previous estimates [7] - Year-end 2025 cash and investments are projected to be between $6.5 billion and $7 billion, an increase from earlier expectations of about $6 billion [7] Pipeline Developments - Moderna plans to complete approval submissions for its seasonal flu vaccine (mRNA-1010) in the U.S., Canada, Australia, and Europe by January 2026 [8] - The company intends to refile for approval of the flu/COVID combination vaccine (mRNA-1083) with Health Canada in 2025 and is awaiting further guidance from the FDA, while the filing is under review with the EMA [8] Stock Performance - At the time of publication, Moderna shares were up 3.82% at $24.45, nearing its 52-week low of $23.15 [9]

Core Insights - Moderna reported a loss of 51 cents per share on $1.02 billion in third-quarter sales, which was better than analysts' expectations of a $2.12 loss per share and $880 million in sales [1][2] - The company's previous year earnings were 3 cents per share with $1.86 billion in sales, indicating a significant decline in performance year-over-year [1] - Moderna has narrowed its revenue outlook for the year to between $1.6 billion and $2 billion, which is $50 million lower than its previous forecast [2] Financial Performance - Moderna's stock surged 8.6% to $25.58 in premarket trading following the earnings report [2] - Analysts had projected a per-share loss of $9.61 and $1.89 billion in sales, indicating that the actual results exceeded expectations [2] Market Context - The stock market is experiencing mixed futures amid earnings reports, with Moderna being a notable mover [1] - The overall sentiment in the market may be influenced by Moderna's performance and guidance adjustments [2]

Group 1 - U.S. stock indices opened lower, with Dow Jones down 0.06%, S&P 500 down 0.14%, and Nasdaq down 0.26% [1] - Snap's stock rose over 17% after reporting Q3 revenue of $1.51 billion and global daily active users reaching 477 million, both exceeding expectations [1] - Duolingo's stock fell over 26% as the company lowered its Q4 booking guidance by 3.6% [1] - Moderna's stock increased over 7% after reporting Q3 revenue and EPS that surpassed expectations [1] - Nasdaq Golden Dragon Index rose 1% to 8223.78 points [1] Group 2 - Samsung Electronics completed the acquisition of European ventilation company FläktGroup, aiming to develop integrated air conditioning solutions and maximize synergies [2] Group 3 - Nissan Motor Company announced the sale of its global headquarters building in Yokohama for 97 billion yen (approximately 4.5 billion RMB), planning to continue using the building under a lease [3] - The sale is part of Nissan's operational restructuring efforts [3] Group 4 - Intel's Vice President highlighted that personal computers are undergoing a disruptive upgrade with the introduction of AI PCs, marking a significant evolution in computing [4] - Deutsche Bank reported Q3 net profit of €591 million with revenue of €2.94 billion, maintaining a forecast of approximately €2.5 billion net profit for the year [4]

Core Insights - Moderna reported a quarterly loss of $0.51 per share, significantly better than the Zacks Consensus Estimate of a loss of $2.15, representing an earnings surprise of +76.28% [1] - The company generated revenues of $1.02 billion for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 18.13%, although this is a decline from $1.86 billion in the same quarter last year [2] - Moderna has surpassed consensus EPS estimates in all four of the last quarters and has topped consensus revenue estimates three times during the same period [2] Financial Performance - The earnings report indicates a loss of $0.51 per share compared to a profit of $0.03 per share a year ago, adjusted for non-recurring items [1] - The company has shown a mixed trend in estimate revisions ahead of the earnings release, currently holding a Zacks Rank 3 (Hold), suggesting expected performance in line with the market [6] - Current consensus EPS estimate for the upcoming quarter is -$2.90 on revenues of $805.49 million, and for the current fiscal year, it is -$9.74 on revenues of $1.9 billion [7] Market Context - Moderna shares have declined approximately 43.3% since the beginning of the year, contrasting with the S&P 500's gain of 15.6% [3] - The Medical - Biomedical and Genetics industry, to which Moderna belongs, is currently ranked in the top 41% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The performance of Moderna's stock may also be influenced by the earnings outlook and trends in earnings estimate revisions, which have shown a strong correlation with near-term stock movements [5]

Financial Data and Key Metrics Changes - In Q3 2025, the company's revenue was $1 billion, a 45% year-over-year decline primarily due to lower COVID vaccine demand [4][10][12] - The net loss for the quarter was $200 million, compared to a net income of $13 million in Q3 2024, resulting in a loss per share of $0.51 [15][12] - Cash and investments at the end of Q3 were $6.6 billion, down from $7.5 billion at the end of Q2 2025 [16] Business Line Data and Key Metrics Changes - Revenue from U.S. markets was $800 million in Q3, with the majority from COVID vaccines, while international revenue was $200 million, with Canada accounting for half of that [10][11] - The cost of sales decreased by 60% year-over-year to $207 million, driven by lower inventory write-downs and reduced manufacturing capacity [14] - R&D expenses were $801 million, a 30% decrease from the previous year, reflecting lower clinical trial costs [14] Market Data and Key Metrics Changes - Cumulative retail vaccinations in the U.S. were 13.2 million as of October 24, 2025, down approximately 30% year-over-year [23][45] - The company's market share for COVID vaccines in the U.S. increased to 42%, with mNEXSPIKE accounting for 55% of COVID vaccination volume [23][65] Company Strategy and Development Direction - The company is focused on driving the use of its commercial products, advancing its pipeline, and executing with financial discipline [5][8] - Strategic partnerships have been established in Canada, the U.K., and Australia, with manufacturing facilities and multi-year offtake agreements [5][6] - The company aims to transition from a pandemic-focused product line to a diversified portfolio including seasonal vaccines and oncology medicines [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing cost reduction efforts, projecting a $500 million reduction in cash costs since the last investor call [9][31] - The company anticipates a cash break-even point by 2028, with a focus on revenue growth through geographic expansion and new product introductions [57][58] - Management acknowledged challenges in the COVID vaccination market but remains optimistic about the potential for mNEXSPIKE and other pipeline products [30][65] Other Important Information - The company announced the discontinuation of its CMV vaccine program after failing to meet primary efficacy endpoints [8][46] - The company is on track to reduce its GAAP operating expenses significantly, with a new target of $5.3 billion for 2025 [17][19] Q&A Session Summary Question: Expense management and strategy for 2026 - Management indicated that cost reductions are driven by efficiencies rather than deprioritization of investments, with a focus on optimizing R&D execution [35][36] Question: U.S. COVID revenue and inventory tracking - Management confirmed that U.S. sales are primarily measured by vaccinations, with a 30% decline in shots in arms year-over-year [42][45] Question: Norovirus program and case accrual - Management noted that slow case accrual was anticipated and does not reflect a change in the commercial opportunity for the norovirus vaccine [50][52] Question: Confidence in cash break-even guidance for 2028 - Management emphasized that achieving break-even will depend on both revenue growth and continued cost reductions [56][57] Question: Feedback on mNEXSPIKE and market share evolution - Management reported positive feedback on mNEXSPIKE, which has become the leading product in the COVID franchise, with expectations for continued growth [63][65]

Financial Data and Key Metrics Changes - In Q3 2025, the company's revenue was $1 billion, a 45% year-over-year decline primarily due to lower COVID vaccine demand [3][10] - The net loss for the quarter was $200 million, compared to a net income of $13 million in Q3 2024, resulting in a loss per share of $0.51 [12][13] - Cash and investments at the end of Q3 were $6.6 billion, down from $7.5 billion at the end of Q2 2025 [13] Business Line Data and Key Metrics Changes - Revenue from U.S. markets was $800 million in Q3, with the majority from COVID vaccines, while international revenue was $200 million, with approximately half from Canada [8][9] - Cost of sales decreased by 60% year-over-year to $207 million, driven by lower inventory write-downs and reduced manufacturing capacity [11] - R&D expenses were $801 million, a 30% decrease from the previous year, reflecting lower clinical trial costs [12] Market Data and Key Metrics Changes - The U.S. COVID vaccination market saw a 30% year-over-year decline in cumulative retail vaccinations, with Moderna's market share increasing to 42% [20][21] - The company expects fourth-quarter sales in the U.S. to range from $100 million to $400 million, with full-year U.S. revenue guidance adjusted to $1 billion to $1.3 billion [9][10] Company Strategy and Development Direction - The company is focused on driving the use of its commercial products, advancing its pipeline, and executing with financial discipline [4][6] - Strategic partnerships have been established in Canada, the U.K., and Australia, with local manufacturing facilities and multi-year offtake agreements [4][5] - The company aims to transition from a pandemic-focused business to a diversified portfolio in seasonal vaccines, oncology, and rare diseases [30][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in the COVID vaccine market but expressed confidence in the growth of mNEXSPIKE and the overall pipeline [29][30] - The company is committed to achieving cash break-even by 2028, with ongoing cost reductions and revenue growth strategies [30][56] Other Important Information - The company has discontinued the development of its CMV vaccine after failing to meet primary efficacy endpoints [6][24] - The company has narrowed its revenue guidance for 2025 to $1.6 billion to $2 billion, down from $1.5 billion to $2.2 billion [9][16] Q&A Session Summary Question: Can you help us understand what's being deprioritized to allow for expense management? - The company is driving efficiencies without deprioritizing investments, focusing on reducing unutilized manufacturing capacity and waste [34][35] Question: What is the learning from the CMV vaccine trial? - The pentamer neutralizing antibody response was not sufficient to improve prevention of infection, and further data will be analyzed [44][46] Question: Are you surprised by the slow case accruals in the norovirus program? - The company anticipated the need for a two-season study and remains confident in the commercial opportunity for a highly effective vaccine [50][51] Question: What gives you confidence in the cash break-even target for 2028? - The company sees opportunities for revenue growth through geographic expansion and new product introductions while continuing cost reductions [55][56] Question: How do you expect the split between mNEXSPIKE and Spikevax to evolve? - mNEXSPIKE has become the leading product in the COVID franchise, with expectations for continued growth, while Spikevax will still serve a specific pediatric market [60][61]

Core Viewpoint - Moderna's stock surged over 11% in pre-market trading following the release of its third-quarter earnings report, despite a significant year-over-year revenue decline [1] Financial Performance - Revenue for the third quarter was reported at $1.02 billion, a 45% decrease compared to the previous year, but it exceeded analyst expectations of $879.6 million [1] - Sales from COVID-19 vaccines reached $971 million during the quarter, which included $781 million in sales from the U.S. and $190 million from international markets [1] - The company recorded a net loss of $200 million, translating to a loss of $0.51 per share, which was significantly better than the analyst forecast of a loss of $2.11 per share [1]