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]

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 has faced challenges in maintaining revenue growth from its coronavirus vaccine but has shown a strong start in 2026 with a 58% increase in stock price, raising questions about a potential sustained bull run for the company [1]. Group 1: Recent Developments - Moderna's recent data from a five-year follow-up study on intismeran autogene, in combination with Merck's Keytruda, demonstrated a 49% reduction in disease recurrence or death for advanced melanoma patients compared to Keytruda alone [3]. - Intismeran autogene is currently in a phase 3 study and is being investigated across multiple cancer types, with a total of eight phase 2 or phase 3 studies ongoing [4]. Group 2: Market Position and Opportunities - Moderna has established itself as a leader in mRNA-based therapies and the coronavirus vaccine market, with recent clinical progress and the launch of mRESVIA, a vaccine for respiratory syncytial virus [5]. - The partnership with Merck for intismeran autogene presents a significant commercial opportunity, potentially leading to blockbuster status, despite profit-sharing with Merck [6]. Group 3: Future Prospects - Moderna is expected to make sustained clinical and regulatory progress with several candidates in mid or late-stage clinical trials, which could diversify its lineup of approved products in the next three years [7].

Market Overview - U.S. stock futures rose on Thursday following a more than 1% gain in major indices on Wednesday after President Trump withdrew tariff threats against the EU [1] - The 10-year Treasury bond yielded 4.24%, while the two-year bond was at 3.59%, with a 95% likelihood of unchanged interest rates projected for January [2] Index Performance - Dow Jones increased by 1.21% to 49,077.23 - S&P 500 rose by 1.16% to 6,875.62 - Nasdaq Composite gained 1.18% to 23,224.82 - Russell 2000 saw a 2.00% increase to 2,698.17 [10] Stocks in Focus - Intel Corp. (NASDAQ: INTC) was up 1.60% in premarket trading, projected to post quarterly earnings of 8 cents per share on revenue of $13.38 billion [7] - Microsoft Corp. (NASDAQ: MSFT) rose 1.06% after announcing a multiyear partnership with Mercedes-AMG PETRONAS F1 Team to integrate cloud and AI technologies [7] - Moderna Inc. (NASDAQ: MRNA) jumped 5.64% following positive updates on a cancer therapy study in collaboration with Merck & Co. Inc. [7] - The Metals Company Inc. (NASDAQ: TMC) gained 5.51% after a new rule by NOAA modernized regulations for deep-seabed mining permits [16] - Micron Technology Inc. (NASDAQ: MU) increased by 2.73% as CEO highlighted a memory chip shortage due to rising AI demand [16] Analyst Insights - BlackRock maintains a "pro-risk" investment stance for early 2026, driven by AI's transformative power and a supportive macroeconomic backdrop [11] - They expect the Federal Reserve to continue cutting interest rates, supported by a softening labor market and declining inflation [11] - BlackRock prefers equities over government bonds, keeping an underweight position on long-term U.S. Treasuries due to fiscal sustainability concerns [13]

Market Overview - The stock market experienced a significant rally due to positive developments in international trade, particularly the suspension of planned tariffs on EU countries by President Trump [1] - Major U.S. stock indexes saw notable gains, with the Dow Jones Industrial Average increasing by 1.2% to 49,077.23, the S&P 500 rising by 1.16% to 6,875.62, and the Nasdaq adding 1.18% to 23,224.82 [1] Company Highlights - **Intel Corporation (NASDAQ:INTC)**: - Intel's stock rose by 11.72% to close at $54.25, nearing its 52-week high of $54.41, with an after-hours gain of 1.2% to $54.92 [2] - Anticipation builds for Intel's fourth-quarter earnings report, expected to show earnings per share of 8 cents and revenue of $13.38 billion, following a previous quarter where revenue was $13.65 billion and earnings per share were 23 cents [3] - **Moderna Inc (NASDAQ:MRNA)**: - Moderna shares surged by 15.84% to $49.81, reaching a 52-week high of $50, with an after-hours increase of 4.4% to $52 [4] - Investor enthusiasm is driven by a recent update on a cancer therapy study in collaboration with Merck & Co, which showed significant improvements in recurrence-free survival for melanoma patients [5] - **The Metals Company Inc (NASDAQ:TMC)**: - TMC's stock climbed by 13.31% to $8.17, with an after-hours increase of 9.4% to $8.94 [6] - The company welcomed a new rule from the National Oceanic and Atmospheric Administration that modernizes regulations for deep seabed mining permits, aligning with TMC's strategy for transitioning to commercial production [7] - **Microsoft Corporation (NASDAQ:MSFT)**: - Microsoft's stock fell by 2.29% to $444.11, remaining below its 52-week high of $555.45 [8] - CEO Satya Nadella emphasized the need for artificial intelligence to deliver tangible benefits to maintain public trust, particularly in sectors like healthcare and education [8] - **Lucid Group Inc (NASDAQ:LCID)**: - Lucid's stock jumped by 17.88% to $11.47, with an expansion of its manufacturing partnership in Saudi Arabia enhancing its growth outlook [9] - The collaboration with Rockwell Automation aims to implement advanced manufacturing systems at Lucid's plant, providing real-time visibility and control over production lines [10]

Core Insights - Moderna's stock surged over 15% following the announcement of positive clinical trial results for its experimental skin cancer vaccine in collaboration with Merck [1] Group 1: Clinical Trial Results - Five-year follow-up data from a phase 2 study indicated that Moderna's mRNA-based therapy, intismeran autogene, combined with Merck's Keytruda, reduced the risk of recurrence or death by 49% compared to Keytruda alone for patients with high-risk melanoma [3] - Merck's Dr. Marjorie Green highlighted the significance of demonstrating the long-term potential of this combination therapy in reducing recurrence risk for stage III/IV melanoma patients [4] Group 2: Broader Implications and Future Trials - Intismeran autogene is designed to trigger an antitumor immune response based on the unique mutations in a patient's tumor, indicating a personalized approach to cancer treatment [4] - Moderna and Merck are conducting additional clinical trials to explore the potential of their technology for treating various tumors, including lung, kidney, and bladder cancers [5] - Moderna's Dr. Kyle Holen emphasized the company's commitment to oncology investments due to encouraging outcomes that showcase mRNA's potential in cancer care [5]

Core Insights - Moderna's shares increased by 13% following the announcement of preliminary sales for 2025 and business outlook for 2026 and beyond [2] - The company reported unaudited total revenues of $1.9 billion for 2025, exceeding the previous guidance range of $1.6-$2.0 billion [3] - Moderna expects operating expenses for 2025 to be between $5.0 billion and $5.2 billion, lower than the prior guidance of $5.2-$5.4 billion [3] Financial Performance - Moderna anticipates ending 2025 with cash and cash equivalents of $8.1 billion, an increase from the previous forecast of $6.5-$7.0 billion [4] - The company projects up to 10% revenue growth for 2026, with targeted operating expenses of approximately $4.9 billion [4] - For 2027, while no revenue guidance was provided, operating expenses are expected to be in the range of $4.2-$4.7 billion [5] Stock Performance - Year-to-date, Moderna's shares have risen by 20%, compared to the industry's growth of 19% [6] Pipeline and Milestones - Moderna has over 30 mRNA-based investigational candidates in various clinical stages, targeting multiple indications including cancer [9] - The company submitted regulatory filings for its seasonal influenza vaccine mRNA-1010 in several regions, with expectations for approval this year but a commercial launch anticipated next year [10] - Data readouts from late-stage studies on RSV and norovirus vaccines are expected before the end of this year [12] Oncology Focus - A key candidate in Moderna's pipeline is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, with a commercial launch targeted for next year [13] - Moderna is expanding its oncology pipeline, prioritizing the development of mRNA-4359, with a data readout expected before the end of 2026 [14]

Core Insights - The company announced a three-year business strategy aiming for up to 10% revenue growth by 2026 [1] - The seasonal vaccine franchise is expected to expand from three to up to six approved products by 2028 [1] - The company targets readouts from nine ongoing Phase 2 and Phase 3 clinical studies in its oncology pipeline, including three Phase 3 programs for intismeran autogene [1] - Expected GAAP operating expenses for 2026 and 2027 are improved by approximately $0.5 billion each year, with a path to targeted cash breakeven in 2028 [1]

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 (MRNA) is expected to report Q3 2025 earnings on November 6, with sales estimated at $860 million and a loss of $2.15 per share, indicating a significant decline from the previous year [1] - The consensus estimate for loss per share has widened from $9.50 to $9.74 over the past month [1] Earnings Performance - Moderna has beaten earnings estimates in the last four quarters, with an average surprise of 37.78%, including a 28.76% surprise in the last reported quarter [2][3] Revenue Expectations - The majority of Q3 revenues are anticipated to come from COVID-19 vaccines, with combined sales estimated at $762 million, reflecting a significant decline due to reduced demand for boosters [5][6] - Minimal sales of the RSV vaccine, mResvia, are expected at $30 million, significantly lower than competitors GSK's Arexvy and Pfizer's Abrysvo [7] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, with a focus on updates following the recent setback in the CMV vaccine program [8] - The pivotal Phase III study for mRNA-1647 failed to meet primary efficacy endpoints, leading to its discontinuation, although it continues to be studied in mid-stage trials [9] - Investors are also focused on mRNA-1083, a COVID-19/influenza combination vaccine, which is on track for FDA resubmission [10] - Intismeran autogene, a personalized cancer therapy developed with Merck, is undergoing pivotal studies, and updates on its progress are anticipated [11] Stock Performance and Valuation - Year-to-date, Moderna's shares have decreased by 40%, underperforming the industry and the S&P 500 [13][14] - The stock is trading at a premium valuation, with a price/sales ratio of 3.14 compared to the industry average of 2.33 [16] Investment Outlook - Despite significant declines in revenue, Moderna's cash position of approximately $7.5 billion allows for continued investment in pipeline development [18] - The recent CMV vaccine setback has raised concerns about the company's growth trajectory and reliance on other late-stage assets [19][20] - Plans to launch 10 new marketed products by 2028 targeting a market exceeding $30 billion are now clouded by the CMV failure and underwhelming sales of mResvia [21] - Current premium valuation and downward revisions to earnings estimates suggest caution for investors considering building positions in Moderna stock [22]