Moderna (NasdaqGS:MRNA) 2025 Analyst Day November 20, 2025 09:00 AM ET Company ParticipantsAmanda Sorrento - Head of HR CoreDarren Edwards - Program Leader for mRNA-1283Nathan Sauveur - Manager of HR Technical OperationsRaffael Nachbagauer - Head of Platform and Technology Integration and VP of DevelopmentNone - Company RepresentativeCraig Kennedy - Head of Global Supply ChainDan Culpdon - Senior Fellow leading Computational Design and In Vitro SelectionGerhard Eller - Senior Director of Global Logistics an ...

Core Insights - Moderna reported Q3 CY2025 revenue of $1.02 billion, a 45.4% year-on-year decline, but exceeded Wall Street expectations by 32% [1][6] - The company's full-year revenue guidance was lowered to $1.8 billion, 4.4% below analysts' estimates [1][6] - GAAP loss per share was $0.51, significantly better than the consensus estimate of -$2.38, representing a 78.6% beat [1][6] Financial Performance - Revenue: $1.02 billion vs analyst estimates of $769.6 million, reflecting a 45.4% decline year-on-year [6] - EPS (GAAP): -$0.51 vs analyst estimates of -$2.38, a 78.6% beat [6] - Adjusted EBITDA: -$208 million vs analyst estimates of -$911.9 million, indicating a 77.2% beat [6] - Operating Margin: -25.6%, down from -3.8% in the same quarter last year [6] - Market Capitalization: $9.50 billion [6] Management Commentary - Management attributed the outperformance to cost discipline, with a 34% reduction in combined costs compared to last year [3][5] - Future growth is expected to rely on expanding the commercial portfolio, particularly in respiratory and oncology segments [4] - The company aims to reach cash breakeven by 2028 through revenue growth and further cost reductions [4]

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]

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]

Financial Performance - Moderna's 3Q25 revenue was approximately $1.0 billion[7], with total revenue for the first three quarters of 2025 reaching approximately $1.3 billion[13] - The company experienced a net loss of $0.2 billion in 3Q25[8] - Operating expenses decreased by 34%, a reduction of $656 million, from 3Q24 to 3Q25[8] - Cash and investments stood at $6.6 billion as of September 30, 2025[8], a decrease of $0.9 billion or 12% compared to June 30, 2025[19] Revenue Outlook - The projected total revenue for FY 2025 is expected to be in the range of $1.6 billion to $2.0 billion[15] - Expected 4Q revenue from U S is projected between $0.1 billion and $0.4 billion[15] - Expected 4Q revenue from RoW (Rest of World) is projected between $0.3 billion and $0.4 billion[15] Cost Management - The company anticipates a $0.5 billion improvement in 2025 projected cash costs compared to the 2Q25 projection, and a $0.9 billion improvement compared to the January 2025 projection[11] - Moderna is ahead of plan on cash cost reduction, with a $0.9 billion improvement in the 2025 projection year-to-date[49] - The company is increasing its ending 2025 cash range to $6.5 billion - $7.0 billion, up by $0.5 billion - $1.0 billion from the prior framework[49] Product Development - The updated 2025-26 formula for Spikevax has been approved in 40 countries[9, 35] - mRESVIA has been approved in 40 countries for adults 60 years and older, and also approved in 31 of those countries for high-risk adults aged 18-59[10, 35]

Core Insights - Moderna, Inc. reported third quarter revenue of $1.0 billion, with a GAAP net loss of $(0.2) billion and a GAAP EPS of $(0.51) [1] - The company narrowed its 2025 projected revenue range to $1.6 - $2.0 billion [1] - Expected GAAP operating expenses for 2025 were improved by $0.7 billion to a range of $5.2 - $5.4 billion [1] - The expected year-end cash balance for 2025 was increased by $0.5 billion - $1 billion to a range of $6.5 - $7.0 billion [1] - CEO Stéphane Bancel highlighted strong commercial and financial performance in Q3, driven by COVID vaccine sales and cost-reduction initiatives [1]

Core Insights - Moderna is a leading player in the biopharmaceutical industry, focusing on mRNA technology for vaccines and therapeutics across various disease categories [1] - The company has been recognized as a top employer for eleven consecutive years, reflecting its commitment to innovation and employee values [2] - In 2025, Moderna received approval for mNEXSPIKE, a new COVID-19 vaccine targeting specific age groups, supported by investments in advanced manufacturing [3] - The company emphasizes social responsibility through its charitable foundation and the integration of AI and robotics in its operations [4] - Despite recent achievements, Needham maintained a Hold rating for Moderna, with the stock price at $26.01 [5][6] Company Developments - Moderna's focus includes developing vaccines and therapeutics for infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases [1] - The approval of mNEXSPIKE marks a significant milestone in expanding Moderna's product portfolio [3] - Investments in manufacturing hubs in Australia, Canada, and the UK enhance the company's pandemic readiness [3] Recognition and Ratings - The company has been recognized as a top employer in the biopharmaceutical industry for eleven consecutive years, highlighting its workplace culture [2][6] - Needham's Hold rating indicates a cautious outlook despite the company's ongoing developments and market interest [5][6] Social Responsibility and Innovation - Moderna's commitment to social responsibility is demonstrated through its charitable foundation and annual health impact report [4] - The integration of AI and robotics is aimed at driving innovation and creating a lasting impact in medicine [4]

Core Insights - Moderna is transitioning to a new era, aiming to leverage its mRNA technology beyond COVID-19, with new vaccine approvals and a focus on cancer and artificial intelligence [2][4] - The company has faced significant challenges post-pandemic, with a notable decline in revenue and increased competition, raising questions about the sustainability of its recovery [2][3] Financial Performance - In the second quarter, Moderna reported total revenue of $142 million, a significant drop from pandemic highs, and a net loss of $825 million, although this was an improvement from a $1.3 billion loss a year prior [4] - The company has maintained strong cash and investment reserves of $7.5 billion, which provides a buffer as it navigates the post-COVID-19 landscape [5] - Operational expenses have been reduced by 40% year-over-year on a cash-cost basis, saving $581 million compared to the same period in 2024 [5] Product Development and Approvals - Moderna received three key FDA approvals this year, including mNEXSPIKE, mRESVIA for RSV, and full approval of Spikevax for children aged six months to 11 years, indicating progress in stabilizing its vaccine portfolio [6] - The company revealed promising Phase 3 data for its flu vaccine, which could lead to a flu-COVID-19 combination shot, enhancing its market position [7] - Moderna is expanding its non-respiratory vaccination and rare disease portfolios, and strengthening its oncology collaboration with Merck, focusing on customized neoantigen therapy [7]

Financial Performance - Total revenue for Q2 2025 was $142 million, a decrease of 41% compared to $241 million in Q2 2024[12] - Net product sales decreased by 38%, from $184 million in Q2 2024 to $114 million in Q2 2025[12] - Net loss was $825 million in Q2 2025, a 35% improvement compared to a net loss of $1279 million in Q2 2024[12] - Operating expenses decreased by 35%, a reduction of $555 million, from $1604 million in Q2 2024 to $1049 million in Q2 2025[8, 12] - Cash, cash equivalents, and investments decreased by 11%, from $84 billion as of March 31, 2025, to $75 billion as of June 30, 2025[8, 14] Pipeline and Approvals - The company received three new U S FDA approvals, expanding the commercial portfolio[9] - Positive Phase 3 data for mRNA-1010, the flu vaccine, showed superior relative vaccine efficacy compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older[9, 35] Financial Outlook and Cost Reduction - The company updated its 2025 GAAP financial framework, lowering the high end of the total revenue range from $25 billion to $15 - $22 billion, primarily due to the timing of UK COVID shipments moving from 2H25 to 1Q26[15] - The company is reducing 2025 GAAP operating expenses by approximately $04 billion and progressing toward intermediate-term cost reduction goals[16] - The company continues to target cash breakeven in 2028[55]