Key Takeaways CHMP issued a positive opinion recommending EU approval of Moderna's new COVID-19 vaccine mNexspike.Per phase III data, MRNA's mNexspike was non-inferior to Spikevax, with 9.3% higher rVE overall.mNexspike showed safety comparable to Spikevax, fewer local reactions, and similar systemic adverse events.Moderna (MRNA) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the EU approval of mNexspike ( ...

Core Insights - Moderna's ambitious vision of becoming a leading pharmaceutical company has faced significant setbacks, with its market value plummeting by 90% from its peak of nearly $200 billion to under $10 billion [1][2] - The company's challenges stem from both internal strategic miscalculations and external political pressures, particularly following the COVID-19 pandemic [6][9] Group 1: Ambition and Market Dynamics - Moderna initially thrived due to the rapid development and approval of its mRNA COVID-19 vaccine, which generated $18.471 billion in revenue in 2021, propelling it into the top 20 global pharmaceutical companies [3][4] - The company aimed to leverage its mRNA technology to create a "respiratory vaccine empire" and tackle cancer with personalized vaccines, but overestimated the technology's immediate applicability beyond COVID-19 [4][5] - The failure of the CMV vaccine in Phase III trials, which had a potential market size of $2-5 billion, further eroded investor confidence and led to a significant drop in stock price [5][10] Group 2: Strategic Missteps and Financial Pressure - Moderna's aggressive expansion strategy post-COVID led to a fourfold increase in employee count from 1,500 to nearly 6,000 and substantial investments in global production facilities, resulting in over $1 billion in losses [6][7] - The company's R&D expenses surged from $496 million in 2019 to $4.845 billion in 2023, reflecting a reckless spending approach driven by overconfidence in mRNA technology [6][7] - Internal attempts to implement cost control measures were rejected, leading to a lack of accountability and vulnerability to external policy changes [7][8] Group 3: External Challenges and Regulatory Environment - Political and regulatory shifts, including the withdrawal of a dual COVID/flu vaccine application, have compounded Moderna's difficulties, as the FDA's new requirements necessitate additional clinical trials [8][9] - The political landscape has become increasingly hostile towards mRNA vaccines, with significant funding cuts and public scrutiny affecting the entire sector [9][12] - Despite holding over $4 billion in cash reserves and ongoing revenue from its COVID-19 vaccine, the uncertainty surrounding its pipeline and external pressures leaves Moderna's future precarious [11][12]

Summary of Moderna FY Conference Call (December 02, 2025) Company Overview - **Company**: Moderna (NasdaqGS:MRNA) - **Industry**: Biotechnology, specifically focusing on messenger RNA vaccines and medicines Key Points and Arguments Current Challenges and Market Dynamics - Moderna's shares have faced pressure due to decreasing immunization rates post-COVID pandemic [1][2] - The company is experiencing scrutiny regarding the safety of mRNA vaccines, particularly in light of claims related to children's deaths [2][4][6] - Vaccination rates for COVID vaccines are down approximately 27% to 30% compared to the previous year [6][9] Financial Outlook - For FY 2025, Moderna projects revenues of $1.6 to $2 billion, with $1 to $1.3 billion expected from the U.S. and $600 to $700 million from international markets [7][9] - The company anticipates that COVID-related revenues will dominate until flu and norovirus vaccines are fully integrated into their portfolio [7][10] Product Development and Pipeline - Moderna is preparing to file for regulatory approvals for seasonal flu vaccines by January 2026, targeting a market entry in 2027 [13][15] - The company has seen significant market share for its MNEXP spike vaccine, capturing 55% of the market compared to Spikevax at 45% [11] - The RSV vaccine, mRESVIA, has had a slow market entry due to competition and the need for clearer public health guidelines on revaccination [27][28] Future Growth Drivers - Moderna identifies ten growth drivers for the next three years, with a focus on expanding its vaccine portfolio, including flu and norovirus vaccines [10][12] - The company is optimistic about the potential for a combination vaccine that could increase both flu and COVID vaccine uptake [19] - The oncology segment is a significant area of investment, with ongoing trials for individualized neoantigen therapy in collaboration with Merck [38][40] Financial Strategy - Moderna ended Q3 2025 with $6.6 billion in cash and has entered a credit facility to ensure financial flexibility as it aims for break-even by 2028 [46][48] - The company is confident in its financial strategy, emphasizing low-cost, non-dilutive financing options to support its growth initiatives [46][48] Market Position and Competitive Landscape - Moderna faces competition from established players like Pfizer and GSK in the RSV market, which has seen a contraction since its peak [27][28] - The company is also exploring opportunities in the oncology space, with promising data from ongoing trials [40][42] Additional Important Insights - The company is optimistic about the future growth of its vaccine portfolio, particularly with the anticipated approval of new products and the expansion of existing ones [12][30] - There is a strong emphasis on the importance of bundling vaccines to enhance market penetration and customer engagement [16][19] This summary encapsulates the critical insights from Moderna's FY conference call, highlighting the company's current challenges, financial outlook, product pipeline, growth strategies, and competitive positioning in the biotechnology industry.

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]

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 (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]

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]

Core Insights - "Buying the dip" can be risky, especially in defensive sectors like healthcare, where stocks may continue to decline for valid reasons [1] Group 1: Moderna - Moderna transitioned from a biotech start-up to a profitable drug company in 2021 and 2022 due to high demand for its COVID-19 vaccine, Spikevax, generating billions in revenue [2] - Demand for COVID-19 vaccines has significantly decreased, leading to a sharp decline in revenue, with last quarter's total sales at just $142 million [3] - Share prices have fallen approximately 35% year-to-date and around 95% from all-time highs in 2021, with potential for further declines unless positive news is announced in the upcoming earnings report on Nov. 6 [4] Group 2: Novo Nordisk - Novo Nordisk, once a leader in GLP-1 therapies, faces increased competition from companies like Eli Lilly, resulting in a forecasted slowdown in earnings growth for this year and 2026 [5] - Earnings per share are projected to increase by only 3.8% this year and 4.8% in 2026, despite a 22% increase in 2024, with potential negative impacts from governmental pressure on GLP-1 prices [6][8] - Although Novo Nordisk appears cheap with a forward P/E ratio of 14 compared to Eli Lilly's 27, its valuation may not be justified given the growth outlook and potential price pressures [8]