This article first appeared on GuruFocus .
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Total Revenue:$1.3 billion in Q3 2026, up 29% year-over-year, driven primarily by higher COVID sales; year-to-date revenue of $1.8 billion.
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Geographic Revenue Mix:Approximately 60% US and 40% international for the quarter; year-to-date international revenue of $900 million, $200 million ahead of full-year 2025.
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Cost of Sales:$318 million, representing 24% of total revenue; up 54% year-over-year on higher product sales volume and manufacturing-related costs.
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R&D Expenses:$583 million, down 27% year-over-year, driven by study completions/wind-downs and efficiency gains.
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SG&A Expenses:$282 million, up 5% year-over-year.
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Net Income:$162 million, an improvement of $362 million versus last year.
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Diluted EPS:$0.38, compared to a loss per share of $0.51 last year.
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Cash and Investments:$8 billion at quarter end, up from $6.9 billion at the end of Q2, driven by $2.6 billion net proceeds from convertible note issuance and cap call transaction, partially offset by a $950 million litigation settlement payment and seasonal working capital impact.
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Cash Cost Reduction:Cash costs reduced 10% compared to Q3 last year.
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Convertible Financing:Raised $3 billion in 0% convertible notes; approximately $2.6 billion in net proceeds after cap calls and fees.
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Full-Year 2026 Revenue Outlook:Raised to 15%25% growth (exceeding prior framework of up to 10%); approximately even US/international split expected.
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Full-Year 2026 Cost of Sales:Unchanged at $1.7 billion, including $0.9 billion litigation settlement charge.
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Full-Year 2026 R&D Outlook:Lowered by $200 million to $2.7 billion.
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Full-Year 2026 SG&A Outlook:Approximately $1 billion, flat versus prior year.
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Full-Year 2026 Operating Expenses:Total GAAP operating expenses of $4.5 billion and $3.8 billion of cash costs (excluding the $0.9 billion litigation charge), each a $200 million improvement versus prior framework.
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Full-Year 2026 CapEx:Lowered to $200 million from prior range of $200 million$300 million.
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Year-End 2026 Cash Outlook:Projected at $8.1 billion$8.3 billion; excluding the $2.6 billion net convertible proceeds, $5.5 billion$5.7 billion (improved from prior $4.7 billion$5.2 billion).
Release Date: November 06, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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Moderna Inc ( NASDAQ:MRNA ) reported Q3 2026 revenue of $1.4 billion, a 29% year-over-year increase, driven by strong commercial performance.
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The company achieved net income of $200 million in Q3 2026, a significant improvement from a net loss in the prior year.
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Moderna Inc ( NASDAQ:MRNA ) raised its full-year 2026 revenue growth guidance to 15-25%, up from previous expectations of up to 10% growth.
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Positive Phase III results for intismeran autogene in adjuvant melanoma showed a 42% reduction in risk of recurrence or death, with even greater benefit in the MITT population.
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Moderna Inc ( NASDAQ:MRNA ) strengthened its balance sheet with $8 billion in cash and investments, aided by a $3 billion convertible debt financing at 0% interest.
Negative Points
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Cost of sales increased 54% year-over-year to $318 million, representing 24% of total revenue, due to higher product sales volume and manufacturing costs.
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The norovirus vaccine program (mRNA-1403) did not meet statistical criteria for early success in Phase III and the company decided not to enroll an additional cohort, delaying progress.
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Moderna Inc ( NASDAQ:MRNA ) recorded a $900 million litigation settlement charge, which impacted GAAP operating expenses and overshadowed gross margin improvements.
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Uncertainty remains around the U.S. filing for the combination influenza/COVID-19 vaccine (mRNA-1083) as discussions with the FDA are ongoing and timing is unclear.
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The rare disease program for methylmalonic acidemia (MMA) has been deferred pending results from the propionic acidemia (PA) trial, creating a gap in pipeline advancement.
Q & A Highlights
Q: Can you frame your confidence in the interim renal cell carcinoma (RCC) data and address questions about the LNP's contribution to immunogenicity in the melanoma trial? A: David Berman (Chief Development Officer) expressed confidence in the RCC trial, noting it is event-driven and could read out late this year or early next. He cited RCC's sensitivity to anti-PD-1 therapies and the consistent efficacy seen in both high and low TMB patients in the Phase II melanoma trial. Regarding the LNP, he stated the evidence is not strong enough to claim it contributes to immunogenicity, noting conflicting data from different cancer centers and that the LNP alone could not generate the strong hazard ratio observed.
Q: What are the gating steps for the BLA submission for the individualized neoantigen therapy (INT) in melanoma, and when might we see data from the lung cancer studies? A: Stephen Hoge (President) stated the company is working intensely with Merck to ensure the BLA submission happens this year, with the goal of approval next year. This includes preparing for pre-approval inspections. David Berman (Chief Development Officer) added that the adjuvant lung cancer study is fully enrolled, but it is too soon to predict a readout as they have just started monitoring events.
Q: What is the potential for the Phase II RCC study to support a registration, and what are the key inputs for pricing the INT therapy? A: David Berman (Chief Development Officer) noted the Phase II RCC study is large and well-controlled but is still a Phase II. He stated that positive data could be practice-informing, and if results are very strong, they could consider taking it to the FDA. Stephen Hoge (President) commented on pricing, stating it is premature to discuss but that Moderna will always look to price its products to represent the value they create for healthcare systems.
Q: Can you elaborate on the next development steps for the pancreatic cancer program following the Phase I data, and what is the strategy for the upcoming Phase II RCC study? A: David Berman (Chief Development Officer) stated the pancreatic cancer data was exciting because they could generate T-cells reactive to neoantigens in a low-TMB tumor. Next steps are being discussed with Merck and could include the same regimen or combination with a RAS inhibitor. For the RCC study, he noted they are stratifying by histology and risk, and believe the approach can work across multiple subpopulations as long as neoantigens are present.
Q: What will the upcoming presentation for mRNA-2808 add beyond the initial response data, and what are the drivers behind the increased 2026 revenue guidance? A: David Berman (Chief Development Officer) said the mRNA-2808 data at ASH will include more patients and longer follow-up, and will evaluate activity in patients with prior BCMA and GPRC5D treatment. He noted it's the first time three antigens have been targeted, proving the platform's ability to multiplex. Jamey Mock (CFO) added that the 2026 revenue guidance increase is broad-based, driven by strong performance of the updated COVID vaccine in the U.S. and strategic international partnerships.
Q: What changed in the norovirus vaccine program that led to the decision not to enroll another cohort, and what is the path forward? A: Stephen Hoge (President) explained that the Phase III study did not meet the criteria for early success. After reviewing the program, the company decided the most appropriate next step was not to proceed with the planned cohort but instead to consult with regulators to determine the future of the program. He stated it was premature to guide further until those discussions are complete.
Q: How does Moderna's antigen selection algorithm account for non-canonical antigens like endogenous retroviral elements in RCC, and what is the protective moat for the INT platform? A: David Berman (Chief Development Officer) stated that while the role of endogenous retrovirals is an interesting hypothesis, their algorithm already includes indels, which are important in RCC. He noted recent publications show sufficient neoantigens can be identified without them. Stephen Hoge (President) added that the proprietary algorithm is a part of the drug, and the company's growing experience and data from thousands of neoantigens across multiple trials serve as a significant protective moat.
Q: What have you learned about the optimal number of neoantigens to include in the INT therapy? A: David Berman (Chief Development Officer) stated that in melanoma, 34 selected neoantigens are sufficient to achieve a strong hazard ratio. He noted that while they are learning more about what makes an optimal neoantigen, it's not clear if more is always better, as the current results against Keytruda are already very strong. He added that the Phase III data will be crucial to decode these questions further.
Q: Can you provide an update on the timeline for the COVID-plus-flu combination vaccine in the U.S.? A: Stephen Hoge (President) stated that the company is now in the process of engaging with the FDA following the recent launches of its updated flu and COVID vaccines. He noted that this will take some time, and in the next few months, they will better understand the FDA's expectations for a submission. An update will be provided once that information is available.
Q: What is the breakdown of the international revenue growth, and how much of it is durable versus opportunistic? A: Jamey Mock (CFO) stated that a significant portion of international revenue is very durable, with strategic partnerships comprising over 50% of the total. He also highlighted that growth is coming from other markets where Moderna is increasing its share and where vaccination rates are becoming more stable, which he hopes will be a durable trend moving forward.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
