Moderna Outlines Next Phase of Growth at Analyst Day

Positive Phase 3 melanoma results support preparations for potential commercialization of intismeran with Merck, subject to regulatory approval.

Rhea-AI Summary

Moderna (MRNA) raised its expected 2026 revenue growth to 15%–25% while outlining oncology development and commercial expansion plans at Analyst Day. The prior outlook was up to 10%. Moderna expects approximately 10 percentage points of gross margin expansion in 2026, excluding the litigation settlement charge.

With Merck, intismeran plus KEYTRUDA reduced recurrence or death risk by 42% versus KEYTRUDA alone in Phase 3 melanoma testing. Potential commercialization remains subject to regulatory approval. Moderna is preparing a broader mFLUSIVA launch for the 2027–2028 respiratory season.

The company expects approximately $4 billion in 2027 cash costs and approximately $9 billion in year-end 2026 liquidity, including undrawn borrowing capacity. Amendments to its $1.5 billion Ares credit facility extend maturity to 2031 and cut interest on drawn amounts by 75 basis points.

23 points · 2 major

PositiveiHow this balance works

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point. Forward-looking: it has not happened yet and may not happen.2026 revenue growth outlook increased to 15%–25%, from up to 10%.
• Major pointIntismeran Phase 3 melanoma study met its primary recurrence-free survival and key secondary distant metastasis-free survival endpoints.
• Moderate point. Forward-looking: it has not happened yet and may not happen.2026 gross margin expansion expected at approximately 10 percentage points, excluding the litigation settlement charge.
• Moderate pointCost reductions brought the previously announced 2027 cash cost framework forward into 2026.
• Moderate pointAres credit facility amendments extend maturity one year to 2031 and reduce drawn interest by 75 basis points.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Year-end 2026 total liquidity expected at approximately $9 billion, including cash, investments and undrawn borrowing capacity.
• Moderate pointmFLUSIVA received U.S. and Canadian approvals in 2026; limited U.S. launch delivered more than 110,000 vaccinations.
• Moderate pointLong-term UK, Canadian and Australian agreements provide recurring revenue and support domestic manufacturing.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Infectious disease profitability expected to improve through revenue growth, lower development spending and manufacturing efficiencies.

14 minor points

• Minor pointRemaining $900 million borrowing capacity availability extended through 2029.
• Minor pointIntismeran plus KEYTRUDA reduced recurrence or death risk 42% versus KEYTRUDA alone in Phase 3 melanoma testing.
• Minor pointIntismeran plus KEYTRUDA reduced distant metastasis or death risk 38% versus KEYTRUDA alone.
• Minor pointIntismeran combination safety was consistent with individual therapies; common adverse events were generally low-grade, transient and manageable.
• Minor point. Forward-looking: it has not happened yet and may not happen.Marlborough facility began supplying intismeran clinical study material in September 2025; global supply role expected in 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Intismeran commercialization plan calls for U.S. co-promotion with Merck; Merck will lead outside the United States.
• Minor point. Forward-looking: it has not happened yet and may not happen.Broader mFLUSIVA commercialization planned for the 2027–2028 respiratory season.
• Minor pointmCOFLU approved in Canada for adults aged 50 and older; mNEXSPIKE approved in Europe.
• Minor point. Forward-looking: it has not happened yet and may not happen.New Mexico and Taiwan agreements expand commercial opportunities in Latin America and Asia-Pacific.
• Minor pointmNEXSPIKE observational study found 35.9% lower medically attended COVID-19 risk versus Comirnaty in U.S. Veterans aged 65 and older.
• Minor pointmNEXSPIKE observational study found 47.0% lower COVID-19 hospitalization risk versus Comirnaty in the same population.
• Minor pointmRNA-2808 Phase 1/2 study observed responses in 4 of 11 heavily pretreated multiple myeloma patients.
• Minor pointmRNA-4359 is advancing in Phase 2 testing for melanoma and non-small cell lung cancer.
• Minor point. Forward-looking: it has not happened yet and may not happen.mRNA-3927 registrational study readout expected in late 2026; treatment exposure exceeds 50 cumulative patient-years.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.Annual cash costs expected at approximately $4 billion–$4.5 billion from 2027 through 2030, primarily reflecting increased oncology investment.
• Minor pointIntismeran commercialization remains subject to regulatory approval, including approvals needed for the potential Marlborough-supported launch.
• Minor pointmNEXSPIKE observational findings may reflect residual confounding, may not generalize, and do not establish comparative vaccine safety.

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CAMBRIDGE, MA / ACCESS Newswire / November 12, 2026 / Moderna, Inc. (NASDAQ:MRNA) today outlined the next phase of growth at its 2026 Analyst Day, highlighting how more than a decade of investment in the Company's mRNA platform has enabled the development of multiple modalities of mRNA medicines, each with the potential to create durable franchises. Moderna also provided updates on commercial growth, oncology pipeline progress, manufacturing readiness and mid-term financial objectives.

"We founded Moderna on the belief that mRNA could transform medicine, and over the past decade we have built a powerful platform to realize that vision," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our strategy is to create new modalities that can generate families of medicines and build durable franchises. We have demonstrated the potential of this approach in infectious diseases and are now advancing intismeran toward potential commercialization. Artificial intelligence and automation are accelerating what our platform can achieve, positioning Moderna to bring the next generation of mRNA medicines to patients around the world."

Business Strategy & Commercial Growth Drivers

Moderna's strategy is built on an integrated mRNA platform combining mRNA science, delivery technologies and manufacturing capabilities. By developing modalities that share underlying technologies and processes, Moderna aims to improve development efficiency and capital productivity while expanding the potential applications of mRNA medicines.

Moderna has developed three established modalities spanning infectious disease vaccines, individualized cancer treatments and rare genetic liver diseases, with intismeran advancing toward potential commercialization following positive Phase 3 results in adjuvant melanoma, subject to regulatory approval. The Company continues to invest across multiple horizons, from emerging clinical programs to new modalities and technologies designed to enable future therapeutic opportunities.

Commercial growth opportunities in 2027 and beyond include:

• Seasonal influenza: Following U.S. and Canadian approvals of mFLUSIVA® in 2026, Moderna is preparing for a broader commercial launch during the 2027-2028 respiratory season.
• European expansion: With four approved respiratory vaccines in the European Union, Moderna is positioned for additional growth as a competitor COVID-19 vaccine contract expires.
• Strategic partnerships: Long-term agreements in the United Kingdom, Canada and Australia provide recurring revenue and support domestic manufacturing. New agreements in Mexico and Taiwan expand opportunities in Latin America and Asia-Pacific.
• Expanded respiratory portfolio: The Canadian approval of mCOFLU®, Moderna's combination influenza and COVID-19 vaccine (known as mCOMBRIAX® in the European Union), and European approval of mNEXSPIKE® create additional commercial opportunities.
• Oncology: Positive Phase 3 results for intismeran in adjuvant melanoma support preparations for potential commercialization and continued investment in additional indications.

Moderna plans to fund future infectious disease vaccine investments through growth in the franchise, while deploying balance sheet capital toward intismeran, cancer antigen therapies, rare diseases and emerging modalities. Investment decisions will be guided by clinical data, commercial differentiation and potential patient benefit.

Artificial intelligence and automation are increasingly embedded across Moderna's platform, connecting computational design, experimentation and data to accelerate scientific learning and improve development efficiency. The Company is also deploying these capabilities across manufacturing and business operations to increase productivity and support disciplined capital allocation.

Global Production Network

Manufacturing is a core component of Moderna's integrated mRNA platform, supporting commercial vaccine supply, strategic partnerships and the potential launch of individualized cancer therapies. Manufacturing operations across the United States, United Kingdom, Canada and Australia provide regional supply capabilities, geographic diversification and flexibility for future product launches.

In infectious diseases, Moderna continues to focus on manufacturing efficiency, productivity and margin expansion. The mRNA platform enables rapid vaccine design and production, with opportunities to shorten manufacturing timelines compared with traditional vaccine technologies.

The Marlborough, Massachusetts, facility was purpose-built for intismeran, an investigational individualized neoantigen therapy being developed with Merck. The facility began supplying clinical study material in September 2025 and is on track to support a potential commercial launch, subject to applicable regulatory approvals.

In 2027, Marlborough is expected to become the global supply site for intismeran. Advanced automation, robotics and compact manufacturing equipment are designed to improve turnaround times, increase productivity and reduce manufacturing costs. Modular production units allow capacity to expand in phases as demand grows, with the potential to supply tens of thousands of patients annually.

Moderna and Merck are also preparing an integrated commercial model for intismeran. The companies plan to co-promote the therapy in the United States, combining Merck's oncology infrastructure with dedicated Moderna capabilities. Merck will lead commercialization outside the United States.

Pipeline Progress

Highlights from Moderna's approved vaccines and prioritized development portfolio include:

Infectious Disease Vaccines

• mNEXSPIKE® (mRNA-1283, COVID-19 vaccine): Continued commercial uptake and geographic expansion, supported by growing real-world evidence. A study published in JAMA Network Open involving more than 294,000 U.S. Veterans aged 65 and older found that mNEXSPIKE was associated with a 35.9% lower risk of medically attended COVID-19 and a 47.0% lower risk of COVID-19-associated hospitalization compared with Comirnaty®. The most commonly reported adverse reactions following mNEXSPIKE vaccination include injection-site pain, fatigue, headache and muscle pain. As an observational effectiveness study, the analysis was not designed to establish comparative vaccine safety. As an observational study, the findings may be subject to residual confounding and may not be generalizable to other populations.
• mFLUSIVA® (mRNA-1010, seasonal influenza vaccine): Approved in the United States and Canada in 2026. The limited U.S. launch has delivered more than 110,000 vaccinations, supporting preparations for broader commercialization during the 2027-2028 respiratory season.
• mCOFLU® (mRNA-1083, influenza and COVID-19 combination vaccine): Approved in Canada for adults aged 50 and older (known as mCOMBRIAX® in the European Union), with additional regulatory and commercial opportunities ahead. A Phase 4 study is evaluating comparative effectiveness against separately administered influenza and COVID-19 vaccines.
• mRESVIA® (mRNA-1345, RSV vaccine): Continued geographic expansion and generation of clinical and real-world evidence, including studies evaluating RSV vaccine effectiveness and investigational revaccination strategies.

Oncology Therapeutics

• Intismeran autogene (mRNA-4157/V940): In collaboration with Merck, the Phase 3 INTerpath-001 study in resected high-risk melanoma met the primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival. Intismeran in combination with KEYTRUDA® (pembrolizumab) demonstrated a 42% reduction in the risk of recurrence or death and a 38% reduction in the risk of distant metastasis or death compared with KEYTRUDA alone. The safety profile of intismeran in combination with KEYTRUDA was consistent with the known profiles of the individual therapies. The most common adverse events in the combination arm included fever, injection-site pain and fatigue, which were generally low-grade, transient and manageable with standard supportive care. The Phase 3 results were published in the New England Journal of Medicine. The companies continue to advance clinical development across multiple tumor types and treatment settings.
• Cancer antigen therapies: Moderna is advancing a portfolio of off-the-shelf cancer antigen therapies, including mRNA-4359 in a Phase 2 clinical trial in melanoma and non-small cell lung cancer, along with mRNA-4106, mRNA-4200 and mRNA-4194 in early clinical development. mRNA-4194 is being developed with the goal of intercepting cancer before it develops in people with Lynch syndrome, an inherited condition associated with an increased risk of certain cancers.
• T-cell engagers: mRNA-2808, an investigational mRNA-encoded therapy designed to target three multiple myeloma antigens, demonstrated encouraging early clinical activity, with responses observed in 4 of 11 heavily pretreated patients in an ongoing Phase 1/2 study. The results will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2026.

Rare Disease Therapeutics

• mRNA-3927 (propionic acidemia therapeutic): Long-term data representing more than 50 cumulative patient-years of treatment exposure continue to support clinical development. Moderna expects a registrational study readout in late 2026.

Moderna Research and Early Development (mRED)

• Emerging modalities: Moderna is advancing new mRNA modalities across oncology and other therapeutic areas, while investing in technologies designed to enable future modalities. Selected future modalities have the potential to advance into first-in-human clinical studies over the mid-term.
• Platform innovation: Moderna continues to invest in new delivery technologies and AI-enabled research to expand the applications of mRNA medicines.

For more details on the programmatic updates shared during Moderna's Analyst Day, please visit "Events and Presentations" in the Investors section of the Moderna website.

Financial Updates

Moderna expects 2026 revenue growth of 15% to 25%, compared with the original outlook of up to 10%, and is on track to achieve approximately 10 percentage points of gross margin expansion in 2026, excluding the litigation settlement charge.

The Company has accelerated cost reductions, bringing forward the previously announced 2027 cash cost framework into 2026. Moderna expects approximately $4 billion in cash costs in 2027 and annual cash costs of approximately $4 billion to $4.5 billion from 2027 through 2030, primarily driven by increased investment in oncology.¹

Moderna expects to improve infectious disease vaccine profitability, supported by continued revenue growth, lower development spending as clinical studies conclude, manufacturing efficiencies and operating leverage. The Company will continue to reinvest cash flow in the infectious disease vaccine pipeline with discipline.

Moderna also announced amended terms for the $1.5 billion credit facility with Ares Management Credit Funds, extending maturity by one year to 2031, extending the availability of the remaining $900 million in borrowing capacity through 2029 and reducing the interest rate on drawn amounts by 75 basis points. The amendments provide additional financial flexibility to support prioritized investments.

The Company anticipates ending 2026 with approximately $9 billion in total liquidity, including cash, investments and undrawn borrowing capacity.

Moderna's mid-term financial objectives are to build on renewed revenue growth, improve infectious disease vaccine profitability, continue disciplined capital allocation toward oncology and emerging pipeline opportunities, and maintain a strong balance sheet.

Formal 2027 financial guidance is expected during the fourth-quarter 2026 earnings call.

¹ Cash costs are defined as GAAP expenses less stock-based compensation and depreciation and amortization.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Investigational Products and Regulatory Status

Intismeran autogene and Moderna's other investigational oncology and rare disease therapies have not been approved by the FDA. Their safety and effectiveness have not been established, and any future commercialization is subject to applicable regulatory approval.

Trademarks

mRESVIA®, mNEXSPIKE®, mCOMBRIAX®, mCOFLU® and mFLUSIVA® are registered trademarks of Moderna.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's ability to execute on its next phase of growth and its mid-term financial strategy; the potential of intismeran and Moderna's broader oncology portfolio; Moderna's commercial and manufacturing readiness for intismeran; Moderna's ability to improve infectious disease vaccine franchise profitability; the potential regulatory approval and commercial launch of intismeran; the potential of intismeran in additional tumor types and across settings; mRNA-4194's potential in Lynch syndrome; Moderna's use of AI and automation to accelerate innovation and increase productivity; commercial growth opportunities in 2027 and beyond; Moderna's investment strategy, capital allocation and portfolio priorities; expected data for mRNA-3927 in 2026; Moderna's 2026 financial framework, including expected revenue growth of 15% to 25%, gross margin expansion, cost reductions, and liquidity; Moderna's continued cost discipline; and anticipated progress and milestones for Moderna's pipeline programs. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

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What is Moderna's updated 2026 revenue growth outlook?

Moderna expects 15% to 25% revenue growth in 2026, compared with its original outlook of up to 10%. It also expects approximately 10 percentage points of gross margin expansion in 2026, excluding the litigation settlement charge.

What did Moderna and Merck's Phase 3 intismeran melanoma trial show?

Intismeran plus KEYTRUDA reduced the risk of recurrence or death by 42% and distant metastasis or death by 38% versus KEYTRUDA alone. The study in resected high-risk melanoma met its primary and key secondary endpoints. The combination's safety profile was consistent with the known profiles of the individual therapies.

How does Moderna define its cash cost targets?

Moderna defines cash costs as GAAP expenses less stock-based compensation and depreciation and amortization. It expects approximately $4 billion in cash costs in 2027 and annual cash costs of approximately $4 billion to $4.5 billion from 2027 through 2030.

When will Moderna provide formal 2027 financial guidance?

Moderna expects to provide formal 2027 financial guidance during its fourth-quarter 2026 earnings call.