Moderna Provides Business and Pipeline Updates at 44th Annual J.P. Morgan Healthcare Conference

Rhea-AI Summary

Moderna (NASDAQ:MRNA) provided business and pipeline updates at the 44th J.P. Morgan Healthcare Conference on January 12, 2026. The company expects 2025 revenue ≈ $1.9B (unaudited), improved GAAP operating expense outlook to $5.0–$5.2B, and year-end cash ≈ $8.1B. Moderna reiterated a target of up to 10% revenue growth in 2026, expects GAAP operating expenses of ~$4.9B in 2026, and aims for cash breakeven by 2028. Key 2026 catalysts include potential approvals for seasonal flu and flu/COVID vaccines and multiple pivotal data readouts across oncology, rare disease, and infectious disease.

Positive

• 2025 revenue raised to approximately $1.9B
• Year-end cash balance increased to approximately $8.1B
• GAAP operating expense outlook improved by $200M for 2025
• Targeting up to 10% revenue growth in 2026
• Multiple pivotal data readouts expected in 2026

Negative

• 2025 GAAP operating expenses still large at $5.0–$5.2B
• 2026 GAAP operating expenses expected at approximately $4.9B
• Cash breakeven not expected until 2028

News Market Reaction

-1.34% 1.8x vol

138 alerts

-1.34% News Effect

+11.3% Peak in 32 hr 28 min

-$211M Valuation Impact

$15.51B Market Cap

1.8x Rel. Volume

On the day this news was published, MRNA declined 1.34%, reflecting a mild negative market reaction. Argus tracked a peak move of +11.3% during that session. Our momentum scanner triggered 138 alerts that day, indicating very high trading interest and price volatility. This price movement removed approximately $211M from the company's valuation, bringing the market cap to $15.51B at that time. Trading volume was above average at 1.8x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

2025 revenue outlook: $1.9 billion Revenue midpoint beat: $100 million 2025 GAAP opex: $5.0–$5.2 billion +5 more

8 metrics

2025 revenue outlook $1.9 billion Expected 2025 revenue, unaudited, above prior midpoint

Revenue midpoint beat $100 million Above midpoint of prior $1.6–$2.0 billion 2025 range

2025 GAAP opex $5.0–$5.2 billion Improved 2025 expected GAAP operating expenses, unaudited

Year-end 2025 cash $8.1 billion Cash, cash equivalents and investments at year-end 2025, unaudited

Term loan facility $1.5 billion Five-year term loan facility size referenced in cash balance

Drawn from term loan $0.6 billion Amount drawn from $1.5B term loan facility included in cash

2026 GAAP opex $4.9 billion Expected 2026 GAAP operating expenses framework

2027 GAAP opex range $4.2–$4.6 billion Planned GAAP operating expenses reduction target for 2027

Market Reality Check

Price: $51.87 Vol: Volume 7,435,862 is below...

normal vol

$51.87 Last Close

Volume Volume 7,435,862 is below the 20-day average of 10,573,140, suggesting a modest pre-event positioning rather than heavy trading. normal

Technical Shares at $34.30 are trading above the 200-day MA of $27.41 and about 28.09% below the 52-week high of $47.70.

Peers on Argus

Sector peers showed mixed, mostly modest moves, while momentum scanners flagged ...

1 Up

Sector peers showed mixed, mostly modest moves, while momentum scanners flagged only ABVX with a strong move up and no related news. With limited synchronized action across key biotechnology peers, pre-event trading in MRNA appeared more company-specific than sector-driven.

Historical Context

5 past events · Latest: Jan 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Flu filing update	Positive	+4.2%	Global regulatory submissions for mRNA-1010 flu vaccine backed by positive Phase 3 data.
Dec 18	CEPI trial funding	Positive	+1.4%	Up to $54.3M CEPI funding for pivotal Phase 3 H5 pandemic influenza vaccine trial.
Dec 17	Conference participation	Neutral	+2.1%	Announcement of participation in the 44th J.P. Morgan Healthcare Conference with webcast access.
Dec 15	EMA positive opinion	Positive	+1.6%	EMA committee positive opinion recommending authorization of mNEXSPIKE COVID-19 vaccine.
Nov 20	Analyst Day strategy	Positive	-7.5%	Three-year strategy with growth, cost reductions and cash breakeven path outlined to investors.

Pattern Detected

Recent news with positive commercial or regulatory implications has usually aligned with upward price reactions, though a major strategy update in November 2025 saw a notable negative divergence.

Recent Company History

Over the last few months, Moderna has highlighted expansion of its seasonal vaccine franchise and late‑stage pipeline, including positive influenza data and regulatory submissions on Jan 5, 2026 and an H5 CEPI funding deal on Dec 18, 2025. Earlier, an Analyst Day on Nov 20, 2025 outlined targets for up to 10% 2026 revenue growth and a cash breakeven goal in 2028. Today’s business and pipeline update reiterates and extends many of these themes on financial discipline and late‑stage readouts.

Market Pulse Summary

This announcement detailed a clearer financial framework and late-stage pipeline calendar, including...

Analysis

This announcement detailed a clearer financial framework and late-stage pipeline calendar, including expected $1.9 billion 2025 revenue, GAAP operating expenses near $5.0–$5.2 billion, and year-end 2025 cash of about $8.1 billion. It also outlined anticipated 2026 pivotal data across oncology and rare disease plus potential flu and flu/COVID approvals. Investors may track progress versus 2026–2027 expense goals and the timing and quality of those clinical readouts.

Key Terms

GAAP, Phase 3, term loan facility, registrational study, +2 more

6 terms

GAAP financial

"Improves 2025 expected GAAP operating expenses by $200 million since 3Q25 Earnings Call"

GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.

Phase 3 medical

"mRESVIA®, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

term loan facility financial

"includes a $0.6 billion draw down from our recently announced $1.5 billion term loan facility."

A term loan facility is a type of loan provided by a lender that is repaid over a set period of time, usually with fixed payments. It functions like a large, upfront loan that a borrower agrees to pay back gradually, often used to fund major investments or projects. For investors, understanding a company's use of such loans helps assess its financial stability and risk level.

registrational study medical

"mRNA-3927, is in a registrational study and target enrollment has been reached."

A registrational study is a late-stage clinical trial designed to give the government regulators the evidence they need to decide whether a drug, therapy, or medical device can be approved for sale. Think of it as the final exam or road test for a medical product: its results largely determine whether the product can reach the market, which directly affects potential revenue, company valuation, and investor risk.

EMA regulatory

"mRNA-1083 filing is under review with the European Medicines Agency (EMA)."

Exponential moving average (EMA) is a type of trend line that smooths a stream of recent price data while giving more weight to the newest prices, similar to how a spotlight focuses more on what's happening now than what happened long ago. Investors use EMAs to see whether a stock’s short-term direction is changing, to compare fast and slow averages for momentum signals, and to help time entries, exits, and risk controls without overreacting to random day-to-day noise.

FDA regulatory

"awaiting further guidance from the U.S. FDA on refiling."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

Expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above midpoint communicated on 3Q25 Earnings Call

Improves 2025 expected GAAP operating expenses by $200 million since 3Q25 Earnings Call

Increases 2025 projected year-end cash balance to approximately $8.1 billion (unaudited)

Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026

Anticipates potential first approvals of flu and flu/COVID combination products in 2026

Expects pivotal trial data readouts in oncology, rare disease and infectious disease in 2026

CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / January 12, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced business updates and progress across its pipeline of mRNA medicines. Moderna enters 2026 with a focus on growing sales, launching new infectious disease products and delivering pivotal readouts across oncology, rare disease and infectious disease portfolios.

"In 2025, we strengthened our commercial execution, successfully launched our third product, and continued to advance our mRNA pipeline. At the same time, we reduced our annual operating expenses by approximately $2 billion, significantly exceeding the financial cost reduction commitments we set at the start of the year," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain focused on our strategy to build a large seasonal vaccine franchise for at-risk populations, creating a strong cash engine to fund our next phase of innovation in oncology and rare disease. We expect this approach to support up to 10 percent revenue growth in 2026, as we further reduce costs, expand our commercial portfolio with approvals of additional seasonal vaccines, and anticipate multiple clinical data catalysts driven by our late-stage oncology pipeline."

The Company's presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available.

Summary of Financial Updates

2025 financial updates: Moderna expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above the midpoint of the $1.6 - $2.0 billion range communicated on the Company's 3Q25 Earnings Call. The Company is also improving2025 expected GAAP operating expenses by $200 million to a range of $5.0 - $5.2 billion (unaudited). Cash, cash equivalents and investments at year-end 2025 were approximately $8.1 billion (unaudited), which includes a $0.6 billion draw down from our recently announced $1.5 billion term loan facility. Full financial details will be reported in connection with the Company's Earnings Call on February 13, 2026.

2026 financial framework: Moderna reiterates its target of up to 10% revenue growth in 2026. The Company expects GAAP operating expenses of approximately $4.9 billion in 2026. Moderna expects to further reduce GAAP operating expenses to $4.2 - $4.6 billion in 2027, on the path to targeted cash breakeven in 2028.

Summary of Late-Stage Pipeline and Approved Product Milestones

Seasonal vaccines:

• COVID vaccines: Moderna's new COVID vaccine, mNEXSPIKE^®, is currently approved in the U.S., Canada and Australia. Moderna is expecting potential approvals of mNEXSPIKE in Europe, Japan and Taiwan in 2026.

• RSV vaccine: Moderna's RSV vaccine, mRESVIA^®, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026.

• Seasonal flu vaccine: The Company has completed submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe and expects potential approvals to begin in 2026.

• Seasonal flu/COVID vaccine: The Company's mRNA-1083 filing is under review with the European Medicines Agency (EMA). Moderna submitted for approval to Health Canada in 2025. The Company is awaiting further guidance from the U.S. FDA on refiling.

• Norovirus vaccine: Moderna's ongoing Phase 3 study of mRNA-1403 is enrolling a second Northern Hemisphere season (2025-2026) for additional case accruals, which will inform the timing of the Phase 3 readout. The Company expects an interim analysis in 2026.

Oncology therapeutics:

• Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. In adjuvant melanoma, Moderna expects the five-year Phase 2b data in early 2026, and the Phase 3 data potentially in 2026.

• mRNA-4359: Moderna's Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.

Rare disease therapeutics:

• Propionic acidemia (PA) therapeutic: The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects a potential data readout in 2026.

• Methylmalonic acidemia (MMA) therapeutic: Moderna's mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.

Corporate Updates:

• Moderna announced it closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds.

• Moderna announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase 3 clinical trial to help advance Moderna's investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure.

Key 2026 Investor and Analyst Event Dates

• Fourth Quarter and Fiscal Year 2025 Earnings Call: February 13, 2026

• Analyst Day: November 12, 2026

Event Information

Moderna's presentation will take place on Monday, January 12, 2026, at 4:30 p.m. PT/7:30 p.m. ET at the 44th Annual J.P. Morgan Healthcare Conference. A live webcast of both the presentation and the question-and-answer session will be available under "Events and Presentations" in the investor section of Moderna's website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for at least 30 days following the presentation.

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.

mRESVIA^® and mNEXSPIKE^® 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 projected commercial and financial performance; Moderna's 2026 financial framework, including projected up to 10% revenue growth and expected operating expenses; Moderna's expected further operating expense reductions; Moderna's targeted cash breakeven in 2028; anticipated potential first approvals of flu and flu/COVID combination products in 2026; Moderna's ability to launch new infectious disease products and advance its oncology pipeline; anticipated 2026 pivotal trial data readouts in oncology, rare disease and infectious disease; the five-year Phase 2b and Phase 3 melanoma data for intismeran and Phase 2 data for mRNA-4359; Moderna's ability to create a strong cash engine to fund its next phase of innovation; and the potential and timing for future product approvals, additional data readouts and commercial launches. 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, 2024, 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
Head of Global Media Relations
+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

What 2025 revenue guidance did Moderna (MRNA) announce on January 12, 2026?

Moderna expects 2025 revenue of approximately $1.9 billion (unaudited).

How much cash did Moderna (MRNA) report at year-end 2025?

Moderna reported cash, cash equivalents and investments ≈ $8.1 billion at year-end 2025 (unaudited).

What is Moderna's (MRNA) GAAP operating expense outlook for 2026 and 2027?

Moderna expects GAAP operating expenses ≈ $4.9B in 2026 and $4.2–$4.6B in 2027.

Which late-stage product approvals does Moderna (MRNA) anticipate in 2026?

Moderna anticipates potential first approvals in 2026 for seasonal flu and flu/COVID combination vaccines.

What clinical readouts does Moderna (MRNA) expect in 2026?

Moderna expects pivotal readouts in oncology, rare disease and infectious disease in 2026, including registrational and Phase 2/3 results.

When is Moderna's next earnings call after the January 12, 2026 update?

The Fourth Quarter and Fiscal Year 2025 Earnings Call is scheduled for February 13, 2026.