Moderna Beats Q4 Estimates Amid FDA Flu Vaccine Setback

Moderna reported fourth-quarter revenue of $678 million, exceeding analyst estimates, while posting a narrower-than-expected loss as the company navigates a significant regulatory setback for its flu vaccine program. The Cambridge, Massachusetts-based biotechnology company reported a GAAP loss of $2.11 per share for the quarter ended in fiscal year 2025, beating consensus estimates of $2.79 per share.

The company's quarterly revenue of $678 million topped analyst expectations of $611.14 million to $660.2 million, driven by stronger COVID-19 vaccine sales. However, revenue declined 33.2% compared to the same period in the previous year, when the company posted a loss of $2.91 per share. For fiscal year 2025, Moderna reported total revenue of $1.9 billion, a 40% decline from the prior year, down from peak revenues of more than $19 billion in 2022.

The U.S. FDA issued a refusal-to-file for Moderna's new mRNA flu vaccine application, citing inadequate trial design. The decision raises near-term uncertainty for one of the company's key pipeline catalysts and threatened to remove a key near-term revenue driver. Moderna has requested a Type A meeting with the agency. Regulators in other markets, including the EU and U.K., accepted the candidate for regulatory review.

Despite the regulatory setback, management reiterated a target of approximately 10% revenue growth for 2026, projecting revenue of approximately $2.1 billion. The company highlighted pipeline progress, noting that its Norovirus Phase 3 trial is fully enrolled and other trials are advancing. Moderna expects pivotal data readouts in 2026 for its norovirus vaccine, a cancer antigen therapy, and a key rare disease program.

The company successfully cut operating expenses by $2.2 billion in 2025 and maintains a cash position of $8.1 billion to fund its pipeline through a targeted 2028 cash breakeven. This quarter, Moderna generated an operating margin of negative 126%, up 2.6 percentage points year on year, while the operating margin improved from negative 129% in the same quarter last year. The free cash flow margin reached 131%, up from 31.4% in the same quarter last year.

Moderna's personalized cancer vaccine (mRNA-4157), developed with pharmaceutical giant Merck, remains a key focus. Previous trial data showed a 49% reduction in cancer recurrence or death in melanoma patients over five years when the therapy was paired with Merck's blockbuster drug Keytruda. Phase 3 results expected later this year could be a major valuation and eventual revenue catalyst for the business.

Growth in 2026 will be driven by international expansion in the U.K., Canada, and Australia, as well as the company's new COVID-19 vaccine, mNEXSPIKE, which holds a 34% share of the 65+ retail market. Management also highlighted new international manufacturing capacity as a sign of sustainable recovery beyond COVID tailwinds.

Shares of Moderna traded up $2.86 to $42.97 during midday trading on Friday following the earnings report. The stock had a trading volume of 11,584,746 shares, compared to its average volume of 13,346,577. Moderna has a 52-week low of $22.28 and a 52-week high of $55.20. The company has a market capitalization of $16.50 billion to $16.79 billion, a price-to-earnings ratio of approximately negative 5.31 to negative 5.81, and a beta of 1.32.

Traders purchased 146,946 call options on the stock on Friday, representing an increase of approximately 75% compared to the average volume of 83,847 call options, signaling outsized short-term bullish positioning.

Director Noubar Afeyan sold 23,853 shares of Moderna stock in a transaction on Thursday, December 11th. The stock was sold at an average price of $29.48, for a total value of $703,186.44. Following the transaction, the director directly owned 3,924 shares in the company, valued at approximately $115,679.52. This trade represents a 85.87% decrease in their position.

Analyst sentiment appears cautious. A number of brokerages recently weighed in on the stock. UBS Group downgraded Moderna from a "buy" rating to a "neutral" rating and dropped their price objective for the company from $40.00 to $34.00 in a research report on Tuesday, January 6th. BMO Capital Markets raised shares of Moderna from a "market perform" rating to a "buy" rating in a research note on Monday, January 12th. Wall Street Zen upgraded shares of Moderna from a "sell" rating to a "hold" rating in a research note on Saturday, January 17th. JPMorgan Chase & Co. cut their price target on shares of Moderna from $26.00 to $25.00 and set an "underweight" rating on the stock in a report on Thursday, October 23rd. Two equities research analysts have rated the stock with a Buy rating, eleven have assigned a Hold rating and five have assigned a Sell rating to the company's stock. The stock has an average rating of "Reduce" and a consensus price target of $28.77 to $39.21.

Over the next 12 months, sell-side analysts expect revenue to remain flat to up approximately 10%. Wall Street expects Moderna's full-year EPS of negative $7.26 to improve to negative $6.68, and analysts forecast the company will post negative $9.61 EPS for the current fiscal year. Institutional ownership is robust at 70.28%, while insider ownership is 6.03% to 10.90%. The company's Altman Z-Score of 4.26 indicates a low risk of financial distress, while the Beneish M-Score of negative 2.51 suggests the company is unlikely to be manipulating its financial statements. However, the company's Piotroski F-Score of 3 is low, implying potential operational challenges.

As of August 2025, Moderna had 35 mRNA development candidates in clinical studies, spanning therapeutic areas such as infectious diseases, oncology, cardiovascular disease, and rare genetic diseases. The company operates on the principle that mRNA can program human cells to produce proteins that prevent or fight disease. Moderna was founded in September 2010 as ModeRNA Therapeutics, a portmanteau of Modified and RNA, by a team including a Harvard stem cell biologist, an MIT professor and biomedical engineer, a venture capital firm that provided initial seed capital, and Harvard-affiliated scientists. The CEO was appointed in 2011. In December 2018, Moderna completed the largest initial public offering in biotech history.