Moderna, Inc. (MRNA)

On 22 October 2026 Merck and Moderna reported that their melanoma treatment, intismeran autogene, cut the risk of recurrence or death by 42 percent when added to Keytruda in a Phase 3 trial 5. The companies said they are engaging with regulatory authorities 5.

In September 2026 Moderna completed a $3 billion sale of convertible notes due in 2032, after paying a $950 million litigation settlement in July 61. Cash and investments stood at $6.9 billion on 30 June 2026, before that payment 2.

The FDA approved Moderna's influenza vaccine mFLUSIVA for adults 50 and older, announced on 6 August 2026 4. The company called it its fifth approved product worldwide and its fourth to win FDA approval 4.

In its latest reported quarter, the second, Moderna reported on 31 July 2026 revenue of $145 million, against $142 million a year earlier, and a net loss of $782 million 2.

The company says it is targeting up to 10 percent revenue growth over 2025 and expects about 55 percent of its second-half 2026 revenue in the third quarter 2. Third-quarter results are due on 6 November 2026 8.

Moderna was founded in 2010 and spent its first decade as a research company 3. Its revenue was $60 million in 2019 and $803 million in 2020, made up of $529 million of grants, $74 million of collaboration income and the first $200 million of COVID vaccine sales 9.

The COVID vaccine changed the business after the FDA and Health Canada authorized it for emergency use in December 2020 9. Revenue rose to $18.5 billion in 2021, with product sales up $17.5 billion from sales to governments and buying groups such as Gavi and the African Union 9.

Revenue grew another 4 percent to $19.3 billion in 2022, helped by a higher average price and a different mix of customers 10. Merck's $250 million participation payment on the cancer vaccine collaboration also counted that year 10. Net income was $8.4 billion in 2022, down from $12.2 billion in 2021 10.

Revenue then fell 64 percent to $6.8 billion in 2023 as the COVID vaccine became a seasonal product and sales volumes dropped in every region 11. In the third quarter of 2023 the company began a program to resize its vaccine manufacturing costs 11. The net loss was $4.7 billion that year 11.

Revenue fell a further 53 percent to $3.2 billion in 2024 12. The company said revenue from Europe and the rest of the world had come mostly from advance purchase agreements with governments during the pandemic, and that business moved to a seasonal market 12. Sales of the RSV vaccine began in the third quarter of 2024 but were small 12.

In 2025 revenue fell 40 percent to $1.9 billion, mainly on lower COVID vaccine volumes in all regions 3. The new mNEXSPIKE shot helped in the United States during the 2025/2026 season 3. Research and development spending fell to $3.1 billion from $4.5 billion, and the net loss narrowed to $2.8 billion 3.

On 3 March 2026 Moderna settled all worldwide patent litigation with Arbutus and Genevant over Spikevax and mRESVIA for a lump sum of $950 million, with no future royalties owed 1. It recorded $876 million of that in cost of sales 1. Moderna has appealed a related court ruling and could owe up to $1.3 billion more depending on the outcome 1.

The product line widened as mNEXSPIKE won FDA approval in May 2025, mCOMBRIAX, a flu and COVID shot, won European approval in April 2026 and mFLUSIVA won FDA approval in August 2026 14. In November 2025 Moderna also took a five-year credit facility of up to $1.5 billion and began moving drug product manufacturing to Norwood, Massachusetts 3.

COVID vaccines: Spikevax and mNEXSPIKE

Spikevax is the original COVID vaccine and mNEXSPIKE is the newer one, which the company launched in the third quarter of 2025 and calls its leading product in the U.S. retail channel 3. COVID vaccine sales were $91 million in the second quarter of 2026 against $114 million a year earlier, and $436 million for six months against $198 million 1.

mNEXSPIKE is approved for adults 65 and older and for people 12 through 64 with at least one underlying risk factor 1. The 10-K names Pfizer and BioNTech as the main rivals for COVID vaccines, with Sanofi and Novavax also in the market 3.

RSV vaccine: mRESVIA

mRESVIA protects against respiratory syncytial virus, a common cause of lung infection in older adults 3. The FDA approved it in May 2024 for adults 60 and older and in June 2025 for adults 18 through 59 at increased risk 1. Sales were $3 million in the second quarter of 2026 and $10 million for six months 1.

In the second quarter the company signed a joint procurement contract with the European Commission for up to 24 million doses of mRESVIA 2. The 10-K names Pfizer and GlaxoSmithKline as rivals that reached the U.S. market first 3.

Flu and flu plus COVID vaccines

mFLUSIVA is a seasonal flu vaccine made with mRNA, approved by the FDA for people 50 and older 4. The approval for people 65 and older is an accelerated approval that may depend on a confirmatory trial 4. The main trial enrolled 40,805 adults in 11 countries 4.

mCOMBRIAX combines flu and COVID protection and is approved in the European Union for adults 50 and older 1. The company is awaiting guidance from the FDA on refiling the U.S. application 2.

Cancer: intismeran with Merck

Intismeran autogene is made for each patient from a sample of the patient's own tumor, and Merck and Moderna develop it together 5. Under their agreement they share costs and any profits and losses worldwide equally 3. Nine Phase 2 and Phase 3 trials are underway, including three Phase 3 trials in lung cancer 5.

In the Phase 3 melanoma trial, 1,137 patients whose cancer had been removed by surgery received the treatment with Keytruda or a placebo with Keytruda 5. After a median follow-up of 24.6 months, the combination cut the risk of recurrence or death by 42 percent, and two-year recurrence-free survival was 82.2 percent against 70.0 percent 5. Merck's own results release lists the trial among its Q3 highlights 15.

Rare disease and other programs

The propionic acidemia candidate mRNA-3927 is in a registrational study that has reached its target enrollment, and Moderna expects potential data in 2026 2. In January 2026 Moderna entered a collaboration with Recordati to carry it through the final stages and, if approved, commercialization 3.

The Phase 3 norovirus vaccine mRNA-1403 did not meet the statistical criteria for early success at its interim analysis, and the company is preparing to enroll an additional cohort 2.

Plants and property

Moderna has two main campuses in Massachusetts: the Moderna Science Center in Cambridge, about 462,000 square feet, and the Moderna Technology Center in Norwood, about 722,000 square feet, which the company bought in December 2024 3. It also owns a 140,000 square foot plant in Marlborough, Massachusetts, in operation since August 2025 for the intismeran program 3.

Abroad, it owns a 100,000 square foot plant in Laval, Quebec, able to make up to 100 million doses a year, and a 130,000 square foot plant in Clayton, Australia 3.

People

Stephane Bancel is chief executive, Stephen Hoge is president, James Mock is chief financial officer and Shannon Thyme Klinger is chief legal officer, with Noubar Afeyan as chairman 13. Moderna had about 4,700 full-time employees in 18 countries at the end of 2025 3.

Ester Banque became chief commercial officer on 15 June 2026, and Michael McDonnell, a former Biogen finance chief, joined the board on 8 July 2026 2. Juan Andres, who ran manufacturing at Moderna from 2018 through 2022, returned as chief operating officer on 5 October 2026 in a newly created role 7.

Problems and lawsuits

Moderna has sued Pfizer and BioNTech for patent infringement in the U.S. and five other countries, and they have asserted defenses seeking to revoke its patents 1. GSK, Northwestern University, CureVac, Sanofi units and others have filed complaints against Moderna over patents 1. Shareholder class actions over statements about the RSV vaccine are pending 1.

The umbrella, in words

The brands are the vaccines Spikevax, mNEXSPIKE, mRESVIA, mCOMBRIAX and mFLUSIVA; the company has no consumer brands 14.

The annual report's subsidiaries exhibit lists principal affiliates as of 31 December 2025, among them ModernaTX, Inc., Moderna US, Inc. and Moderna Biopharma Canada Corporation 14.

The tie to Merck is an agreement: the two share costs and profits on intismeran equally 3. The tie to Recordati is also an agreement, covering development and commercialization of mRNA-3927 3. Neither is an ownership stake 3.

On control, the March 2026 proxy statement reports that Bancel beneficially owned 7.6 percent of the common stock, counting options exercisable within 60 days, as of 9 March 2026 13. It lists FMR LLC at 10.4 percent, The Vanguard Group at 9.8 percent, BlackRock at 6.4 percent and Baillie Gifford at 5.2 percent 13.

Moderna reports third-quarter 2026 results on 6 November 2026 and holds an Analyst Day on 12 November 82.

For 2026 the company is targeting up to 10 percent revenue growth over 2025, split about evenly between the U.S. and international markets 2. It expects cost of sales near $1.7 billion including the $0.9 billion litigation settlement charge, research spending near $2.9 billion and sales and administrative spending near $1.0 billion 2.

Capital spending is expected at $0.2 to $0.3 billion, and year-end cash and investments at $4.7 to $5.2 billion, a figure that leaves out further drawdowns of the remaining $0.9 billion under the credit facility 2. That outlook was issued on 31 July, before the September note sale 26.

On the pipeline, Merck and Moderna say they are engaging with regulatory authorities on intismeran in melanoma, with no filing date given 5. Overall survival data in the melanoma trial are not yet mature, and the study continues 5.

Moderna expects potential data in 2026 for the propionic acidemia candidate, and it has deferred its decision on a pivotal trial for the methylmalonic acidemia candidate mRNA-3705 until that data arrives 2. Approvals of the flu vaccine mRNA-1010 are expected to begin in 2026 in Europe, Canada and Australia, where applications are under review 2.

On manufacturing, construction of drug product capability at Norwood has begun, with completion targeted in the first half of 2027, which would allow end-to-end mRNA manufacturing in the United States 3. The 10-K also says the company expects to reduce costs further in 2026 and 2027 and sees multiple growth opportunities in 2027 and 2028 3.

A court decision is also pending: Moderna's appeal to the Federal Circuit could lead to an additional payment of up to $1.3 billion to Arbutus and Genevant 1.