Moderna has reported continued pipeline progress, improving financial discipline and a strengthened 2026 outlook as the biotechnology company moved closer to potential new product approvals and advanced key late-stage programs.

 

The company said second-quarter execution helped improve its operating expense outlook while advancing commercial partnerships and regulatory milestones across vaccines, oncology and rare disease treatments.

 

"The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial profile with an improved 2026 operating expense outlook," said Stéphane Bancel, Chief Executive Officer of Moderna. 

 

"In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs."

 

Moderna expanded its global commercial footprint during the quarter through new partnerships, supply agreements and regulatory approvals.

 

In Brazil, the company signed a collaboration with a local manufacturer supporting a COVID vaccine supply agreement. In Europe, Moderna entered a joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA.

 

The company also secured regulatory approvals for mRESVIA in Australia and Mexico, and for mNEXSPIKE in Japan and Taiwan. Meanwhile, its investigational seasonal influenza vaccine, mFLUSIVA, received unanimous support from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of its August 5 Prescription Drug User Fee Act (PDUFA) goal date in the U.S.

 

Moderna reported second-quarter 2026 revenue of $145 million, slightly above the $142 million reported in the same period last year.

 

Lower COVID vaccine sales in the U.S. and South America were offset by deliveries in the United Kingdom under a long-term government partnership, along with higher stand-ready manufacturing and collaboration revenue.

 

U.S. revenue totaled $87 million, while international markets contributed $58 million.

 

The company reduced cost of sales to $93 million, down 22% year over year, driven by lower unutilized manufacturing capacity costs and continued operational improvements. The figure included $41 million in inventory write-downs, $23 million in unused manufacturing capacity costs and $11 million in third-party royalties.

 

Research and development expenses declined 7% to $651 million, reflecting lower clinical development costs after the wind-down of several late-stage programs. Selling, general and administrative expenses also fell 6% to $216 million as Moderna continued organization-wide cost discipline.

 

Moderna reported a second-quarter net loss of $0.8 billion, improving by $43 million, or 5%, compared with the same period in 2025.

 

Loss per share improved to $1.97 from $2.13 a year earlier.

 

The company ended June 30, 2026, with $6.9 billion in cash, cash equivalents and investments, compared with $7.5 billion at the end of March. Moderna said the decline reflected ongoing investment in operations, research and development and pipeline advancement.

 

The company later paid $950 million in July 2026 related to a litigation settlement announced earlier in the year.

 

Moderna maintained its focus on revenue growth, targeting up to 10% growth from 2025 revenue and expecting an approximately even split between U.S. and international sales in 2026.

 

The company expects about 55% of second-half 2026 revenue to be recognized during the third quarter.

 

The company lowered its 2026 cost of sales outlook to approximately $1.7 billion from $1.8 billion and reduced its research and development expense forecast to approximately $2.9 billion from $3.0 billion.

 

Moderna projects selling, general and administrative expenses of approximately $1.0 billion, negligible full-year tax expense and capital expenditures of $200 million to $300 million.

 

Year-end cash and investments are now expected to reach $4.7 billion to $5.2 billion, an improvement of approximately $200 million. The projection excludes further drawdowns from the company’s remaining $900 million credit facility.

 

Moderna highlighted several late-stage programs expected to shape its future growth.

 

The company received European Commission marketing authorization for mCOMBRIAX, its seasonal influenza and COVID combination vaccine, while regulatory filings for mRNA-1083 remain under review in Japan, Canada and Australia.

 

Moderna is awaiting further guidance from the U.S. FDA on refiling its flu-plus-COVID combination vaccine submission.

 

Regulatory filings for the company’s seasonal flu vaccine mRNA-1010 are under review in Europe, Canada and Australia, with potential approvals expected to begin in 2026. The FDA has assigned an August 5, 2026 PDUFA date for mRNA-1010.

 

Moderna’s Phase 3 norovirus vaccine study for mRNA-1403 did not meet statistical criteria for early success at interim analysis. The trial remains ongoing and blinded as the company enrolls an additional cohort.

 

Moderna continues to expand development of intismeran autogene (mRNA-4157) in collaboration with Merck, with nine Phase 2 and Phase 3 studies underway across multiple cancers, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.

 

The company expects potential Phase 3 adjuvant melanoma data in 2026.

 

Moderna’s propionic acidemia candidate mRNA-3927 has reached target enrollment in its registrational study, with potential data expected in 2026.

 

The company has deferred a decision on a pivotal trial for its methylmalonic acidemia program, mRNA-3705, until results from the propionic acidemia registrational study are available.

 

With regulatory decisions approaching and multiple late-stage programs progressing, Moderna is positioning 2026 as a pivotal year for expanding beyond COVID vaccines and building its next wave of commercial products.