Moderna Inc. (NASDAQ:MRNA) reported on Friday a second-quarter loss of $2.13 per share, beating the consensus of a $2.98 loss, an improvement from a loss of $3.33 a year ago.
The COVID-19 vaccine maker reported quarterly sales of $142 million, beating the consensus of $116.34 million.
Sales fell 41% from $241 million in the same period in 2024. The decline was primarily driven by lower COVID-19 vaccine sales, which totaled $114 million in the quarter.
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Demand is expected to be concentrated in the second half of the year, aligning with the fall and winter seasons as the vaccine transitions into a seasonal respiratory product.
The company reported $114 million in Spikevax sales in the second quarter of 2025, including $88 million in U.S. and $26 million in international sales.
Moderna recently announced U.S. Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for Spikevax in children 6 months through 11 years of age who are at increased risk for COVID-19 disease.
The company’s COVID-19 vaccine (mRNA-1273) was previously available for pediatric populations under Emergency Use Authorization (EUA). Additionally, the company announced it has received final approval from the European Medicines Agency for Spikevax targeting the LP.8.1 variant in individuals six months of age and older.
Moderna also announced FDA approval for mNEXSPIKE (mRNA-1283), a next-generation vaccine against COVID-19, for use in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor.
On Wednesday, the European Commission approved the updated formulation of the COVID-19 vaccine Spikevax, targeting the SARS-CoV-2 variant LP.8.1, for individuals six months of age and older.
Moderna reported negligible mRESVIA (RSV vaccine) sales in the second quarter of 2025. Moderna’s RSV vaccine for adults aged 60 years and older has been approved in approximately 40 countries.
Additionally, Moderna recently announced that the FDA has approved mRESVIA (mRNA-1345), expanding the previous indication, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.
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Cost of sales for the second quarter of 2025 was $119 million, which included third-party royalties of $6 million, inventory write-downs of $38 million, and unutilized manufacturing capacity and wind-down costs of $52 million.
Cost of sales was relatively flat compared to the same period in 2024. The increase in cost of sales as a percentage of net product sales, to 105% from 62% in the second quarter of 2024, was mainly driven by lower net product sales.
R&D expenses were $700 million, a 43% decrease year over year. The reduction was primarily driven by lower clinical trial and manufacturing expenses, reflecting reduced production spending, program wind-downs, and the timing of trial activities across the company’s respiratory vaccine portfolio.
Moderna has revised its 2025 revenue outlook to $1.5 billion-$2.2 billion compared to $1.5 billion-$2.5 billion, compared to a consensus of $2.09 billion, reflecting a $300 million reduction at the high end of the range.
The update is primarily driven by the timing shift of deliveries of contracted revenue for the U.K. into the first quarter of 2026. Moderna expects a revenue split of 40-50% in the third quarter for the second half of the year, with the balance in the fourth quarter of 2025.
Cost of sales for 2025 is expected to be approximately $1.2 billion. Full-year 2025 research and development expenses are anticipated to be $3.6 to $3.8 billion, lowered from previous expectations of approximately $4.1 billion.
Year-end cash and investments for 2025 are projected to be approximately $6 billion.
Recently, Moderna announced an organizational restructuring that will reduce its global workforce by approximately 10%. The company anticipates a total headcount of under 5,000 by year-end.
On Friday, Moderna announced that the U.K. Court of Appeal upheld the validity of Moderna’s EP’949 patent. European patent EP’949 relates to chemically modified mRNA, one of Moderna’s foundational technologies.
The decision affirms the High Court’s initial ruling from July 2024 that the EP’949 patent is valid and infringed by Pfizer Inc (NYSE:PFE) / BioNTech SE’s (NASDAQ:BNTX) COVID-19 vaccine, Comirnaty. Pfizer/BioNTech subsequently appealed.
With this ruling, the U.K. becomes the first jurisdiction globally to issue a second-instance decision confirming the validity of one of Moderna’s core mRNA patents.
In Germany, the Regional Court found that Pfizer and BioNTech infringed Moderna’s modified mRNA patent and confirmed Moderna’s right to seek damages. An appeal is pending.
The European Patent Office upheld the validity of EP’949 in opposition proceedings. An appeal is pending.
Price Action: Moderna stock is trading 7.92% lower to $27.22 premarket at last check Friday.
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This article Moderna’s Key Patent Win Overshadowed By Gloomy Outlook originally appeared on Benzinga.com
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