While Moderna preps an entry to the oncology market next year with a personalized cancer vaccine, COVID sales are holding steady with several other vaccine launches underway around the world.
While several Big Pharmas have reported declining vaccine rates that have eaten into sales, mRNA bigwig Moderna is seeing steady revenue from its COVID-19 shots thanks to global adoption.
Moderna’s revenue grew 29% to $1.3 billion for the quarter, compared to $1 billion for the same period a year earlier. The company has so far totaled $1.8 billion in revenue this year, CFO Jamey Mock said on a Friday morning earnings call. He attributed this jump to higher COVID vaccine sales, with mNEXSPIKE and Spikevax available globally for the coming season.
“In the U.S., while the vaccination season is still ongoing, we have seen increased uptake of mNEXSPIKE, and vaccination rates have been relatively stable versus the prior year,” Mock said.
The U.S. has been a tough market for vaccines over the past two seasons amid political hampering that have spurred declining rates, as reported by major drugmakers like GSK and Pfizer.
Pfizer, which marketed Comirnaty with partner BioNTech, reported declining sales across its COVID franchise, which also includes the treatment Paxlovid.
Despite Mock’s reported increase in uptake for mNEXSPIKE, U.S. revenue for the product is overall declining, with the global expansion leading Moderna’s sales there, Jefferies noted. Moderna could gain more market share once Pfizer’s contract in the EU expires at the end of this year, the firm said.
Moderna did not return a request for clarification on the COVID product sales as of publication.
Jefferies attributed the COVID vaccine strength in the quarter to “favorable COVID seasonality.” Vaccinations typically pick up in the third quarter, when Moderna generally records the bulk of its vaccine revenue for the year.
Moderna did not provide specific sales numbers for the COVID shots but vaccine sales overall totaled $1.27 billion, higher than consensus of $891 million, William Blair said in a Friday morning note. That number would also include mRESVIA for respiratory syncytial virus (RSV), mFLUSIVA and mCOFLU, which became available in some global markets this year.
“Both the U.S. and international markets delivered stronger than expected revenue in 3Q, driven by a mix of increased demand, operational execution and timing of shipments between the third and fourth quarters,” Mock said.
In response to the strong quarter, Moderna raised revenue expectations for the year to an increase of 15–25%, compared to 10% previously. Analysts questioned if any of that is coming from advanced vaccine deliveries for 2027 arriving in 2026. Mock was confident that 2027 will see growth, as the flu vaccines have yet to fully pick up steam after approval and launch. The company also has major partnerships in Europe and Latin America that will drive revenue.
Moderna received approval of the flu shot mFLUSIVA in August but is still waiting to hear from the FDA on a path forward for the combined flu and COVID shot, which has been made available elsewhere in the world as mCOFLU. The mFLUSIVA approval marked a major triumph for Moderna, after the FDA leadership initially refused to even review the application.
Elsewhere in the clinic, Moderna reported early in the third quarter that the norovirus vaccine mRNA-1403 did not meet the early bar for advancement in a Phase 3 clinical trial. The company announced today that another cohort will not be enrolled this coming season but they will take existing data to regulators to discuss next steps. Hoge declined to provide more detail on the program’s future.
But perhaps more important for Moderna is its work outside of vaccines. In 2027, the biotech is looking to launch into its next major chapter: oncology.
Coming soon
Early in the third quarter, Moderna’s shares jumped on the news that the Merck-partnered personalized cancer vaccine intismeran autogene improved outcomes in patients with melanoma when paired with Keytruda. Last month, the partners revealed more detailed data at the European Society of Medical Oncology meeting in Spain, showing a reduction in the risk of recurrence or death of 42%.
Moderna is working with Merck to get a biologics license agreement for melanoma submitted by year end, with an FDA decision to come in 2027, according to President Stephen Hoge.
“I can assure you, we’re working around the clock to make sure that not only the submission happens on time, but the review is facilitated with the FDA because our goal here ultimately is approval,” Hoge said.
On the earnings call, analysts probed for details on an upcoming Phase 2 readout for the vaccine in renal cell carcinoma (RCC). Chief Development Officer David Berman expressed confidence in the vaccine given its previous success during a mid-stage melanoma trial in a population of patients that bear similar tumor signatures to RCC. The disease is also sensitive to anti-PD1 therapies, which work by reactivating T cells. Moderna’s vaccine creates novel T cells to fight the disease, Berman explained.
Berman also said that, should the results be strong enough from the large 282-patient trial, Moderna and Merck could go straight to the FDA with the Phase 2 study for the RCC indication.
“At a base case, I would say it can be practice-informing,” Berman said. “In an upside, if the results are very strong, I think we can consider taking it to FDA. But it will be data dependent.”
