Moderna hikes full-year outlook for COVID vaccine despite Q2 sales dive

03 Aug 2023
firstwordpharma.com
VaccinePhase 3mRNAFinancial Statement
Moderna reported Thursday that revenues for the second quarter sank to $344 million, compared to $4.7 billion the same time last year, although it still came in ahead of the $308 million analysts had projected. According to Moderna, the weaker performance was largely due to a 94% decline in sales of its COVID-19 vaccineCOVID-19 vaccine, which brought in $293 million over the course of the three-month period.
Moderna also posted a narrower-than-expected net loss of $1.4 billion during the second quarter, compared to a profit of $2.2 billion in the corresponding 2022 period. Company shares rallied as much as 8.4% in premarket trade Thursday following the release of the earnings report.
"Second-quarter sales were on target, given the seasonal nature of COVID," stated CEO Stéphane Bancel. Looking ahead, Moderna said it now expects sales of its COVID-19 vaccineCOVID-19 vaccine to be between $6 billion and $8 billion this year, up from guidance it provided in May of at least $5 billion.
Eye on US vaccine uptake this fall
"The US commercial team appears to be making strong progress to get new contracts in place for this fall," remarked Third Bridge analyst Lee Brown.
During the company's earnings call, chief commercial officer Arpa Garay suggested the "biggest factor" that will determine whether sales fall within the new range is US vaccine uptake from September to December, as the shots enter the US commercial market for the first time. Garay noted that the company expects US demand of 50 million to 100 million doses in the autumn, but acknowledged that it is "difficult to accurately predict market volumes and…how many Americans will come in this fall for their shots."
Moderna said it is in talks with purchasers in the US, EU and other parts of the world for additional possible orders, and noted that $1 billion in previously anticipated 2023 sales were pushed to 2024. The company also recently presented "potent neutralisation and cross-reactivity" data for its updated COVID vaccine mRNA-1273.815, which targets the XBB.1.5 Omicron subvariant, and has submitted it to regulatory bodies for approval as well, saying it "is ready for the fall vaccination season with ample and timely supply."
Ramping up R&D efforts
Meanwhile, Moderna's R&D spend during the second quarter jumped to $1.1 billion, up 62% versus the prior-year period, spurred by an increase in development activities for its respiratory syncytial virus (RSV), seasonal influenza and cytomegalovirus (CMV) programmes.
Bancel said "our late-stage clinical pipeline is firing on all cylinders with four infectious disease vaccines in Phase III," including the RSV vaccine mRNA-1345, which was submitted to several global regulators last month for use in older adults. The company and partner Merck & Co. also recently announced the start of a Phase III trial testing the individualised neoantigen therapy mRNA-4157/V940 in resected high-risk melanoma, while Moderna's lead rare disease programme mRNA-3927 for propionic acidaemia is in the dose-confirmation stage of an ongoing Phase I/II trial. "We believe that all these products should launch in 2024, 2025 or 2026, and we are continuing to invest in scaling Moderna to bring forward an unprecedented number of innovative mRNA medicines for patients," Bancel said.
Moderna has also completed enrolling a Phase III study testing an enhanced formulation of its influenza vaccine candidate mRNA-1010. Earlier this year, it said that while mRNA-1010 was superior against influenza A strains, it fell short against influenza B, although it hopes the updated formulation will generate a better immune response to these strains. An update on the trial dubbed P303 is due in the third quarter.
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