Moderna said Thursday that revenues totalled $1.9 billion in the first three months of this year, up from $8 million in the prior-year period, reflecting a full quarter of commercial sales for its COVID-19 vaccine mRNA-1273 in the US and an initial ramp-up of its use internationally. However, analysts were predicting sales of $2.1 billion. The company said it delivered 102 million doses of mRNA-1273 during the quarter, which accounted for $1.7 billion of its total sales, with grant and collaboration revenues making up the rest.
It also posted a profit of $1.2 billion for the three-month period, versus a loss of $124 million in the same quarter of 2020, with CEO Stéphane Bancel noting the results made it the "first profitable quarter in [our] history." Moderna said it spent $401 million on R&D in the quarter, versus $115 million a year ago, citing increases in clinical trial and manufacturing expenses largely due to mRNA-1273.
The company says it has signed $19.2-billion worth of advance purchase agreements for its COVID-19 vaccine scheduled for delivery in 2021, surpassing the $18.4 billion in sales it had predicted in February. Analysts were projecting revenues of $17.1 billion for the year. The forecast comes shortly after Pfizer said the COVID-19 vaccine it makes with BioNTech could generate $26 billion in sales this year (see ViewPoints: Pfizer wins a COVID crown). However, the prospect of a temporary loss of patent protections for COVID-19 vaccines cast a pall over the upbeat sales performance and outlook.
Earlier this week, the US reversed its position on a proposal to temporarily lift intellectual-property (IP) protections for COVID-19 vaccines, with the Biden administration saying it now supports such a measure in the context of the pandemic. The news hit shares of several major COVID-19 vaccine developers, including Moderna, whose stock price tumbled about 10% (see ViewPoints: Biopharma deems Biden IP proposal patently unfair).
Still, Bancel insists "it doesn't change anything for Moderna – we had said last October we would not enforce our COVID-19-related patents during the pandemic," but a patent waiver "will not help supply more mRNA vaccines to the world any faster in 2021 and 2022," given the complexity of the technology, and lack of manufacturing capacity and employees with sufficient expertise. According to the CEO, the best course of action would be to maximise supply this year and add capacity to boost supplies next year, which he noted is what Moderna is doing. The company recently increased its 2021 supply forecast to between 800 million and 1 billion doses, and also anticipates producing up to 3 billion doses in 2022.
"We are now actively engaged in discussions and agreements for 2022 with all of the governments we are currently supplying for 2021," Bancel said, highlighting a recent partnership with COVAX and discussions with new governments in Asia, Middle East, Africa and Latin America. He said these "make us believe that our total advance purchase agreements for 2022 should be higher than those in 2021."
Moderna's vaccine is currently authorised by the FDA as well as other global regulators for emergency use, but the company says it plans to initiate a rolling submission for full US approval this month.
Also on Thursday, Moderna disclosed an initial analysis of its Phase II/III TeenCOVE trial of mRNA-1273 in adolescents ages 12 to 17 years, saying its vaccine showed an efficacy rate of 96% in seronegative participants who received at least one dose. The analysis was based on 12 cases starting 14 days after the first dose. "Because the incidence rate of COVID-19 is lower in adolescents, the case definition is less stringent than for [the pivotal Phase III] COVE [study], resulting in vaccine efficacy against milder disease," the company said. Moderna added it is continuing to gather TeenCOVE data and is in discussions with regulators about a potential amendment to its regulatory filings.
Separately, Moderna also disclosed initial findings indicating that a booster dose of either mRNA-1273, or a new updated candidate, increased neutralising titres against the B.1.351 and P.1 variants of concern in previously vaccinated people.
To read more Top Story articles, click here.