Moderna said Thursday that it generated sales of $4.2 billion for its COVID-19 vaccine mRNA-1273 during the second quarter, delivering 199 million doses in the period, for a total of 302 million doses so far this year. The vaccine comprised the bulk of Moderna's quarterly sales, which totalled $4.4 billion in all when grant revenues were taken into account, coming in slightly ahead of analyst expectations and towering over the $67 million it made in the prior-year period.
Company profit surged to $2.8 billion in the second quarter, beating estimates of $2.5 billion, whereas it had recorded a loss of $117 million the same time last year. The drugmaker added that it has the capacity to produce between 800 million and 1 billion doses of mRNA-1273 this year, and has advance purchase agreements for sales of $20 billion in 2021, up from its previous forecast of $19.2 billion. "We are not taking any more orders for 2021 because we are totally maxed out," commented CEO Stéphane Bancel.
For 2022, Moderna says it has already signed $12 billion worth of advanced purchase agreements, plus $8 billion in options, and that it expects to be able to produce between 2 billion and 3 billion doses next year. "Numerous additional negotiations are still ongoing for 2022," the company noted, adding it has also started signing supply deals for 2023 as "forward-looking countries prepare for the endemic phase of COVID-19."
Moderna, whose vaccine was authorised for emergency use in the US last December, said it intends to complete its rolling submission for full FDA approval this month. The company also believes people who received its two-dose vaccine will need another shot to keep strong protection against newer variants of the coronavirus.
"We believe a dose three of a booster will likely be necessary to keep us as safe as possible," remarked Stephen Hoge, president of Moderna, because "what we see is the potential for waning immunity." The company on Thursday provided an update to previously announced efficacy data, with mRNA-1273 "showing durable efficacy of 93% through six months," according to Bancel, but there was a decline in antibody levels, especially against newer strains. He said "[we] recognise that the Delta variant is a significant new threat, so we must remain vigilant." The six-month data also suggest Moderna's vaccine still provides 98% protection against severe disease and was 100% effective at preventing death from COVID-19, whereas there were three deaths among placebo recipients.
Pfizer has made similar claims of waning efficacy about its COVID-19 vaccine BNT162b2, which is partnered with BioNTech. Last week, Pfizer predicted sales from the vaccine would hit $33.5 billion this year, although one analyst believes that figure will go even higher (see ViewPoints: Pfizer's COVID-19 vaccine sales set to reach around $45 billion in 2021). The FDA is also expected to grant full approval to BNT162b2 as early as next month.
Meanwhile, in an ongoing Phase II trial, Moderna is testing a 50-mcg dose of three booster candidates in previously vaccinated individuals. The candidates include a third shot of the original vaccine, as well as two modified variant-specific formulations, all of which it says induced "robust antibody responses" against variants of concern including Gamma, Beta and Delta. In addition, the company said it has wrapped up enrollment for a Phase I study of its next-generation COVID-19 vaccine mRNA-1283.
Bancel stated "we now have mRNA candidates in clinical trials across five therapeutic areas including infectious diseases, cardiovascular, oncology, rare disease and autoimmune disorders." He noted that Moderna has begun preparing late-stage studies for its influenza vaccine and respiratory syncytial virus (RSV) vaccine, "and [we] are looking forward towards our vision of a single-dose annual booster that provides protection against COVID-19, flu and RSV for adults."
The company also said it continues to expect capital investments of $450 million to $550 million for 2021, including a planned capacity expansion announced in April. Moreover, Moderna said it plans to consider "attractive strategic opportunities that further enable and complement our platform." Meanwhile, in another sign of the company's rapid growth, it said it employed about 1800 people at the end of June, compared with just over 930 a year ago.
In a pipeline update, Moderna disclosed that it has ended further development of its standalone OX40L candidate mRNA-2416, with focus now shifting to mRNA-2752, which comprises mRNAs for OX40L plus two cytokines, IL23 and IL36-gamma.
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