Moderna rounds out 2022 with $18.4B in vaccine sales, boosts R&D budget for 2023

Moderna CEO Stéphane Bancel is revving the engines going into 2023, with a whopping $4.5 billion R&D budget and a new priority review voucher.

The company’s full-year sales totaled $18.4 billion, it announced on Monday, falling shy of the chief executive’s previous $21 billion projections. Bancel cited delivery delays, short-term supply shortages and a “very complex third quarter from a manufacturing standpoint” upon lowering the guidance last quarter, while promising that the company is “in a much better place” for 2023.

At this year’s JP Morgan healthcare conference in San Francisco, Bancel pegged at least $5 billion in 2023 Covid vaccine sales from already confirmed advance purchase agreements and 2022 contract deferrals. Despite slow uptake of bivalent boosters in the US — just over 15% of people aged 5 years and older have received the updated shots — Moderna’s chief commercial officer Arpa Garay predicted on the latest quarterly call that the Covid vaccine market would be “as large or larger than” the flu market.

On Monday, Bancel told the Wall Street Journal at JPM that Moderna is considering pricing its vaccine between $110 and $130 per dose in the US. Pfizer suggested the same range for its vaccine last fall, according to multiple reports. Moderna was not immediately available for comment on the pricing of its vaccine.

Across the broader respiratory pipeline, Moderna said its Phase III RSV study has met the number of cases required to perform a first efficacy analysis, and flu data are likely coming this quarter.

Moderna is also hoping to initiate a Phase III trial this year for its mRNA-based cancer vaccine in combination with Merck’s Keytruda in melanoma, the company said in its Monday news release.

The partners claimed last month that their regimen significantly reduced the risk that patients’ cancers would return and be fatal in what they called the first results from an mRNA therapy in a randomized trial with cancer patients. Just last week, BioNTech inked a deal with the UK government to speed up trial recruitment for its own mRNA-based cancer therapies.

To help move things along, Bancel is padding this year’s R&D budget with an extra $1.2 billion. The company’s stock $MRNA was up about 2% on Monday afternoon, trading at around $184.52 per share.

“Our board has approved a significant increase to our R&D investments, with a budget for 2023 of around $4.5 billion,” he said in a news release.

Executives also revealed that Moderna purchased a new priority review voucher, which can be used to shorten a new drug’s FDA review from 10 months to 6 months. The company has one other voucher, which it received last year for the approval of its Covid-19 vaccine Spikevax. While Moderna declined to provide more information on the new voucher, it said in the news release that it  “intends to use both PRVs to accelerate review of two expected BLA filings from our pipeline.”

Bancel noted last quarter that the business development team remains “very active,” as evidenced last week by its $85 million deal to buy out Tokyo-based OriCiro Genomics and its work on cell-free synthesis and amplification of plasmid DNA.

“2023 is going to be a very exciting year for Moderna, and most importantly, for patients,” Bancel said in the news release.

Read More