Novavax on Wednesday said that the postmarketing commitment study is anticipated to occur during 2025 and 2026 and cost between $70 million and $90 million to complete.
Novavax Inc. (NVAX) on Wednesday said that the postmarketing commitment study for its COVID-19 vaccine Nuvaxovid will not have an impact on its operating profit for 2025.
“Sanofi is picking up the vast majority of expenses as we keep the momentum, right, in the vaccine advancing in the marketplace,” Novavax CFO Jim Kelly said.
Novavax got the U.S. Food and Drug Administration’s approval for Nuvaxovid in May for the prevention of COVID-19 in adults 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from the disease.
The FDA then requested the company to conduct a postmarketing commitment (PMC) study.
On Stocktwits, retail sentiment around NVAX jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘high’ levels.
A Stocktwits user opined that the company needs to diversify its partnership portfolio to prevent limiting its upside.
Novavax on Wednesday said that the Nuvaxovid study is anticipated to occur during 2025 and 2026 and cost between $70 million and $90 million to complete. The company will conduct the study on behalf of its partner Sanofi, which will reimburse 70% of the total costs, or about $55 million.
While Novavax is also expected to incur some costs, they are included within the company’s research and development expense targets and capped under the agreement with Sanofi, the company said.
Novavax on Wednesday raised its annual adjusted revenue forecast to between $1 billion and $1.05 billion, from $975 million to $1.03 billion earlier.
The company reported total revenue of $239 million, above an analyst estimate of $147.55 million, thanks to a $175 million milestone payment from Sanofi over the approval of Nuvaxovid.
Transfer of marketing authorization of the vaccine to Sanofi for the U.S. and European Union markets is expected in Q4, which will trigger an additional $50 million in combined milestones from Sanofi, Novavax said.
Novavax’s diluted net income per share came in at $0.62, above consensus estimates.
NVAX stock is down by 6% this year and by about 35% over the past 12 months.
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