Novavax, Inc (NASDAQ:NVAX) shares fell over 12% in the after-hours trading on Monday after closing almost 8.8% lower in regular trading.
What Happened: The after-hours dip came as the Maryland-based company said that it is unlikely to seek emergency use authorization for its COVID-19 vaccine candidate in the United States until July at the earliest.
The announcement was made during the company’s first-quarter earnings call, the Washington Post reported.
People familiar with the matter had told the Post earlier that the filing was delayed due to manufacturing regulatory issues until June.
Novavax shares fell 12.9% in the after-hours session to $139.80 in Monday’s after-hours trading after closing 8.81% lower at $160.50 in the regular session.
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Why It Matters: Novavax earnings per share for Q1 2021 were down 425.86% year-on-year to minus $3.05, which is better than the street expectations of minus $3.60.
Revenue came in at $447.23 million, which is 13,143.88% higher than the same period last year, beating an estimate of $233.9 million.
Executives of the company reportedly said that raw material shortages were responsible for the company’s inability to reach manufacturing targets.
In March, the company said its NVX-CoV2373 vaccine was 96.4% effective “against mild, moderate and severe disease caused by the original COVID-19 strain” in Phase 3 trials.
At the time, Novavax said that its vaccine candidate showed 86% efficacy against the U.K. strain and 55% effective against the one first discovered in South Africa.