U.S. drugmaker Novavax (NVAX) has reported its first profitable quarter as sales of its COVID-
19 vaccine ramp-up in several countries, including Canada.
Novavax reported net income of $203 million U.S. in the first quarter, compared to a net loss of
$222.7 million U.S. a year ago. The company reiterated its 2022 revenue guidance of $4 billion
U.S. to $5 billion U.S.
However, Novavax still has not yet received an order from Covax, the international partnership
that procures vaccines for Africa and other low-income jurisdictions and nations. The timing and
quantities of future orders from Covax are unclear, which could impact Novavax’s revenue
guidance, the company said.
Novavax’s COVID-19 vaccine still has not been approved by the U.S. Food and Drug
Administration (FDA). The company said it anticipates the FDA will authorize the shots for
adults ages 18 and older as a two-dose primary vaccination series this summer.
The FDA’s committee of independent advisors is set to meet June 7 to review Novavax’s data
and make a recommendation on whether the vaccine should be cleared for use. Novavax has
also submitted vaccine data on adolescents ages 12 to 17 to the FDA and will submit additional
data on booster doses.
Novavax was one of the early participants in “Operation Warp Speed,” the U.S. government-
backed race to develop a COVID-19 vaccine in 2020. Pfizer (PFE), Moderna (MRNA) and
Johnson & Johnson (JNJ) beat the company to the punch as it struggled to ramp up its
manufacturing capacity.
Novavax has received authorizations in 41 countries for its two-dose COVID-19 vaccine outside
the U.S., including from Health Canada. The company shipped more than 42 million doses of its
shots this year in markets including the European Union, Canada, South Korea, Australia, New
Zealand and Indonesia.
If authorized by the FDA, Novavax’s vaccine would offer an alternative for people who do not
want to take the Pfizer or Moderna vaccines. Novavax uses more traditional protein-based
technology, while Pfizer and Moderna’s shots use messenger RNA for the first time.
Novavax stock fell 19% in extended trading on news of its latest financial results. Year to date,
Novavax’s share price has declined 63% to trade at $53.26 U.S. a share.