Novavax posts first profitable quarter as Covid vaccine rolls out around the world

Novavax on Monday reported its first profitable quarter as its Covid vaccine rolls out across several countries around the world, though the company still missed earnings and revenue expectations.

Novavax stock was down more than 8% in after hours trading.

Novavax reported net income of $203 million in the first quarter, compared to a net loss of $222.7 million the same period last year. The company reiterated its 2022 revenue guidance of $4 billion to $5 billion.

Here’s how the company performed compared with what Wall Street expected, based on analysts’ average estimates compiled by Refinitiv:

• Adjusted earnings: $2.56 per share, vs. $2.69 expected
• Revenue: $704 million, vs. $845 million expected

Novavax’s two-dose Covid vaccine for adults ages 18 and older could receive authorization in the U.S. as early as this summer. The Food and Drug Administration’s committee of independent advisors is set to meet June 7 to review the data on the shot and make a recommendation on whether it should be cleared for use.

Novavax was one of the early participants in Operation Warp Speed, the U.S. government-backed race to develop a Covid vaccine in 2020. Pfizer, Moderna and Johnson & Johnson ultimately beat the company to the punch as it struggled to ramp up its manufacturing capacity. Novavax asked the FDA to authorize the shot four months ago in January, but officials said the review process is complicated.

“This is an incredibly complex review process that involves review of not just clinical data but also manufacturing data that will be needed to make a determination about emergency use authorization,” Dr. Doran Fink, deputy director of clinical review at the FDA’s vaccine division, told the Center for Disease Control and Prevention’s committee of independent vaccine advisors last month.

Novavax has received several authorizations for its two-dose Covid vaccine outside the U.S. since it published clinical trial data late last year. Australia, Canada, the European Union, Japan and the U.K. among others have cleared the vaccine for adults ages 18 and older.

Novavax’s clinical trial in the U.S. and Mexico found that the protein-based vaccine was 90% effective at preventing mild illness and 100% percent effective at preventing severe illness. However, the study was conducted from December 2020 through April 2021, well before the delta and omicron variants emerged and weakened Covid vaccines ability to block infections.

Novavax released results from a lab study in December that showed the vaccine triggered an immune response against omicron, though not as strong the response against the original strain of the virus. A third dose boosted the immune response against omicron to levels similar to the U.S. and Mexico clinical trial, suggesting a high level of protection with a booster.

If authorized by the FDA, Novavax’s shots would offer an alternative for people who do not want to take the Pfizer and Moderna vaccines. Novavax uses more traditional protein-based technology, while Pfizer and Moderna’s shots use messenger RNA for the first time. Though Moderna and Pfizer shots have proven safe and effective against severe illness, some people may prefer technology that has a longer track record.