• Novavax reported its first profitable quarter, though it still missed expectations on earnings and revenue.
• Novavax's Covid vaccine has rolled out in several major economies around the world.
• The two-dose vaccine could receive U.S. authorization this summer.

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 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.

However, Novavax has not yet received an order from Covax, the international partnership that procures vaccines for lower-income nations. The timing and quantities of future orders from Covax are unclear which could affect the revenue guidance, Chief Financial Officer Jim Kelly told analysts during the company's earnings call.

 "It's an unclear marketplace right now in the low- and middle-income countries," CEO Stanley Erck told analysts.

Novavax stock was down nearly 19% in extended trading.

Chief commercial officer John Trizzino told analysts there's also upside to the revenue guidance in the U.S. market if the vaccine is authorized by the Food and Drug Administration. Novavax anticipates the FDA will authorize the shots for adults ages 18 and older as a two-dose primary vaccination series this summer, according to Erck. The company is currently in negotiations with the U.S. government on how it can meet demand after authorization, the CEO said.

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

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 shots should be cleared for use. Erck said Novavax's manufacturing partner Serum Institute of India successfully passed on FDA inspection ahead of the committee meeting. Novavax also has submitted vaccine data on adolescents ages 12 to 17 to the FDA and will submit additional data on booster doses, Erck said.

Novavax will start clinical trials on a vaccine that targets mutations on the omicron variant this month, the CEO said. The FDA committee is also holding a meeting on June 28 on whether the U.S. needs to switch to a new vaccine design that targets recent virus mutations. The current vaccines still target the original strain of the virus that emerged in Wuhan, China, in 2019.

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 Centers for Disease Control and Prevention's committee of independent vaccine advisors last month.

Novavax has received authorizations in 41 countries for its two-dose Covid vaccine outside the U.S. 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, according to Trizzino.

"As we look ahead to the second quarter, we expect our shipments to key markets to increase," Trizzino said. Novavax is fulfilling a 42 million dose order to the EU which should result in increased revenue for the second quarter, he said.

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 as 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.

"We continue to hear from our market research as well as anecdotally that there's a high demand for a choice in the marketplace," Trizzino said.