Rafael Henrique LightRocket | Getty Images
Novavax reported its first profitable quarter on Monday as its Covid vaccine is introduced in several countries around the world, although the company still missed earnings and revenue expectations.
Novavax shares fell 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 in the same period last year. The company has repeated its revenue guidelines for 2022 of $ 4 billion to $ 5 billion.
Here’s how the company performed compared to what Wall Street expected, based on average analysts ’estimates collected by Refinitive:
- Adjusted earnings: $ 2.56 per share, compared to the expected $ 2.69
- Income: $ 704 million, compared to the expected $ 845 million
Novavax’s two-dose Covid vaccine for adults aged 18 and over could get approval in the U.S. as early as this summer. A committee of independent advisers to the Food and Drug Administration is scheduled to meet on June 7 to review the vaccine’s data and make a recommendation on whether it should be approved for use.
Novavax was one of the first participants in Operation Warp Speed, a US-backed race to develop the Covid 2020 vaccine. Pfizer, Moderna and Johnson & Johnson ultimately defeated the company as it struggled to increase its production capacity. Four months ago in January, Novavax asked the FDA to approve the injection, but officials said the review process was complicated.
“This is an incredibly complex review process that includes reviewing not only clinical data but also production data that will be needed to make an emergency approval decision,” said Dr. Doran Fink, deputy director of clinical review in the FDA’s vaccine division. told the Board of Independent Vaccine Advisors last month at the Center for Disease Control and Prevention.
Novavax has received several approvals for its two-dose Covid vaccine outside the U.S. since it released data from clinical trials late last year. Australia, Canada, the European Union, Japan and the United Kingdom, among others, have released a vaccine for adults aged 18 and over.
A Novavax clinical trial in the United States and Mexico has shown that a protein-based vaccine is 90% effective in preventing mild disease and 100% effective in preventing severe disease. However, the study was conducted from December 2020 to April 2021, long before delta and omicron variants emerged and weakened the ability of the Covid vaccine to block infections.
Novavax released the results of a laboratory study in December that showed the vaccine elicited an immune response to omicron, though not as strong a response to the original strain of the virus. The third dose elicited an immune response against omicron to levels similar to a clinical trial in the United States and Mexico, indicating a high level of protection with the booster.
If approved by the FDA, Novavax injections would offer an alternative for people who do not want to take Pfizer and Moderna vaccines. Novavax uses more traditional protein-based technology, while photos of Pfizer and Moderna use messenger RNA for the first time. Although Moderna and Pfizer injections have been shown to be safe and effective against serious illnesses, some people may prefer technology that has a longer experience.