By
Godfrey Benjamin
October 4th, 2023
Novavax has some key meetings ahead with the US Food and Drug Administration next month for the approval of its two-dose vaccine in the US.
On Monday, May 9, Novavax Inc (NASDAQ: NVAX) reported the earnings for its first quarter Q1 2022, marking it the first profitable quarter amid the plans to roll out its coronavirus vaccine worldide. This happens as the company rolls out the Covid-19 vaccine all across the world. But despite a profitable quarter, the company still missed its earnings and revenue estimates. For Q1 2022, Novavax reported a net income of $203 million during the first quarter. This was a significant improvement considering the $222 million loss in the same quarter last year. Novavax has reiterated its 2022 revenue prediction to be somewhere at $4 billion to $5 billion.
But Novavax has yet to get an order from its international partner Covax which aims to procure vaccines for low-income nations. However, there’s still some uncertainty regarding future orders from Covax. Chief Financial Officer Jim Kelly said that this could potentially impact the company’s revenue guidance for 2022.
Amid the broader market correction, Novavax stock was down 19% on extending trading on Monday. The NVAX stock is already down further by 25% in the pre-trading session today.
Novavax Focusing on the US Vaccine Market
Novavax’s Chief commercial officer John Trizzino told analysts there could be an upside to the revenue guidance if the US Food and Drug Association authorized its vaccine.
As per the company expectations, the USFDA will authorize the shots for adults above 18. Novavax CEO Stanley Erck said that the company is currently in negotiations with the US government on how it can meet the demand after authorization.
FDA’s independent advisors will meet next month on June 7 for reviewing Novavax’s data and deciding on whether to clear its vaccine shots for use. Novavax’s manufacturing partner Serum Institute of India has already passed the FDA inspection. Dr. Doran Fink, deputy director of clinical review at the FDA’s vaccine division said:
“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”.
Outside the US, Novavax has received authorization in 41 countries for its two-dose Vaccine. The company has already shipped over 42 million doses of its shots in markets such as Canada, the European Union, Australia, Indonesia, South Korea, etc.
“As we look ahead to the second quarter, we expect our shipments to key markets to increase. 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.