Novavax (NASDAQ: NVAX) on Monday reports its first profitable quarter, driven by its COVID vaccine's global roll-out. However, the shot has yet to be authorized in the United States and has not received orders from the World Health Organization's (WHO) COVAX program.
For the first quarter, Novavax reported net income of $203 million, compared to a net loss of $222.7 million for the same period last year. The company also reiterated its 2022 revenue guidance of $4 billion to $5 billion.
Despite the profitable quarter, Novavax has been met with uncertainty over global demand for its vaccine as its slowly starts to delivery. The company said back in September it had targeted to deliver at least 2 billion doses of its COVID vaccine this year. So far in 2022, the company has delivered about 42 million doses globally.
Chief Business and Commercial Officer John Trizzino said during Novavax's Q1 earnings call that the company continues to see low vaccination rates across low-income nations. Trizzino added that the company has yet to receive an order from Gavi--the organization behind the international partnership with the goal of supplying vaccines to lower-income nations, known as COVAX--and "the timing and quantities of future orders to deliver [the vaccine] to the COVAX facility are unclear".
Trizzino told analysts that a potential upside for its revenue guidance could come if the vaccine is authorized by the U.S. Food and Drug Administration for use in the United States. Novavax expects the FDA to authorize its two-dose shot primary regimen for adults ages 18 and older this summer, Chief Executive Officer Stanley Erck told analysts. The company is already in negotiations with the Biden administration on how to meet demand after the shot is authorized, Erck added.
Novavax has also submitted vaccine data for adolescents ages 12 to 17 to the U.S. drug regulator and plans to submit additional data on booster shots once ready, Erck said. The company also expects to begin clinical trials for a next-gen COVID vaccine that targets mutations on the Omicron variant this month, Erck added.
Novavax was one of the first participants in the Trump administration's Operation Warp Speed, the initiative to fast-track a COVID vaccine in 2020. Other COVID vaccine developers like Pfizer (NYSE: PFE)-BioNTech (NASDAQ: BNTX), Moderna (NASDAQ: MRNA) and Johnson & Johnson (NYSE: JNJ) ultimately beat Novavax to produce effective vaccines as the company was met with manufacturing and regulatory delays.