In January, biotech company Novavax (NVAX 3.54%) finally completed its application for an emergency use authorization (EUA) for its coronavirus vaccine, NVX-CoV2373, in the U.S. The much-anticipated application came after the company ran into delays that pushed back its timeline to submit the EUA in the country.
However, Novavax has yet to earn the nod in the U.S., and what's more, the company's shares continue to struggle. The biotech's stock is currently trading near its 52-week low. Should investors give up on Novavax?
Novavax's hopes in the U.S.
Novavax announced that it had completed its regulatory application to the U.S. Food and Drug Administration (FDA) for its COVID shot on Jan. 31. Unlike for regulatory submissions, there is no set timeline for the review process of a EUA. The standard review process for a drug or vaccine typically takes 10 months for the agency to complete. And for those products that receive priority review, it takes six months.
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EUAs, on the other hand, can take anywhere from a couple of weeks to several months to be completed. Other factors likely affect the review time, such as whether there is an urgent need for the product in question. At this stage of the pandemic, there are plenty of vaccines available for COVID-19, which means it is less urgent for regulators to approve a new shot than it would have been at the peak of the outbreak.
Plenty of regulatory approvals
Although Novavax has yet to secure the U.S. EUA, it is worth noting that the COVID vaccine has been granted the green light in many other countries. The list of places where the product has been approved includes Canada, the U.K., the European Union, and Australia, among others. While the U.S. is undoubtedly an important market, Novavax's ability to earn regulatory authorization in these other countries will help the company generate some revenue from its vaccines in these other countries.
Further, it doesn't seem as though there are any safety or efficacy issues related to the vaccine. True, every country has its own regulatory process for approving vaccines. The fact that the Novavax jab earned the green light elsewhere does not guarantee that the FDA will take the same route. Still, these regulatory approvals strongly suggest that the vaccine works as intended.
It's too early to give up on Novavax
There are more reasons to be optimistic about Novavax. The company has several coronavirus-related regulatory decisions on the way, and it keeps pocketing new approvals. On April 19, the COVID vaccine was green lighted by authorities in Japan for primary and booster immunization in adults. On April 13, the shot was granted conditional marketing authorization in Switzerland. And on April 8, the vaccine was given EUA in Thailand.
Last year, Novavax generated $1.15 billion in revenue. That number will almost certainly increase substantially this year. Analysts expect the company to post revenue of $4.49 billion in 2022, which is well within the company's guidance of between $4 billion and $5 billion and would represent a year-over-year increase of about 290%.
The rest of Novavax's pipeline deserves mention. The company's late-stage programs include NanoFlu, a potential flu vaccine for adults aged 65 and older, and a potential respiratory syncytial virus (RSV) vaccine called ResVax. NanoFlu has already proved safe and effective in a phase 3 study. But Novavax put this program on the back burner when the pandemic started. The company's other programs include a potential vaccine for malaria and a combined flu and COVID-19 vaccine.
Another silver lining: On Wednesday, the company announced that its combination flu and COVID vaccine candidate showed promising results in early stage clinical trials.
Investors can expect regulatory wins for the company (not related to the COVID vaccine) within the next couple of years. Novavax's stock has been hammered in the past year, and the company is currently trading near its 52-week low. The biotech's forward price-to-sales ratio of 0.92 is also as low as it has been in over a year. At current levels, Novavax looks like an exciting biotech stock to buy, at least for those willing to look past the company's near-term issues.
