Long-time investors know that the market is always forward-looking. What's potentially on the way is always more important than what's in the past. Novavax (NASDAQ:NVAX) just provided a great example of this.
The biotech announced its fourth-quarter results after the market closed on Monday. And what Novavax had to say about the future mattered a lot more than what it had to say about its Q4 performance.
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By the numbers
We shouldn't ignore how Novavax performed in the fourth quarter, though. After all, the company delivered its best top-line figure ever. Novavax reported Q4 revenue of $279.7 million. That's a huge leap from revenue of $8.8 million generated in the prior-year period. However, it fell short of the Wall Street consensus of $304.9 million.
On the other hand, Novavax's bottom line in the fourth quarter was the worst it's ever been. The biotech announced a net loss of $177.6 million, or $2.70 per share, based on generally accepted accounting principles (GAAP). By comparison, Novavax posted a net loss of $31.8 million, or $1.13 per share, in the prior-year priod. The company's bottom line was also much worse than the average analyst estimate of a net loss of $1.49 per share.
Perhaps the most important statistic for Novavax's future, though, related to its cash position. The company ended the fourth quarter with cash, cash equivalents, restricted cash, and marketable securities totaling $806.4 million. At the end of 2019, Novavax's cash stockpile stood at $82.2 million.
What really mattered
My Motley Fool colleague Adria Cimino wrote last week that there were two important things to look for in Novavax's Q4 update: the potential timing of authorizations and progress on a booster shot. I agree that those items are what really mattered with Novavax's quarterly announcement. The biotech mentioned both (albeit briefly) in its press release announcing the Q4 results.
Novavax stated that it will potentially file for authorization of COVID-19 vaccine NVX-CoV2373 in the United Kingdom by early Q2. That implies sometime in April.
What about the prospects for emergency use authorization (EUA) in the U.S.? The company said that it could potentially file in the second quarter of 2021. However, Novavax also stated that it's "engaged in ongoing dialogue with the U.S. Food and Drug Administration (FDA)."
If the FDA doesn't agree to use Novavax's U.K. data as the sole basis for EUA submission, there's a lot riding on the late-stage study of NVX-CoV2373 being conducted in the U.S. and Mexico. Novavax said that interim data from this study is expected sometime in Q2. Importantly, though, the company added that this timing is "dependent on the overall COVID-19 attack rate." In other words, if enough participants don't get COVID-19 quickly enough to meet study thresholds, it could take longer for the interim results to be available.
The biotech said that it's moving forward with the evaluation of a six-month booster dose in phase 1/2 studies being conducted in the U.S. and Australia. Novavax is already evaluating candidate vaccines targeting new coronavirus variants (including both stand-alone and bivalent vaccines) in preclinical testing in non-human primates. The company plans to advance one or more of these candidates into clinical testing by mid-year.
What's next for the stock?
Investors will anxiously await Novavax's progress on securing authorizations for NVX-CoV2373. The biotech stock has already more than doubled so far this year. Positive news with authorizations in the U.K. and especially the U.S. should send Novavax's shares even higher.
