Novavax (NASDAQ:NVAX) is inching closer to its goal: the commercialization of its coronavirus vaccine candidate. And that probably will be the focus of its earnings report on May 10. The biotech company is clinical-stage -- so it doesn't yet generate product revenue.
In recent days, we've heard news about potential Novavax vaccine deliveries to Europe by year-end. And Novavax just expanded its U.S. trial to include teens. Meanwhile, the shares have pulled back. They lost more than 20% in less than a week. Now, the question is whether it's a good idea to scoop up Novavax shares ahead of the upcoming earnings report. Let's take a closer look.
A crucial moment
Novavax has reached a crucial moment. The company expects to report data from its phase 3 U.S. trial any day now -- and that will serve as a basis for an Emergency Use Authorization (EUA) request. Novavax said in its previous earnings report that it aimed to complete the EUA request in the second quarter. The final timeline will depend on the accrual of coronavirus cases in trial participants. The company has enrolled 30,000 participants in the trial across the U.S. and Mexico. This follows a U.K. phase 3 trial that showed 96% vaccine efficacy against the original coronavirus strain.
Once the company submits these trial results to the U.S. Food and Drug Administration (FDA), action may be quick. The FDA issued EUAs to rivals Pfizer, Moderna, and Johnson & Johnson a few weeks after they submitted phase 3 data. Of course, the regulatory agency faces less pressure to move forward with an EUA today than it did months ago. That's because the U.S. already has enough vaccine doses to vaccinate all Americans.
Still, the U.S. has reason to bring the Novavax candidate to market as quickly as those of earlier-to-market peers. The government effort formerly known as Operation Warp Speed recently increased investment in Novavax's program by about $147 million to reach a total of $1.74 billion. The funding includes an order for 100 million vaccine doses to be delivered after product authorization. Last week, President Joe Biden said the U.S. is ready to share vaccine doses with other countries -- and he mentioned Novavax.
A deal with Europe
And speaking of other countries, Reuters reported that Novavax and the European Union are getting closer to a formal contract for 200 million vaccine doses. Some investors were disappointed that delivery of most of these doses is planned for late this year and into 2022. They were hoping for an earlier rollout. But the key point here is meeting deadlines. I would rather Novavax agree to a 2022 deadline and reach it than struggle to fulfill an earlier one.
During Novavax's earnings report, any update on these particular points may be a catalyst for the shares -- with movement higher or lower according to the news.
So, does this mean you should buy Novavax's shares ahead of the report? This depends on your investment strategy and risk tolerance.
Novavax shares have traded as low as $112 and as high as $319 since the start of the year -- with double-digit gains and losses often in a single trading session. It's likely this sort of movement will continue. That's because Novavax shares are very dependent on coronavirus vaccine news. So, if you're uncomfortable with volatility, it's best to avoid Novavax right now.
A buying opportunity?
However, if you're an aggressive investor, now may be a good time to consider Novavax. The losses we've seen in recent days represent a buying opportunity. At today's level, Novavax trades at 9.7 times forward earnings estimates. The stock traded as high as more than 16 times estimates back in February. And this is just considering potential coronavirus vaccine sales.
Novavax also has a flu vaccine candidate -- NanoFlu -- that could be big. The candidate met all primary endpoints in a pivotal trial last year. The next step is regulatory submission. If the FDA approves NanoFlu and authorizes the coronavirus vaccine candidate, Novavax can transition from a zero-product company to a two-product company rather quickly.
Also on the horizon: Novavax is investigating a combination of NanoFlu with the coronavirus vaccine candidate. That could be a potential post-pandemic product.
Novavax shares have had a bumpy ride so far this year, but overall, they're delivering a win to investors. They've climbed more than 70% year to date. And if the coronavirus and flu programs are successful, the winning streak is likely to continue.