Vaxart (VXRT 20.20%) might just be gearing up to steal coronavirus vaccine market share from Moderna (MRNA -0.74%) in the next couple of years, making its investors wealthy in the process. The biotech's vaccine tablets could have a few advantages that Moderna's shots don't, including one, in particular, that might be a public health holy grail at the moment.
However, there's only a slim chance for the scrappy underdog biotech to beat out one of the industry's most imposing new players next year. Here's why.
Topping Moderna in 2023 is a long shot, but it could happen
For Vaxart's stock to beat Moderna's next year, two things need to happen. First, its coronavirus vaccine pill will need to live up to its promise of being able to prevent people from getting infected. Second, it'll need to actually conclude its clinical trials and get regulators to assent to commercializing the pills.
In a nutshell, there is some preliminary evidence from its phase 1 clinical trials and also its preclinical trials suggesting that Vaxart's candidate can induce immunity in the mouth, nose, and other elements of the upper respiratory tract, which are where SARS-CoV-2 infections start. They're also the locations where the shots produced by Moderna and also Pfizer tend to fall short.
Where the offerings by Moderna and Pfizer are effective at eliciting an immune system response to infection in the lower respiratory tract, thereby warding off severe disease, their coverage for the upper respiratory tract is often insufficient to prevent people from getting infected. And Vaxart's pills might not have that problem, even while likely protecting against severe disease too.
That means that the pills would have a massive, obvious advantage in gaining market share against Pfizer and Moderna, assuming that they could actually yield enough immunity to ward off getting sick entirely. Such an advantage would likely lead to a global rush to buy the tablets, as they're also shelf-stable and easy to administer, making their logistical footprint very simple for the public health benefit they could provide.
It's reasonable to expect the biotech's share price to skyrocket if it reports any new data that points to it being able to realize such an advantage in the future. It's also reasonable to expect that such a jump in share price would drive it to outperform for the year compared to Moderna, especially if Moderna is facing declining demand for its jabs to use as booster shots.
But Vaxart's phase 2 clinical trial for its lead vaccine candidate is still ongoing, so the jury's still out. And it isn't estimated to finish that trial until June 2023. So if it finishes on time, it'll still need to initiate and conclude a phase 3 clinical trial, putting its earliest chances of commercialization likely sometime in 2024.
If regulators with the Food and Drug Administration (FDA) are satisfied with the number of coronavirus vaccines that are currently approved in the U.S. when it's the company's time to submit their filings, it'll make the entire process take even longer, as it'll reduce the chances of it being able to use accelerated approval pathways like an Emergency Use Authorization (EUA). In other words, there's simply zero chance of the stock outperforming Moderna's due to the time needed for commercializing its pills in 2023, even if good trial data could still drive it to outperform.
It could be a favorable investment anyway
Right now, Vaxart has no recurring revenue, much like Moderna before its tumultuous (and ultimately victorious) year in 2020. If it eventually succeeds in getting its vaccine pill approved for sale, it'll post tremendous growth, and its stock will follow accordingly.
Nonetheless, given the riskiness of biotech stocks in general, it's clear that it isn't the right investment for everyone. The company's late-stage clinical trials could flop if they fail to demonstrate the pill's efficacy, especially in comparison to the jabs of competitors that are already on the market. Therefore, if you're scared by the idea of losing 30% or more of your investment overnight with little hope of recovery, don't buy this stock.
On the other hand, if you can tolerate the risk in light of the potential rewards, it's probably a good idea to buy a few shares. Vaxart might not beat Moderna or the market next year, but on the off chance that it does, investors will pocket a home run. And if its competitors can't adapt their shots to prevent infection, it'll be a strong sign for outperformance in 2024 and beyond, too.
