Novavax (NVAX 4.86%) has taken investors on quite an exciting ride since it entered the coronavirus vaccine race. The biotech leaped into the spotlight in the early days of the pandemic when it won $1.6 billion in support from the U.S. government. And the company finished 2020 with a gain of more than 2,700%.
But the Novavax story became more complicated last year. Investors expected Novavax to apply for U.S. regulatory authorization in the first half. Instead, troubles with a manufacturing ramp up got in the way. The stock has dropped nearly 60% from highs reached in February of last year. Novavax has since resolved its production issues and today is on track to apply for U.S. authorization in about a month. Now the question is whether we should hang on to hopes and buy or hold the shares -- or whether we should sell. Let's take a closer look.
Billions of dollars in revenue
First of all, it's important to note that over 30 countries have already authorized the Novavax vaccine. That means revenue is just ahead. This is particularly significant because until this point, Novavax didn't have any product revenue. It's too early to say exactly how much revenue we should expect. But in an earnings report last year, Novavax mentioned generating billions of dollars in the four to six quarters following regulatory authorization.
The company said it will put the focus on providing doses to countries most in need first. These are the countries that pay less for doses -- so revenue may start slowly. But Novavax could eventually become an important player in high-income countries too. Last year, the company signed a deal with the European Union to deliver as many as 200 million doses through 2023. And the U.S. investment in Novavax included an order for as many 100 million doses.
You may wonder what role Novavax could play, though, in countries where vaccination rates are high. For instance, 62% of the U.S. population and 70% of the European Union population are fully vaccinated. It's true that first-to-market players like Pfizer and Moderna are likely to keep their positions.
But Novavax could carve out a decent share of these markets for two reasons. First, Novavax presents an alternative to the leaders' mRNA vaccines. There isn't anything wrong with mRNA vaccines. But some people may not be able to take them for a specific reason. And others may be more comfortable with a more traditional vaccine technology. Novavax is a protein subunit vaccine, like the currently commercialized hepatitis B vaccine. Subunit vaccines contain parts of a pathogen (instead of the whole pathogen) to spur an immune response. The Novavax candidate contains genetically engineered spike protein in nanoparticle form along with an adjuvant.
"Mixing and matching" vaccines
Second, Novavax may benefit from the idea of "mixing and matching" vaccines. The U.S. Food and Drug Administration gave this practice the nod a few months ago. The idea is if you've received a primary series of, say, the Moderna vaccine, you can opt for another brand as a booster. As the omicron variant gains ground worldwide, many countries are encouraging residents to go for boosters. So, Novavax clearly could benefit here.
Further down the road, Novavax has a couple of more important catalysts. The company's flu vaccine candidate -- NanoFlu -- met all primary endpoints in a pivotal trial. The next step is a regulatory submission. This could be another important product for Novavax in the near future. And NanoFlu may be a component of a blockbuster a few years from now. Novavax has completed enrollment in a phase 1/2 trial of its combined flu/coronavirus vaccine candidate. Rival Moderna is also working on such a candidate -- but Novavax is further ahead.
Cheap right now
Considering this, Novavax stock is incredibly cheap right now. It's trading at a bit more than five times forward earnings estimates.
All of this sounds very positive, right? So, should we all go out and buy Novavax shares? It depends on your investment style. Novavax still faces two big risks. I'm thinking back to the manufacturing struggles last year. If these issues arise again and slow down vaccine rollout, I would expect the shares to suffer. And the shares also may drop if there are any more delays in Novavax's quest for authorization in the U.S. So, if you're uncomfortable with volatility, this probably isn't the best time to pick up Novavax shares.
But if you're an aggressive long-term investor, I favor buying or holding shares of this company for all of the elements I mentioned above. This could be a big year for Novavax.