Novavax (NVAX 4.73%) grabbed investors' attention in the early days of the coronavirus vaccine race. The biotech scored $1.6 billion in funding from the U.S. government. And the company was among the first to launch clinical trials. As a result, the shares soared a mind-boggling 2,700% in 2020. Since, the stock has gone from losing momentum to actually suffering. The shares are down more than 60% this year.
The reason? Novavax disappointed investors when its regulatory submissions fell behind. Since, it's done a good job of catching up. More than 35 countries have authorized the vaccine so far. Now, all eyes are on Novavax's next step: winning authorization in the U.S. Could this nudge the stock out of its slump -- and even turn it into a multibagger?
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A promising financial picture
Let's start by taking a look at Novavax's first quarter as a commercial-stage company. The financial picture looks promising. Novavax reported revenue of $704 million and net income of $203 million. That's thanks to its coronavirus vaccine -- it's only commercialized product. The company reiterated its forecast for $4 billion to $5 billion in revenue this year. And Novavax's cash level increased to $1.6 billion from $1.5 billion in December.
Still, investors were disappointed about one particular element. It concerns Novavax's advance purchase agreement with Gavi, the Vaccine Alliance for 1.1 billion doses. Novavax will produce as many as 350 million doses and the Serum Institute of India will take care of the rest. Gavi is an organization providing equitable access to vaccines.
But so far, Gavi hasn't placed an actual order for doses. And Novavax said the timing and size of orders look "unclear." The per dose price in this agreement is lower than that paid by high-income countries. But the agreement with Gavi still remains an important part of Novavax's revenue picture. It's the company's biggest single contract. So, investors clearly will be keeping an eye on what happens next.
Speaking of advance purchase agreements, Novavax also has orders for as many as 450 million doses from seven countries and the European Union. And Novavax has licensing agreements to bring up to 400 million doses of its vaccine to various countries in Asia. The company delivered its product across these areas in the first quarter.
NASDAQ: NVAX
Key Data Points
A deal with the U.S.
Finally, Novavax's agreement with the U.S. includes the delivery of 110 million doses. It's important to keep in mind that the U.S. doesn't really "need" the vaccine right now. About 66% of the population already is fully vaccinated. And vaccines are readily available throughout the country for those who haven't yet gotten a jab.
All of this shows us that areas outside the U.S. probably represent more near-term opportunity for Novavax. Yet, the big focus has been on the U.S. Food and Drug Administration's (FDA) decision. An advisory committee is set to meet June 7 to discuss Novavax's submission.
Are we wrong to direct so much attention to the FDA meeting? Or could it be the element that sets off big share gains for Novavax? I'll answer both questions with a "no." Here's why. A positive FDA decision is important because it sets the stage for Novavax's future position in the U.S. market. Novavax' combined flu/coronavirus vaccine candidate is in a phase 1/2 trial right now. That product could be a game-changer down the road. But it would be easier for the product to carve out market share if Novavax already was a player -- even a small one -- in the U.S. coronavirus vaccine space. And Novavax today could gain some market share in the U.S. -- especially among people who prefer more of a traditional vaccine instead of an mRNA vaccine.
Multibagger potential?
Now, let's talk multibagger potential. I don't think a potential authorization in the U.S. will cause the stock to skyrocket. But I do think Novavax has multibagger potential over time. The company is profitable and on track to generate billion-dollar revenue this year. And its flu/coronavirus vaccine candidate could ensure it a prime spot in the long-term vaccine market.
If Novavax shares increased by three from today's price, they still would be a few dollars below Wall Street's very lowest 12-month share price forecast. Even if the stock doesn't gain that much in the next 12 months, it could over a longer timeframe.
At this point, Novavax still remains a stock best left to aggressive investors. There is a lot of uncertainty about vaccine demand as the pandemic shifts to an endemic situation. And if demand is lower than expected, the shares could suffer. But experts do expect the virus to stick around. That means at least the most vulnerable members of the population will need vaccines. So, over the long term, Novavax's revenue -- and share price -- could multiply.
