At the start of 2020, Novavax (NVAX 1.27%) shares were trading at $3.98, and the idea of a commercialized product seemed far off. Then two elements sent the shares into the stratosphere and spurred hope for not one -- but two -- marketed products in the near term. The company said its flu vaccine candidate met all primary endpoints in a pivotal trial. At the same time, Novavax began developing a coronavirus vaccine.
The stock has skyrocketed more than 2,900% winning the title of this year's top performer -- over all companies in all industries. Looking ahead, we might ask ourselves where this biotech-on-the-move may be a year from now. Will this year's work begin to bear fruit? Let's consider what Novavax has accomplished so far and what's next on the agenda.
One of the leading players
Novavax won't be first to market with a coronavirus vaccine. Pfizer (PFE -5.12%) already claimed that title when it received Emergency Use Authorization (EUA) for its vaccine candidate this month. And that's fine. Global need for a vaccine means there is room for more than one -- now and into the future.
Novavax still remains one of the leading players in the vaccine race. It is among the 13 programs in phase 3 trials. The company expects interim data in the early part of the first quarter from its U.K. phase 3 trial. Novavax says the results will support emergency use authorization requests. If Novavax follows in Pfizer's footsteps from a timeline perspective, its coronavirus vaccine candidate could enter the market in a matter of weeks.
That means the biotech company could start generating revenue in the first half of the year. So far, Novavax has agreements to supply at least 286 million doses to various countries, including the U.S. Novavax hasn't specified how much it is charging for its vaccine. But let's use the price the U.S. is paying as a general guide. The government offered Novavax $1.6 billion in exchange for 100 million doses of vaccine. That's $16 a dose. At that price, all of Novavax's orders so far would generate more than $4.5 billion in revenue. And Novavax is ramping up capacity to 2 billion doses by the middle of the year. That would represent $32 billion in potential revenue -- if orders match Novavax's full capacity.
Moving along to Novavax's flu vaccine candidate: In phase 3, NanoFlu met primary endpoints of general safety and non-inferior immune response compared with Sanofi's (SNY -0.06%) Fluzone Quadrivalent. And it even demonstrated higher antibody responses than those produced by Fluzone. The company recently assembled a team to shepherd NanoFlu through the regulatory approval process.
Novavax hasn't said when it will file for approval, but it's likely that will happen in the coming year. If the regulatory process goes smoothly, NanoFlu revenue could be something to look for in 2022.
Progress on a flu/coronavirus vaccine
And finally, a year from now, Novavax might be making progress on its plan to develop a combined flu/coronavirus vaccine. This would be for use after the pandemic. If the timeline resembles that of the coronavirus vaccine candidate, Novavax may be testing the potential product in humans by this time next year. If the timeline is more traditional, though, the program might only advance into preclinical tests during the coming 12 months.
So, a year from now, Novavax may have a coronavirus vaccine on the market, billions of dollars in product revenue, a soon-to-be commercialized flu vaccine, and a flu/coronavirus vaccine in human trials.
What does this mean for investors? In 2020, investors placed bets on Novavax's future. Risk was (and is still) high, and so was reward. Once the company has a product on the market and is generating revenue, risk will be lower. But the potential for rewards won't go away. Wall Street's average 12-month share price forecast calls for a 50% gain from today's level. Potential revenue from a coronavirus vaccine is the catalyst to take the shares to that point -- or maybe even higher.
And the story isn't over there for this biotech stock. NanoFlu and a possible flu/coronavirus vaccine could be the catalysts to power gains well into 2022.