Moderna (MRNA -1.66%) is nearing the finish line in the coronavirus vaccine race. This biotech company has been among the leaders from the start. Back in March, it became the first company to launch a coronavirus vaccine trial in humans. Now, Moderna awaits a crucial step: word from the U.S. Food and Drug Administration (FDA). The FDA meets with an advisory committee on Dec. 17 to discuss whether to offer Emergency Use Authorization (EUA) to Moderna's investigational vaccine.
The company's path from early vaccine development to EUA request has been a smooth one. And that's reflected in the share price. Moderna shares have soared more than 700% this year. Now, the question is whether this stock still represents a good bet on coronavirus vaccines. Let's take a closer look.
The first two players
Moderna is likely to be among the first two players to begin selling coronavirus vaccines. Rivals Pfizer (PFE 1.30%) and biotech partner BioNTech (BNTX 1.17%) applied for an EUA 10 days earlier than Moderna. Eleven other programs are in phase 3 trials -- but EUA requests aren't imminent. So, this means Moderna and Pfizer -- if granted authorization -- will initially have the market all to themselves.
That doesn't mean Moderna can sell vaccine doses to half of the world's population, however. Production capacity imposes limits. Moderna said it can supply 20 million doses in the U.S. by the end of this year. The company expects to produce between 100 million and 125 million doses of the vaccine for use globally in the first quarter. Including those doses, Moderna aims to manufacture 500 million to 1 billion doses of vaccine in 2021.
How much revenue can Moderna make from the doses? The company's pricing may vary according to order size and other factors. However, we can use the price the U.S. government paid for doses to offer us a ballpark figure. The government is paying $1.5 billion for 100 million doses. So, each of those doses costs $15. At that price, Moderna could generate nearly $1.9 billion in revenue in the first quarter. That's not bad for a company that hasn't yet had product revenue. If the FDA likes what it sees in Moderna's clinical trial data, it may grant an EUA before the end of the year. That makes a full quarter of revenue by March a strong possibility.
Blockbuster revenue levels
This would be huge for Moderna. Outside of the coronavirus vaccine candidate, the company's closest-to-market products are in phase 2 trials. So, an EUA would bring Moderna revenue years earlier than investors -- and the company itself -- expected prior to the coronavirus crisis. And even better -- that revenue would be at blockbuster drug levels.
But what happens when rivals enter the market? Moderna -- and its rivals -- probably won't have to worry about competition right away. Considering the global need for vaccine, the five leaders in this race could produce at full capacity, and there still wouldn't be enough doses for everyone.
That said, a few years down the road, the story might change. Many more vaccines may reach the market, and then, governments may have the necessary leverage to lower prices. Or they simply might switch to a vaccine deemed more efficacious, safer, or more practical. For the next couple of years, however, I expect Moderna and other early entrants to sell as many doses as they're able to produce -- as long as their vaccines continue to be safe and effective.
Is Moderna a good bet?
Let's get back to our original question: Is Moderna stock a good bet on coronavirus vaccines? Yes. But as with all players in this vaccine race, risks remain. The FDA may refuse the company's EUA request or ask for further data. Or, further down the road, long-term vaccine data may disappoint. That's why I recommend caution when investing in players that depend on one product for revenue.
Still, considering the information available to us, a nod from the FDA seems likely. And beyond the U.S., others such as the European Union, Canada, and Switzerland have already ordered vaccine doses. That sets Moderna up for a first quarter of dramatic revenue levels. And that gives the shares plenty of fuel for gains in the coming year.