Investors -- and governments -- have rallied behind Novavax (NASDAQ:NVAX) since the start of the coronavirus vaccine race. The major excitement began after the company won a $1.6 billion order from the U.S. government last summer. At the time, it was one of the government's biggest investments in a vaccine developer. And the shares soared more than 2,700% last year.
Since, Novavax has lost a considerable amount of steam -- in spite of strong clinical trial data. The stock has gained 73% this year. But it's down nearly 40% from a high reached in February. Can Novavax's dynamism return? Next week's earnings report may offer some clues. Here are the three things that will make it or break it for the clinical stage biotech.
1. A regulatory update
Earlier this year, investors hoped Novavax would use data from a successful U.K. trial to support regulatory submissions in various countries. That could have led to authorization as soon as in the first quarter of this year. Instead, Novavax waited to report data from its U.S. trial -- and aimed for second-quarter regulatory submissions. But in the last earnings report, Novavax changed its plan. The company said it would complete submissions in the third quarter.
It's critical that Novavax updates investors in next week's earnings report regarding the submission plan. And it's critical for Novavax to stay on track. The company already has lost time -- and a position in the market -- to earlier rivals like Pfizer and Moderna. As I've written before, that's OK. There will be room for additional players in the next stages of vaccination. Still, investors may lose patience if there's another delay. The sooner Novavax enters the market, the sooner it can start generating revenue.
2. Managing manufacturing
The subject of regulatory submissions leads me to a related point. And that's manufacturing. For Novavax to gain authorization, it must show countries that it actually can make the doses on a large scale. The problem here is Novavax has run into some raw materials concerns in recent months. There have been global shortages of certain items -- like plastic bags -- needed to produce the eventual vaccine.
During the last earnings report, Novavax said it expected its suppliers to address the issues and ramp up production. In turn, Novavax would be able to ramp up production of the potential vaccine. At the time, Novavax aimed for full capacity during the fourth quarter. Its earlier prediction was full capacity during the third quarter.
Again, it's crucial for Novavax to stick by the latest goal. If it instead reports continued struggles, investors (and countries that order doses) may start to worry about the company's ability to manufacture steadily and at great quantities. The issue already has had an impact on Novavax's market position in Australia. The country won't rely on Novavax for its vaccination plan this year, according to The Guardian. Instead, Novavax will be part of Australia's booster program.
3. Potential in Europe
During Novavax's last earnings report, the company said it was in talks with the European Union regarding a supply deal. Securing orders internationally is extremely important for Novavax. Here's why: The U.S. bought enough doses of mRNA vaccines Pfizer and Moderna to cover the whole population this year. Will the U.S. favor these tried-and-true players into the future? It's possible.
At the same time, Europe has struggled to vaccinate its population. First, there weren't enough doses to go around. Then, blood clots linked to Johnson & Johnson and AstraZeneca vaccines scared some countries away from those products. Europe recently ordered up to 1.8 billion doses from Pfizer and said more big orders (with other companies) would be on the way.
Europe could represent a big market for Novavax. The Novavax candidate offers an alternative to mRNA vaccines. And unlike J&J and AstraZeneca vaccines, it hasn't been linked to blood clots. So, it will be important for Novavax to update investors on where it stands with the European Union.
The answers to three questions
These three issues are key because they should offer answers to key questions: When will Novavax begin generating revenue? Can Novavax produce the doses it's promised? Can Novavax carve out a share of a major vaccine market?
Even if all of the answers are positive, I'm not expecting Novavax's shares to gain more than 2,000% again this year. But if the earnings report delivers encouraging information on the above points, the stock could move considerably higher. However, if Novavax disappoints, the stock may struggle until this company can offer investors a clear view of the future.