It's probably fair to say that no one in late 2019 would have foreseen the crazy ride that Moderna (MRNA 3.04%) has had so far this year. Global pandemics aren't all that easy to predict.
Moderna, once lauded for its biggest biotech IPO in history, is now celebrated as one of the leaders (some even think the leader) in developing a COVID-19 vaccine. Its shares have skyrocketed as a result. But what's the outlook for Moderna now?
Where things stand
To get a sense of what could be in store for Moderna in the future, we have to first look at where things stand right now for the company. The best place to start is with the biotech's COVID-19 vaccine candidate, mRNA-1273.
Moderna finished dosing the first participants in a phase 2 clinical study of mRNA-1273 on May 29. It has already enrolled 300 healthy participants between the ages of 18 and 55 and at least 50 adults aged 55 or older of the 300 planned for the age cohort. Participants will receive two immunizations of mRNA-1273 28 days apart. They'll then be followed for 12 months after the second vaccination.
Does that mean it's going to be a while before Moderna's COVID-19 vaccine will move forward? Nope. The biotech has already hammered out the details of its planned phase 3 study with the FDA and intends to begin a late-stage trial in July that will enroll 30,000 participants.
Meanwhile, Moderna is gearing up to produce at least 500 million doses of its COVID-19 vaccine and possibly up to 1 billion doses annually beginning in 2021. In May, the company teamed up with Swiss drugmaker Lonza to expand production capacity for mRNA-1273.
But while most of the attention is rightfully focused on Moderna's COVID-19 vaccine candidate, the company has 22 other mRNA pipeline candidates, with 12 of them in clinical studies. Its lead candidate in this group is cytomegalovirus (CMV) vaccine mRNA-1647. Moderna expects to report its first interim analysis from a phase 2 study of the CMV vaccine in the third quarter of 2020 and is planning for a late-stage study to hopefully start next year.
Identifying where things stand now is the easy part. Going forward, there are several variables that could significantly impact what happens with Moderna. And it's difficult to predict exactly how these factors might play out.
The obvious variable is how well mRNA-1273 performs in clinical testing. The most worrisome gotcha for Moderna would be potential safety problems with its COVID-19 vaccine. However, efficacy is very important as well.
Another key variable is the progress of other drugmakers racing to develop COVID-19 vaccine candidates. Five other COVID-19 vaccines are already in clinical testing, with Johnson & Johnson planning to begin a phase 1 study of its candidate in the second half of July. If other companies stumble along the way and Moderna doesn't, it will dramatically change the market dynamics.
How well others fare in their COVID-19 vaccine programs could make a big difference in the ultimate pricing of the vaccines. For example, big drugmakers such as J&J or Pfizer, which is developing a messenger RNA vaccine for the novel coronavirus with BioNTech, could opt to price their vaccines at lower prices since they already make plenty of money with other products.
Perhaps the biggest variable is the spread of COVID-19 itself. A major second wave of global outbreaks would almost certainly heighten the stakes for Moderna and others developing vaccines. On the other hand, if signs begin to point to herd immunity being developed in populations across the world, it's possible that the prospects for the companies could be significantly reduced.
An admittedly hazy outlook
So what does the future hold for Moderna? It's definitely complicated, but here's an admittedly hazy outlook.
I'm cautiously optimistic that mRNA-1273 will be successful. My take is based on the limited information available from phase 1 testing of the vaccine and the FDA's quick green light for moving forward with both phase 2 and phase 3 studies.
At the same time, I suspect that several additional COVID-19 vaccine candidates could also be successful. It won't surprise me at all if AstraZeneca and its partner, the University of Oxford, Pfizer and BioNTech, J&J, Novavax, and potentially others eventually make it to market with their respective COVID-19 vaccines.
Moderna's market cap of close to $24 billion already has some expectation of success baked into the price. I still think, though, that the biotech stock has room to run assuming all goes well with mRNA-1273. Good news for its CMV vaccine in a few months would add more icing on the cake.
I don't look for Moderna to come anywhere close to quadrupling again as it has done so far this year. A 40% jump by sometime next year isn't out of the question, though, in my view. But my cautious optimism could be cautiously wrong. Probably the best prediction for Moderna is that the crazy ride will continue, one way or the other.