Moderna Inc. (MRNA) - Get Report shares rose for the first day in four Thursday as the U.S. Food & Drug Administration prepares to grant emergency use approval for its coronavirus vaccine amid questions over the sustainability of the stock's 600% year-to-date surge.
The FDA's Vaccines and Related Biological Products Advisory Committee will meet later today for what is likely to be a quick approval process for the Cambridge, Massachusetts-based drugmaker's mRNA-based vaccine, which reached a 94% efficacy rate against coronavirus infections in late-stage trials.
The Committee vote is expected late Thursday, with full FDA approval likely coming on Frida. The European Medicines Agency is slated to decide on Moderna's approval request by January 12.
The vaccine can last for up to six months when stored at standard freezer temperatures of -4 degrees Fahrenheit, Moderna has claimed, compared to the -94 degree temperatures required for the Pfizer (PFE) - Get Report/BioNtech (BNTX) - Get Report vaccine, which received EUA approval last week.
Moderna shares have fallen for five of the past six trading sessions, however, and look set to trade in the red again today as larger investment firms worry that vaccine competition, as well as limited pricing power with governments, raise concerns regarding the drugmaker's six-fold advance so far this year.
Moderna shares were marked 4.2% higher in early trading Thursday to change hands at $142.75 each, trimming its one-month gain to around 50%.
The stock has gained around 600% so far this year, however, amid speculation that day-traders have driven its value to increasingly higher levels on bets of FDA approval, but haven't taken into account the impact vaccine sales will have on the group's top and bottom line over the next two years.
However, analysts at Brookline Capital Markets not that mRNA-1273 is "one of 17 experimental clinical compounds Moderna has in development ... that have the potential for combined estimated sales of $77.1 billion by 2030."
"In addition, Moderna has seven preclinical programs that have the potential for combined 2030 sales of $8.4 billion," analyst Leah Rush Cann noted in a recent report.
Contracts with the U.S. government, as part of Operation Warp Speed, as well as those signed with Britain and the European Union, provided an early revenue boost for the Cambridge, Massachusetts-based biotech, while extended orders into 2021 and beyond could boost its topline to around $4.5 billion, analysts have estimated.
Modena said it could have 20 million doses available for the U.S. market this year, as well as a total supply of between 500 million and 1 billion doses worldwide next year.
U.S. Army General Gustave Perna, who is coordinating the government's Operation Warp Speed vaccine rollout, said some 5.9 million doses of the Moderna vaccine could be rolled out next week.