Moderna stock broke out for the first time in a year on Thursday after beating Wall Street's first-quarter expectations as its second potential approval looms.
The company hopes to win Food and Drug Administration approval for its RSV vaccine. RSV, the shorthand name for respiratory syncytial virus, causes coldlike symptoms in most people. But it can be serious or deadly in babies and older adults. The FDA is due to make its decision on Moderna's shot in less than two weeks. Moderna hopes to launch its vaccine for older adults this fall.
If approved, this would be Moderna's second commercial product behind its Covid vaccine, Chief Financial Officer Jamey Mock told Investor's Business Daily in an interview.
"We're super excited for many reasons," he said. "It's our second product, so I think it helps validate the mRNA, or Moderna, platform. I think it's the second product in the world from an mRNA perspective, so we're encouraged as we anticipate approval in the first half of the year."
On the stock market today, Moderna stock surged 12.7% to 125.59. Shares topped a buy point at 115.89 out of a cup-with-handle base, MarketSurge shows. The biotech stock last broke out of a cup with handle in December 2022.
Moderna Stock: Big Sales Beat
During the first quarter, sales of its Covid vaccine plummeted nearly 91% to $167 million, but handily beat analysts' forecast for $93 million, according to FactSet. It lost $3.07 per share, flipping from a year-earlier gain of 19 cents. But that beat projections for a loss of $3.56 per share.
Moderna says the European Union is planning to buy up to 36 million doses of its Covid vaccine each year for at least four years. Further, the company expects "higher vaccination uptake" in the U.S. if its updated Covid vaccine is available in timing with the seasonal flu shot.
Now, investors are zeroing in on what's next for the former highflier.
"I think the overall punchline is that we're off to a good start to what could be a truly incredible year," Mock said. "Somewhat financially, but more so about our pipeline."
Biotech Retains 2024 Guidance
From a financial standpoint, Moderna is retaining its outlook for the year. The company expects to notch $4 billion in sales of its respiratory vaccines. That will be weighted to the back half of the year with less than $300 million in sales projected for the first half of 2024.
Moderna stock analysts project $4.19 billion in full-year revenue, including $4.06 billion in sales from the company's products.
The RSV vaccine could be a big moneymaker for Moderna. Pfizer and GSK launched their RSV shots for older adults last year. In the first quarter, Pfizer's Abrysvo brought in $145 million in sales. Arexvy, from GSK, generated $228 million.
Awareness has increased following the Abrysvo and Arexvy vaccine launches, Mock said. Importantly, Moderna stock analysts already expect some sales of Moderna's product — $10 million in the June quarter, according to FactSet.
William Blair analyst Myles Minter noted the Advisory Committee on Immunization Practices is set to meet in late June. He expects the committee to make recommendations on age eligibility and frequency of RSV vaccines. The Pfizer and GSK shots are available to people age 60 and older. Women can also get the Pfizer vaccine between weeks 32 and 36 of their pregnancy.
The Pipeline Is Key For Moderna Stock
Moderna is also planning to work with U.S. regulators on the timing of its next Covid vaccine. Officials will choose the next variant to target in booster shots on May 16. Then, it will be off to the races, so to speak, to run testing for Moderna's updated shot.
Moderna's goal, CFO Mock said, is to be able to launch the Covid booster shot in timing with the fall flu vaccine campaign. That didn't happen last year and about 3 million Americans got their flu shot before the new Covid booster jab launched.
It's also important to note, Moderna expects to have updated test results for its combined Covid and flu shot later this year.
Beyond the respiratory diseases pipeline, Moderna expects to have the interim results of a final-phase study in cytomegalovirus, or CMV, before year-end. Moderna is working on a vaccine to prevent CMV, a latent disease tied to chickenpox, herpes and mononucleosis.
"There's no vaccine out there for CMV," Mock said. "It's an important product for many reasons."
Further, the company is testing a potential combination vaccine to prevent flu and Covid. Results from that study are expected this year. Eventually, Moderna could launch a triple vaccine to prevent Covid, flu and RSV, he said.
"Our vision is to simplify this for patients into one or two shots at most," he said.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
