For the first time in its 11-year existence, Moderna has turned an annual profit. The Cambridge company, which had burned through hundreds of millions of dollars developing its mRNA technology, said in an earnings call Thursday that it made more than $12 billion in profits in 2021.
That bonanza, of course, was the result of the biotech’s COVID-19 vaccine. Moderna sold 807 million doses for a total of $17.7 billion last year. The company expects strong demand for the vaccine worldwide to buoy its income this year, too, with advanced purchase agreements signed for least $19 billion worth of doses. And the demand for additional booster shots could increase that figure.
The pandemic has enabled the company to grow at blinding speed. At the end of 2019, just before the world learned of the virus, Moderna had 820 full time employees. By the end of last year, its headcount had ballooned to 3,000. Research and development spending quadrupled during the same period, from $500 million to $2 billion. In its call with investors, the firm said R&D spending on programs new and old could rise to $3 billion this year.
The company is also ramping up its manufacturing capacity, thanks to a new 15 year partnership with Thermo Fisher Scientific. Under the agreement, the Waltham company will make COVID-19 vaccines and other still-experimental mRNA medicines for Moderna.
“Our top investment priority has been, and will continue to be, reinvesting in the base business across multiple areas,” Moderna chief financial officer David Meline said on the call.
Moderna is not banking on its COVID-19 vaccine alone. The company has 44 programs underway that use its mRNA technology for vaccines or therapies. That includes 25 in active clinical trials and three recently announced research-stage vaccine programs for herpes, shingles, and cancer.
Its most advanced programs are vaccines for cytomegalovirus and respiratory syncytial virus, often called RSV. There are no approved vaccines for either virus, and Moderna is testing both shots in large Phase 3 clinical trials. Its flu vaccine, now in a medium-size study, could also be evaluated in a large Phase 3 study later this year. Moderna plans to start a small Phase 1 study of a combination vaccine for COVID-19 and flu later this year, and ultimately add RSV to the combo.
“I’m excited to see this if they can do it,” said said Dr. Sabrina Assoumou, an infectious disease physician at Boston Medical Center and professor at Boston University School of Medicine. “If you are going to give me one vaccine that protects against flu, RSV, and coronaviruses, I would use it.”
After investing in its home-grown programs, Moderna’s second priority is expanding the reach of its mRNA technology into new areas through acquisitions, collaborations, or licenses. Meline highlighted two recent partnerships: one with the Californian gene editing startup Metagenomi and a second with Philadelphian cell therapy startup Carisma.
Moderna also announced that it would spend $3 billion to repurchase its own shares, just as the company’s stock has leveled out from a yearlong rollercoaster ride.
The stock price hit an all-time high of $493 in August, briefly making the single-product company worth $195 billion — more than storied pharma giant Merck & Co.
But Moderna’s stock soon began falling, dropping to about $225 in early November, briefly bouncing up to about $368 in late November with the arrival of the Omicron variant, and slowly falling again to about $135 the day before Moderna’s earning’s call — its lowest point since April 2021. The stock jumped 15 percent Thursday on the news of slightly stronger than expected vaccine sales.
Hartaj Singh, a biotech analyst at the investment bank Oppenheimer, said that the real question about Moderna during the pandemic has not been how large its vaccine revenues would be, but how sustainable those revenues will be going forward. He thinks that demand for annual boosters — including the combination shot for flu and COVID — could earn the company $5 billion to $10 billion per year through most of the decade.
During the call with investors, chief medical officer Paul Burton said the virus is here to stay and will become endemic in 2023. A second booster shot — a fourth dose in total — will be required by fall 2022 to maintain protective antibody levels against the coronavirus, he said.
“While we are hopeful that we are about to enter a period of relative stability in the northern hemisphere, we believe firmly that a vaccine booster dose will be required for the fall of 2022 to provide ongoing protection against this virus,” Burton said.
Moderna is testing second booster of its original vaccine: one tailored to the Omicron variant, and a shot that combines both.
Scientists are split on whether additional boosters make sense. Some think annual boosters are inevitable, while others say that indefinite boosting is impractical, especially when some parts of the world are still waiting for their first shots.
“We need more data,” Assoumou said.
Recent results from a study in Israel suggest that a fourth dose can raise antibody levels but offers little protection against Omicron infections. “It seems like that fourth dose is not providing as much benefit as we hoped. We are not getting as much bang for our buck,” she said. Still, a fourth shot could be important for keeping infections mild in people who are at higher risk of severe disease, she added.
Watching for an increase in severe disease, and not just infections, will be crucial in determining whether a fourth dose is needed, said Dr. Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta and an unpaid member of Moderna’s scientific advisory board.
Orenstein said that scientists still don’t know how far antibody levels can fall before protection is lost, and added that immunity from T cells “may not be declining at the same rate” as antibody immunity. “But the bottom line is to be prepared,” and have the boosters ready to go if needed, he said.
Moderna has several earlier-stage therapies in development for cancer, cardiovascular disease, and rare genetic diseases. The company’s long-term growth could depend on creating successful mRNA therapies, which may carry a higher price tag than vaccines.
“The field needs to make sure that mRNA is not just stuck in its vaccine modality,” said Myles Minter, a biotech research analyst at the investment firm William Blair.
The side effects that commonly accompany COVID-19 vaccines might not be tolerated in a chronic therapy that requires weekly or monthly dosing, so Minter is waiting for data that “gives us confidence that mRNA can be a repeat dose therapeutic.”