Moderna reported its third-quarter earnings, and since it currently only has one commercial product, its COVID-19 vaccine, that was the financial focus.
Moderna_Adam Glanzman/Getty Images
Moderna reported its third-quarter earnings, and since it currently only has one commercial product, its COVID-19 vaccine, that was the financial focus.
With a brand name of Spikevax, it reported $5 billion in sales for the quarter. For the year, Moderna is projecting product sales between $15 billion and $18 billion. Stock prices dropped 14% at the news.
A survey of analysts had projected the company would report $3.9 billion in income on $6.2 billion in revenue, but Moderna instead reported $3.3 billion in profit on revenue of $5 billion. Moderna’s company’s projections for the year are $15 to $18 billion, down from a projection by the company at the end of the second quarter of $20 billion for the year.
In what could easily be called growing pains, as Moderna goes from a research-focused biotech company to handling manufacturing and commercial activities as well, the company’s leadership pointed to supply chain and manufacturing complications.
They are pushing some of the vaccine deliveries globally to 2022. The company says it will deliver between 700 million and 800 million vaccine doses by the end of the year, lower than the original 800 million to 1 billion it had earlier expected. Priority is being given to low-income countries.
“The supply chain became more complex with increased deliveries to many countries around the world,” Stephane Bancel, Moderna’s chief executive officer, told investors at the third-quarterly conference call. “At the beginning of the year, we supplied just a few large countries. We are working through these challenges.”
He added that there were also some production capacity issues. “We have expanded our capacity with our manufacturing partners, which had the temporary impact on our shipments. That work is complete now and we should see a positive impact from this expansion very soon.”
Otherwise, much of Moderna’s third-quarter report focused on its pipeline, which is considerable. It has 37 programs in development, with 21 in ongoing clinical trials.
Those programs include vaccines for seasonal flu, respiratory syncytial virus (RSV), a COVID-19/flu combination, cytomegalovirus (CMV), Epstein-Barr Virus (EBV) vaccines, a personalized cancer vaccine (mRNA-4157), Propionic Acidemia (mRNA-3927), Methylmalonic Acidemia (MMA) and others.
Although in the short term, the company’s profits are tied to COVID-19, investors are expressing excitement about the CMV vaccine candidate, which has the potential to be the company’s next big commercial product. It’s a common virus, and in healthy people, it is not a problem, but it can be devastating in people with suppressed immune systems and newborns.
There are no approved vaccines for CMV and most development programs are in their early stages. Potentially Moderna could be the first to market. The company has projected peak annual revenue for a CMV vaccine to be $2 billion to $5 billion.
The company announced on October 26 that it had dosed the first patient in its Phase III pivotal registration trial of its CMV vaccine. The study is dubbed CMVictory, and the vaccine is labeled mRNA-1647.
CMV is a latent virus that stays in the body after infection for the rest of one’s life. In people with weakened immune systems or infants born with CMV infection, it has profound implications.
Infants born with congenital CMV infections may have long-term problems like learning disabilities, decreased muscle strength and coordination, hearing loss, and vision problems. Some will become ill at birth with jaundice, rash, liver and spleen enlargement, and seizures. It is the leading infectious cause of congenital disabilities in the U.S.
And earlier this week, Moderna announced a strategic research and development deal on new gene editing systems for in vivo (in the body) human therapies with Emeryville, Calif.-based Metagenomi. The partnership will leverage Metagenomi’s novel gene editing technology and Moderna’s mRNA platform, in addition to its lipid nanoparticle (LNP) delivery technologies.
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