Before the pandemic, most of us probably didn't spend a lot of time thinking about messenger RNA (mRNA). But Moderna (MRNA 0.48%) changed that. The biotech company brought mRNA to center stage when it began developing its coronavirus vaccine. The vaccine uses mRNA to instruct the body's cells to produce a specific protein. From here, our immune system creates antibodies necessary to block infection.
Moderna didn't develop this technology overnight, though. The company has been working on it for more than a decade. In fact, it has mRNA candidates in the pipeline for a variety of therapeutic areas. Its coronavirus vaccine rival Pfizer (PFE -0.33%) is a newcomer to mRNA. It got into the business through partnerships with Germany's BioNTech. But Pfizer has big mRNA plans. Now the question is: Should Moderna be worried?
Pfizer's BioNTech partnership
So, let's look at what Pfizer is doing in the mRNA space. Pfizer initially partnered with BioNTech for the development of mRNA flu vaccines back in 2018. Fast forward to 2020. As the pandemic deepened, Pfizer entered into a new agreement with its biotech partner. It would co-develop and co-commercialize BioNTech's investigational mRNA coronavirus vaccine.
Today, the vaccine generates billions of dollars for Pfizer and BioNTech. The companies predict they'll split profit on more than $33 billion in coronavirus vaccine revenue this year.
Meanwhile, Pfizer isn't limiting its mRNA business to the coronavirus product. It recently launched a phase 1 trial of an mRNA vaccine candidate for flu. This is in the context of its partnership with BioNTech. If the candidate makes it to commercialization, Pfizer would pay BioNTech royalties.
But Pfizer isn't stopping with flu, either. The big pharma player says it will develop mRNA candidates for other respiratory illnesses and will expand into oncology and genetic diseases.
A potential blockbuster
Now, let's take a look at Moderna's situation. Since mRNA isn't new to Moderna, the company is well beyond the planning stages. It has 37 programs in the pipeline, and 22 are in clinical studies. Like Pfizer, Moderna also recently began a clinical trial for a flu vaccine candidate.
Importantly, Moderna has five candidates in phase 2 studies and one candidate ready for phase 3. It expects to launch a phase 3 study of its cytomegalovirus vaccine candidate this year. That could be a billion-dollar product.
From a timeline perspective, Moderna remains ahead of Pfizer in the development of potential mRNA products. It's also likely Moderna, after years of focusing on this specific area, might have gained expertise that will be difficult to beat.
Of course, on the subject of timelines, you may think back to the coronavirus vaccine race. Moderna launched the very first clinical trial of a vaccine candidate. Yet the Pfizer/BioNTech team not only caught up, but also beat Moderna to market. Could that happen again? It's not likely.
First of all, both coronavirus candidates were at about the same stage of development. And second, urgent need during the pandemic meant it was easy to quickly enroll clinical trials. In non-pandemic times, people don't always leap at the opportunity to join a clinical trial. So the enrollment process may slow things down.
$15 billion in cash
Last year, Pfizer's experience and resources allowed it to move quickly to the top in the coronavirus vaccine market. But Moderna has learned a thing or two as it's signed contracts and produced and delivered vaccines this year. It has built up financial resources, too. Moderna's cash position is about $15 billion. Pfizer's cash, cash equivalents, and short-term investments total $21.7 billion. Pfizer has the edge, but not by much. Both clearly have what it takes financially to advance their programs and launch potential products.
Does this mean Pfizer isn't a threat to Moderna? Not necessarily. Failure can happen at any clinical-trial stage. If a Moderna candidate fails in the clinic, but Pfizer's rival candidate succeeds even a few years later, then Pfizer wins. That could happen for certain programs. And it could ensure Pfizer a position in this exciting market.
But overall, I don't expect Pfizer to beat Moderna at mRNA. The size of Moderna's mRNA pipeline and the number of late-stage candidates make that unlikely. If all goes smoothly for Moderna during most clinical trials, this biotech company is likely to maintain its reign in the world of mRNA.