The FDA granted Moderna (MRNA 0.05%) an emergency use authorization for mRNA-1273 less than a week ago, and the COVID-19 vaccine is destined to rack up blockbuster sales within a matter of months. Based just on the supply deals the biotech already has in hand, mRNA-1273 should generate well over $13 billion next year.
How much money mRNA-1273 will make after 2021 will depend in large part on how stiff the competition becomes as other coronavirus vaccines earn approval, and how frequently people need to be re-vaccinated. But Moderna won't rest on its laurels after achieving this first success. Let's meet the most likely blockbusters in Moderna's pipeline now.
A mega opportunity against cytomegalovirus
Prior to the onset of the COVID-19 pandemic, the Moderna candidate that typically received the most attention was its hopeful cytomegalovirus (CMV) vaccine, mRNA-1647. CMV ranks as the leading cause of birth defects in the U.S. Up to 12% of babies with symptomatic CMV die before they're 1 year old. At least 70% of those who survive will experience disabilities. And there's currently no approved CMV vaccine.
Like the company's COVID-19 vaccine, mRNA-1647 is based on messenger RNA (mRNA) technology. Moderna developed mRNA that instructs cells to produce proteins that are copies of two CMV antigens. The body's immune system then mounts a defense against these "artificial" antigens so that if cytomegalovirus tries to invade, it's ready to fight back.
Clinical testing of mRNA-1647 has gone well so far, with Moderna reporting positive interim results from a phase 2a study in September. The biotech plans to advance its experimental CMV vaccine to pivotal late-stage testing in 2021. If mRNA-1647 ultimately wins approval, it's expected to generate peak annual sales of between $2 billion and $5 billion.
Turbocharging T cells to fight cancer
Moderna's mRNA-based approach isn't limited to providing protection against viral infections. The company is also working on treatments that attempt to use mRNA to fight cancers. On that front, its leading candidate is mRNA-2416, which it's currently evaluating in a phase 2 study targeting ovarian cancer.
Perhaps the simplest way to describe how mRNA-2416 works is that it turbocharges T cells -- an important part of the body's immune system. The experimental vaccine uses mRNA to spur the body's cells to produce OX40L proteins. These proteins stimulate T cells and can suppress the action of regulatory T cells (T-regs) that themselves suppress other immune cells. After mRNA-2416 is injected directly into a tumor, the OX40L proteins that it causes to be produced boost T cells that attack the tumor.
Moderna is testing mRNA-2416 as a monotherapy and in combination with AstraZeneca's cancer immunotherapy Imfinzi. It's still too early to know if this experimental mRNA cancer therapy will actually become a blockbuster, but it's certainly a possibility.
Other Moderna candidates could become blockbusters, but if they do, not all of the revenues will flow into its coffers. That's because the biotech has joined forces with big drugmakers to develop some of its experimental mRNA therapies.
For example, it's working with Merck (MRK 1.55%) to evaluate personalized cancer vaccine mRNA-4157 in combination with Keytruda in a phase 2 study. How personalized is this vaccine? Genetic sequencing is performed on an individual patient's tumor. Moderna then analyzes the sequence to create mRNA that encodes the neoantigens (mutated antigens that the immune system doesn't recognize) most likely to spur the immune system to attack the tumor.
Merck and Moderna will split any profits from mRNA-4157 equally. The two companies are also developing a vaccine targeting KRAS mutations that occur in more than 20% of human cancers. That experimental vaccine, mRNA-5671, is currently being evaluated in a phase 1 study.
More arrows in the quiver
The aforementioned phase 2 candidates are Moderna's most likely next blockbusters. However, the company has plenty of other early-stage candidates that could also emerge as big winners.
More importantly, the company is likely to soon add more arrows to its quiver. It plans to use the flood of cash generated by its coronavirus vaccine to expand its pipeline to as many as 50 mRNA therapies and vaccines.
Perhaps the biggest mistake investors could make with this biotech stock would be to focus only on the current opportunity. Moderna's long-term prospects extend far beyond COVID-19.