A lot can happen in 12 months in the active and volatile biotech industry, especially for a company like Moderna (MRNA 0.17%). The vaccine maker has a pipeline full of promising candidates in addition to its commercialized COVID-19 product which is bringing in solid revenue for now. Key ongoing developments on both fronts will help shape Moderna's long-term prospects, so investors should stay tuned. Let's look at the likely evolution of this mRNA-focused biotech company over the next year and decide whether it's worth buying its shares right now.
Coronavirus sales will fall off a cliff
Moderna rose to fame over the past three years thanks to its coronavirus vaccine. The company has been handsomely rewarded for developing this product. Moderna generated nearly $40 billion in revenue over the past two years. This is an impressive number for a new commercial-stage company. However, the coronavirus vaccine market is shrinking. Moderna expects only $5 billion in revenue this year, a number that could increase if it signs more agreements.
For context, it recorded $5.1 billion in sales in the fourth quarter of 2022 alone. The $5 billion projected total for 2023 would represent a decrease of 74% year over year. Of note, CEO Stéphane Bancel predicted a decline in demand of 90%, which is how the company justifies setting the price of its vaccines at $130 per dose (up from $20). So in one year, Moderna's sales from its COVID-19 vaccine will look a lot less impressive. The company's guidance for 2024 could be even lower than whatever it will end up recording this year.
Expect clinical and regulatory progress
Moderna has over a dozen non-coronavirus programs in its pipeline. Several of them are in phase 2 or 3 clinical trials. Moderna should make headway with these candidates over the next year. Let's consider a few of them. First, Moderna's personalized cancer vaccine, mRNA-4157/V940, should move on to a pivotal study. Last year, this candidate, in combination with Merck's Keytruda, significantly reduced the risk of recurrence or death in melanoma patients in a phase 2b study, compared to Keytruda alone.
Moderna and Merck will look to replicate these results in a larger trial. There is also Moderna's potential flu vaccine, mRNA-1010, that is undergoing a phase 3 study. This product recently reported mixed results in this study as it seemed effective against some strains of the flu but not others. Moderna's strategy with mRNA-1010 moving forward will depend on the review of the data by an independent party. The company will decide whether to conduct more clinical trials before seeking approval.
Meanwhile, in January, Moderna announced positive results from a pivotal study for its respiratory syncytial virus vaccine, mRNA-1345. The company plans to submit an application to the U.S. Food and Drug Administration (FDA) by June. If everything goes according to plan, mRNA-1345 could earn approval by the end of the first quarter of 2024. Lastly, Moderna's investigational cytomegalovirus vaccine, mRNA-1647, is also in a late-stage study that could deliver top-line data within the next year.
Moderna should successfully start more phase 2 and 3 trials, too. Although the ultimate success of these isn't guaranteed, it's likely a few could be very promising opportunities to supplement declining COVID-19 revenue in the future as it plateaus long-term.
A good bet for patient investors
Moderna's stock looks vulnerable in the short term. Over the next 12 months, the company's sales and stock price will suffer if the coronavirus vaccine market falls even more than expected. Solid clinical progress will help, but it is difficult to predict whether the company's shares will be up or down from their current levels by then.
However, Moderna's prospects beyond the next year matter more to long-term investors. In the next half a decade, Moderna should accomplish a few things. First, it should earn approval for at least two more candidates. Second, sales of its coronavirus products will stabilize and become more predictable.
People, especially the most vulnerable, will seek to be inoculated against COVID-19 every year, even after the pandemic ends. Third, Moderna will have many more programs in mid- and late-stage studies. These developments will help drive Moderna's stock in the right direction. That's why this biotech stock is still worth investing in today despite the coming drop in sales of its coronavirus vaccines.
