Among the pharmaceutical companies closest to developing a Covid-19 vaccine, none has more riding on the outcome than Moderna, a decade-old firm with no approved products and a vast valuation to live up to.
Every incremental headline on Moderna’s vaccine, now in Phase 3, has shifted billions of dollars of the company’s market value, and Wall Street analysts have been one-upping one another for months trying to game out just how lucrative the product might be.
We won’t know whether the vaccine actually works until late this year at the earliest. But it’s clear that how the trial plays out will shape the future of biotech’s most talked-about company.
Here’s a look at four potential outcomes for Moderna’s vaccine — ranging from a best-in-class injection to a waste of glass vials — and what each would mean for the business.
Better than the competition
The best-case scenario for Moderna is not only that its vaccine proves to protect against Covid-19, but that it also beats out the many other vaccines that might eventually win approval.
Moderna’s trial is designed to target a 60% reduction in Covid-19 cases compared to placebo, and the Food and Drug Administration has set the bar at 50% for any product seeking approval. If Moderna’s Phase 3 trial demonstrates protection of 80% or above — and if its rivals come in much lower — the company will claim the lion’s share of the global market, which would translate to about $7 billion in annual revenue, according to the analysts at SVB Leerink.
That kind of success would give Moderna far more freedom on pricing. Pfizer and BioNTech, at work on a technologically similar vaccine, are selling their product to the U.S. government at about $20 per dose, a price that will inform how companies negotiate with global buyers. But if Moderna’s vaccine is demonstrably better, it might be able to justify charging a premium, which would push revenue even higher. The company is already in the process of negotiating with governments, according to a Monday report in the Financial Times, and appears to be pushing for a prize slightly higher than Pfizer’s.
Then there are the downstream benefits. If Moderna’s vaccine, called mRNA-1273, is an unqualified success, it becomes that much more likely that the company’s investigational vaccines for cytomegalovirus, influenza, and respiratory syncytial virus will work, too. Success in Covid-19 would also reflect well on Moderna’s pipeline of therapeutics, including treatments for cancer and rare disease. Moderna’s valuation has passed $30 billion based solely on investor excitement and some Phase 1 data on its Covid-19 vaccine candidate. If mRNA-1273 proves to be best-in-class, that could easily double.
This is the rosiest outlook for Moderna, but might not be the most likely scenario. Moderna’s vaccine uses messenger RNA to expose the immune system to a key protein on the surface of the novel coronavirus. It’s the same approach being tested with the Pfizer and BioNTech vaccine, as well as in early-stage efforts from CureVac and Translate Bio, which is working with Sanofi. Each vaccine is different, but based on the small amount of data available, it’s not clear how Moderna’s could turn out to be dramatically better than the others.
A face in the vaccine crowd
In this scenario, Moderna’s vaccine hits its goal in Phase 3, but so too do a bunch of competitors. If the first wave of vaccines all prove moderately protective — hitting that 60% mark mentioned earlier — and all carry roughly similar side effect profiles, Covid-19 vaccines would likely become commoditized.
For Moderna, that would mean competing for government dollars around the world. Now that Pfizer has established a $20-a-dose benchmark, Moderna and others might have to undercut one another to secure contracts, further eroding revenue in a race to the bottom. Then there’s the issue of public perception. Moderna is in line to receive nearly $1 billion in taxpayer support for its research. Any attempt at maximizing profits is sure to draw scrutiny from pricing activists and members of Congress.Related:
Moderna executives have cashed out $89M in shares this year, as stock price has soared on vaccine hopes
But fighting for a share of a crowded market isn’t so bad. A recent Tufts University poll found that 57% of Americans said they’d get a Covid-19 vaccine if one were available, which translates to about 185 million people. If the going rate for a two-dose vaccine is $40, that sets the U.S. market at nearly $7.5 billion. Then there’s the rest of the world, a market Morgan Stanley estimates at about $20 billion. Even if Moderna has to split that with a handful of other manufacturers, the windfall would be huge.
The other risk is that demand for a Covid-19 vaccine substantially wanes after 2021, making mRNA-1273 a diminishing-returns product. It’s also possible that vaccines in early stages of development — including two from global leaders Merck and Sanofi — prove to be more effective than the first generation of inoculations, which could make Moderna’s revenue-generating period even shorter.
All that being said, success with mRNA-1273 would still reinforce the potential of Moderna’s other vaccines and therapeutics. But Moderna’s valuation — and the blockbuster expectations that prop it up — would have to come down.
Functional but inferior
Here’s where the Moderna story would start to crumble: Its Covid-19 vaccine meets the 50% efficacy threshold set by FDA, but isn’t as good as the competition.
For Moderna, that would likely mean sharply reduced Covid-19 revenue. Will anyone with a choice agree to be inoculated with the worst vaccine on the market? The U.S. government might buy doses for emergency stockpiling purposes, potentially at a significant discount. Then again, with $1 billion of taxpayer money already invested, the government might just demand Moderna vaccine doses for free.
Disappointing results on a Covid-19 vaccine will weaken confidence in the rest of Moderna’s mRNA-based pipeline. It’s the inverse of the home-run scenario described above. Using mRNA to make vaccines has long been seen as the lowest bar to clear for Moderna, while developing medicines with that approach is harder. A middling first vaccine would only amplify the risk to Moderna’s more ambitious efforts to turn mRNA into a drug.
There’s also the matter of how much stock Moderna’s insiders have sold. Since the start of 2020, the company’s five top executives have unloaded about 3 million shares, adding up to $170 million. The vast majority of those trades were scheduled under a federal rule that allows insiders to sell shares without breaking insider trading regulations. They’ve also come as Moderna’s stock price hit repeated all-time highs.
If a lackluster Covid-19 vaccine brings Moderna’s stock crashing back to earth, the fact that executives made millions of dollars selling during the run-up is certain to invite scorn and other recriminations that could have long-term implications for Moderna’s credibility with investors.
It goes without saying that it would be bad for Moderna if its vaccine does not work. It would be worse if Moderna’s vaccine fails but other vaccines — especially other mRNA candidates — do work. And it would be worse yet if all of the above happens and Moderna’s Phase 3 trial reveals a previously unknown safety issue that impacts the rest of the company’s pipeline.
First, if mRNA-1273 fails, it removes any potential for near-term revenue for Moderna, which, according to SVB Leerink, would make the company worth $16 a share, 80% less than its current value. That failure would also cast doubt on Moderna’s other vaccine candidates, a problem that would only be exacerbated by success from the likes of Pfizer and CureVac. Positive results from those companies would suggest the trouble isn’t with mRNA, but with Moderna’s specific technology and development strategy.
The absolute worst-case scenario — one that doesn’t appear likely — would be that the mRNA-1273 trial is plagued by a safety problem so severe that the FDA halts all of its clinical development programs. If none of Moderna’s 23 pipeline treatments ever come to fruition, Morgan Stanley estimates the company would be worth about $7 a share, which is the value of its cash holdings.