A year ago, Moderna Inc. was an unprofitable company with no marketed products and promising but totally unproven technology. None of its experimental drugs and vaccines had ever completed a large-scale trial. Experts were divided on how well the mRNA-based Covid-19 vaccine it was about to enter in a Phase III trial would stack up against older, more established vaccine technologies.
This year, Moderna could deliver 1 billion doses of its Covid shot and bring in $19 billion in revenue. It’s become the rare biotech to hit the big time without being gobbled up by, or splitting profits with, a larger, more established company. Its market value—which hit $100 billion for the first time on July 14—exceeds that of stalwarts such as Bayer AG, the German inventor of aspirin, and biotech peers such as Biogen Inc., founded three decades prior.
The speed with which Moderna and its primary mRNA competitor, a partnership between Pfizer Inc. and BioNTech SE, devised their shots has made a major contribution to the fight to end the pandemic. With strong efficacy, steady supply, and no show-stopping safety scares (officials are carefully monitoring rare heart inflammation cases in teenagers and young adults), mRNA shots have become the vaccines of choice, at least in countries that can get them.
But for Moderna Chief Executive Officer Stéphane Bancel, the Covid vaccine is just the beginning. He’s long-promised that if mRNA works, it will lead to a giant new industry capable of treating almost everything from heart disease to cancer to rare genetic conditions. Moderna has drugs in trials for all three of these categories, and Bancel says his company can also become a dominant vaccine maker, developing shots for emerging viruses such as Nipah and Zika, as well as better-known, hard-to-target pathogens such as HIV.
In the past 40 years, more than 50 new human viruses have been discovered. Only three have authorized vaccines. Bancel views that as an opportunity. “We are going to totally disrupt the vaccine market,” he says during a late May interview at Moderna’s Cambridge, Mass., headquarters, which fills a 10-story building north of the MIT campus. The Swiss drugmaker Novartis AG occupies labs in an adjacent building, and Pfizer and Merck & Co. have offices a few blocks away.
Bancel, who’s 48, wears a pressed blue shirt, dark blue jeans, and a black Hermès belt. An avid runner, he appears even trimmer in person than on his frequent virtual conference appearances. He repeatedly jumps to his feet during the interview to graph on a whiteboard how the Covid outbreak could evolve. One chart forecasts seasonal waves, declining each passing year but still significant. Another projects the possible decay of vaccine efficacy over time, with mRNA shots like his starting in the best position but gradually declining. The take-home message coincides neatly with Moderna’s business prospects: Countries may want to stockpile booster shots soon. “My mother is 72, and she has leukemia,” he says. “I don’t want her to go through the fall without a boost.”
The company has vaccines for 10 viruses that are in, or about to be in, human trials. These include three types of Covid-19 boosters that are in midstage trials, a seasonal flu shot that began its first human study in July, and HIV shots that are slated to begin studies later this year. The furthest along beside the Covid shots combats cytomegalovirus, a ubiquitous bug that spreads through bodily fluids and is a common cause of birth defects; it’s set to begin a Phase III trial this year in women of childbearing age. In the long term, Moderna is aiming to develop an annual super shot that could suppress numerous respiratory ailments, including Covid, the flu, and others. “Our goal is to give you several mRNAs in a single shot at your local CVS or GP every August or September,” Bancel says.
Now comes the difficult part: delivering on that promise while keeping ahead of just about every other vaccine company in the world as they rapidly invest in mRNA. In the future, Moderna won’t have the pandemic to highlight mRNA’s most obvious advantages over older technologies—speed and flexibility. Future vaccines and drugs will usually have to go through the U.S. Food and Drug Administration’s normal approval process, meaning longer follow-ups to gather data and 6- to 10-month review timelines. That time frame will provide space for mRNA-wielding rivals and older technologies to compete.
Pfizer, with its partner BioNTech, has become an mRNA manufacturing juggernaut and expects to produce 3 billion doses this year; it has also dominated the foreign distribution of mRNA vaccines so far. Another vaccine, from CureVac NV in Germany, which took a different approach to mRNA, performed tepidly, proving only 48% effective in Phase III trial data released in June, but still another, from China’s Walvax Biotechnology Co., will soon begin Phase III testing in seven countries.
More established technologies are reasserting themselves, too. On June 14, Novavax Inc. said its recombinant protein vaccine was 90% effective in a nearly 30,000-person trial in the U.S. and Mexico, with relatively few side effects—results that more or less matched those of the best mRNA shots. Vaccine giants Sanofi and GlaxoSmithKline Plc are in Phase III trials on their own protein-based Covid vaccine, which could hit the market by yearend.
Mani Foroohar, an analyst at SVB Leerink LLC, calls Moderna’s accomplishments with the Covid vaccine “truly breathtaking.” But he also says it’s far from certain whether such vaccines will have clear efficacy advantages with other viral diseases. And how big a role the technology could play in treating noninfectious diseases such as cancer is unknown. So though public expectations are boundless, he says, “the revenue opportunity is not.”
The reply, for Bancel and the others pouring money into tiny RNA strands, lies in those two key advantages of speed and adaptability. At their heart, mRNA vaccines are a modular technology; they deliver the genetic code telling cells how to make the virus proteins that provoke an immune response, and the cells do the hard work from there. Now that Moderna is profitable and sitting on almost $8 billion in cash—Bancel’s own stake, including options, is worth around $7 billion, according to the Bloomberg Billionaires Index—it can move quickly and aggressively into numerous new applications simply by changing the genetic code it puts into the mRNA. While Moderna’s shot appears to be holding up well against the currently surging delta variant, for example, it’s a straightforward process for the company to incorporate mutations into the vaccine if needed. “We don’t have to introduce new technology or new processes,” Bancel says. “It’s exactly the same thing.”
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