At the start of 2020's J.P. Morgan Healthcare Conference, news of a strange, pneumonia-like disease outbreak in China was only days old, and Moderna and BioNTech were unproven biotechs thought to be years away from having marketed products.
Fast forward to 2021 and those companies have, in record time, each developed highly effective coronavirus vaccines that hold the promise to curb what's become the world's worst pandemic in a century.
Repurposed drugs and newly invented medicines are now critical tools for doctors treating COVID-19 in hospitals around the world.
In just one year, the pandemic has reshaped long-held views of drug development and offered lessons on how to rapidly run large trials capable of delivering definitive answers.
For the pharmaceutical industry, however, COVID-19 has also become a business opportunity. Because SARS-CoV-2 could become endemic, returning year after year, executives are debating whether their company's research this year will lead to steady revenues in the future.
Moderna's vaccine windfall
How lucrative are coronavirus vaccines? Moderna gave a bit of a glimpse on Monday during its JP Morgan presentation.
So far, Moderna’s shot is authorized in 30 countries, most recently Israel. Company CEO Stephane Bancel said that governments around the world have already signed $11.7 billion in advanced purchase agreements for its shot for the 2021 fiscal year. "We're not done,"Bancel added, noting that the figure is as of Jan. 11.
Moderna is also working on expanding access to other groups, which could drive revenue numbers substantially higher. The company aims to gain clearance to vaccinate 12 to 17 year olds by the summer, so adolescents can be vaccinated in time for school in September.
Testing in younger children, from 1 to 11, will take longer, with results more likely to come in 2022, Bancel said. Moderna’s vaccine is currently cleared for use in adults 18 and up.
Pfizer's Prevnar 13, the world's top-selling vaccine, generated $5.8 billion in sales in 2019.
BioNTech's next crucial data
Unlike Moderna, BioNTech didn't detail how much money it's already banked from government purchase agreements. But the German biotech did give a few notable updates on the rollout of its vaccine and how it might perform against new, more infectious coronavirus variants spreading throughout several countries.
During its presentation Monday, BioNTech announced that, as of Sunday, it had shipped nearly 33 million of the 1 billion doses pre-ordered by national governments. It also now believes it can make 2 billion doses this year, in part because the Food and Drug Administration altered its emergency clearance to boost the number of doses in every vial of vaccine from five to six.
BioNTech CEO Ugur Sahin said that the company intends to develop a formulation of the vaccine that doesn't contain polyethylene glycol, a component suspected to be involved in the rare cases of allergic reactions that have occurred so far. It's also working on a "thermostable" shot that won't require ultra-cold temperatures for storage, which could help broaden the reach of the vaccine. The thermostable shot could be available in the second half of 2021, Sahin said.
The emergence of new, rapidly spreading variants that originated in the U.K. and South Africa has led to concerns about the staying power of BioNTech and Moderna's vacines. Sahin said there will be data available very soon — within 10 days — that should show how effective BioNTech's vaccine is against both of them. BioNTech and Moderna have each expressed confidence that their shots will hold up.
"I'm more or less completely comfortable in our vaccine because it has [immune] responses ... that will be not directly affected by these types of mutations," he said.
Gilead shines, Regeneron disappoints
Gilead primed investors for the meeting by upgrading its 2020 financial projections by $500 million before CEO Daniel O'Day's presentation. The reason: strong sales of the coronavirus antiviral treatment Veklury, which remains the only drug to gain a full approval from the FDA to treat COVID-19. That product, which a year ago was in trials to treat Ebola, will likely bring in $2.8 billion for the 2020 fiscal year, Gilead said.
O'Day said Veklury is now being used in around half of eligible patients, up from around 30% in October. That has helped boost the sales numbers, along with a grim rise in hospitalization rates that have quadrupled over the same period.
Regeneron, meanwhile, told a more disappointing story at J.P. Morgan. Though the company gained wide notoriety when its antibody drug cocktail, REGN-CoV2, was used to treat President Donald Trump's coronavirus infection in October, strong sales haven't followed. Logistical issues and other problems have slowed the rollout of antibody drugs for COVID-19, resulting in a majority of the doses going unused.
Fourth quarter sales were $144 million and total sales $184 million in 2020, the company said, well below analyst forecasets. Cantor Fitzgerald, for instance, projected sales of $225 million and $263 million. Nonetheless, Regeneron believes an uptick is coming.
"That's a little bit lower than some of you might have been expecting, but that's just a timing event, we think, because we'll be delivering those products in the first part of this quarter," CEO Leonard Schleifer said. "We're in negotiations [to sell] additional doses. We think there's substantial demand for this cocktail."