Gilead Sciences Inc. may spend $1 billion on its breakthrough new treatment for COVID-19 this year alone, Chief Executive Officer Daniel O’Day said. How much revenue — if any — the company expects to generate is another matter.
Details from a U.S. government study and a separate trial conducted by the company itself suggest remdesivir may become the first medication approved to treat the novel coronavirus, which has sickened 3.2 million people worldwide and killed 233,000. Gilead is still in the early stages of developing and getting approvals for the medication to treat the pathogen, which first emerged in China less than six months ago.
The company has pledged to donate 1.5 million vials of the drug, its entire current supply, while O’Day said it is working with other major pharmaceutical companies to boost production of the medication, which must be given intravenously. The unprecedented pace and nature of the operation has left investors and the analysts who scrutinize corporate performance scrambling to understand what the business will ultimately look like.
Geoff Porges, an analyst at SVB Leerink LLC, asked what he termed a controversial question on Gilead’s first-quarter earnings call on Thursday. The biotechnology giant has built a profitable business with drugs that have nearly eliminated hepatitis C and turned HIV into a chronic condition from a death sentence. Will it generate the same sort of returns with remdesivir? “What’s special about COVID?” Porges asked. “Should we assume the capital returns and the profitability for providing a global treatment for COVID long-term, after the first 200,000 or 300,000 courses are provided on a donation basis? Should we assume the returns are going to be similar to the returns you have generated in other parts of the business?”
O’Day responded by citing the unprecedented nature of the pandemic.
“There has been no other time like this in the history of the planet,” O’Day said. “There is no rule book out there, other than that we need to be thoughtful about how we can make sure we provide access of our medicines to patients around the globe and do that in a sustainable way for the company, for shareholders, and we acknowledge that. So point’s well-taken.”
The CEO said it would be premature to discuss potential revenue because there are “a lot of moving parts right now.” He said Gilead would seek to come up with a sustainable model that would benefit patients around the world.
“We understand our responsibility, and we understand the responsibility to a variety of different audiences,” he added.
On the call, O’Day attempted to establish remdesivir as a standard of care for COVID-19, saying that future studies of treatments for the condition will have to compare against the drug or use it in a combination therapy. He also said that Foster City, California-based Gilead is working closely with the U.S. Food and Drug Administration to get full approval of the medication, though Gilead may first need to get an emergency-use authorization as an initial step toward full approval.
The company would be able to charge for the drug if it is granted an emergency clearance rather than a full approval, he said. Additional studies may not be needed to meet FDA demands, he said.
The government’s trial results “demonstrate safety and efficacy at a highly statistical level, which is usually the barrier for a full approval,” he said. “So that’s what we are working with them on. And I don’t want to get ahead of the agency on that.”