Gilead expects to receive emergency approval for its potential Covid-19 drug remdesivir soon, as it expands production to be able to make 140,000 10-day courses by the end of May — and 1m by the end of 2020.
Daniel O’Day, Gilead’s chief executive, said there was a “sense of urgency” in the biotech group’s discussions with the US Food and Drug Administration, with added intensity in the past 48 hours as it became clear a US-led trial showed positive results for the drug.
“I think the FDA understands the importance of reacting quickly to this,” he said.
President Donald Trump has said he would like the regulator to move as fast as possible. An authorisation for emergency use would be the first step before Gilead sought full approval, Mr O’Day said.
The California-based company said on Thursday that it had spent $50m on remdesivir research and development in the first quarter, increasing its overall R&D investment to $1.1bn. It said spending on the drug may become a material investment this year.
Gilead has made the first 1.5m vials available free either for patients in trials or on a compassionate use basis. But when pressed by analysts, Mr O’Day would not commit to a price or profit margin.
“There’s been no other time like this in the history of the planet that any of us have been alive,” he said. “We need to be very thoughtful about how we can make sure we provide access to medicine for patients around the globe. And do that in a sustainable way for the company, for you as shareholders. Rest assured, we understand our responsibility.”
Gilead is exploring the possibility of allowing other manufacturers to produce remdesivir as well. But Mr O’Day warned they would have to be careful to bolster the supply chain for the ingredients, as Gilead is trying to do with a consortium of pharmaceutical chemical manufacturers.
“Given the scarcity of some of the starting materials, we want to make sure that we don’t do anything to impact our supply chain. That is the quickest route to getting product to patients,” he said.
Gilead published a study on Wednesday showing that some patients may do just as well on a five-day course of treatment, so the supplies may cover more patients than originally predicted based on a 10-day course.
In the longer term, Gilead is also researching whether remdesivir could be developed in different formats such as an inhaler. It is currently given as an intravenous solution.
Gilead did not give forecasts for the coming year. The shares fell 1.9 per cent to $82.39 in after-hours trading in New York.
Gilead shares have soared so far this year on investor hopes that remdesivir could help Covid-19 patients. On Wednesday, there were positive signs from a randomised trial run by the US National Institutes of Health showing that patients taking the drug recovered 31 per cent faster than those on placebo. The news buoyed the stock by almost 6 per cent.
In the first quarter, Gilead beat expectations on earnings and revenue. It reported adjusted earnings per share of $1.68, above the average analyst estimate of $1.57, and net income of $1.6bn, down 21 per cent year-on-year.
Sales were buoyed by stockpiling, especially of HIV medications, which Gilead said added about $200m to the quarter. Total revenue was $5.5bn, just higher than expected, and up 5 per cent year-on-year.
Mr O’Day said he thought the pharmaceutical industry’s role in the crisis would help bolster its reputation — though he said concerns about drug prices would continue. He said the public would see the industry’s “ability to solve a human crisis like this because of the decades of at-risk investments”.