Gilead Sciences Inc. plans to distribute 1.5 million doses of the potential COVID-19 treatment remdesivir by the end of May, CEO Daniel O'Day said on the company's first-quarter earnings call.

Gilead and government researchers in China and the U.S. have begun to report results from clinical trials showing mixed efficacy between trials. However, top-line results from a trial conducted by the U.S. National Institute of Allergy and Infectious Disease, or NIAID, showed that remdesivir helped severely ill patients recover faster from COVID-19.

Gilead has embarked on a rolling submission for approval from the U.S. Food and Drug Administration, and the company and regulator are in the process of securing an emergency use authorization for remdesivir, according to O'Day. The authorization would allow the unapproved drug to be used in a health crisis.

The 1.5 million doses, which is the entirety of Gilead's supply through early summer, will be donated to slow the pandemic. The amount accounts for 140,000 10-day treatment courses, and O'Day said the drugmaker hopes to have enough supply to treat over 1 million patients by the end of the year.

The company spent approximately $50 million on clinical trials and manufacturing scale-up for remdesivir in the first quarter.

As far as profitability down the road for remdesivir, O'Day said because there is no precedent for this type of pandemic, balancing responsibility to patients and shareholders is a careful line for the company to tread. He confirmed that Gilead would be permitted to charge for the drug under emergency use authorization.

"There is no rule book out there other than that we need to be very thoughtful about how we can make sure to provide access to our medicine to patients around the globe and do that in a sustainable way for the company, for you as shareholders, and we acknowledge that," O'Day said. Gilead currently profits on treatments for infectious diseases such as hepatitis C and HIV, but O'Day said the COVID-19 situation is unique.

O'Day said it is premature to predict any potential revenue from remdesivir.

Cantor Fitzgerald analyst Alethia Young said in an April 29 note that the NIAID results could lead to an approval for remdesivir before subsequent trials are seen.

"Although we do not expect Gilead to monetize remdesivir in the near-term, we think that this readout is [a] meaningful moment for the company's R&D capability and all of biopharma," Young said.

O'Day was cautious about indicating a specific timeline.

"There's a lot of moving parts right now," O'Day said. "We're just now going through the clinical data, the demand scenarios, the regulatory approvals — all these things are essential for us to input into our plan about how that will work post the donation."

O'Day said the company's focus since the beginning of the year has been to ramp up supply of the drug for clinical trials and ultimate distribution. He said Gilead has worked with other global drugmakers to help establish separate end-to-end manufacturing supply chains as well.

"We are working with a number of companies around the world that you and others know well to see what we could do together and if there's an opportunity to benefit patients in that way," O'Day said.

O'Day said the pandemic has led to a shift in the way pharmaceutical companies are viewed, particularly in Washington.

"At the end of the day, I think this will certainly help the industry's reputation," O'Day said. "I think the ability to solve a human crisis like this because of the decades of investment and the at-risk investment that's done by so many companies, the general public will see that."

Pandemic impact on business

Gilead's other businesses began to show strain from the pandemic due to a reduction in patients' physician visits, which impacted new prescriptions in the first quarter and would likely continue at least through the first half of the year, CFO Andrew Dickinson said.

"On the commercial side, driven by lessened health care provider access and fewer patient visits, we may see revenues adversely impacted in Q2 and potentially beyond," Dickinson said. "This would likely be different across our franchises, with our HCV franchise disproportionately affected due to the acute care nature of therapy."

In HIV, Dickinson said Gilead has seen certain kinds of therapies impacted more than others. For instance, the number of new prescriptions of the company's preventive HIV drug Descovy had dropped in April, but patients receiving treatment for HIV were more likely to continue refilling prescriptions.

"The overall effect on our business has been modest, and it remains unclear what the ultimate impact will be," Dickinson said. "Given the significant uncertainty regarding the duration and magnitude of the COVID-19 pandemic, we are actively planning for a number of scenarios, and we'd like to focus on our base case assumptions today, which we are making from data drawn from a number of sources, including epidemiologists, economists and public health officials."