- Gilead earned nearly $900 million from sales its COVID-19 drug Veklury between July and September, reflecting broad use of the antiviral treatment in U.S. hospitals following the Food and Drug Administration's emergency clearance earlier this year.
- The boost from Veklury drove third quarter sales and profits for Gilead higher by double digits over last year, according to figures released by the drugmaker Wednesday. But the company trimmed the top end of its revenue forecast for the year down by $1.5 billion, suggesting demand for the drug moving forward may not be as strong as the company originally anticipated.
- Earlier this month, the FDA gave a full approval to Veklury, granting the drug a permanent place on the market even if the pandemic should recede. Recent data from a large World Health Organization-backed study, however, found Veklury did not prevent COVID-19 deaths — a finding Gilead disputes.
Gilead's sales numbers for Veklury — the first the company's posted since the initial supply it donated ran out in June — point to the drug's widespread use in the months since a government-run study showed it could hasten the recovery of people hospitalized with COVID-19.
On a conference call Wednesday, company executives didn't break out exactly how many people it believes have been treated with Veklury to date. But commercial chief Johanna Mercier told analysts Gilead estimates between 40% and 50% of hospitalized COVID-19 patients in the U.S. received treatment with Veklury.
With cases surging in the U.S., and Veklury now fully approved, the drug could earn Gilead still more sales in the months ahead, likely making it the first billion-dollar product of the pandemic.
Still, there are signs Gilead expects sales to plateau, or even slow, in the U.S.
In July, the company had boosted its sales guidance, revising its predictions for 2020 product sales to between $23 billion and $25 billion, up $1.2 billion and $2.8 billion, respectively, from February. The increase was largely due to Veklury, then being distributed by the U.S. government under a supply deal with Gilead.
On Wednesday, Gilead lowered the upper ceiling on its sales forecasts to $23.5 billion, a change executives said was the result of "uncertainty" in demand for Veklury.
Hospitalization rates for COVID-19, for example, have come down since the second quarter, potentially reflecting greater infection rates among younger people. New treatments and vaccines are advancing quickly, too, potentially changing how physicians use Veklury in the future.
Third quarter sales also included a build-up of Veklury inventory in the U.S., likely meaning domestic sales will be lower between October and December as that supply is worked through. Slides posted by the company, for example, note Gilead expects the majority of Veklury sales in the fourth quarter to be in Europe and countries outside the U.S.
Gilead has stirred controversy with the high price it set for Veklury, charging $2,340 per 5-day treatment course to government insurance and $3,120 for commercial insurance. The price is lower than some on Wall Street had expected, but will still make the drug a blockbuster treatment.
That price, Gilead said, was based on the benefit shown in a study run by the National Institutes of Health, which found treatment with Veklury sped the recovery of patients hospitalized with COVID-19 by five days versus placebo. The data did not prove a survival benefit for the drug, however, and new results from an international study called SOLIDARITY raised further questions about Veklury's ultimate effectiveness.
The trial, which separately tested three other repurposed treatments in addition to Veklury, found Gilead's drug didn't prevent deaths from COVID-19 among hospitalized patients. The trial was designed for rapid implementation, though, and collected less data from participants than the NIH study.
Merdad Parsey, Gilead's chief scientific officer, noted several design flaws in the study on Wednesday's call, suggesting they may have contributed to the negative outcome.
The Institute for Clinical and Economic Review, an influential voice in the drug pricing debate, largely supported Gilead's price for Veklury, but has said that if later data don't prove a survival benefit, the drug wouldn't be cost-effective at a price higher than $310 per course.
Shares in Gilead fell by nearly 2% in after hours trading Wednesday