Gilead criticised a World Health Organization study that raised doubts about its Covid-19 treatment, insisting that the overnight blockbuster drug does improve survival rates for a large group of hospitalised patients.
The company mounted the defence of remdesivir as it revealed that the drug, which had not even been approved by the US Food and Drug Administration at the start of the year, generated $873m in revenue in the third quarter.
The WHO study published this month found remdesivir, now known by its brand name Veklury, had little effect on mortality, reducing time in hospital or whether a patient ends up on a ventilator.
Merdad Parsey, Gilead’s chief medical officer, on Wednesday said a large amount of data was missing from the WHO’s preliminary analysis, questioned the study design, and suggested the results may be clarified in the peer review process.
He said that the WHO Solidarity trial had failed to distinguish between patients requiring low or high levels of oxygen. Remdesivir improved survival rates for patients on low levels of oxygen, according to an analysis of data from another trial run by the US National Institutes of Health, he said.
“These results are what we would have expected and hoped for with an antiviral therapy that should have the most impact when given earlier in the course of the disease, before the inflammatory cascade leads to critical illness,” Dr Parsey said.
Soumya Swaminathan, the WHO’s chief scientist, said the Solidarity trial provided “robust, generalisable, clinically relevant information”. No drug in the trial reduced mortality, hospitalisation or the need for a ventilator, she said.
Remdesivir, which was developed to treat Ebola, received FDA approval last week for hospitalised Covid-19 patients after being used under an emergency use authorisation. A push to massively expand manufacturing means supply now outstrips demand.
Daniel O’Day, Gilead’s chief executive, said the benefits of remdesivir had been “unequivocally demonstrated by the gold standard of global clinical trials”.
“At the start of the year, most of the world had not even heard of Covid-19,” he said. “Today, less than 10 months later, we have an FDA-approved therapy that is helping patients around the world to recover faster. And for some groups of patients, Veklury is lowering the risk of death.”
But this unusually rapid success still did not meet Gilead’s more optimistic expectations, leading the company to reduce its full-year forecasts to the lower end of its previous guidance. Shares in Gilead fell 1.5 per cent in after-hours trading to $57.86.
Gilead warned that there was “significant volatility and uncertainty” around remdesivir sales, explaining that hospitals had stockpiled the drug at lower rates than it had forecast.
Analysts had forecast $1bn of remdesivir sales in the third quarter, and $2.6bn for the full year, as the company signs commercial deals in the US and with governments in other countries.
Johanna Mercier, Gilead’s chief commercial officer, said about 40 to 50 per cent of Covid-19 patients hospitalised in the US were given remdesivir and that may increase now that it has received regulatory approval.
“The assumption, in light of the surge this fall both in Europe as well as in the US, [is] that those numbers will pop back up a little bit,” she said.
The NIH study initially said remdesivir speeded up recovery but did not improve survival rates. However, Dr Parsey said further analysis showed that for about 40 per cent of hospitalised patients, those receiving low levels of oxygen, taking remdesivir led to a 72 per cent reduction in mortality at day 15.
Gilead now expects full-year product sales of between $23bn and $23.5bn, compared with projections in July of between $23bn and $25bn. It predicts non-GAAP earnings per share of between $6.25 and $6.60, rather than $6.25 to $7.65.
In the third quarter, Gilead reported revenue of $6.6bn, up 17 per cent year on year, and higher than the consensus forecast for $6.4bn. Diluted non-GAAP earnings per share soared 29 per cent to $2.11, compared with the average analyst estimate for $1.95. Net income was $360m.