Gilead Sciences, Inc. ( GILD Quick Quote GILD - Free Report) announced that its antiviral treatment Veklury is now recommended by the World Health Organization (WHO) to treat patients with severe COVID-19. The organization also continues to conditionally recommend Veklury for those with non-severe COVID-19 at the highest risk of hospitalization.
This conditional recommendation of the WHO for Veklury’s use in treating patients with severe COVID-19 was based on the final results of the WHO-sponsored SOLIDARITY study. The trial showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline compared to the standard of care.
Data also showed a statistically significant 13% lower relative risk of mortality with Veklury treatment for those patients hospitalized on supplemental oxygen and not requiring mechanical ventilation versus the standard of care.
However, Veklury had no significant effect on patients with COVID-19 who were already being ventilated and did not demonstrate a mortality benefit in the overall population or other baseline oxygen subgroups in the SOLIDARITY study.
Veklury was approved by the FDA in October 2020 for adults and pediatric patients aged 12 years and above, and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. In January 2022, the regulatory body approved Veklury’s label expansion to include non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19, including hospitalization or death.
The FDA also approved Veklury in April 2022 to treat pediatric patients who are more than 28 days old and weighing at least 3 kg, hospitalized or not hospitalized and at a high risk of progression to severe COVID-19, including hospitalization or death.
Veklury sales came in at $2 billion in the first half of 2022. Management expects the drug’s sales of approximately $2.5 billion in 2022 as hospitalization rates are declining worldwide.
While the rollout of vaccines and boosters kept the pandemic in check in recent times, the upcoming winter season might see a surge in the infection rate. Further, emerging variants do pose a cause for concern.
Gilead’s stock has lost 10.5% so far in the year compared with the
industry's decline of 22.8%.
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Veklury sales are likely to be uncertain in 2022 and most likely decline thereafter.
Gilead is currently looking to strengthen its HIV franchise and develop its oncology business to diversify its revenue base with Trodelvy and its CAR T franchise.
While the HIV business maintains momentum on the back of Biktarvy and the approval of new treatments, competition is stiff in the HIV business from the likes of
GSK plc ( GSK Quick Quote GSK - Free Report) .
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products like Dovato, Cabenuva, Rukobia, Juluca and Apretude as well as a favorable U.S. pricing mix.
Gilead currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the sector are
Bolt Pharmaceuticals ( BOLT Quick Quote BOLT - Free Report) and Dynavax ( DVAX Quick Quote DVAX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed on earnings in three of the trailing four quarters and missed on the same in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.