Gilead HCV drug sales down in 2017 third quarter compared with 2016

Gilead announced that combined third-quarter sales for Harvoni, Sovaldi, Epclusa and Vosevi were $2.2 billion compared with $3.3 billion the third quarter of 2016, related to fewer patients initiating treatment and increased drug competition.

“Thirty-nine thousand patients began treatment on a Gilead treatment regimen during the quarter, down 9% from the prior quarter, continuing the gradual decline in HCV patient starts that we've seen since the beginning of 2017,” Jim Meyers, earned value professional of commercial operations at Gilead said during a conference presentation.

According to Gilead, the decline was due to lower sales of Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) across all major markets. However, the decline was partially offset by sales of Epclusa (sofosbuvir/velpatasvir), which was approved in the U.S. in June 2016 and in Europe July 2016, and sales of Vosevi (sofosbuvir/velpatasvir/voxilaprevir), approved in the U.S. and Europe in July 2017.

Specifically, sales of HCV regimens declined from $3,325,000 in the third quarter of 2016 to $2,197,000 in the third quarter of 2017, representing a year-to-year decrease of 34%. HIV and HBV combined sales, however, increased slightly from $3,516,000 in the third quarter of 2016 to $3,646,000 in the third quarter of 2017, representing a year-to-year increase of 4%.

Geographically, sales declined in the U.S., Europe and other international markets. Gilead stated that the decrease in the U.S. was related to declining patient starts and the impact of increased competition. Regarding Europe, the decrease correlated with recognition of deferred revenue in the second quarter due to an HCV contract and fewer patient starts.

“As we have noted in the past, revenues in the HCV market are driven by four variables: patient starts, net pricing, market share and treatment duration,” Meyers said. “While patient starts have exceeded our expectations in 2017, the arrival of new competition has further eroded Gilead's market share and net pricing, which is now similar across genotypes.”

Meyers continued: “Some of those changes can be seen in our third quarter results, but the impact on net pricing and market share will be fully reflect in the fourth quarter. Importantly, we have worked with payers to ensure that physician and patient access to Harvoni and Epclusa in 2018 will remain similar to what we say in 2017.”

Additional details from the conference call include approval of Sovaldi for treatment of hepatitis C genotypes 1 through 6 in China and FDA approval of expanded labeling for Epclusa to include use in patients coinfected with HIV. Vosevi was also approved by the FDA for retreatment in patients with HCV genotypes 1 through 6.

Gilead also announced that it had 40 abstracts accepted by the AASLD for The Liver Meeting 2017, including study results on an acetyl-CoA carboxylase inhibitor for NASH, high cure rates with sofosbuvir-based regimens in patients with HBV, and improved long-term bone and renal safety with a switch from Vemlidy (tenofovir alafenamide) to Viread (tenofovir disoproxil fumarate).

“We continue to make significant progress in our liver disease pipeline,” John Milligan, president and CEO of Gilead, said during the presentation. “We are confident in the underlying strength of Gilead's business, driven by successful execution of key product launches and advancement of various programs in HCV, liver disease and now cellular therapy--all of which position us well for long-term success.”

Reference: www.gilead.com