Industry News

Gilead announces continued focus on HBV, HCV, NASH

During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.

Product sales for HIV and HBV as a combined market were $3.6 billion in the second quarter of 2017, compared with $3.1 in the same quarter of 2016. According to Robin Washington, company executive vice president and chief financial officer, the increase was primarily due to continued uptake of the company’s Vemlidy (tenofovir alafenamide)-based products. Overall sales increased 11% from the previous quarter.

HCV products sales, including Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), were $2.9 billion in the second quarter, compared with $4 billion in the same quarter of 2016, which Washington said was due to overall lower sales of Harvoni and Sovaldi, partially offset by sales of Epclusa. Overall sales increased 9% from the previous quarter.

Washington also provided an update on the company’s full year 2017 guidance. The company increased net product sale guidance from a range of $22,500 to $24,500 up to $24,000 to $25,500, and HCV-specific product sales from a range of $7,500 to $9,000 up to $8,500 to $9,500.

Norbert Bischofberger, company earned value professional, research and design, discussed the current pipeline of products for the treatment of NASH. Selonsertib, an apoptosis signal-regulating kinase 1 inhibitor is being tested in two ongoing phase 3 trials for fibrosis stage 3 (STELLAR 3) and stage 4 (STELLAR 4), respectively. GS-9674, a non-steroidal Farnesoid X receptor agonist, and GS-0976, an acetyl-CoA carboxylase inhibitor, are both currently in phase 2 trials. Bischofberger stated that Gilead is confident the phase two trials for GS-9674 and GS-0976 will be fully enrolled by the first quarter of 2018.

In response to a question regarding the company’s sustainability in the HCV market, Kevin Young, company chief operating officer, said that Gilead is pleased with the increased number of patients with HCV seeking testing and treatment in the first part of 2017.

“Naturally, we’re going to be careful and sensitive going into 2018,” he said. “We still consider this a large, important market for Gilead,” he continued, stating that although there will be a gradual decrease as patients with HCV continue to be cured, the company will be watchful for the “bottoming out point.”

Young also praised Gilead’s “Focus Program” and the company’s overall commitment to increasing awareness of HIV and HCV. He believes it has been an aid to the increased number of patient testing, especially among baby boomers.

John Milligan, company president and chief executive officer, concluded the conference by reviewing the details of Vosevi’s (sofosbuvir/velpatasvir/voxilaprevir) recent FDA approval. “We are aware that prescriptions of Vosevi were written within hours of its approval,” Milligan said. Gilead anticipates approval in the EU for Vosevi in the third quarter of 2017. – by Talitha Bennett

Reference: Gilead Sciences. Second Quarter 2017 Financial Results. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-earnings. Published July 26, 2017. Accessed July 26, 2017.

During an earnings conference call today, executives from Gilead Sciences disclosed second quarter earnings and projected pipeline goals with a focus on the company’s hepatitis B, hepatitis C and nonalcoholic steatohepatitis treatments.

Product sales for HIV and HBV as a combined market were $3.6 billion in the second quarter of 2017, compared with $3.1 in the same quarter of 2016. According to Robin Washington, company executive vice president and chief financial officer, the increase was primarily due to continued uptake of the company’s Vemlidy (tenofovir alafenamide)-based products. Overall sales increased 11% from the previous quarter.

HCV products sales, including Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), were $2.9 billion in the second quarter, compared with $4 billion in the same quarter of 2016, which Washington said was due to overall lower sales of Harvoni and Sovaldi, partially offset by sales of Epclusa. Overall sales increased 9% from the previous quarter.

Washington also provided an update on the company’s full year 2017 guidance. The company increased net product sale guidance from a range of $22,500 to $24,500 up to $24,000 to $25,500, and HCV-specific product sales from a range of $7,500 to $9,000 up to $8,500 to $9,500.

Norbert Bischofberger, company earned value professional, research and design, discussed the current pipeline of products for the treatment of NASH. Selonsertib, an apoptosis signal-regulating kinase 1 inhibitor is being tested in two ongoing phase 3 trials for fibrosis stage 3 (STELLAR 3) and stage 4 (STELLAR 4), respectively. GS-9674, a non-steroidal Farnesoid X receptor agonist, and GS-0976, an acetyl-CoA carboxylase inhibitor, are both currently in phase 2 trials. Bischofberger stated that Gilead is confident the phase two trials for GS-9674 and GS-0976 will be fully enrolled by the first quarter of 2018.

In response to a question regarding the company’s sustainability in the HCV market, Kevin Young, company chief operating officer, said that Gilead is pleased with the increased number of patients with HCV seeking testing and treatment in the first part of 2017.

“Naturally, we’re going to be careful and sensitive going into 2018,” he said. “We still consider this a large, important market for Gilead,” he continued, stating that although there will be a gradual decrease as patients with HCV continue to be cured, the company will be watchful for the “bottoming out point.”

Young also praised Gilead’s “Focus Program” and the company’s overall commitment to increasing awareness of HIV and HCV. He believes it has been an aid to the increased number of patient testing, especially among baby boomers.

John Milligan, company president and chief executive officer, concluded the conference by reviewing the details of Vosevi’s (sofosbuvir/velpatasvir/voxilaprevir) recent FDA approval. “We are aware that prescriptions of Vosevi were written within hours of its approval,” Milligan said. Gilead anticipates approval in the EU for Vosevi in the third quarter of 2017. – by Talitha Bennett

Reference: Gilead Sciences. Second Quarter 2017 Financial Results. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-earnings. Published July 26, 2017. Accessed July 26, 2017.