Gilead details Japan hep C takeoff in Q3 and outreach globally

Gilead Sciences ($GILD) detailed the fast pace of its hepatitis C gains in Japan since launches in May and September, showcasing its ability to carve out market share from earlier entrant Bristol-Myers Squibb ($BMY) in the major reimbursement market.

During the Oct. 27 third-quarter earnings call, Paul Carter, executive vice president of commercial operations, went over the ground in Japan and plans for further expansion abroad.

"Turning to Japan, we are very pleased with the execution of the launches of our two HCV products," he said. "HCV revenues for the third quarter were $454 million. Since the launch of Sovaldi in May and Harvoni in September, through the end of the quarter we have generated sales of approximately $515 million in Japan."

Earlier this week, BMS also updated its number in Japan on hepatitis C.

"So in Japan the sales were $175 million and that's down from about $235 million, if I recall, in the second quarter," Chief Financial Officer Charlie Bancroft said.

Bancroft also said that business in Japan "continued to do reasonably well in the quarter, but we do see an increasingly competitive landscape there, which will impact our business going forward."

The gains in Japan come against expansion plans in Asia and emerging markets that include talks with China on pricing for Sovaldi as the country stands outside of an access program by the U.S. drugmaker that relies heavily on manufacturing and sales licensing to mostly India-based companies.

The discussions are also held against a backdrop of China seeking to expand insurance access for serious illness coverage--in a place where Gilead does not yet have regulatory approval.

"We are in discussions with the Chinese authorities regarding access to Sovaldi, yes," Gilead spokesman Nick Francis said in an email to FiercePharmaAsia in August. "But [we] cannot comment further than that though."

Carter said that HCV sales outside of the U.S. were just shy of $1 billion.

"For the rest of the world, which includes Japan, product revenues were $958 million," he said. "Beginning with hepatitis C, we continue to be pleased with the number of patients we are reaching with Sovaldi and Harvoni which are now approved in 57 and 44 countries, respectively. Total HCV revenue for the third quarter was $4.8 billion, a 2% decrease over the second quarter and a 70% increase year over year."

The revenues outside the U.S. then, Carter said, represent a major growth opportunity and the company is busy on that front.

"A key objective for Gilead moving forward is to bring diagnosed and undiagnosed patients into care. It's clear that governments, healthcare systems, policymakers, payers, patients and healthcare advocacy groups recognize the opportunity to treat many more people now that we have simple, safe and highly effective medicines for HCV," he said.

"Today we have Gilead teams around the world focused on collaborating with these diverse groups and supporting their efforts towards a long-term ambitious goal of controlling and possibly eliminating HCV. Indeed, we have several collaborations in different countries and different settings that aim to demonstrate that upscaled HCV intervention and treatment can be highly impactful to individuals and public health care systems."

- here's the release