An updated model ahead of the second-quarter earnings acted as a catalyst for the increased price objective. Merrill Lynch adjusted its second-quarter estimates to total hepatitis C virus (HCV) vaccine sales of $4.53 billion, up from $4.32 billion, and earnings per share (EPS) of $2.84, up from $2.76. The 2015 and 2016 adjusted EPS estimates were also increased to $10.84, from $10.56, and $9.14, from $8.57, respectively.
According to Merrill Lynch:
Harvoni NRx down 3.92% week over week; total HCV TRx up 1.79% 3,256 new patients started treatment with Harvoni (as measured by IMS NRx) during the week ending June 26th, down 3.92% week over owee. Harvoni TRx was 8,823, up 1.32%. Sovaldi NRx was 581, up 8.6% w/w while TRx was 1,739, up 4.26%.
On July 2, the Japanese Ministry of Health, Labor and Welfare approved Harvoni for the treatment of genotype 1 HCV. This genotype represents 70% to 80% of the estimated more than a million patients in Japan. Merrill Lynch detailed that it typically takes up to three months to finalize pricing and reimbursement with the government. The Japanese pricing for Harvoni is expected to be similar to Sovaldi ($43,350 for a course of 12 weeks of therapy).
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Just the day before, Gilead announced new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for a once-daily single tablet regimen for the treatment of HIV infection. It combines three antivirals (rilpivirine/emtricitabine/tenofovir alafenamide, or R/F/TAF) to stop HIV from replicating itself in the body. The NDA submission represents Gilead’s third NDA for a TAF-containing regimen within the past year. Merrill Lynch estimates R/F/TAF sales of $50 million in 2016 and $1.1 billion in 2020, approximately 12% of Gilead’s HIV sales for that year.
Shares of Gilead were up 1% at $116.16 Monday afternoon. The stock has a consensus analyst price target of $122.00 and a 52-week trading range of $84.75 to $123.37.
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