Loss of Hep C Drug Status Weighs on Merck Earnings

For the 2015 full year, Merck expects EPS to be between $3.32 and $3.47 and revenues to be in the range of $38.3 billion to $39.8 billion. The consensus estimates for the 2015 full year are $3.49 in EPS and revenue of $40.50 billion.

The company accelerated its hepatitis C virus (HCV) clinical development program in 2014. Merck recently announced that it expects to file a New Drug Application (NDA) with the FDA in the first half of 2015 for grazoprevir/elbasvir, the company’s investigational oral, once-daily combination regimen for the treatment of chronic HCV infection. At the end of January, the FDA notified Merck of an intent to rescind Breakthrough Therapy Designation status for this combination treatment regimen. Merck expects to discuss this matter with the FDA and does not expect that it will impact its ability to file an NDA for this combination regimen or the timing of that filing.

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As a whole, total revenues were down 7% from the same period in the previous year. This was led in dollar amount by the Pharmaceutical segment, which reported revenues for the fourth quarter as:

• Januvia/Janumet, up 2% to $1.65 billion
• Zetia/Vytorin, down 10% to $1.03 billion
• Remicade, down10% to $557 million
• Gardasil, down 10% to $356 million
• Isentress, down 5% to $418 million
• Proquad/M-M-M-R II and Varivax, up 34% to $366 million
• Nasonex, down 18% to $268 million
• Singualar, up 7% to $319 million

Kenneth C. Frazier, chairman and CEO of Merck, said:

Our stronger focus has led to better, consistent execution, and our results in 2014 demonstrate the significant progress we’ve made in evolving the company to better serve health care markets around the world. As we look forward to 2015 and beyond, we will continue to focus our resources on those internal and external opportunities that can generate the most value for patients, customers and shareholders.

In premarket trading Thursday, following the earnings report, Merck shares were down about 1.5% at $60.01, and they were down further to $59.64 after the opening bell. The stock has a consensus analyst price target of $64.39 and a 52-week trading range of $52.49 to $63.62.

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