Merck & Co., Inc. (NYSE: MRK) reported Q1 EPS of $0.88, $0.09 better than the analyst estimate of $0.79. Revenue for the quarter came in at $10.3 billion versus the consensus estimate of $10.44 billion.

Key Developments

Clinical

• Interim Phase 2 data for MK-5172/MK-8742, an investigational oral combination regimen for treatment of chronic hepatitis C virus (HCV), presented at the 2014 Annual Meeting of the European Association for the Study of the Liver, showed sustained viral response in hard-to-cure and treatment-naïve, non-cirrhotic patients.
• Interim Phase 2b data on doravirine (MK-1439), an investigational treatment for HIV, presented at the 21st Conference on Retroviruses and Opportunistic Infections, demonstrated potent antiretroviral activity in treatment-naïve HIV-1 infected adults in combination with tenofovir/emtricitabine after 24 weeks of therapy; a Phase 3 clinical program is planned to begin in the second half of 2014.

Regulatory

• The U.S. Food and Drug Administration (FDA) approved GRASTEK (Timothy Grass Pollen Allergen Extract) and RAGWITEK (Short Ragweed Pollen Allergen Extract), the company’s sublingual allergen extract immunotherapy tablets.
• The FDA accepted a Biologics License Application for V503, a 9-valent HPV vaccine candidate, in February.
• The FDA accepted the resubmission of a New Drug Application for suvorexant for insomnia in April.
• The European Committee for Medicinal Products for Human Use issued a positive opinion for vintafolide in patients with platinum-resistant ovarian cancer.

Merck & Co., Inc. reaffirmed FY2014 guidance.

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