Summary
Merck & Co., Inc. filed an 8-K on February 3, 2011, primarily to report on the results of operations and financial condition for the fourth quarter of 2010 and a material impairment charge. The company incorporated by reference a press release and supplemental information detailing its Q4 2010 earnings. The key financial impact disclosed in this filing relates to a significant impairment charge of $1.7 billion in the fourth quarter of 2010. This impairment charge is directly linked to the investigational drug vorapaxar, a thrombin receptor antagonist. Following recommendations from the Data and Safety Monitoring Board (DSMB) for the TRACER and TRA-2P clinical trials, Merck decided to discontinue the TRACER study and modify the TRA-2P study. Specifically, patients with a history of stroke in the TRA-2P study will no longer receive vorapaxar due to an observed increase in intracranial hemorrhage that outweighs potential benefits. This development necessitated the write-down of the vorapaxar in-process research and development intangible asset, which was established as part of the Schering-Plough acquisition.
Key Highlights
- 1Merck reported Q4 2010 earnings, with details provided in an incorporated press release (Exhibit 99.1) and supplemental information (Exhibit 99.2).
- 2A significant pre-tax impairment charge of $1.7 billion was recognized in Q4 2010.
- 3The impairment charge relates to the in-process research and development intangible asset for vorapaxar.
- 4Clinical trials for vorapaxar (TRACER and TRA-2P) have undergone significant changes based on DSMB recommendations.
- 5The TRACER study has been discontinued.
- 6In the TRA-2P study, vorapaxar will be discontinued for patients with a history of stroke due to increased intracranial hemorrhage risk.
- 7The impairment charge is a direct consequence of the adverse findings and study modifications for vorapaxar.