Merck has posted its financial returns for the 2010 fourth quarter and the fiscal year 2010, recording a net drop in net income, partly due to charges related to its struggling antiplatelet drug vorapaxar.
The New York City-based company posted generally accepted accounting principles (GAAP) net loss for the 2010 fourth quarter of $531 million, compared with a net income of $6.49 billion in the previous year’s fourth quarter. In the 2010 fourth quarter, Merck incurred a $1.7 billion pre-tax charge related to its vorapaxar clinical research program. For its GAAP full-year returns in 2010, the net income experienced a 93 percent drop, but remained in the black, with a net income of $861 million.
In January, researchers at Brigham and Women’s Hospital and the Duke Clinical Research Institute reported that they are following the recommendations of the Data Safety Monitoring Board for two global phase III trials to discontinue vorapaxar in one study among a subset of patients and discontinue the study drug altogether in the other trial, in which the protocol target number of endpoint events had been reached.
For the full year of 2010, worldwide sales were $45.99 billion—a 68 percent increase over the 2009 fiscal year. The worldwide sales for the fourth quarter of 2010 were up 20 percent $12.1 billion over the 2009 fourth quarter.
Global sales of ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin), the company's cholesterol-lowering medicines, rose in the fourth quarter of 2010 of $629 million and $562 million, respectively, compared with $399 million for Zetia and $384 million for Vytorin in the 2009 fourth quarter. Annual worldwide sales of Zetia for 2010 were $2.3 billion and $2 billion for Vytorin. Likewise, the 2010 yearly sales increased globally. In 2010, Zetia booked sales of $2.3 billion, compared with $409 million in 2009; and Vytorin posted $2.01 billion in the 2010 fiscal year, compared with $441 in the previous year.
Global sales for its antiplatelet drug eptifibatide (Integrilin) rose to $63 million in the fourth quarter of 2010, compared with $46 million in the previous year’s fourth quarter. Integrilin’s fiscal year profits also increased, booking $266 million in the 2010 fiscal year, compared $46 million in 2009.
Sitagliptin (Januvia), Merck's DPP-4 inhibitor for the treatment of type 2 diabetes, recorded worldwide sales of $675 million during the fourth quarter of 2010, representing a 21 percent increase compared with the same quarter in 2009. Sitagliptin/metformin hydrochloride (Janumet), a single tablet that targets all three key defects of type 2 diabetes, achieved worldwide sales of $288 million during the quarter, an increase of 42 percent compared with the fourth quarter 2009. The combined Januvia/Janumet franchise had sales of $3.3 billion for the full year of 2010, an increase of 29 percent over 2009.
Global sales of Merck's antihypertensive medicines, losartan potassium (Cozaar) and losartan potassium and hydrochlorothiazide (Hyzaar), were $415 million for the fourth quarter of 2010, representing a 57 percent decrease compared with the fourth quarter of 2009. Full year worldwide sales for Cozaar/Hyzaar were $2.1 billion, a 41 percent decrease compared to the full year of 2009. Merck noted it continues to experience a “significant decline” in Cozaar/Hyzaar sales since these medicines have lost marketing exclusivity in the U.S. and in major European markets.