SILVER SPRING, Md., Feb. 15, 2011 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced its financial results for the fourth quarter and year ended December 31, 2010.
"We finished 2010 with solid operating results led by the growth in our revenues," remarked Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "In addition, we are pleased to announce that we expect to unblind our FREEDOM-M pivotal study of oral treprostinil as monotherapy for pulmonary arterial hypertension in June 2011. We also expect to fully enroll and then unblind our FREEDOM-C2 pivotal study of oral treprostinil as combination therapy for pulmonary arterial hypertension in April and September 2011, respectively."
Total revenues for the three months ended December 31, 2010, were $166.5 million, up from $108.9 million for the quarter ended December 31, 2009. Net income for the three months ended December 31, 2010, was $9.5 million or $0.17 per basic share, compared to a net loss of $3.3 million or $0.06 per basic share for the quarter ended December 31, 2009. For the year ended December 31, 2010, we had net income of $105.9 million, or $1.89 per basic share and $1.78 per diluted share, compared to $19.5 million, or $0.37 per basic share and $0.35 per diluted share, for the year ended December 31, 2009. Earnings before non-cash charges(1) for the three months ended December 31, 2010, were $72.4 million or $1.27 per basic share, compared to $36.2 million or $0.67 per basic share for the three months ended December 31, 2009.
(1) See definition of earnings before non-cash charges, a non-GAAP financial measure, and a reconciliation of net income to earnings before non-cash charges below.
Results
Revenues. Revenues for the quarter ended December 31, 2010 increased by $57.6 million when compared to the quarter ended December 31, 2009. The growth in revenues is predominately from the increase in the number of patients being prescribed our products. In addition, sales of Remodulin increased by approximately $9.2 million as the result of price increases that went into effect during 2010. Gross margin from sales for the quarters ended December 31, 2010 and 2009 were $146.0 million and $95.1 million, respectively, or 88% of total revenue for both of these quarters. These trends were consistent with the results for the years ended December 31, 2010 and December 31, 2009.
The table below summarizes the components of revenues (in thousands):
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Cardiopulmonary products: | ||||||||||||||||
Remodulin | $ | 101,879 | $ | 86,415 | $ | 403,599 | $ | 331,579 | ||||||||
Tyvaso | 48,714 | 15,155 | 151,797 | 20,268 | ||||||||||||
Adcirca | 12,804 | 4,275 | 36,307 | 5,789 | ||||||||||||
Telemedicine products and services | 2,787 | 2,795 | 10,932 | 10,968 | ||||||||||||
License fees | 293 | 283 | 1,196 | 1,244 | ||||||||||||
Total revenues | $ | 166,477 | $ | 108,923 | $ | 603,831 | $ | 369,848 | ||||||||
Operating Expenses. Our operating expenses consist of research and development, selling, general and administrative, and costs of service and product sales.
The table below summarizes research and development expense by major project and non-project components (in thousands):
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Project and non-project: | ||||||||||||||||
Cardiopulmonary | $ | 31,908 | $ | 22,906 | $ | 86,161 | $ | 61,574 | ||||||||
Share-based compensation | 19,774 | 11,129 | 45,878 | 36,294 | ||||||||||||
Other | 10,573 | 6,997 | 34,722 | 24,320 | ||||||||||||
Total research and development expense | $ | 62,255 | $ | 41,032 | $ | 166,761 | $ | 122,188 | ||||||||
Cardiopulmonary. The increase in cardiopulmonary project expenses of $9.0 million for the quarter ended December 31, 2010 compared to the same quarter in 2009 reflected primarily: (1) an increase in expenses incurred in connection with our FREEDOM-M and FREEDOM-C2 Phase III clinical trials, which was largely offset by a decrease in expenses related to our inhaled treprostinil program; and (2) an increase of $9.3 million in expenses related to our development of beraprost-MR, which includes $9.0 million in milestone-related expenses.
Share-based compensation. The increase in share-based compensation expense of $8.6 million for the quarter ended December 31, 2010 over the same quarter in 2009 reflected: (1) an increase in the fair value of awards granted under our Share Tracking Awards Plan (STAP), principally as a result of the increase in the price of our common stock; (2) an increase in the number of outstanding STAP awards; and (3) increases in both the number of STAP awards vested and the time that unvested STAP awards had accrued toward vesting as of December 31, 2010.
Other. Other research and development expenses increased $3.6 million during the quarter ended December 31, 2010 compared to the same quarter in 2009 reflected primarily an increase in personnel, depreciation and overhead costs supporting our research mainly because 2010 was the first full year of operations of our new facilities in North Carolina and Maryland. Research and development expenses for our individual disease platforms include only direct labor and related direct costs.
The table below summarizes selling, general and administrative expense by major categories (in thousands):
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
