LEXINGTON, Mass.—AMAG Pharmaceuticals increased its revenues in 2010 while also reducing its losses, according to the company, which manufactures the iron drug Feraheme.
The company’s total revenues for the fourth quarter of 2010 were $17.2 million compared to $13.1 million for the same period in 2009. Total revenues for 2010 were $66.2 million compared to $17.2 million for the same period in 2009. AMAG said the increases were due to 2010 being the first full year during which AMAG marketed and sold Feraheme following its approval and launch in July 2009.
AMAG also reported a net loss of $19.8 million, or a loss of $0.94 per basic and diluted share, for the fourth quarter of 2010, as compared to a net loss of $18.4 million, or a loss of $1.07 per basic and diluted share, for the same period in 2009. Net loss for 2010 was $81.2 million, or a loss of $3.90 per basic and diluted share, as compared to a net loss of $93.4 million, or a loss of $5.46 per basic and diluted share for the same period in 2009.
As of Dec. 31, 2010, AMAG’s cash, cash equivalents and investments totaled approximately $294 million.
The company said total Feraheme provider demand and launch incentive program utilization for the full year 2010 was approximately 114,000 grams, of which approximately 58 percent was for use in the non-dialysis chronic kidney disease (CKD) setting. Total Feraheme provider demand and launch incentive program utilization for the fourth quarter was approximately 27,600 grams, of which approximately 73 percent was for use in the non-dialysis CKD setting.
Over the course of 2010, provider demand shifted from primarily dialysis in the first quarter to primarily non-dialysis in the fourth quarter, largely due to dialysis provider purchasing decisions in response to the January 1 implementation of the new Medicare prospective payment system for end-stage renal disease patients, also known as the “bundle,” according to AMAG.
Total operating costs and expenses for the quarter ended December 31, 2010 were $37.4 million as compared to $33.3 million for the same period in 2009. Total operating costs and expenses for the year ended December 31, 2010 were $149.2 million as compared to $115.1 million for the same period in 2009. The increases in operating costs and expenses in 2010 over the comparable 2009 periods were primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme and increased research and development costs associated with the Company’s global iron deficiency anemia (IDA) registrational program.
In 2011, AMAG said it expects $55 to $60 million of Feraheme net product revenues; $12 to $15 million cost of Feraheme product sales; and $62 to $68 million in research and development expenses, including $42 to $48 million in external costs related to clinical trials, the majority of which is related to the company’s global IDA registrational program;
“Although faced with several challenges over the past year, we exited 2010 with a strong cash position, a strengthened commercial effort focused on the non-dialysis CKD market segment and a global registrational program underway for a broad iron deficiency anemia indication,” commented Brian J.G. Pereira, MD, president and CEO of AMAG Pharmaceuticals, Inc. “During 2011, we will continue to work to obtain marketing approvals in Canada, Switzerland and Europe with our partner, Takeda Pharmaceutical Company, in an effort to bring Feraheme to market in additional geographies outside of the U.S.”
