AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc.Feb 25 2011

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

“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.”

Business Update

• Total revenues for the year ended December 31, 2010 were $66.2 million, of which $59.3 million were net product revenues from Feraheme® (ferumoxytol) Injection for intravenous (IV) use. For the fourth quarter, total revenues were $17.2 million, of which $15.2 million were Feraheme net product revenues.
• Total Feraheme provider demand and launch incentive program utilization for the full year 2010 was approximately 114,000 grams, of which approximately 58% 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% 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, 2011 implementation of the new Medicare prospective payment system for end-stage renal disease patients, also known as the "bundle."
• In November, AMAG reached agreement with the U.S. Food and Drug Administration regarding an update to the product label for Feraheme.
• In February, the U.S. Department of Justice informed AMAG that it had closed its investigation of the Company, that no further investigation is warranted, and that AMAG need not respond further to the Civil Investigative Demand initially served on the Company in November 2010.

"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 Chief Executive Officer 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."

Fourth Quarter and 2010 Financial Results (unaudited)

As of December 31, 2010, the Company's cash, cash equivalents and investments totaled approximately $294 million.

Total revenues for the quarter ended December 31, 2010 were $17.2 million as compared to $13.1 million for the same period in 2009. Total revenues for the year ended December 31, 2010 were $66.2 million as compared to $17.2 million for the same period in 2009. The increases in revenues in 2010 over the comparable 2009 periods were primarily attributable to 2010 being the first full year during which the Company marketed and sold Feraheme following its approval and subsequent launch in July 2009.

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.

The Company reported a net loss of $19.8 million, or a loss of $0.94 per basic and diluted share, for the quarter ended December 31, 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 the year ended December 31, 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.

2011 Financial Guidance

As previously announced, AMAG expects to realize the following in 2011:

• $55 to $60 million of Feraheme net product revenues;
• $12 to $15 million cost of Feraheme product sales;
• $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;
• $72 to $78 million in selling, general and administrative expenses; and
• $215 to $220 million in cash, cash equivalents and investments at the end of 2011. The year-end 2011 cash guidance does not include $33 million in potential milestones associated with the approval and launch of Feraheme for CKD patients with IDA in the EU and Canada, which AMAG could receive in 2011.

2011 Goals

AMAG expects to achieve the following in 2011:

• Grow Feraheme market share and increase provider demand in non-dialysis sites of care for U.S. CKD patients;
• Complete enrollment in the Company's global registrational program for iron deficiency anemia by the end of 2011;
• Receive a decision by the end of 2011 on the Company's marketing authorization application in the EU; and
• Respond to the Notice of Non-compliance from Health Canada regarding the Company's regulatory application in Canada for CKD patients.