AMAG Pharmaceuticals, Inc. (AMAG), a in vitro diagnostics company, has reported revenues of $1.9 million for the full year of 2008, compared with the revenues of $2.6 million in the previous year-end. It has posted a net loss of $71.6 million, or $4.22 loss per share, for the full year of 2008, compared with the net loss of $33.9 million, or $2.15 loss per share, in the previous year-end.
For the year ended December 31, 2008, the company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $215.0 million. Revenues for the quarter ended December 31, 2008 were $0.6 million as against revenues of $0.4 million for the same period in 2007.
Total operating costs and expenses for the quarter ended December 31, 2008 were $23.8 million as against $13.9 million for the same period in 2007, an increase of $9.9 million. The increase in operating costs and expenses was primarily due to increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme(TM) (ferumoxytol injection). Total operating costs and expenses for the twelve months ended December 31, 2008 were $81.5 million as against $45.0 million for the same period in 2007, an increase of $36.5 million. The increase in operating costs and expenses was primarily due to increased research and development expenses to expand the company’s clinical development infrastructure and scale up the company’s manufacturing capabilities, and increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme.
The company reported a net loss of $21.8 million, or $1.28 per basic and diluted share, for the quarter ended December 31, 2008, as against a net loss of $9.7 million, or $0.57 per basic and diluted share, for the same period in 2007.
“2008 was a successful year for AMAG and we made great progress in our transition to a commercial biopharmaceutical company. During the past year, we advanced the Feraheme regulatory process, completed the scale up of our commercial organization and expanded the company’s infrastructure in support of our anticipated launch of Feraheme,” commented Brian J.G. Pereira, president and chief executive officer of AMAG “We continue to work with the U.S. Food and Drug Administration (FDA) to address the outstanding regulatory issues as quickly as possible and look forward to launching Feraheme in the U.S. shortly after receiving marketing approval,” concluded Pereira.
Recent corporate highlights and accomplishments
Published positive clinical results from one of the company’s phase III safety and efficacy studies in the February edition of the Clinical Journal of the American Society of Nephrology (CJASN). The study enrolled 230 hemodialysis patients with iron deficiency anemia. Three Feraheme studies have been published this past year in peer reviewed medical journals.
Appointed Robert J. Perez to our board of directors. Perez is currently the executive vice president and chief operating officer at Cubist Pharmaceuticals, Inc.
Received a second Complete Response Letter for Feraheme prior to its December 30, 2008 action date set by the FDA. The company continues to work with the FDA to resolve any outstanding regulatory issues.
Presented eight posters at the American Society of Nephrology Meeting held November 4-9, 2008 in Philadelphia, PA, adding to the body of scientific data on Feraheme.