- AMAG expects to report 2012 full year financial results in line with previous guidance, which was positively updated over the course of the year. The company ended 2012 with approximately $227 million in cash and investments.
- For the fourth quarter of 2012, AMAG expects total revenues of between $21.1 million and $21.5 million, including between $14.4 million and $14.8 million of net U.S. Feraheme product revenues. The approximate 14% growth in U.S. net product revenues, compared to the fourth quarter of 2011, was driven by increased volume and an improving net effective price per gram for Feraheme.
- Total operating expenses, excluding cost of goods sold, for the fourth quarter of 2012 are expected to be between $21.0 million and $22.5 million, approximately 31% lower than the fourth quarter of 2011.
- AMAG sold approximately 110,000 grams of Feraheme in the U.S. in 2012, representing record demand and more than 17% volume growth over 2011.
- During the fourth quarter of 2012, AMAG’s partner, Takeda Pharmaceutical Company Limited, launched ferumoxytol in Canada, under the brand name Feraheme, and in several European countries as Rienso® (ferumoxytol). During 2012, AMAG received $33 million in milestone payments related to ex-U.S. approvals and launches, $18 million of which it received in the fourth quarter. Additionally, during the fourth quarter of 2012, AMAG realized its first revenues from royalties and product sales in these regions.
- AMAG submitted a supplemental new drug application (sNDA) for Feraheme to the U.S. Food and Drug Administration (FDA) in December 2012. The company is seeking to expand the label for Feraheme to include all patients with iron deficiency anemia, regardless of the underlying cause, who have failed or could not tolerate oral iron. The company believes that regulatory approval from the FDA for this broader patient population would double the market opportunity in the U.S. for Feraheme.
AMAG Pharmaceuticals Provides Business Update Announces Preliminary 2012 Financial Results And 2013 Financial Guidance
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