AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2012. Total revenues for 2012 were 39% greater than 2011, driven by the recognition of milestone payments received from Takeda Pharmaceutical Company Limited, the company’s ex-US commercial partner, and increased Feraheme® (ferumoxytol) sales. As of December 31, 2012, the company’s cash, cash equivalents and investments totaled approximately $227 million.
- The company reported an increase in U.S. Feraheme net product sales, driven by increased utilization of Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients. Total Feraheme provider demand for 2012 was approximately 110,000 grams, representing a 17% increase in provider demand over 2011. Feraheme provider demand for the fourth quarter of 2012 was approximately 27,500 grams, approximately 14% higher than the fourth quarter of 2011. 1
- The company made significant progress expanding the geographic reach of ferumoxytol, with approvals for use in adult IDA patients with CKD in the European Union (EU), Canada and Switzerland. Takeda has commercial rights to ferumoxytol in these regions, where they launched commercially in the fourth quarter of 2012. In the EU and Switzerland, Takeda launched under the trade name Rienso®; in Canada, Takeda launched under the trade name Feraheme. During 2012, AMAG received $33 million in milestone payments from Takeda related to the approvals and launches of Feraheme/Rienso in Europe and Canada.
- AMAG also made meaningful progress in its efforts to expand the label for Feraheme. The company completed a 1,400 patient, phase III registration program for ferumoxytol in adult IDA patients, regardless of the underlying cause of their anemia. The program was comprised of two phase III trials, both of which achieved their respective primary and secondary endpoints (with high statistical significance). AMAG submitted a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in December 2012 seeking to expand the indication for Feraheme beyond the current CKD indication to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy.
Fourth Quarter and Full Year 2012 Financial Results (unaudited)
Total revenues for the quarter ended December 31, 2012 were $21.1 million, as compared to $14.9 million for the same period in 2011. Total revenues for the year ended December 31, 2012 were $85.4 million as compared to $61.2 million for the year ended December 31, 2011. The increase in total revenues in 2012 was due to increases in both product sales and milestone payments recognized in 2012. Net U.S. Feraheme product sales for the quarter ended December 31, 2012 were $14.4 million, as compared to $12.8 million of net U.S. Feraheme product sales for the same period in 2011. Net U.S. Feraheme product sales for the year ended December 31, 2012 were $58.3 million, as compared to $52.1 million for 2011.