AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company focused on the development and commercialization of Feraheme® (ferumoxytol) Injection for intravenous (IV) use to treat iron deficiency anemia (IDA), today reported unaudited consolidated financial results for the third quarter ended September 30, 2012. The company ended the third quarter of 2012 with approximately $211 million of cash, cash equivalents and investments.
- Total revenues for the third quarter of 2012 were $17.7 million, which included $16.2 of net U.S. Feraheme product revenues. As a result of actions taken earlier this year to improve the pricing dynamics for Feraheme, net revenue realized per gram of Feraheme increased in the third quarter of 2012 compared to the second quarter of 2012, reversing a historically downward trend.
- Feraheme provider demand 1 for the third quarter of 2012 was approximately 27,500 grams, an 11% increase over the third quarter of 2011, with growth continuing to outpace IV iron market growth. Feraheme gained share in the hematology and hospital segments, with demand in these segments growing at 8% and 34%, respectively, compared to the third quarter of 2011.
- The company reported positive data from the second phase III clinical trials of Feraheme for the treatment of iron deficiency anemia regardless of the underlying cause and plans to submit a supplemental new drug application to the U.S. Food and Drug Administration in the fourth quarter of 2012.
- International expansion efforts for ferumoxytol are progressing as planned. The first shipment of ferumoxytol to support European launch of Rienso®, the brand name of ferumoxytol in Europe, occurred in the third quarter. Revenue from these sales has been deferred until the product has been sold to customers of Takeda Pharmaceuticals Company, Ltd., AMAG’s partner in the EU and Canada. Additionally, Feraheme was launched in Canada early in the fourth quarter, for which AMAG has received a $3 million milestone payment, and today, Rienso was launched in Europe. The first commercial sale of Rienso in Europe, which is expected shortly, triggers a $15 million milestone payment from Takeda.
“We are pleased to report the results of our strong third quarter performance. Our updated full-year 2012 financial guidance is a direct result of our renewed focus on Feraheme sales growth and aggressive operating expense management,” commented William Heiden, president and chief executive officer of AMAG. “While I am pleased with the growth achieved in our U.S. Feraheme business this year, I believe that we can do even better. Feraheme represents a tremendous opportunity for AMAG and I want to ensure that we unlock its full potential -- by maximizing the number of adult IDA patients with chronic kidney disease who benefit from Feraheme today, and broadening that to all IDA patients next year, should we gain regulatory approval of an expanded label.”