AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2010. For the second quarter, AMAG reported total revenue of $18.8 million, including $16.0 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues.

“In the near term, we are focused on the successful commercialization of Feraheme in the CKD market and are pleased with the continued growth in Feraheme utilization”

Business Highlights

• In June 2010, AMAG submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the use of Feraheme for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. The MAA has been deemed valid by the EMA and is currently under review.
• During the second quarter, AMAG initiated enrollment in its global registrational program for Feraheme for the treatment of iron deficiency anemia, regardless of the underlying cause. The estimated 1,400-patient program consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The company plans to complete enrollment in this program by year end 2011.

Feraheme Launch Highlights

• AMAG reported second quarter 2010 Feraheme net product revenues of $16.0 million, including $2.4 million of revenues previously deferred under its Feraheme launch incentive program.
• For the second quarter of 2010, Feraheme provider demand, which reflects purchases of Feraheme by providers from wholesalers and distributors as reported by IMS Health, plus launch incentive program utilization, which is reported by Feraheme launch incentive customers to AMAG, increased 34% as compared to the first three months of 2010, with growth achieved in both the dialysis and non-dialysis segments.
• Feraheme inventory levels at wholesalers and distributors decreased from approximately 8,800 grams as of March 31, 2010 to approximately 8,200 grams as of June 30, 2010.
• AMAG estimates approximately 70% of Feraheme provider demand in the second quarter of 2010 was outside of the dialysis setting, with hospitals and hematology clinics representing the majority of this demand.
• From launch through the end of the second quarter of 2010, approximately 2,300 providers have purchased Feraheme, with greater than 73% having purchased on a repeat basis.
• In the second quarter of 2010, more than 620 providers purchased Feraheme for the first time; 68% of these new buyers were hematology clinics and hospitals.

"In the near term, we are focused on the successful commercialization of Feraheme in the CKD market and are pleased with the continued growth in Feraheme utilization," said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG. "Longer term, we plan to expand the reach of Feraheme, both geographically and to new patient populations. The filing of the MAA in Europe and the initiation of the global iron deficiency anemia registrational program are illustrative of the progress we are making on this front."

As of June 30, 2010, the company's cash, cash equivalents and investments totaled $328.0 million, which includes a $60 million upfront payment received in April 2010 in connection with a collaboration agreement between AMAG and Takeda Pharmaceutical Company Limited (Takeda).

Total revenues for the quarter ended June 30, 2010 were $18.8 million, as compared to revenues of $55,000 for the same period in 2009. Total revenues for the 2010 period consisted primarily of $16.0 million of Feraheme net product revenues, $1.5 million in collaboration revenues associated with the amortization of the upfront payment from Takeda and $1.0 million in collaboration revenues associated with reimbursement from Takeda, primarily related to costs associated with the MAA filing and certain other clinical and regulatory costs incurred by AMAG during the second quarter. The increase in revenues in 2010 over the comparable 2009 period was primarily attributable to Feraheme product sales following its U.S. Food and Drug Administration (FDA) approval and subsequent launch in July 2009.

Total operating costs and expenses for the quarter ended June 30, 2010 were $40.7 million, as compared to $27.4 million for the same period in 2009. The increase in operating costs and expenses in 2010 over the comparable 2009 period was primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme, and increased research and development expenses. The company reported a net loss of $21.3 million, or a loss of $1.01 per basic and diluted share, for the quarter ended June 30, 2010, as compared to a net loss of $26.5 million, or a loss of $1.55 per basic and diluted share, for the same period in 2009.

For the six months ended June 30, 2010, AMAG reported total revenues of $32.1 million, as compared to revenues of $1.0 million for the same period in 2009. The increase in revenues in 2010 over the comparable 2009 period was attributable to Feraheme product sales following its FDA approval and subsequent launch in July 2009. Total operating costs and expenses for the six months ended June 30, 2010 were $77.5 million, as compared to $56.3 million for the same period in 2009. The increase in operating costs and expenses in 2010 over the comparable 2009 period was primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme. The Company reported a net loss of $44.4 million, or a loss of $2.16 per basic and diluted share, for the six months ended June 30, 2010, as compared to a net loss of $52.9 million, or a loss of $3.10 per basic and diluted share, for the same period in 2009.