AMAG Pharmaceuticals reports Feraheme net product revenues of $13.1M for first-quarter 2010

AMAG Pharmaceuticals, Inc.Apr 28 2010

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 first quarter ended March 31, 2010.

“Today, we are well positioned to continue the successful commercialization of Feraheme within the CKD indication, advance our efforts to expand the Feraheme label to a broader iron deficiency anemia indication, and extend the global reach of Feraheme through our strategic alliance with Takeda.”

Business Highlights

• In January 2010, AMAG successfully completed a follow-on offering of 3.6 million shares of common stock, with net proceeds to the Company of approximately $165.6 million.
• On March 31, 2010, AMAG entered into a strategic collaboration with Takeda Pharmaceutical Company for Feraheme® (ferumoxytol) Injection for intravenous use in all therapeutic indications in select ex-US territories, including Europe. AMAG received a $60 million upfront payment and is eligible to receive up to $220 million in development and commercial milestones. Additionally, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories.
• During the first quarter, AMAG initiated enrollment in a clinical trial, the ferumoxytol compared to iron sucrose trial (FIRST), in 150 patients with chronic kidney disease and iron deficiency anemia to support the European regulatory filing for Feraheme.

Feraheme Launch Highlights

• AMAG reported first quarter 2010 Feraheme net product revenues of $13.1 million, including $2.2 million of previously deferred product revenues.
• For the first three months 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 57% as compared to the last three months of 2009, with growth achieved in both the dialysis and non-dialysis segments. Feraheme inventory levels at wholesalers and distributors on a grams basis were essentially unchanged from December 31, 2009 to March 31, 2010.
• AMAG estimates approximately 60% of Feraheme provider demand in the first three months of 2010 was outside of the dialysis setting, with hospitals and hematology clinics representing the majority of this demand.
• Through the first three months of 2010, approximately 1,700 providers have purchased Feraheme, with greater than 67% having purchased on a repeat basis.
• In the first quarter of 2010, more than 585 providers purchased Feraheme for the first time; 75% of these new buyers were hematology clinics and hospitals.

"In the first few months of 2010, we have made great progress towards achieving our corporate objectives for the year," said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "Today, we are well positioned to continue the successful commercialization of Feraheme within the CKD indication, advance our efforts to expand the Feraheme label to a broader iron deficiency anemia indication, and extend the global reach of Feraheme through our strategic alliance with Takeda."

As of March 31, 2010, the Company's cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $283.0 million. In addition, AMAG received the $60 million upfront payment from Takeda in April 2010, which is therefore not included in the Company's cash balance as of March 31, 2010.

Revenues for the quarter ended March 31, 2010 were $13.3 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 quarter ended March 31, 2010 were $36.8 million as compared to $28.9 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 $23.1 million, or a loss of $1.15 per basic and diluted share, for the quarter ended March 31, 2010, as compared to a net loss of $26.4 million, or a loss of $1.55 per basic and diluted share, for the same period in 2009.