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AMAG. at/close. AMAG Pharmaceuticals Announces First Quarter 2012 Financial Results
http://finance.yahoo.com/news/amag-pharmaceuticals-announces-first-quarter-200500425.html

LEXINGTON, Mass.--(BUSINESS WIRE)--

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG - News), 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 first quarter ended March 31, 2012. As of March 31, 2012, the company’s cash, cash equivalents and investments totaled approximately $218 million.

Business Update

Total revenues for the quarter ended March 31, 2012 were $15.5 million, of which $13.6 million were net product revenues from Feraheme.
Total Feraheme provider demand for the first quarter of 2012 was approximately 26,600 grams1, representing a 30% increase in provider demand as compared to the first quarter of 2011 and a 10% increase as compared to the fourth quarter of 2011.
Positive data from IDA-302, a phase III clinical trial evaluating Feraheme compared to IV iron sucrose in patients with IDA regardless of the underlying cause, was released in March. Feraheme achieved both primary efficacy endpoints in this study.
Enrollment completed in IDA-301, a phase III clinical trial evaluating Feraheme against placebo in patients with IDA regardless of the underlying cause. Data from IDA-301 and IDA-302 will be the basis for the supplemental new drug application (sNDA) to the U.S. Food and Drug Administration to expand the label for Feraheme to include this broader patient population.
In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the approval of ferumoxytol for the treatment of IDA in adult patients with CKD. EU Commission approval and launch are expected in the second half of 2012, and would trigger $30 million in milestone payments to AMAG. Ferumoxytol will be marketed in Europe as Rienso® by AMAG’s partner, Takeda Pharmaceutical Company Limited.
“The record provider demand for Feraheme in the first quarter is a testament to the progress that we are making in driving organic growth of the brand,” said Frank Thomas, interim president and chief executive officer of AMAG. “We believe that the commercial initiatives that we continue to implement in the U.S. this year and the growth potential of Feraheme through geographic expansion will position us for success in 2012 and beyond. Our decision late last year to realign our expense structure has resulted in a 22% decline in operating expenses as compared to the first quarter of 2011, and, we believe, sets us on a course to profitability.”

First Quarter 2012 Financial Results (unaudited)

Total revenues for the quarter ended March 31, 2012 were $15.5 million as compared to $13.4 million for the same period in 2011. Net Feraheme product revenues for the first quarter of 2012 were $13.6 million, as compared to $10.9 million in the first quarter of 2011.

Total operating costs and expenses, including costs of goods sold, for the quarter ended March 31, 2012 were $28.3 million as compared to $36.2 million for the same period in 2011. The decrease in operating costs and expenses in the first quarter of 2012 versus the first quarter of 2011 was primarily due to the cost reduction efforts implemented by the company associated with the restructuring announced in the fourth quarter of 2011.

The company reported a net loss of $12.4 million, or a loss of $0.58 per share, for the quarter ended March 31, 2012, as compared to a net loss of $22.3 million, or a loss of $1.05 per share, for the same period in 2011.

2012 Financial Guidance

The company reiterates its financial guidance to manage the business to achieve cash flow breakeven in 2012 based on the following guidance:

Net Feraheme product revenues of $53 – $57 million, excluding any royalties from sales outside the U.S.;
Milestones received totaling $33 million associated with potential regulatory approvals and commercial launches in the EU and Canada;
Cost of goods sold (COGS) of approximately 14% – 18% of total product sales;
Total operating expenses, excluding COGS, of $90 – $95 million, of which $40 – $45 million are expected to be research and development expenses and $50 – $55 million are expected to be selling, general and administrative expenses; and
A 2012 year-end cash and investments balance of $225 – $230 million.
Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides at 4:30 p.m. ET during which management will discuss the company’s financial results, commercial progress and development programs.

To access the conference call via telephone, please dial [phone] from the United States or [phone] for international access. A telephone replay will be available from approximately 7:30 p.m. ET on May 1, 2012 through midnight May 8, 2012. To access a replay of the conference call, dial [phone] from the United States or [phone] for international access. The pass code for the live call and the replay is 73223897.

The call will be webcast with slides and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately 7:30 p.m. ET on May 1, 2012 through midnight June 1, 2012.