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AMAG Pharmaceuticals Provides Business Update Announces Preliminary 2012 Financial Results And 2013 Financial Guidance

Stock quotes in this article: AMAG 

The company expects to achieve the following in 2013:

  • Total revenues of between $73 million and $77 million, including:
    • Feraheme U.S. net product revenues of between $63 million and $67 million, driven by a combination of price and double-digit volume growth;
    • Royalties and product sales related to ex-U.S. sales of Feraheme/Rienso and recognition of milestones of approximately $10 million;
  • Cost of goods sold (COGS) of between 14% and 18% of net product sales;
  • Total operating expenses, excluding COGS, of between $78 million and $82 million, representing an approximate 10% reduction from 2012. The reduced operating expenses in 2013 will be driven by decreased clinical trial costs, offset in part by new investments in a lower-cost production process and pre-launch investments to support a potential expansion to Feraheme’s label. The company expects:
    • Research and development expenses of between $24 million and $27 million, representing an approximate 27% reduction from 2012;
    • Selling, general and administrative expenses of between $54 million and $57 million, representing an approximate 2% increase from 2012; and
  • A 2013 year-end cash and investments balance of between $206 million and $211 million, not including the impact of business development transactions.

“AMAG is a different company than it was just 12 months ago – I believe that we are now in a stronger position, both commercially and financially. Feraheme is a on a solid growth trajectory and we are now ready to add additional commercial products to our portfolio to leverage these strengths,” concluded Heiden.

Webcast Information

A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 31 st Annual J.P. Morgan Healthcare Conference will be accessible through the Investors section of the company’s website at www.amagpharma.com on January 9, 2013 at 8:30 a.m. P.T. (11:30 a.m. E.T.). Following the conference, the webcast will be archived on the AMAG Pharmaceuticals, Inc. website until February 9, 2013.

About Iron Deficiency Anemia

More than 4 million Americans have IDA; 1.6 million of whom are estimated to have CKD, while the other 2.4 million suffer from anemia due to other causes. 1 For these patients with anemia due to other causes, the underlying diseases or issues causing IDA include abnormal uterine bleeding, gastrointestinal disorders, inflammatory diseases and chemotherapy-induced anemia. Many IDA patients fail treatment with oral iron due to intolerability or side effects. 2

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® (ferumoxytol) Injection for Intravenous (IV) use in the United States. Along with driving organic growth of its lead product, AMAG intends to expand its portfolio with additional commercial-stage specialty pharmaceuticals. The company is seeking complementary products that leverage the company’s commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.

About Feraheme® (ferumoxytol)/Rienso

In the United States, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com.

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