AMAG Pharmaceuticals Provides Business Update
~ Submits sNDA for expanded indication for Feraheme® (ferumoxytol) ~
~ Achieves 14% growth in fourth quarter 2012 U.S. Feraheme product revenues, compared to fourth quarter of 2011 ~
~ Ends 2012 with approximately $227 million in cash and investments ~
JPMorgan Healthcare Conference 2013
LEXINGTON, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced a business update, including preliminary fourth quarter 2012 financial results and its outlook for 2013. The company will present further details at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9, 2013 at 8:30 a.m. Pacific time.
“AMAG turned a corner in 2012, achieving all of our commercial and development milestones for the year, which together have placed Feraheme on a path to realize its full potential, both in the U.S. and abroad,” stated William Heiden, president and chief executive officer of AMAG. “Additionally, we believe, that the more efficient cost structure that we established in 2012, coupled with continued top-line growth, will help drive our company to profitability.”
Business Highlights and Estimated 2012 Financial Results (unaudited)
- AMAG expects to report 2012 full year financial results in line with previous guidance, which was positively updated over the course of the year. The company ended 2012 with approximately $227 million in cash and investments.
-- For the fourth quarter of 2012, AMAG expects total revenues of between $21.1 million and $21.5 million, including between $14.4 million and $14.8 million of net U.S. Feraheme product revenues. The approximate 14% growth in U.S. net product revenues, compared to the fourth quarter of 2011, was driven by increased volume and an improving net effective price per gram for Feraheme.
-- Total operating expenses, excluding cost of goods sold, for the fourth quarter of 2012 are expected to be between $21.0 million and $22.5 million, approximately 31% lower than the fourth quarter of 2011.
- AMAG sold approximately 110,000 grams of Feraheme in the U.S. in 2012, representing record demand and more than 17% volume growth over 2011.
- During the fourth quarter of 2012, AMAG’s partner, Takeda Pharmaceutical Company Limited, launched ferumoxytol in Canada, under the brand name Feraheme, and in several European countries as Rienso® (ferumoxytol). During 2012, AMAG received $33 million in milestone payments related to ex-U.S. approvals and launches, $18 million of which it received in the fourth quarter. Additionally, during the fourth quarter of 2012, AMAG realized its first revenues from royalties and product sales in these regions.
- AMAG submitted a supplemental new drug application (sNDA) for Feraheme to the U.S. Food and Drug Administration (FDA) in December 2012. The company is seeking to expand the label for Feraheme to include all patients with iron deficiency anemia, regardless of the underlying cause, who have failed or could not tolerate oral iron. The company believes that regulatory approval from the FDA for this broader patient population would double the market opportunity in the U.S. for Feraheme.
2013 Financial Outlook
“As we look to 2013, we plan to deliver accelerating revenue growth, driven by both greater volume and increasing net revenue realized per gram of Feraheme sold,” Heiden stated. “While we will continue to operate as efficiently as possible, we do plan to make strategic investments over the course of 2013 to maximize the commercial potential of Feraheme and to ensure that we are positioned for success in the broader IV iron market, in anticipation of potential regulatory approval for the expanded IDA indication late in the year.”
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.
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