- 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.
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.
Feraheme ® (ferumoxytol) Injection for Intravenous (IV) is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Serious adverse reactions of clinically significant hypotension have been reported. In the post-marketing setting, life-threatening anaphylactic type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness and other safety events have been reported in patients being treated with Feraheme. In clinical trials, the most commonly occurring adverse reactions for Feraheme-treated patients were nausea, dizziness, hypotension, peripheral edema, headache, edema and vomiting. A full list of adverse events can be found in the full prescribing information for Feraheme. For full prescribing information, please visit www.feraheme.com. Forward-looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, our presentation at the 31 st Annual J.P. Morgan Healthcare Conference; the market for Feraheme and our future profitability; our estimates of fourth quarter 2012 total revenues, Feraheme net product revenues, operating expenses and cost of goods sold; our efforts and expectations regarding our supplemental new drug application for Feraheme; revenue growth and plans for strategic investments, including the addition of commercial products to our portfolio; our expectations regarding Feraheme provider demand trends and the effective price per gram for Feraheme; our expected 2013 Feraheme product revenue; our expected 2013 operating expenses and cost of goods sold; our expected 2013 year-end cash and investments balance; potential Feraheme milestone or royalty payments; and our plans to expand the reach of Feraheme to new indications and geographic territories are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: (1) uncertainties regarding our and Takeda's ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (3) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, (4) uncertainties regarding the manufacture of Feraheme/Rienso, (5) uncertainties relating to our patents and proprietary rights, both in the US and outside of the US, (6) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s recently published draft bioequivalence recommendation for ferumoxytol, and (7) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda Pharmaceutical Company Limited. 1 U.S. Census; U.S. Renal Data System , USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES 1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 57–61. 2 Barton, James et al. Intravenous iron dextran therapy in patients with iron deficiency and normal renal function who failed to respond to or did not tolerate oral iron supplementation. Am J Medicine. 2000; 109: 27-32.