Record Provider Demand Drives 29% Increase in U.S. Net Feraheme Revenues Company Updates Financial Guidance; Increases Revenue Projections for 2013 Conference call scheduled for 8:00 a.m. EDT today LEXINGTON, Mass., Aug. 1, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the quarter and six months ended June 30, 2013. Total revenues for the second quarter of 2013 were $19.6 million, of which $17.5 million were U.S. Feraheme® (ferumoxytol) sales, the highest Feraheme quarterly sales since launch. "We set ambitious goals for the year and based on our many successes in the first half of 2013, I am pleased to report that we are well on our way to meeting or exceeding those goals," said William Heiden, president and chief executive officer of AMAG. "So far in 2013, Feraheme's growth trajectory has accelerated, our business development efforts have begun to bear fruit, and we continue to operate our business with financial discipline. Additionally, we have been busy planning for the future – preparing for the potential expansion of Feraheme's labeled indication and announcing several new key executive hires, whose contributions will help AMAG deliver on our vision of building a profitable, high-growth multi-product company focused on improving patients' lives." Business Highlights
- The company reported record U.S. Feraheme net product sales of $17.5 million in the second quarter of 2013, compared to $13.5 million (excluding $0.6 million reduction of reserves for product returns) in the second quarter of 2012, representing a 29 percent increase. AMAG's focused commercial strategy is resulting in increased utilization of Feraheme for the treatment of iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients and an increase in net revenue per gram of Feraheme compared to the second quarter of 2012.
- Feraheme gained a full point of market share in the second quarter compared to the end of the first quarter of 2013, capturing 15 percent of the total volume of the U.S. non-dialysis IV iron market. Total Feraheme provider demand for the second quarter of 2013 hit a record level at approximately 33,500 grams, compared to approximately 28,200 grams in the second quarter of 2012. 1
- During the second quarter, Takeda Pharmaceutical Company Ltd., AMAG's commercial partner in the European Union (E.U.), submitted a regulatory filing with the European Medicines Agency for ferumoxytol, seeking to expand the indication for Rienso® (the brand name for ferumoxytol in the E.U.) beyond the current CKD indication to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy, with an anticipated action date in the first half of 2014.
- The company is preparing for the potential expansion of Feraheme's labeled indication. The company submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in December 2012 seeking to expand the label to include all adult patients with IDA who have failed or otherwise cannot take oral iron therapy; the FDA accepted the filing and, in accordance with the Prescription Drug User Fee Act (PDUFA) guidelines, is targeting October 21, 2013 as the PDUFA action date for the filing.
- In June, AMAG in-licensed the U.S. commercial rights to MuGard™, a marketed product for the management of oral mucositis, from Access Pharmaceuticals, Inc. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients developing the condition each year. The Company is currently in the process of transitioning MuGard promotion to AMAG's sales force.