AMAG Pharmaceuticals Provides Business Update

AMAG Pharmaceuticals, Inc. AMAG +5.11% today announced a business update, including preliminary fourth quarter 2011 financial results and its outlook for 2012. The company will present further details at the 30th Annual J.P. Morgan Healthcare Conference in San Francisco on January 11, 2012 at 3:00 p.m. Pacific time.Fourth Quarter 2011 Business Highlights and Estimated Financial Results (unaudited)-- Over the course of 2011, the company successfully completed the transition of Feraheme(R) provider demand from both dialysis and non-dialysis sites of care to entirely non-dialysis sites of care. Feraheme non-dialysis provider demand for the fourth quarter of 2011 was approximately 24,250 grams(1), consistent with the third quarter of 2011, but 20% percent higher than the fourth quarter of 2010. Of particular note is Feraheme's growth in the hematology/oncology market segment, which increased approximately 65% in 2011 over 2010.-- AMAG expects to report fourth quarter 2011 total revenues of between $14.3 and $15.0 million, including between $12.4 and $13.1 million in net Feraheme product revenues. Total operating costs and expenses are expected to be between $38 and $43 million, including certain restructuring costs and a $2 million termination fee paid to Allos Therapeutics.-- AMAG implemented a restructuring plan on November 4, 2011 to align its operating expenses with projected Feraheme revenues. The restructuring plan included a reduction in force of approximately 25 percent and was designed to position the company to achieve cash flow breakeven in 2012 without impacting growth of Feraheme sales. The company's field sales team was realigned to a more strategically targeted account list and the number of territories was reduced from 72 to approximately 55 during the fourth quarter. The restructuring also included changes to the executive leadership team at AMAG, including the company's chief executive officer and chief commercial officer.-- AMAG hired Jefferies & Company, Inc. as a strategic advisor. Jefferies is assisting the company in identifying and evaluating various strategies to enhance stockholder value and leverage AMAG's core assets -- Feraheme, AMAG's commercial and drug development infrastructure, and the company's balance sheet, which had more than $225 million in cash and investments, and no debt, as of December 31, 2011."AMAG is committed to pursuing all avenues to maximize value for our shareholders, including the potential sale of the company," said Frank Thomas, chief operating officer and interim chief executive officer of AMAG. "While we intend to complete our evaluation of the viability of a sale of the company expeditiously and are pleased with our current progress, we remain focused on establishing a solid foundation from which to drive future growth and stockholder value if the company is not sold."Thomas continued, "Commercially, we have set out three key imperatives for 2012 -- to drive increased provider demand over the comparable 2011 periods, to optimize the pricing strategy for Feraheme ahead of the potential launch of the broad iron deficiency anemia label, and to strengthen our commercial leadership team. Already this year, we are making progress on these initiatives and are fortunate to have attracted a commercial industry veteran to join our ranks -- John Tucker started with AMAG last week as our new vice president of commercial operations. I believe that the addition of John to our management team will bring a fresh commercial perspective and the drive that we need to continue to grow the Feraheme brand."Mr. Tucker brings a strong set of experiences to AMAG, including as president of U.S. commercial operations at Basilea Pharmaceuticals, EVP of sales & marketing at Indevus Pharmaceuticals, senior director of government and institutional sales of Alza, and various senior commercial roles at both biotech and large pharmaceuticals companies. Mr. Tucker brings valuable hospital experience to AMAG, including the development and leadership of the Alza hospital sales team and creation of the U.S. launch plan for Basilea's hospital anti-infective portfolio.Global and Indication ExpansionDuring 2012, AMAG will continue to work with its partner, Takeda Pharmaceutical Company Ltd., in an effort to obtain approval of Feraheme for the treatment of iron deficiency anemia (IDA) in CKD patients in additional territories.-- A Marketing Authorization Application for Feraheme for the treatment of IDA in patients with CKD is under review by the European Medicines Agency. AMAG recently requested, and was granted, a 60-day extension to the filing timeline in order to fully respond to the final set of questions from the Agency to support the optimal label in the E.U. AMAG currently expects a decision from the Committee for Medicinal Products for Human Use (CHMP) in the first half of 2012.-- In Canada, the regulatory application for Feraheme for the treatment of IDA in CKD patients was approved in December 2011, and Feraheme is expected to be launched in Canada in 2012.-- Feraheme commercial launch in Canada and approval and commercial launch in Europe would trigger $33 million in milestone payments from Takeda.AMAG is seeking to expand the U.S. label for Feraheme to all adult patients with iron deficiency anemia regardless of the underlying cause through a 1,400 patient global registrational program. The broad IDA program, which is more than 98 percent enrolled, consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The company plans to complete enrollment in this program this month and submit an sNDA to the U.S. Food and Drug Administration in the second half of 2012.