AMAG Pharmaceuticals, Inc. Reports Financial Results for the Quarter Ended September 30, 2008.LEXINGTON, Mass. -- AMAG AMAG African Microbicides Advocacy Group AMAG Agricultural Machinery Advisory Group Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMAG), a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , today reported unaudited consolidated financial results for the quarter and nine months ended September 30, 2008. As of September 30, 2008, the Company's cash, cash equivalents and investments totaled $241.1 million. Revenues for the quarter ended September 30, 2008 were $0.3 million as compared to revenues of $0.5 million for the same period in 2007. Revenues for the nine month period ended September 30, 2008 were $1.4 million as compared to $2.2 million for the same period in 2007. Total operating costs operating costs npl → gastos mpl operacionales and expenses for the quarter ended September 30, 2008 were $24.8 million as compared to $11.7 million for the same period in 2007, an increase of $13.1 million. Total operating costs and expenses for the nine month period ended September 30, 2008 were $57.8 million as compared to $31.0 million for the same period in 2007. The increase in operating costs and expenses for both the quarter and the nine month period ended September 30, 2008 was primarily due to increased research and development expenses to expand the Company's clinical development infrastructure and scale up the Company's manufacturing capabilities, and increased selling, general and administrative expenses to prepare for the planned commercialization of ferumoxytol. The Company reported a net loss of $23.6 million, or $1.39 per basic and diluted share, for the quarter ended September 30, 2008, as compared to a net loss of $7.0 million, or $0.42 per basic and diluted share, for the same period in 2007. Net loss for the nine months ended September 30, 2008 was $49.9 million, or $2.94 per basic and diluted share, as compared to a net loss of $24.2 million, or $1.57 per basic and diluted share for the same period in 2007. "We are working with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to address the Complete Response letter to our New Drug Application for ferumoxytol to treat iron deficiency anemia Iron Deficiency Anemia Definition Anemia can be caused by iron deficiency, folate deficiency, vitamin B12 deficiency, and other causes. The term iron deficiency anemia means anemia that is due to iron deficiency. in chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is patients. Concurrently, we are continuing our preparations for the planned U.S. commercial launch of ferumoxytol in the first quarter of 2009," commented Brian J.G. Pereira Brian J.G. Pereira is a nationally-recognized expert on kidney disease and nephrology. He is currently a Professor of Medicine at Tufts University School of Medicine and at the Sackler School of Biomedical Sciences of Tufts University. , President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "During the last quarter we made great progress in our transition to a commercial biopharmaceutical company. We are committed to bringing ferumoxytol to market," concluded Dr. Pereira. Recent Corporate Highlights and Accomplishments * Received a Complete Response letter from the FDA to the Company's New Drug Application for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients, whether or not on dialysis. Three issues were raised in the FDA's response letter, which included a request for certain clinical information, observations made during a Good Clinical Practices (GCP GCP Good Clinical Practice GCP Ground Control Point GCP Global Carbon Project GCP Gateway Control Protocol GCP Global Consciousness Project GCP Granulocyte Chemotactic Protein GCP Grand Central Parkway (New York) ) inspection at one of the Company's Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical sites, and observations noted during the pre-approval inspection of the Company's manufacturing facility. The Company is working with the FDA to address the Complete Response letter and believes that it will not need to conduct any additional clinical trials prior to approval. * Initiated a Phase II study of ferumoxytol for vascular-enhanced magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (VE-MRI) in patients with peripheral arterial disease (PAD). The study will enroll approximately 100 patients with PAD, who will be randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. into one of three dose cohorts. Participants will undergo serial imaging with non-contrast magnetic resonance angiography Magnetic resonance angiography A noninvasive diagnostic technique that uses radio waves to map the internal anatomy of the blood vessels. Mentioned in: Cerebral Aneurysm magnetic resonance angiography , ferumoxytol VE-MRI, and digital subtraction angiography digital sub·trac·tion angiography n. A computer-assisted x-ray technique that subtracts images of bone and soft tissue to permit viewing of the cardiovascular system. . In August 2008, the FDA granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for VE-MRI to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease. * Completed hiring of nearly the entire ferumoxytol sales force, medical science liaison A medical science liaison (abbreviated as MSL) is a healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, and managed care companies. group and account management team. The planned sales force will include approximately 80 renal sales specialists and managers who will target over 5,000 nephrologists and hematologists in the U.S. Conference Call and Webcast Access AMAG Pharmaceuticals, Inc. will host a webcast and conference call today at 4:30 p.m. ET to discuss the Company's financial results, business highlights and its development programs. To access the conference call via telephone, please dial (877) 412-6083 from the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. or (706) 902-1303 for international access. A telephone replay will be available from approximately 5:30 p.m. ET on November 3, 2008 through midnight November 6, 2008. To access a replay of the conference call, dial (800) 642-1687 from the United States or (706) 645-9291 for international access. The passcode for the live call and the replay is 70792779. An audio webcast of the call will be available through the Investors section of the Company's website at www.amagpharma.com. The webcast replay will be available from approximately 7:30 p.m. ET on November 3, 2008 through midnight December 3, 2008. About AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. About Ferumoxytol Ferumoxytol is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. In December 2007, the Company submitted a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the FDA for marketing approval of ferumoxytol as an intravenous iron replacement therapy in chronic kidney disease patients. In October 2008, the Company received a Complete Response letter from the FDA with respect to its NDA requesting certain additional information prior to the approval of ferumoxytol for marketing and sale in the U.S. Forward Looking Statements This document contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and other federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to statements regarding the Company's belief that it will not have to conduct any additional clinical trials prior to approval of ferumoxytol, any statements regarding the Company's continued preparations for the planned commercial launch of ferumoxytol in the first quarter of 2009, statements regarding the size and design of our planned Phase II ferumoxytol imaging study, and statements regarding the anticipated size of our ferumoxytol sales force, are forward-looking statements that 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 the following: (1) the possibility that we may not be able to adequately address the issues raised and provide the information requested by the FDA in the ferumoxytol Complete Response letter and obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or the possibility that we may not be able to address such issues, provide such information, or obtain such approvals in a timely manner; (2) the fact that we have limited sales and marketing expertise; (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement therapy and imaging markets; (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. for ferumoxytol, if approved; (5) uncertainties regarding our ability to manufacture ferumoxytol; (6) uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc our patents and proprietary rights; and (7) other risks identified in our Securities and Exchange Commission filings. We caution readers 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. [TABLE OMITTED] |
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