LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the first quarter ended March 31, 2010.
Feraheme Launch Highlights
“In the first few months of 2010, we have made great progress towards achieving our corporate objectives for the year,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “Today, we are well positioned to continue the successful commercialization of Feraheme within the CKD indication, advance our efforts to expand the Feraheme label to a broader iron deficiency anemia indication, and extend the global reach of Feraheme through our strategic alliance with Takeda.”
As of March 31, 2010, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $283.0 million. In addition, AMAG received the $60 million upfront payment from Takeda in April 2010, which is therefore not included in the Company’s cash balance as of March 31, 2010.
Revenues for the quarter ended March 31, 2010 were $13.3 million as compared to revenues of $1.0 million for the same period in 2009. The increase in revenues in 2010 over the comparable 2009 period was attributable to Feraheme product sales following its FDA approval and subsequent launch in July 2009.
Total operating costs and expenses for the quarter ended March 31, 2010 were $36.8 million as compared to $28.9 million for the same period in 2009. The increase in operating costs and expenses in 2010 over the comparable 2009 period was primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.
The Company reported a net loss of $23.1 million, or a loss of $1.15 per basic and diluted share, for the quarter ended March 31, 2010, as compared to a net loss of $26.4 million, or a loss of $1.55 per basic and diluted share, for the same period in 2009.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a webcast with slides and conference call today at 4:30 p.m. ET to discuss the company’s financial results, business highlights, commercial plans and development programs.
To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 6:30 p.m. ET on April 27, 2010 through midnight April 29, 2010. 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 70132254.
The call will be webcast with slides and accessible through the Investors section of the Company’s website at www.amagpharma.com. The webcast replay will be available from approximately 6:30 p.m. ET on April 27, 2010 through midnight May 27, 2010.
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 iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. On June 30, 2009, AMAG received approval from the U.S. Food and Drug Administration to market Feraheme® (ferumoxytol) Injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients. For additional company and product information, please visit www.amagpharma.com.
Forward Looking Statements
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, statements regarding our estimate of Feraheme provider demand in the first quarter of 2010 outside of the dialysis setting, the fact that we are well-positioned to continue the successful commercialization of Feraheme within the CKD indication, progress our efforts to expand the Feraheme label to the broader iron deficiency anemia indication, and extend the global reach of Feraheme through our strategic alliance with Takeda 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 ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in territories outside of the U.S., (3) the fact that we have limited experience developing and commercializing a pharmaceutical product on our own or with a partner like Takeda, particularly outside of the U.S., (4) uncertainties regarding our ability to ensure favorable coverage, pricing and reimbursement for Feraheme, (5) uncertainties regarding our ability to manufacture Feraheme, (6) uncertainties relating to our patents and proprietary rights, (7) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, and (8) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2009. 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, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except for per share data)
|Three Months Ended March 31,|
|Operating costs and expenses (1):|
|Cost of product sales||1,010||61|
|Research and development expenses||12,368||11,072|
|Selling, general and administrative expenses||23,456||17,750|
|Total operating costs and expenses||36,834||28,883|
|Interest and dividend income, net||471||1,256|
|Other income (expense)||4||69|
|Net loss before income taxes||(23,053||)||(26,602||)|
|Income tax benefit||-||179|
|Net loss per share - basic and diluted:||$||(1.15||)||$||(1.55||)|
|Weighted average shares outstanding used to compute net loss per share:|
|Basic and diluted||19,985||17,021|
(1) Stock-based compensation included in operating costs and expenses:
|Cost of product sales||$||75||$||-|
|Research and development||1,205||1,095|
|Selling, general and administrative||3,021||2,407|
AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
|March 31, 2010||December 31, 2009|
|Cash and cash equivalents||$||212,747||
|Short-term investments and settlement rights||21,832||30,366|
|Receivable from collaboration||60,000||
|Other current assets||4,900||5,472|
|Total current assets||326,524||122,729|
|Net property, plant & equipment||12,064||12,417|
|Deferred revenues - short term||14,258||10,198|
|Total current liabilities||38,919||37,561|
|Deferred revenues - long term||55,000||1,000|
|Other long term liabilities||3,011||3,081|
|Total long term liabilities||58,011||4,081|
|Total stockholders’ equity||290,550||142,977|
|Total liabilities and stockholders’ equity||$||387,480||$||184,619|
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
1IMS Health DDD data through the period ending April 2, 2010.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
Carol Miceli, 617-498-3361
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical