Newsroom

AMAG Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2009







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 anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the third quarter and nine months ended September 30, 2009.


Business Highlights

    —  The Company commenced the U.S. commercial launch of Feraheme(TM)
(ferumoxytol) Injection on July 13, 2009, within two weeks of receipt of
FDA approval. The Company reported $3.0 million of total revenues for
the third quarter of 2009, of which $2.9 million was related to the sale
of Feraheme. An additional $11.5 million was recorded as deferred
revenue as of September 30, 2009. This deferred revenue was primarily
associated with a launch incentive program implemented to advance the
adoption of Feraheme by dialysis organizations.
— More than 500 customers have purchased Feraheme; collectively, these
customers used 140,000 grams of all forms of IV iron over the past 52
weeks1.
— Approximately 65 percent of Feraheme provider demand in the third
quarter was outside of the dialysis setting. The Company views
non-dialysis chronic kidney disease as a significant market opportunity
for a safe and effective IV iron with the dosing profile ofFeraheme.


“During the third quarter, years of hard work by AMAG employees culminated in the launch of Feraheme, which completed the transformation of AMAG into a commercial biopharmaceutical company,” commented Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “We are now focused on making Feraheme a commercial success in the chronic kidney disease market in the United States and unlocking the value of this asset for iron deficiency anemia patients, with or without chronic kidney disease, around the world.”


As of September 30, 2009, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $151.8 million. Total revenues for the quarter ended September 30, 2009 were $3.0 million as compared to total revenues of $0.3 million for the same period in 2008. Total revenues for the nine month period ended September 30, 2009 were $4.0 million as compared to $1.4 million for the same period in 2008.


Total operating costs and expenses for the quarter ended September 30, 2009 were $25.6 million as compared to $24.8 million for the same period in 2008. Total operating costs and expenses for the nine month period ended September 30, 2009 were $81.9 million as compared to $57.8 million for the same period in 2008. The increase in operating costs and expenses over the comparable nine month periods was primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.


The Company reported a net loss of $22.1 million, or a loss of $1.29 per basic and diluted share, for the quarter ended September 30, 2009, as compared to a net loss of $23.6 million, or a loss of $1.39 per basic and diluted share, for the same period in 2008. Net loss for the nine months ended September 30, 2009 was $74.9 million, or a loss of $4.39 per basic and diluted share, as compared to a net loss of $49.9 million, or a loss of $2.94 per basic and diluted share for the same period in 2008.


Conference Call and Webcast Access


AMAG Pharmaceuticals, Inc. will host a webcast and conference call today at 8:30 a.m. ET to discuss the Company’s financial results and condition, 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 10:00 a.m. ET on October 29, 2009 through midnight November 2, 2009. 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 36056615.


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 10:00 a.m. ET on October 29, 2009 through midnight November 12, 2009.


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. AMAG recently received approval from the U.S. Food and Drug Administration to market Feraheme for the treatment of iron deficiency anemia in adult chronic kidney disease patients. For additional company and product information, please visit www.amagpharma.com.


Feraheme(TM) is a trademark of AMAG Pharmaceuticals, Inc.


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, statements regarding the significance of the pre-dialysis market opportunity for Feraheme, 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 manufacture Feraheme, (2) the fact that we have limited experience commercializing a pharmaceutical product on our own, (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market, (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for Feraheme, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 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.


1IMS Health DDD derived annual grams for the 12 month period ending September 2009.

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(unaudited, amounts in thousands, except for per share data)

Three Months Ended Nine Months Ended

September 30, September 30,

2009 2008 2009 2008

Total revenues $ 3,021 $ 260 $ 4,032 $ 1,358

Operating costs and expenses
(1):

Cost of product sales 128 3 189 78

Research and development 6,109 10,269 27,295 22,153
expenses

Selling, general and 19,351 14,543 54,369 35,539
administrative expenses

Total operating costs and 25,588 24,815 81,853 57,770
expenses

Operating Loss (22,567 ) (24,555 ) (77,821 ) (56,412 )

Interest and dividend 503 2,021 2,542 7,486
income, net

Other income (expense) 2 (1,321 ) 161 (1,237 )

Net loss before income taxes (22,062 ) (23,855 ) (75,118 ) (50,163 )

Income tax benefit – 278 179 278

Net loss $ (22,062 ) $ (23,577 ) $ (74,939 ) $ (49,885 )

Net loss per share – basic $ (1.29 ) $ (1.39 ) $ (4.39 ) $ (2.94 )
and diluted:

Weighted average shares
outstanding used to compute
net loss per share:

Basic and diluted 17,117 17,001 17,059 16,989

(1) Stock-based compensation
included in operating costs
and expenses:

Research and development 1,162 1,049 3,498 2,641

Selling, general and 2,845 2,826 8,134 7,122
administrative

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

September 30, 2009 December 31, 2008

Cash and cash equivalents $ 62,302 $ 64,182

Short-term investments and settlement 39,840 94,914
rights

Accounts receivable 16,454 408

Inventories 5,532 96

Other current assets 4,035 4,710

Total current assets 128,163 164,310

Net property, plant & equipment 11,231 11,223

Long-term investments and settlement 49,701 55,901
rights

Other assets 460 521

Total assets $ 189,555 $ 231,955

Accounts payable $ 1,960 $ 2,305

Accrued expenses and other short term 15,871 11,571
liabilities

Deferred revenues – short term 11,450 516

Total current liabilities 29,281 14,392

Long term liabilities 4,141 4,149

Total stockholders’ equity 156,133 213,414

Total liabilities and stockholders’ $ 189,555 $ 231,955
equity



    Source: AMAG Pharmaceuticals, Inc.

Contact: AMAG Pharmaceuticals Amy Sullivan, 617-498-3303 or Kristen Galfetti, 617-498-3362 or Carol Miceli, 617-498-3361