AMAG Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2009
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http://www.businesswire.com/news/home/20091029005140/en
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 (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 of Feraheme.
"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 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 expenses 6,109 10,269 27,295 22,153
Selling, general and administrative expenses 19,351 14,543 54,369 35,539
Total operating costs and expenses 25,588 24,815 81,853 57,770
Operating Loss (22,567 ) (24,555 ) (77,821 ) (56,412 )
Interest and dividend income, net 503 2,021 2,542 7,486
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 and diluted: $ (1.29 ) $ (1.39 ) $ (4.39 ) $ (2.94 )
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 administrative 2,845 2,826 8,134 7,122
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 rights 39,840 94,914
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 rights 49,701 55,901
Other assets 460 521
Total assets $ 189,555 $ 231,955
Accounts payable $ 1,960 $ 2,305
Accrued expenses and other short term liabilities 15,871 11,571
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` equity $ 189,555 $ 231,955
AMAG Pharmaceuticals
Amy Sullivan, 617-498-3303
or
Kristen Galfetti, 617-498-3362
or
Carol Miceli, 617-498-3361
Copyright Business Wire 2009
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