Feraheme™ (ferumoxytol) Injection Approved, Product Launch Underway
AMAG Pharmaceuticals, Inc. (NASDAQ: 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, today reported unaudited consolidated financial
results for the quarter and six months ended June 30, 2009.
“The approval of Feraheme by the FDA in the second quarter is a
momentous and exciting achievement for our Company,” commented Brian
J.G. Pereira, M.D., President and Chief Executive Officer of AMAG
Pharmaceuticals, Inc. “We are very pleased with the label for Feraheme
and feel that it reflects the strength of our safety and efficacy data. Feraheme
is now commercially available and our sales and marketing efforts are
well under way and on track.”
As of June 30, 2009, the Company’s cash, cash equivalents, investments
and settlement rights associated with certain auction rate securities
totaled $175.8 million. Revenues for the quarter ended June 30, 2009
were $55 thousand as compared to revenues of $0.5 million for the same
period in 2008. Revenues for the six month period ended June 30, 2009
were $1.0 million as compared to $1.1 million for the same period in
2008.
Total operating costs and expenses for the quarter ended June 30, 2009
were $27.4 million as compared to $19.7 million for the same period in
2008, an increase of $7.7 million. Total operating costs and expenses
for the six month period ended June 30, 2009 were $56.3 million as
compared to $33.0 million for the same period in 2008. The increase in
operating costs and expenses was due to increased research and
development expenses to scale up the Company’s manufacturing
capabilities and expand the Company’s development infrastructure, and
increased selling, general and administrative expenses associated with
the commercialization of Feraheme.
The Company reported a net loss of $26.5 million, or $1.55 per basic and
diluted share, for the quarter ended June 30, 2009, as compared to a net
loss of $17.0 million, or $1.00 per basic and diluted share, for the
same period in 2008. Net loss for the six months ended June 30, 2009 was
$52.9 million, or $3.10 per basic and diluted share, as compared to a
net loss of $26.3 million, or $1.55 per basic and diluted share for the
same period in 2008.
Recent Corporate Highlights and Accomplishments
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The Company commenced the U.S. commercial launch of Feraheme on
July 13, 2009. Feraheme is being distributed through
wholesalers and specialty distributors. The Company will market and
sell Feraheme through its commercial organization consisting of
approximately 150 seasoned professionals, including an 80-person
specialized sales force, an experienced account management and
reimbursement team, and a contract nurse team. The wholesale
acquisition cost (WAC) of Feraheme is $396.78 per 510 mg vial.
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On June 30, 2009 the U.S. Food and Drug Administration granted
marketing approval for Feraheme for the
treatment of iron deficiency anemia in adult patients with chronic
kidney disease.
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Ricardo Zayas was appointed Senior Vice President of Operations. Mr.
Zayas is responsible for leading the Company's manufacturing,
materials management, quality assurance, quality control, and supply
chain functions.
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An article by Balakrishnan et al., titled “Physiochemical Properties
of Ferumoxytol, a New Intravenous Iron Preparation” was published in
the June issue of the European Journal of Clinical Investigations.
The Company has published five articles in peer-reviewed journals over
the past 18 months.
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 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 7:30 p.m. ET on
July 29, 2009 through midnight July 31, 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 20620209.
An audio webcast of the earnings call will be available through the
Investors section of the Company’s website at www.amagpharma.com.
A replay of the webcast will also be available from approximately 6:30
p.m. ET on July 29, 2009, through midnight August 29, 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 our plan to market and sell Feraheme through a 150-person
commercial organization, 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 and imaging markets, (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 March 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.
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AMAG Pharmaceuticals, Inc.
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(unaudited, amounts in thousands, except for per share data)
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Condensed Consolidated
Statements of Operations
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Three Months Ended June 30,
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Six Months Ended June 30,
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2009
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2008
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2009
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2008
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Revenues:
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$
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55
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$
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486
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$
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1,011
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$
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1,098
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Costs and expenses (1):
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Cost of product sales
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-
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31
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61
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75
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Research and development expenses
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10,114
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7,061
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21,186
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11,884
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Selling, general and administrative expenses
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17,268
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12,611
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35,018
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20,996
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Total costs and expenses
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27,382
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19,703
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56,265
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32,955
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Operating Loss
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(27,327
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)
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(19,217
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(55,254
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)
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(31,857
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)
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Interest and dividend income, net
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783
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2,198
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2,039
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5,465
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Other income (expense)
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90
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12
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159
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84
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Net loss before income taxes
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(26,454
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)
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(17,007
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(53,056
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)
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(26,308
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)
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Income tax benefit
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-
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-
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179
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-
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Net loss
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$
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(26,454
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$
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(17,007
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)
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$
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(52,877
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)
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$
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(26,308
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Net loss per share - basic and diluted:
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$
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(1.55
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)
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$
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(1.00
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)
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$
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(3.10
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)
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$
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(1.55
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Weighted average shares outstanding used to compute net loss per
share:
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Basic and diluted
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17,038
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16,994
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17,030
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16,982
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(1) Stock-based compensation expenses included in costs and expenses
amounted to approximately:
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Research and development
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$
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1,241
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$
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883
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$
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2,336
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$
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1,592
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Selling, general and administrative
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2,882
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2,311
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5,289
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4,296
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Condensed Consolidated Balance
Sheets
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6/30/2009
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12/31/2008
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Cash, cash equivalents, short-term investments and settlement rights
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$
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125,669
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$
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160,662
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Long-term investments
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$
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50,097
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$
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54,335
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Working capital
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$
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115,136
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$
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149,918
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Total assets
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$
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190,546
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$
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231,955
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Total stockholders' equity
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$
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172,684
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$
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213,414
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AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362