LEXINGTON, Mass., Jul 28, 2010 (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 second quarter and six
months ended June 30, 2010. For the second quarter, AMAG reported total
revenue of $18.8 million, including $16.0 million of Feraheme(R)(ferumoxytol)
Injection for intravenous (IV) use net product revenues.
Business Highlights
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In June 2010, AMAG submitted a marketing authorization application
(MAA) to the European Medicines Agency (EMA) for the use of Feraheme
for the treatment of iron deficiency anemia in adult chronic kidney
disease (CKD) patients. The MAA has been deemed valid by the EMA and
is currently under review. -
During the second quarter, AMAG initiated enrollment in its global
registrational program for Feraheme for the treatment of iron
deficiency anemia, regardless of the underlying cause. The estimated
1,400-patient program consists of two phase III studies, one comparing
treatment with Feraheme to placebo, and the other comparing
treatment with Feraheme to treatment with intravenous iron
sucrose. The company plans to complete enrollment in this program by
year end 2011.
FerahemeLaunch Highlights
-
AMAG reported second quarter 2010 Feraheme net product revenues
of $16.0 million, including $2.4 million of revenues previously
deferred under its Feraheme launch incentive program. -
For the second quarter of 2010, Feraheme provider demand1,
which reflects purchases of Feraheme by providers from
wholesalers and distributors as reported by IMS Health, plus launch
incentive program utilization, which is reported by Feraheme launch
incentive customers to AMAG, increased 34% as compared to the first
three months of 2010, with growth achieved in both the dialysis and
non-dialysis segments. - Feraheme inventory levels at wholesalers and distributors
decreased from approximately 8,800 grams as of March 31, 2010 to
approximately 8,200 grams as of June 30, 2010. -
AMAG estimates approximately 70% of Feraheme provider demandin the second quarter of 2010 was outside of the dialysis
setting, with hospitals and hematology clinics representing the
majority of this demand1. -
From launch through the end of the second quarter of 2010,
approximately 2,300 providers have purchased Feraheme, with
greater than 73% having purchased on a repeat basis1. -
In the second quarter of 2010, more than 620 providers purchased Feraheme
for the first time; 68% of these new buyers were hematology clinics
and hospitals1.
“In the near term, we are focused on the successful commercialization of Feraheme
in the CKD market and are pleased with the continued growth in Feraheme
utilization,” said Brian J.G. Pereira, MD, President and Chief
Executive Officer of AMAG. “Longer term, we plan to expand the reach of Feraheme,
both geographically and to new patient populations. The filing of the
MAA in Europe and the initiation of the global iron deficiency anemia
registrational program are illustrative of the progress we are making on
this front.”
As of June 30, 2010, the company’s cash, cash equivalents and
investments totaled $328.0 million, which includes a $60 million upfront
payment received in April 2010 in connection with a collaboration
agreement between AMAG and Takeda Pharmaceutical Company Limited
(Takeda).
Total revenues for the quarter ended June 30, 2010 were $18.8 million,
as compared to revenues of $55,000 for the same period in 2009. Total
revenues for the 2010 period consisted primarily of $16.0 million of Feraheme
net product revenues, $1.5 million in collaboration revenues associated
with the amortization of the upfront payment from Takeda and $1.0
million in collaboration revenues associated with reimbursement from
Takeda, primarily related to costs associated with the MAA filing and
certain other clinical and regulatory costs incurred by AMAG during the
second quarter. The increase in revenues in 2010 over the comparable
2009 period was primarily attributable to Feraheme product sales
following its U.S. Food and Drug Administration (FDA) approval and
subsequent launch in July 2009.
Total operating costs and expenses for the quarter ended June 30, 2010
were $40.7 million, as compared to $27.4 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,
and increased research and development expenses. The company reported a
net loss of $21.3 million, or a loss of $1.01 per basic and diluted
share, for the quarter ended June 30, 2010, as compared to a net loss of
$26.5 million, or a loss of $1.55 per basic and diluted share, for the
same period in 2009.
For the six months ended June 30, 2010, AMAG reported total revenues of
$32.1 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 six months ended June 30, 2010 were $77.5
million, as compared to $56.3 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 $44.4 million, or a loss of $2.16 per
basic and diluted share, for the six months ended June 30, 2010, as
compared to a net loss of $52.9 million, or a loss of $3.10 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 a
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 7:30 p.m. ET on
July 28, 2010 through midnight July 30, 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 86083939.
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 7:30p.m.
ET on July 28, 2010 through midnight August 28, 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. AMAG manufactures and sells two commercial products, Feraheme(R)
(ferumoxytol) Injection for intravenous (IV) use and GastroMARK(R),
an oral contrast agent used in magnetic resonance imaging. For
additional company and product information, please visit www.amagpharma.com.
About Feraheme
In the United States, Feraheme(R) (ferumoxytol) Injection for intravenous
(IV) use is indicated for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease (CKD).
Feraheme is contraindicated in patients with evidence of iron
overload, known hypersensitivity to Feraheme or any of its
components, and those with anemia not caused by iron deficiency. For
more important safety information see full prescribing information and
visit www.feraheme.com.
Feraheme received marketing approval from the U.S. Food and Drug
Administration on June 30, 2009 and was commercially launched by AMAG in
the U.S. shortly thereafter. Feraheme is under regulatory review
in Canada and Europe for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease.
AMAG is seeking to expand the label and geographic availability of Feraheme
to treat patients with iron deficiency anemia regardless of the
underlying cause by conducting additional clinical trials and by forming
strategic partnerships around the world. AMAG has two partners for the
development and commercialization of Feraheme outside of the
U.S.: 3SBio Inc. to develop and commercialize Feraheme for CKD in
China; and Takeda Pharmaceutical Company to develop and commercialize Feraheme
for all therapeutic applications in five ex-U.S. regions, including
Europe, Canada, Turkey, the Commonwealth of Independent States and
several Asia Pacific countries. AMAG has exclusive rights to
commercialize Feraheme in the U.S. and certain ex-U.S.
territories.
In addition to the global iron deficiency anemia registrational program,
AMAG is evaluating Feraheme in a clinical trial, the ferumoxytol
compared to iron sucrose trial (FIRST), which will
enroll 150 patients with chronic kidney disease and iron deficiency
anemia, and has plans to initiate pediatric studies and a Feraheme
retreatment study in the coming year.
Feraheme was discovered, developed and is manufactured by AMAG
Pharmaceuticals, Inc. For more information about Feraheme,
including full prescribing information, please visit www.feraheme.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 the fact that we plan to complete enrollment in our global
registrational program for Feraheme for the treatment of iron
deficiency anemia in adult chronic kidney disease patients by year end
2011, our estimate that approximately 70% of Feraheme provider
demandin the second quarter of 2010 was outside of the
dialysis setting, our plan to expand the reach of Feraheme, both
geographically and to new patient populations, our plan to enroll 150
patients in the FIRST study , and our plans to initiate pediatric
studies and a Feraheme retreatment study 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 new indications and 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 and Quarterly
Report on Form 10-Q for the three months ended March 31, 2010. 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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Condensed Consolidated Statements of Operations |
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(unaudited, amounts in thousands, except for per share data) |
||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||
| Revenues | $ | 18,827 | $ | 55 | $ | 32,133 | $ | 1,011 | ||||
| Operating costs and expenses (1): | ||||||||||||
| Cost of product sales | 1,884 | – | 2,894 | 61 | ||||||||
|
Research and development
expenses |
14,784 | 10,114 | 27,152 | 21,186 | ||||||||
|
Selling, general and
administrative expenses |
24,004 | 17,268 | 47,460 | 35,018 | ||||||||
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Total operating costs and
expenses |
40,672 | 27,382 | 77,506 | 56,265 | ||||||||
| Operating Loss | (21,845) | (27,327) | (45,373) | (55,254) | ||||||||
| Interest and dividend income, net | 404 | 783 | 875 | 2,039 | ||||||||
| Other income (expense) | 6 | 90 | 10 | 159 | ||||||||
| Net loss before income taxes | (21,435) | (26,454) | (44,488) | (53,056) | ||||||||
| Income tax benefit | 111 | – | 111 | 179 | ||||||||
| Net loss | $ | (21,324) | $ | (26,454) | $ | (44,377) | $ | (52,877) | ||||
| Net loss per share – basic and diluted: | $ | (1.01) | $ | (1.55) | $ | (2.16) | $ | (3.10) | ||||
|
Weighted average shares outstanding
used to compute net loss per share: |
||||||||||||
| Basic and diluted | 21,017 | 17,038 | 20,504 | 17,030 | ||||||||
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(1) Stock-based compensation included
in operating costs and expenses: |
||||||||||||
| Cost of product sales | $ | 125 | $ | – | $ | 200 | $ | – | ||||
| Research and development | 1,333 | 1,241 | 2,538 | 2,336 | ||||||||
| Selling, general and administrative | 3,477 | 2,882 | 6,498 | 5,289 | ||||||||
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AMAG Pharmaceuticals, Inc. |
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Condensed Consolidated Balance Sheets |
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(unaudited, amounts in thousands) |
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| June 30, 2010 |
December 31, |
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| Cash and cash equivalents | $ | 135,793 | $ | 50,126 | ||
| Short-term investments and settlement rights | 153,337 | 30,366 | ||||
| Accounts receivable | 14,230 | 27,350 | ||||
| Inventories | 15,431 | 9,415 | ||||
| Receivable from collaboration | 1,029 | – | ||||
| Other current assets | 4,930 | 5,472 | ||||
| Total current assets | 324,750 | 122,729 | ||||
| Net property, plant & equipment | 11,886 | 12,417 | ||||
| Long-term investments | 38,876 | 49,013 | ||||
| Other assets | 460 | 460 | ||||
| Total assets | $ | 375,972 | $ | 184,619 | ||
| Accounts payable | $ | 3,855 | $ | 5,432 | ||
|
Accrued expenses and other short term
liabilities |
27,548 | 21,931 | ||||
| Deferred revenues – short term | 12,367 | 10,198 | ||||
| Total current liabilities | 43,770 | 37,561 | ||||
| Deferred revenues – long term | 53,500 | 1,000 | ||||
| Other long term liabilities | 2,936 | 3,081 | ||||
| Total long term liabilities | 56,436 | 4,081 | ||||
| Total stockholders’ equity | 275,766 | 142,977 | ||||
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Total liabilities and stockholders’
equity |
$ | 375,972 | $ | 184,619 | ||
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
1IMS Health DDD data (in grams) through the period ending
July 2, 2010.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. Contacts
Amy Sullivan, 617-498-3303
Carol Miceli, 617-498-3361
