LEXINGTON, Mass., Apr 27, 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 first quarter ended
March 31, 2010.
Business Highlights
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In January 2010, AMAG successfully completed a follow-on offering of
3.6 million shares of common stock, with net proceeds to the Company
of approximately $165.6 million. -
On March 31, 2010, AMAG entered into a strategic collaboration with
Takeda Pharmaceutical Company for Feraheme(R)(ferumoxytol)
Injection for intravenous use in all therapeutic indications in select
ex-US territories, including Europe. AMAG received a $60 million
upfront payment and is eligible to receive up to $220 million in
development and commercial milestones. Additionally, AMAG will receive
tiered, double-digit royalties based on net sales of Feraheme in
the licensed territories. -
During the first quarter, AMAG initiated enrollment in a clinical
trial, the ferumoxytol compared to iron sucrose trial
(FIRST), in 150 patients with chronic kidney disease and iron
deficiency anemia to support the European regulatory filing for Feraheme.
FerahemeLaunch Highlights
-
AMAG reported first quarter 2010 Feraheme net product revenues
of $13.1 million, including $2.2 million of previously deferred
product revenues. -
For the first three months 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 57% as compared to the last
three months of 2009, with growth achieved in both the dialysis and
non-dialysis segments. Feraheme inventory levels at wholesalers
and distributors on a grams basis were essentially unchanged from
December 31, 2009 to March 31, 2010. -
AMAG estimates approximately 60% of Feraheme provider demandin the first three months of 2010 was outside of the dialysis
setting, with hospitals and hematology clinics representing the
majority of this demand1. -
Through the first three months of 2010, approximately 1,700 providers
have purchased Feraheme, with greater than 67% having purchased
on a repeat basis1. -
In the first quarter of 2010, more than 585 providers purchased Feraheme
for the first time; 75% of these new buyers were hematology clinics
and hospitals1.
“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 6:30p.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(R) (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.
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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) |
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| Three Months Ended March 31, | ||||||||
| 2010 | 2009 | |||||||
| Revenues | $ | 13,306 | $ | 956 | ||||
| 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 | ||||||
| Operating loss | (23,528 | ) | (27,927 | ) | ||||
| 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 | $ | (23,053 | ) | $ | (26,423 | ) | ||
| Net loss per share – basic and diluted: | $ | (1.15 | ) | $ | (1.55 | ) | ||
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Weighted average shares outstanding used to compute net loss per share: |
||||||||
| Basic and diluted | 19,985 | 17,021 | ||||||
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(1) Stock-based compensation included in operating costs and |
||||||||
| Cost of product sales | $ | 75 | $ | – | ||||
| Research and development | 1,205 | 1,095 | ||||||
| Selling, general and administrative | 3,021 | 2,407 | ||||||
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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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| March 31, 2010 | December 31, 2009 | |||||
| Cash and cash equivalents | $ | 212,747 |
$ |
50,126 | ||
| Short-term investments and settlement rights | 21,832 | 30,366 | ||||
| Accounts receivable | 15,004 | 27,350 | ||||
| Inventories | 12,041 | 9,415 | ||||
| Receivable from collaboration | 60,000 |
– |
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| Other current assets | 4,900 | 5,472 | ||||
| Total current assets | 326,524 | 122,729 | ||||
| Net property, plant & equipment | 12,064 | 12,417 | ||||
| Long-term investments | 48,432 | 49,013 | ||||
| Other assets | 460 | 460 | ||||
| Total assets | $ | 387,480 | $ | 184,619 | ||
| Accounts payable | $ | 4,146 | $ | 5,432 | ||
| Accrued expenses | 20,515 | 21,931 | ||||
| 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.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
or
Carol Miceli, 617-498-3361
