LEXINGTON, Mass., Mar 01, 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 fourth quarter and year
ended December 31, 2009.
Business Highlights
-
AMAG reported fourth quarter 2009 Feraheme(R) net product
revenues of $12.8 million, including $1.3 million of the $11.5 million
in previously deferred product revenues. -
To date, more than 1,300 providers have purchased Feraheme(R)(ferumoxytol)
Injection; collectively, these providers purchased approximately
240,000 grams of all forms of IV iron over the past 52 weeks1. -
Of the providers that have purchased Feraheme to date, more
than 1,100 are treating non-dialysis dependent chronic kidney disease
patients and more than 60 percent have purchased on a repeat basis. -
AMAG estimates that more than half of Feraheme provider demand
in 2009 was outside of the dialysis setting.
“We are very pleased with the progress made by AMAG in 2009,” said Brian
J.G. Pereira, MD, President and Chief Executive Officer of AMAG
Pharmaceuticals, Inc. “In addition to receiving marketing approval for
our first therapeutic product in the U.S., we launched Feraheme
within two weeks of approval, and ended the year with a strong
foundation from which to grow.”
Dr. Pereira continued, “We enter 2010 with ambitious plans to continue
the successful launch of Feraheme for the treatment of iron
deficiency anemia in adult chronic kidney disease patients in the U.S.;
expand the development of Feraheme to IDA patients, with and
without CKD around the world; advance our ferumoxytol imaging program;
and secure a commercial partner for Feraheme in the E.U.”
As of December 31, 2009, the Company’s cash, cash equivalents,
investments and settlement rights associated with certain auction rate
securities totaled $129.5 million. 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.
Revenues for the quarter ended December 31, 2009 were $13.1 million as
compared to revenues of $0.6 million for the same period in 2008.
Revenues for the year ended December 31, 2009 were $17.2 million as
compared to $1.9 million for the same period in 2008. The increases in
revenues in 2009 over the comparable 2008 periods were attributable to Feraheme
product sales following its approval and subsequent launch in July 2009.
Total operating costs and expenses for the quarter ended December 31,
2009 were $33.3 million as compared to $23.8 million for the same period
in 2008. Total operating costs and expenses for the year ended December
31, 2009 were $115.1 million as compared to $81.5 million for the same
period in 2008. The increases in operating costs and expenses in 2009
over the comparable 2008 periods were primarily due to increased
selling, general and administrative expenses associated with the
commercialization of Feraheme.
The Company reported a net loss of $18.4 million, or a loss of $1.07 per
basic and diluted share, for the quarter ended December 31, 2009, as
compared to a net loss of $21.8 million, or a loss of $1.28 per basic
and diluted share, for the same period in 2008. Net loss for the year
ended December 31, 2009 was $93.4 million, or a loss of $5.46 per basic
and diluted share, as compared to a net loss of $71.6 million, or a loss
of $4.22 per basic and diluted share for the same period in 2008.
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a webcast with slides and
conference call today at 8:00 a.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 11:00 a.m. ET on
March 1, 2010 through midnight March 3, 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 54914959.
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 11:00 a.m. ET on
March 1, 2010 through midnight April 1, 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 plans to continue the successful launch of Feraheme
for the treatment of iron deficiency anemia in chronic kidney disease
patients in the U.S.; expand the development of Feraheme to IDA
patients, with and without CKD around the world; advance our ferumoxytol
imaging program; and secure a commercial partner for Feraheme in
the E.U. 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, (2) the
fact that we have limited experience developing and commercializing a
pharmaceutical product on our own, particularly outside of the U.S., (3)
uncertainties regarding our ability to ensure favorable coverage,
pricing and reimbursement for Feraheme, (4) uncertainties
regarding our ability to manufacture Feraheme, (5) uncertainties
relating to our patents and proprietary rights, and (6) 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.
Important Safety Information about Feraheme
Feraheme is contraindicated in patients with evidence of iron
overload, known hypersensitivity to Feraheme or any of its
components, and patients with anemia not caused by iron deficiency.
In clinical studies, hypotension was reported in 1.9% (33/1,726) of
subjects receiving Feraheme, including three patients with
serious hypotensive reactions. Serious hypersensitivity reactions were
reported in 0.2% (3/1726) of patients. Patients should be observed for
signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme
injection and the drug should only be administered when treatment for
hypersensitivity reactions is readily available. Excessive therapy with
parenteral iron can lead to excess storage of iron with the possibility
of iatrogenic hemosiderosis. Patients should be regularly monitored for
hematologic response during parenteral iron therapy. As a
superparamagnetic iron oxide, Feraheme may transiently affect
magnetic resonance diagnostic imaging but will not affect X-ray, CT,
PET, SPECT, ultrasound, or nuclear imaging. In clinical trials, the most
commonly occurring adverse reactions in Feraheme treated patients
versus oral iron treated patients were diarrhea, nausea, dizziness,
hypotension, constipation and peripheral edema.
|
AMAG Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (unaudited, amounts in thousands, except for per share data) |
||||||||||||||||
| Three Months Ended
December 31, |
Twelve Months Ended
December 31, |
|||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Revenues: | $ | 13,146 | $ | 580 | $ | 17,178 | $ | 1,938 | ||||||||
| Operating costs and expenses (1): | ||||||||||||||||
| Cost of product sales | 824 | 214 | 1,013 | 292 | ||||||||||||
|
Research and development expenses |
8,978 | 9,563 | 36,273 | 31,716 | ||||||||||||
|
Selling, general and administrative expenses |
23,460 | 13,997 | 77,829 | 49,536 | ||||||||||||
|
Total operating costs and expenses |
33,262 | 23,774 | 115,115 | 81,544 | ||||||||||||
| Operating Loss | (20,116 | ) | (23,194 | ) | (97,937 | ) | (79,606 | ) | ||||||||
|
Interest and dividend income, net |
612 | 1,653 | 3,154 | 9,139 | ||||||||||||
| Other income (expense) | 3 | (221 | ) | 164 | (1,458 | ) | ||||||||||
|
Net loss before income taxes |
(19,501 | ) | (21,762 | ) | (94,619 | ) | (71,925 | ) | ||||||||
|
Income tax benefit |
1,089 | – | 1,268 | 278 | ||||||||||||
| Net loss | $ | (18,412 | ) | $ | (21,762 | ) | $ | (93,351 | ) | $ | (71,647 | ) | ||||
| Net loss per share – basic and diluted: | $ | (1.07 | ) | $ | (1.28 | ) | $ | (5.46 | ) | $ | (4.22 | ) | ||||
|
Weighted average shares outstanding used to compute net loss per |
||||||||||||||||
| Basic and diluted | 17,258 | 17,007 | 17,109 | 16,993 | ||||||||||||
|
(1) Stock-based compensation included in operating costs and expenses: |
||||||||||||||||
| Cost of product sales | $ | 43 | $ | – | $ | 43 | $ | – | ||||||||
| Research and development | 948 | 1,119 | 4,446 | 3,760 | ||||||||||||
|
Selling, general and administrative |
2,798 | (2,845 | ) | 10,932 | 4,277 | |||||||||||
|
AMAG Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (unaudited, amounts in thousands) |
||||||
| December 31, 2009 | December 31, 2008 | |||||
| Cash and cash equivalents | $ | 50,126 | $ | 64,182 | ||
| Short-term investments and settlement rights | 30,366 | 94,914 | ||||
| Accounts receivable, net | 27,350 | 408 | ||||
| Inventories | 9,415 | 96 | ||||
| Other current assets | 5,472 | 4,710 | ||||
| Total current assets | 122,729 | 164,310 | ||||
| Net property, plant & equipment | 12,417 | 11,223 | ||||
| Long-term investments and settlement rights | 49,013 | 55,901 | ||||
| Other assets | 460 | 521 | ||||
| Total assets | $ | 184,619 | $ | 231,955 | ||
| Accounts payable | $ | 5,432 | $ | 2,305 | ||
| Accrued expenses | 21,931 | 11,571 | ||||
| Deferred revenues | 10,198 | 516 | ||||
| Total current liabilities | 37,561 | 14,392 | ||||
| Long-term liabilities | 4,081 | 4,149 | ||||
| Total stockholders’ equity | 142,977 | 213,414 | ||||
|
Total liabilities and stockholders’ equity |
$ | 184,619 | $ | 231,955 | ||
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
1IMS Health DDD derived annual grams for the period ending
February 12, 2010.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
or
Carol Miceli, 617-498-3361
