-
Year-over-year quarterly Feraheme® sales and provider demand
growth continued - Reduced operating expenses by 42% from the third quarter of 2011
-
Updates financial guidance for 2012, raising Feraheme sales and
lowering expense forecasts
company focused on the development and commercialization of Feraheme®
(ferumoxytol) Injection for intravenous (IV) use to treat iron
deficiency anemia (IDA), today reported unaudited consolidated financial
results for the third quarter ended
ended the third quarter of 2012 with approximately
cash equivalents and investments.
Business Update
-
Total revenues for the third quarter of 2012 were
$17.7 million , which
included$16.2 of net U.S. Feraheme product revenues. As a result of
actions taken earlier this year to improve the pricing dynamics for
Feraheme, net revenue realized per gram of Feraheme increased in the
third quarter of 2012 compared to the second quarter of 2012,
reversing a historically downward trend. -
Feraheme provider demand1 for the third quarter of 2012 was
approximately 27,500 grams, an 11% increase over the third quarter of
2011, with growth continuing to outpace IV iron market growth.
Feraheme gained share in the hematology and hospital segments, with
demand in these segments growing at 8% and 34%, respectively, compared
to the third quarter of 2011. -
The company reported positive data from the second phase III clinical
trials of Feraheme for the treatment of iron deficiency anemia
regardless of the underlying cause and plans to submit a supplemental
new drug application to theU.S. Food and Drug Administration in the
fourth quarter of 2012. -
International expansion efforts for ferumoxytol are progressing as
planned. The first shipment of ferumoxytol to support European launch
of Rienso®, the brand name of ferumoxytol inEurope , occurred in the
third quarter. Revenue from these sales has been deferred until the
product has been sold to customers ofTakeda Pharmaceuticals Company, , AMAG’s partner in the EU and
Ltd.Canada . Additionally, Feraheme was
launched inCanada early in the fourth quarter, for which AMAG has
received a$3 million milestone payment, and today, Rienso was
launched inEurope . The first commercial sale of Rienso inEurope ,
which is expected shortly, triggers a$15 million milestone payment
from Takeda.
“We are pleased to report the results of our strong third quarter
performance. Our updated full-year 2012 financial guidance is a direct
result of our renewed focus on Feraheme sales growth and aggressive
operating expense management,” commented
chief executive officer of AMAG. “While I am pleased with the growth
achieved in our U.S. Feraheme business this year, I believe that we can
do even better. Feraheme represents a tremendous opportunity for AMAG
and I want to ensure that we unlock its full potential — by maximizing
the number of adult IDA patients with chronic kidney disease who benefit
from Feraheme today, and broadening that to all IDA patients next year,
should we gain regulatory approval of an expanded label.”
Heiden continued, “Additionally, we have extended the international
reach of Feraheme/Rienso with launches in
on-track for our fourth quarter sNDA filing in the U.S. for our Feraheme
label expansion and are making progress in our search to acquire
additional commercial products.”
Third quarter and Nine Month 2012 Financial Results (unaudited)
Total revenues for the quarter ended
million
the nine months ended
of
period in 2011. The increase in total revenues for the nine-month period
ended
Feraheme and the recognition of a
Takeda in 2012.
Net U.S. Feraheme product revenues for the third quarter of 2012 were
associated with changes in estimated
reserves. These reductions in estimated reserves reflect AMAG’s lower
launch in 2009. For comparison, net U.S. Feraheme product revenues for
the third quarter of 2011 were
of revenues associated with a change in estimated
Total cost of goods sold (COGS) for the quarter ended
were
2011. Total COGS for the nine months ended
million
increase in COGS for the nine months ended
primarily due to a
additional
the company’s
Total operating expenses, excluding COGS, for the quarter ended
the third quarter of 2011. Total operating expenses, excluding COGS, for
the nine months ended
to
operating expenses in the 2012 periods were due to decreased research
and development costs associated with the company’s global IDA
registration program and decreased selling, general and administrative
expenses as the company realized the benefits of its streamlined cost
structure.
For the quarter ended
decreased 76% to
share, as compared to a net loss of
per basic and diluted share, for the third quarter of 2011. AMAG’s net
loss for the nine months ended
a loss of
of
same period in 2011.
Updated Annual 2012 Financial Guidance
The company is updating its 2012 full year financial guidance. AMAG now
expects:
-
Increased net Feraheme product revenue of
$58 –$60 million , including
the impact of changes in estimated reserves already recorded this
year; and -
Reduced total operating expenses, excluding COGS, of
$87 –$90 million .
AMAG confirms prior annual 2012 guidance for the following:
-
COGS of approximately 20% – 24% of total product sales, which includes
accelerated depreciation and idle capacity associated with the closure
of the company’s manufacturing facility; -
Cash milestones totaling
$33 million associated with regulatory
approvals and commercial launches in the EU andCanada ,$18 million of
which have already been received; and -
A 2012 year-end cash and investments balance of
$225 –$230 million ,
not including the impact of a business development transaction.
Conference Call and Webcast Access
slides today at
telephone, dial 877-412-6083 from
international access. A telephone replay of the conference call will be
available from approximately
midnight
for the live call and the telephone replay is 37432497.
A live webcast of the conference call and accompanying slides will be
accessible through the Investors section of the company’s website at www.amagpharma.com
beginning today at
webcast replay will be available today at approximately
and will be archived on the
midnight
About Feraheme
In
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received marketing
approval from the
was commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol received marketing approval in
the
additional product information, please visit www.feraheme.com.
About
pharmaceutical company focused on the development and commercialization
of an intravenous iron to treat iron deficiency anemia (IDA). For
additional company information, please visit www.amagpharma.com.
Pharmaceuticals, Inc.
Rienso is a registered trademark of
1IMS Health Data (in grams) through the period ending
AMAG Pharmaceuticals, Inc. | |||||||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||||||
(unaudited, amounts in thousands, except for per share data) | |||||||||||||||||||||
Three Months Ended Sept 30, | Nine Months Ended Sept 30, | ||||||||||||||||||||
2012 | 2011 | 2012 | 2011 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Product sales, net | $ | 16,176 | $ 15,802 | $ | 44,304 | $ | 39,905 | ||||||||||||||
License fee, collaboration and royalty revenues | 1,566 | 1,753 | 19,930 | 6,437 | |||||||||||||||||
Total revenues | 17,742 | 17,555 | 64,234 | 46,342 | |||||||||||||||||
Operating costs and expenses (1): | |||||||||||||||||||||
Cost of product sales | 4,323 | 2,669 | 10,193 | 7,792 | |||||||||||||||||
Research and development expenses | 5,260 | 14,894 | 25,393 | 45,155 | |||||||||||||||||
Selling, general and administrative expenses | 12,160 | 17,230 | 40,442 | 53,690 | |||||||||||||||||
Restructuring expense | 562 | – | 1,620 | – | |||||||||||||||||
Total operating costs and expenses | 22,305 | 34,793 | 77,648 | 106,637 | |||||||||||||||||
Operating income (loss) | (4,563 | ) | (17,238 | ) | (13,414 | ) | (60,295 | ) | |||||||||||||
Interest and dividend income, net | 295 | 378 | 1,026 | 1,390 | |||||||||||||||||
Other income (expense) | 2 | 14 | (1,469 | ) | (194 | ) | |||||||||||||||
Net income (loss) before income taxes | (4,266 | ) | (16,846 | ) | (13,857 | ) | (59,099 | ) | |||||||||||||
Income tax benefit | 299 | 215 | 793 | 611 | |||||||||||||||||
Net income (loss) | $ | (3,967 | ) | $ (16,631 | ) | $ | (13,064 | ) | $ | (58,488 | ) | ||||||||||
Net income (loss) per share – basic and diluted | $ | (0.19 | ) | $ (0.78 | ) | $ | (0.61 | ) | $ | (2.76 | ) | ||||||||||
Weighted average shares outstanding used to compute net loss per share: |
|||||||||||||||||||||
Basic and diluted | 21,403 | 21,194 | 21,374 | 21,169 | |||||||||||||||||
(1) Stock-based compensation included in operating costs and expenses: |
|||||||||||||||||||||
Cost of product sales | $ | 52 | $ 131 | $ | 198 | $ | 483 | ||||||||||||||
Research and development | 473 | 84 | 1,420 | 1,365 | |||||||||||||||||
Selling, general and administrative | 1,525 | 1,487 | 3,694 | 6,950 |
AMAG Pharmaceuticals, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(unaudited, amounts in thousands) | ||||||||
September 30, 2012 | December 31, 2011 | |||||||
Cash and cash equivalents |
$ | 42,900 | $ | 63,474 | ||||
Short-term investments | 167,943 | 148,703 | ||||||
Accounts receivable | 7,363 | 5,932 | ||||||
Inventories | 12,227 | 15,206 | ||||||
Receivable from collaboration | 777 | 428 | ||||||
Assets held for sale | 2,300 | – | ||||||
Other current assets | 7,627 | 6,288 | ||||||
Total current assets | 241,137 | 240,031 | ||||||
Net property, plant & equipment | 3,411 | 9,206 | ||||||
Long-term investments | – | 17,527 | ||||||
Other assets | 460 | 460 | ||||||
Total assets | $ | 245,008 | $ | 267,224 | ||||
Accounts payable | $ | 3,620 | $ | 3,732 | ||||
Accrued expenses and other short-term liabilities | 16,674 | 28,916 | ||||||
Deferred revenues | 7,250 | 6,346 | ||||||
Total current liabilities | 27,544 | 38,994 | ||||||
Deferred revenues | 40,624 | 45,196 | ||||||
Other long-term liabilities | 2,136 | 2,438 | ||||||
Total long-term liabilities | 42,760 | 47,634 | ||||||
Total stockholders’ equity | 174,704 | 180,596 | ||||||
Total liabilities and stockholders’ equity | $ | 245,008 | $ | 267,224 |
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, our belief
that “we can do better,” our expectation to submit a supplemental new
drug application to the
2012, our progress in our search to acquire additional products and our
expected financial results for the 2012 fiscal year, 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
and Takeda’s 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 the broader IDA indication and in territories outside of the
U.S., including the
safety or drug interaction problems could arise with respect to
Feraheme, (4) uncertainties regarding the ability to manufacture
Feraheme, (5) uncertainties relating to our patents and proprietary
rights, (6) uncertainty regarding our ability to acquire additional
products for our portfolio, and (7) other risks identified in our
Report on Form 10-Q for the quarter ended
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.
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303