Achieves Record Quarterly Provider Demand for Feraheme®
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 first quarter ended
2012
approximately
Business Update
-
Total revenues for the quarter ended
March 31, 2012 were$15.5 , of which
million$13.6 million were net product revenues from Feraheme. -
Total Feraheme provider demand for the first quarter of 2012
was approximately 26,600 grams1, representing a 30%
increase in provider demand as compared to the first quarter of 2011
and a 10% increase as compared to the fourth quarter of 2011. -
Positive data from IDA-302, a phase III clinical trial evaluating Feraheme
compared to IV iron sucrose in patients with IDA regardless of the
underlying cause, was released in March. Feraheme achieved both
primary efficacy endpoints in this study. -
Enrollment completed in IDA-301, a phase III clinical trial evaluating Feraheme
against placebo in patients with IDA regardless of the underlying
cause. Data from IDA-301 and IDA-302 will be the basis for the
supplemental new drug application (sNDA) to theU.S. Food and Drug to expand the label for Feraheme to include this
Administration
broader patient population. -
In April, the
Committee for Medicinal Products for Human Use (CHMP) of
theEuropean Medicines Agency (EMA) issued a positive opinion for the
approval of ferumoxytol for the treatment of IDA in adult patients
with CKD.EU Commission approval and launch are expected in the second
half of 2012, and would trigger$30 million in milestone payments to
AMAG. Ferumoxytol will be marketed inEurope as Rienso® by AMAG’s
partner,Takeda Pharmaceutical Company Limited .
“The record provider demand for Feraheme in the first quarter is
a testament to the progress that we are making in driving organic growth
of the brand,” said
officer of AMAG. “We believe that the commercial initiatives that we
continue to implement in the U.S. this year and the growth potential of Feraheme
through geographic expansion will position us for success in 2012 and
beyond. Our decision late last year to realign our expense structure has
resulted in a 22% decline in operating expenses as compared to the first
quarter of 2011, and, we believe, sets us on a course to profitability.”
First Quarter 2012 Financial Results (unaudited)
Total revenues for the quarter ended
as compared to
product revenues for the first quarter of 2012 were
compared to
Total operating costs and expenses, including costs of goods sold, for
the quarter ended
million
expenses in the first quarter of 2012 versus the first quarter of 2011
was primarily due to the cost reduction efforts implemented by the
company associated with the restructuring announced in the fourth
quarter of 2011.
The company reported a net loss of
share, for the quarter ended
of
2011.
2012 Financial Guidance
The company reiterates its financial guidance to manage the business to
achieve cash flow breakeven in 2012 based on the following guidance:
-
Net Feraheme product revenues of
$53 –$57 million , excluding
any royalties from sales outside the U.S.; -
Milestones received totaling
$33 million associated with potential
regulatory approvals and commercial launches in the EU andCanada ; -
Cost of goods sold (COGS) of approximately 14% – 18% of total product
sales; -
Total operating expenses, excluding COGS, of
$90 –$95 million , of
which$40 –$45 million are expected to be research and development
expenses and$50 –$55 million are expected to be selling, general and
administrative expenses; and -
A 2012 year-end cash and investments balance of
$225 –$230 million .
Conference Call and Webcast Access
slides at
company’s financial results, commercial progress and development
programs.
To access the conference call via telephone, please dial (877) 412-6083
from
telephone replay will be available from approximately
conference call, dial (855) 859-2056 from
537-3406 for international access. The pass code for the live call and
the replay is 73223897.
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
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
30, 2009
thereafter. Ferumoxytol received marketing approval in
Agency
and in the
Pharmaceutical Company Limited
please visit www.feraheme.com.
About
development and commercialization of a therapeutic iron compound to
treat iron deficiency anemia. AMAG manufactures and sells Feraheme®
(ferumoxytol) Injection for intravenous use.
For additional company or product information, please visit www.amagpharma.com
or http://feraheme.com.
Rienso is a registered trademark of
Limited
AMAG Pharmaceuticals, Inc. | |||||||||||
Condensed Consolidated Statements of Operations | |||||||||||
(unaudited, amounts in thousands, except for per share data) | |||||||||||
Three Months Ended March 31, | |||||||||||
2012 | 2011 | ||||||||||
Revenues: | |||||||||||
Product sales, net | $ | 13,708 | $ | 11,022 | |||||||
License fee, collaboration and royalty revenues | 1,772 | 2,363 | |||||||||
Total revenues |
15,480 |
13,385 | |||||||||
Operating costs and expenses (1): | |||||||||||
Cost of product sales | 2,646 | 3,041 | |||||||||
Research and development expenses | 12,462 | 13,566 | |||||||||
Selling, general and administrative expenses | 13,181 | 19,634 | |||||||||
Total operating costs and expenses | 28,289 | 36,241 | |||||||||
Operating Loss | (12,809 | ) | (22,856 | ) | |||||||
Interest and dividend income, net | 393 | 560 | |||||||||
Other income (expense) | – | 1 | |||||||||
Net loss | $ | (12,416 | ) | $ | (22,295 | ) | |||||
Net loss per share – basic and diluted: | $ | (0.58 | ) | $ | (1.05 | ) | |||||
Weighted average shares outstanding used to compute net loss per share: |
|||||||||||
Basic and diluted | 21,349 | 21,144 | |||||||||
(1) Stock-based compensation included in operating costs and expenses: |
|||||||||||
Cost of product sales | $ | 78 | $ | 195 | |||||||
Research and development | $ | 422 | $ | 642 | |||||||
Selling, general and administrative | $ | 1,185 | $ | 3,638 |
AMAG Pharmaceuticals, Inc. | ||||||||||
Condensed Consolidated Balance Sheets | ||||||||||
(unaudited, amounts in thousands) | ||||||||||
|
March 31, 2012 | December 31, 2011 | ||||||||
Cash and cash equivalents | $ | 37,619 | $ | 63,474 | ||||||
Short-term investments | 162,833 | 148,703 | ||||||||
Accounts receivable, net | 6,278 | 5,932 | ||||||||
Inventories | 14,255 | 15,206 | ||||||||
Receivable from collaboration | 370 | 428 | ||||||||
Other current assets | 5,740 | 6,288 | ||||||||
Total current assets | 227,095 | 240,031 | ||||||||
Property, plant & equipment, net | 8,702 | 9,206 | ||||||||
Long-term investments | 17,409 | 17,527 | ||||||||
Other assets | 460 | 460 | ||||||||
Total assets | $ | 253,666 | $ | 267,224 | ||||||
Accounts payable | $ | 3,398 | $ | 3,732 | ||||||
Accrued expenses | 27,986 | 28,916 | ||||||||
Deferred revenues | 6,346 | 6,346 | ||||||||
Total current liabilities | 37,730 | 38,994 | ||||||||
Deferred revenues | 43,672 | 45,196 | ||||||||
Other long-term liabilities | 2,341 | 2,438 | ||||||||
Total long-term liabilities | 46,013 | 47,634 | ||||||||
Total stockholders’ equity | 169,923 | 180,596 | ||||||||
Total liabilities and stockholders’ equity | $ | 253,666 | $ | 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: the
statement that the data from our IDA-301 and IDA-302 studies will be the
basis for the sNDA for Feraheme in the broader IDA patient
population; our plan to achieve cash flow breakeven status in 2012; our
expectation regarding
launch of Rienso(R) in the EU, the expected timing thereof, and the
milestone payments we expect to receive from Takeda in connection
therewith; the statement that our commercial initiatives we are
implementing, together with Feraheme geographic expansion
will position us for success; statements that our decline in operating
expenses will drive the company to profitability; statements regarding
our 2012 financial guidance, including our expected 2012 net Feraheme product
revenues, our expected 2012 operating expenses, including expected
research and development and selling, general and administrative
expenses, our expected cost of goods sold, and our expected 2012
year-end cash and investments balance; and any potential milestone
payments we expect to receive, 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 European Union, (3) the fact that significant safety or
drug interaction problems could arise with respect to Feraheme,
(4) uncertainties regarding our ability to manufacture Feraheme,
(5) uncertainties relating to our patents and proprietary rights,
(6) the risk that ferumoxytol/Rienso(R) does not receive final marketing
approval in the EU from the
identified in our Securities and Exchange Commission filings, including
our Annual Report on Form 10-K for the year ended December 31, 2011. 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.
The important safety information below is based on
prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease. Feraheme is contraindicated
in patients with known hypersensitivity to Feraheme or any of its
components.
Warnings and precautions
Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal, have been
reported in patients receiving Feraheme. Observe patients for
signs and symptoms of hypersensitivity during and after Feraheme
administration for at least 30 minutes and until clinically stable
following completion of each administration. Only administer the
drug when personnel and therapies are immediately available for the
treatment of anaphylaxis and other hypersensitivity reactions.
Anaphylactic type reactions, presenting with cardiac/cardiorespiratory
arrest, clinically significant hypotension, syncope, and
unresponsiveness have been reported in the post-marketing experience.
In clinical studies, serious hypersensitivity reactions were reported in
0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions
potentially associated with hypersensitivity (e.g., pruritus, rash,
urticaria or wheezing) were reported in3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have
been reported in the post-marketing experience. In clinical studies,
hypotension was reported in 1.9% (33/1,726) of subjects, including three
patients with serious hypotensive reactions. Monitor for signs and
symptoms of hypotension following each Feraheme injection. 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,
noting that lab assays may overestimate serum iron and transferrin bound
iron values in the 24 hours following administration of Feraheme. As a
superparamagnetic iron oxide, Feraheme may transiently affect magnetic
resonance diagnostic imaging studies for up to 3 months following the
last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT,
ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in
Feraheme treated patients versus oral iron treated patients reported in
≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%),
nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs.
0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs.
3.2%). In clinical trials, adverse reactions leading to treatment
discontinuation and occurring in 2 or more Feraheme treated patients
included hypotension, infusion site swelling, increased serum ferritin
level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic
renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during
post-approval use of Feraheme. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The following serious adverse reactions have been reported from the
post-marketing spontaneous reports with Feraheme: life-threatening
anaphylactic-type reactions, cardiac/cardiorespiratory arrest,
clinically significant hypotension, syncope, unresponsiveness, loss of
consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic
myocardial events, congestive heart failure, pulse absent, and cyanosis.
These adverse reactions have occurred up to 30 minutes after the
administration of Feraheme injection. Reactions have occurred following
the first dose or subsequent doses of Feraheme.
For full prescribing information, please visit www.feraheme.com.
1
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303