changes to its operating expenses that further align its cost structure
with the company’s focus on advancing Feraheme® and expanding its
product portfolio with commercial stage assets. First, AMAG is moving to
an outsourced manufacturing model and intends to divest the company’s
manufacturing facility in
global phase III broad iron deficiency anemia (IDA) clinical program for Feraheme,
which will support an sNDA filing later this year, will conclude this
year. Along with the natural attrition of external development costs
associated with the conclusion of the IDA development program, AMAG is
reducing internal development expenses to match the reduced activities
at this time, and will continue to adapt development
resources to meet the company’s future development needs.
“The decision to eliminate positions is never easy and I want to thank
the impacted individuals who have contributed greatly to AMAG over the
years. Today’s announcement signals a continuation of AMAG’s
transformation into a highly focused, commercially oriented specialty
pharmaceutical company,” said
executive officer of AMAG. “The actions that the company took in
progress in implementing a strategy to become a leaner and nimbler
company focused on providing specialty drugs to hematology/oncology and
hospital sites of care. These changes will allow AMAG to more
efficiently make decisions, react quickly to changing market dynamics
and rapidly identify and evaluate new product opportunities – these are
important changes that will help ensure our success in the short- and
long-term.”
Heiden continued, “Our corporate structure, both in terms of financial
and human resources, is now being brought into alignment with our
corporate strategy. We are focusing these resources against two key
priorities for the organization. First, advancing Feraheme across
our four growth opportunities of increasing market share in our current
indication in the US, pursuing a broader label expansion for all
patients with IDA, geographic expansion through international launches
and expansion of the IV iron market. We are also focusing aggressively
on our second corporate priority of expanding our product portfolio with
specialty drugs that fit into our commercial call points. I believe that
the combination of Feraheme, our strong balance sheet and our
experienced leadership team give us a very strong base from which to
continue to build a profitable specialty pharmaceutical company – the
steps taken today demonstrate the real and continuing progress that we
are making towards achieving this goal.”
Plan Details
-
By year-end 2012, AMAG expects to reduce its workforce by
approximately 45 positions, the majority of which are expected to be
associated with the company’s manufacturing and development
infrastructure. Some of the eliminated positions are budgeted, open
positions that the company will not fill. The company expects to incur
approximately$1.0 million in charges associated with the
restructuring, which will be spread over the remainder of 2012, with
$0.5 million expected to be recognized in the second quarter of 2012. -
With the intended divestiture of the company’s manufacturing facility,
AMAG will stop producing GastroMark and has entered into agreements
with the commercial parties that sell GastroMark in the US and EU.
AMAG will incur one-time costs associated with the GastroMark
agreements of$1.6 million in the second quarter of 2012. The company
expects to sell itsCambridge, MA manufacturing facility, which AMAG
owns outright. -
The changes implemented in 2012, will result in reduced
employee-related operating expenses beginning in 2013. In addition,
external research and development expenses associated with the
company’s broad IDA clinical development program planned for 2012 will
not recur, leading to further reductions in the company’s 2013
operating expenses. The full impact of these reductions will be
communicated when the company issues its 2013 financial guidance,
later this year. -
The expected change in manufacturing supply chain strategy for the
company will lower the costs associated with the manufacture of Feraheme.
The company expects that these changes will result in lower costs of
goods sold beginning in 2014.
The company may provide updated 2012 financial guidance when it reports
second quarter financial results.
About
manufactures and markets ferumoxytol under the brand name Feraheme® in
About Feraheme (ferumoxytol)
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. Feraheme received marketing approval in
product 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 divestiture of our manufacturing facility in
MA
clinical program for Feraheme by the end of 2012; the expected
filing of an sNDA with respect to a broad iron deficiency anemia
indication for Feraheme by the end of 2012; the expectation that
changes at AMAG will help ensure our success in the short- and
long-term; the expected
restructuring; the expected reduction in operating expenses in 2013; the
lowering of costs associated with the manufacturing of Feraheme;
and the expected reduction in cost of goods sold in 2014 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., including the
EU, (2) uncertainties regarding our ability to successfully and timely
complete our clinical development programs and obtain regulatory
approval for Feraheme/Rienso in the broader IDA indication
both in the U.S. 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/Rienso,
(4) uncertainties regarding the manufacture of Feraheme/Rienso,
(5) uncertainties relating to our patents and proprietary rights, and
(6) other risks identified in our Securities and Exchange
Commission filings, including our Quarterly Report on Form 10-Q for the
quarter ended
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
