AMAG Announces Fourth Quarter and Year End 2012 Financial Results

Increased total revenue by 39% over 2011

Reduced operating expenses by 32% over 2011

Reduced net loss by 79% over 2011

LEXINGTON, Mass.–(BUSINESS WIRE)–Mar. 1, 2013–
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical
company, today reported unaudited consolidated financial results for the
fourth quarter and year ended December 31, 2012. Total revenues for 2012
were 39% greater than 2011, driven by the recognition of milestone
payments received from Takeda Pharmaceutical Company Limited, the
company’s ex-US commercial partner, and increased Feraheme®
(ferumoxytol) sales. As of December 31, 2012, the company’s cash, cash
equivalents and investments totaled approximately $227 million.

2012 Highlights

• The company reported an increase in U.S. Feraheme net product sales,
  driven by increased utilization of Feraheme for the treatment of iron
  deficiency anemia (IDA) in chronic kidney disease (CKD) patients.
  Total Feraheme provider demand for 2012 was approximately 110,000
  grams, representing a 17% increase in provider demand over 2011.
  Feraheme provider demand for the fourth quarter of 2012 was
  approximately 27,500 grams, approximately 14% higher than the fourth
  quarter of 2011.¹
• The company made significant progress expanding the geographic reach
  of ferumoxytol, with approvals for use in adult IDA patients with CKD
  in the European Union (EU), Canada and Switzerland. Takeda has
  commercial rights to ferumoxytol in these regions, where they launched
  commercially in the fourth quarter of 2012. In the EU and Switzerland,
  Takeda launched under the trade name Rienso®; in Canada, Takeda
  launched under the trade name Feraheme. During 2012, AMAG received $33
  million in milestone payments from Takeda related to the approvals and
  launches of Feraheme/Rienso in Europe and Canada.
• AMAG also made meaningful progress in its efforts to expand the label
  for Feraheme. The company completed a 1,400 patient, phase III
  registration program for ferumoxytol in adult IDA patients, regardless
  of the underlying cause of their anemia. The program was comprised of
  two phase III trials, both of which achieved their respective primary
  and secondary endpoints (with high statistical significance). AMAG
  submitted a supplemental new drug application (sNDA) with the U.S.
  Food and Drug Administration (FDA) in December 2012 seeking to expand
  the indication for Feraheme beyond the current CKD indication to
  include all adult patients with IDA who have failed or otherwise
  cannot take oral iron therapy.

Fourth Quarter and Full Year 2012 Financial Results (unaudited)

Total revenues for the quarter ended December 31, 2012 were $21.1
million, as compared to $14.9 million for the same period in 2011. Total
revenues for the year ended December 31, 2012 were $85.4 million as
compared to $61.2 million for the year ended December 31, 2011. The
increase in total revenues in 2012 was due to increases in both product
sales and milestone payments recognized in 2012. Net U.S. Feraheme
product sales for the quarter ended December 31, 2012 were $14.4
million, as compared to $12.8 million of net U.S. Feraheme product sales
for the same period in 2011. Net U.S. Feraheme product sales for the
year ended December 31, 2012 were $58.3 million, as compared to $52.1
million for 2011.

Cost of goods sold (COGS) in 2012 were $14.2 million, or 24% of U.S. net
product sales, compared to $10.5 million, or 20% of U.S. net product
sales, in 2011. The increase in 2012 was attributable to several
one-time charges associated with the closure of our Cambridge, MA
manufacturing facility and the move to an outsourced manufacturing
supply chain.

Excluding COGS, total operating expenses for the year ended December 31,
2012 were $88.6 million, as compared to $130.5 million for 2011. The
decrease in operating costs in 2012 versus 2011 was primarily
attributable to lower research and development expenses due to the
completion of the phase III IDA program and lower selling, general and
administrative expenses due primarily to lower promotional expenses and
the realignment of the company’s sales force.

The company reported a net loss of $3.7 million, or a loss of $0.17 per
share, for the quarter ended December 31, 2012, as compared to a net
loss of $18.6 million, or a loss of $0.87 per share, for the year ended
December 31, 2011. Net loss for the year ended December 31, 2012 was
$16.8 million, or a loss of $0.78 per share, as compared to a net loss
of $77.1 million, or a loss of $3.64 per share for the same period in
2011.

“In 2012, we took actions to stabilize our business – such as stopping
the historical decline of our average net revenues per gram,” stated William Heiden, president and chief executive officer of AMAG. “We then
turned our focus to putting Feraheme on a solid growth trajectory,
achieving 12 percent dollar growth for the year, while reducing expenses
by more than 30 percent as compared to 2011. Our goals for 2013 are
clear, to continue to drive growth of Feraheme while we prepare for the
potential launch in the broader IDA indication, expand our product
portfolio and continue the disciplined management of our expenses.”

2013 Goals

AMAG intends to achieve the following in 2013:

• Achieve double-digit growth of Feraheme revenues, driven by both
  volume (gram) growth in the CKD patient population and increases in
  our realized net revenue per gram of Feraheme sold;
• Complete all pre-launch activities to ensure that the company is
  prepared for the potential launch of Feraheme in the broader IDA
  patient population, pending regulatory approval later this year;
• Support a timely FDA review of the company’s sNDA for Feraheme in the
  treatment of IDA in adult patients, regardless of underlying cause,
  who fail or otherwise cannot take oral iron;
• Work closely with Takeda to ensure a timely submission of an
  equivalent label expansion filing in the EU, as well as supporting
  similar submissions in other Takeda geographies;
• Expand the company’s product portfolio through the execution of an
  acquisition or in-license of commercial-stage specialty pharmaceutical
  product(s); and
• Deliver on the company’s 2013 annual financial guidance.

2013 Financial Outlook

The company reiterates the following guidance for 2013:

• Total revenues of between $73 million and $77 million, including:
  • Feraheme U.S. net product sales of between $63 million and $67
    million;
  • Revenue from royalties, ex-U.S. product sales and milestones of
    approximately $10 million;
• COGS of between 14% and 18% of net Feraheme product sales;
• Total operating expenses of between $78 million and $82 million,
  including:
  • Research and development expenses of between $24 million and $27
    million, and
  • Selling, general and administrative expenses of between $54
    million and $57 million; and
• A 2013 year-end cash and investments balance of between $206 million
  and $211 million, not including the impact of business development
  transactions.

About Iron Deficiency Anemia

More than 4 million Americans have IDA; 1.6 million of whom are
estimated to have CKD, while the other 2.4 million suffer from anemia
due to other causes.² For these patients with anemia due to
other causes, the underlying diseases or issues causing IDA include
abnormal uterine bleeding, gastrointestinal disorders, inflammatory
diseases and chemotherapy-induced anemia. Many IDA patients fail
treatment with oral iron due to intolerability or side effects.³

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that
manufactures and markets Feraheme® (ferumoxytol) Injection for
Intravenous (IV) use in the United States. Along with driving organic
growth of its lead product, AMAG intends to expand its portfolio with
additional commercial-stage specialty pharmaceuticals. The company is
seeking complementary products that leverage the company’s commercial
footprint and focus on hematology and oncology centers and hospital
infusion centers. For additional company information, please visit www.amagpharma.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG
Pharmaceuticals, Inc.

Rienso is a registered trademark of Takeda Pharmaceutical Company
Limited.

About Feraheme® (ferumoxytol)/Rienso

In the United States, Feraheme (ferumoxytol) Injection for Intravenous
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received marketing
approval from the U.S. Food and Drug Administration on June 30, 2009 and
was commercially launched by AMAG in the U.S. shortly thereafter.
Ferumoxytol received marketing approval in Canada in December 2011,
where it is marketed by Takeda as Feraheme, and in the European Union in
June 2012 and Switzerland in August 2012, where it is marketed by Takeda
as Rienso®. For additional product information, please visit www.feraheme.com.

Feraheme ® (ferumoxytol) Injection for Intravenous (IV) 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.

Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal, have been
reported in patients receiving Feraheme. Serious adverse reactions of
clinically significant hypotension have been reported. In the
post-marketing setting, life-threatening anaphylactic type reactions,
cardiac/cardiorespiratory arrest, clinically significant hypotension,
syncope, unresponsiveness and other safety events have been reported in
patients being treated with Feraheme. In clinical trials, the most
commonly occurring adverse reactions for Feraheme-treated patients were
nausea, dizziness, hypotension, peripheral edema, headache, edema and
vomiting. A full list of adverse events can be found in the full
prescribing information for Feraheme.

For full prescribing information, please visit www.feraheme.com.

Forward-looking Statement

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 market
for Feraheme and our future profitability; the management of our
operating expenses and cost of goods sold; our efforts and expectations
regarding the review and possible approval of our supplemental new drug
application for Feraheme; regulatory filings to be submitted by Takeda
outside of the U.S.; our expectations for revenue growth and plans for
strategic investments, including the acquisition or in-license of
commercial-stage specialty pharmaceutical product(s); our expectations
regarding the potential patient population for Feraheme and the
effective price per gram for Feraheme; delivery of financial guidance;
our expected 2013 Feraheme product revenue; our expected 2013 operating
expenses and cost of goods sold; our expected 2013 year-end cash and
investments balance; potential Feraheme milestone or royalty payments;
and our plans to expand the reach of Feraheme to new indications and
geographic territories 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 US and outside the US, 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
US and outside of the US, including the EU, (3) the possibility 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, both in the US and outside of the US, (6) the risk
of an Abbreviated New Drug Application (ANDA) filing following the FDA’s
recently published draft bioequivalence recommendation for ferumoxytol,
and (7) other risks identified in our Securities and Exchange Commission
filings, including our Quarterly Report on Form 10-Q for the quarter
ended September 30, 2012 and subsequent filings with the SEC. 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.

¹ IMS Health

² U.S. Census; U.S. Renal Data System, USRDS 2010 Annual
Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease
in the United States, National Institutes of Health, National
Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD,
2010: 41-42; Fishbane, S. et al. Iron Indices in CKD in the NHANES
1998-2004. Clin J Am Soc Nephrol. 2009 January; 4(1): 57–61.

³ Barton, James et al. Intravenous iron dextran therapy in
patients with iron deficiency and normal renal function who failed to
respond to or did not tolerate oral iron supplementation. Am J
Medicine. 2000; 109: 27-32.

Source: AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303