AMAG Announces First Quarter 2013 Financial Results

Total revenue increased 16%, operating expenses decreased 24%,
resulting in a 69% reduction in net loss

Conference call scheduled for 4:30 EDT today

LEXINGTON, Mass.–(BUSINESS WIRE)–Apr. 23, 2013–
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical
company, today reported unaudited consolidated financial results for the
quarter ended March 31, 2013. Total revenues for the first quarter of
2013 were $17.9 million, 16 percent greater than the first quarter of
2012, driven by increased Feraheme® (ferumoxytol) U.S. sales. As of
March 31, 2013, the company’s cash, cash equivalents and investments
totaled approximately $217 million.

“We have gotten off to a very strong start in 2013, delivering record
results through a combination of solid top-line growth and disciplined
financial management,” said William Heiden, president and chief
executive officer of AMAG. “In the first quarter, we achieved our
largest volume of non-dialysis Feraheme sales since launch. Our new
chief commercial officer, Greg Madison, and his team did an excellent
job of driving Feraheme performance this quarter, achieving especially
strong growth in the largest segment of the non-dialysis IV iron market,
the hospital segment.”

Business Highlights

• The company reported $15.6 million in U.S. Feraheme net product sales,
  compared to $13.1 million (excluding $0.5 million reduction of
  reserves for product returns) in the first quarter of 2012,
  representing a 19 percent increase. The growth in U.S. product sales
  was driven by increased utilization of Feraheme for the treatment of
  iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients
  and an increase in net revenue per gram of Feraheme. Total Feraheme
  provider demand for the first quarter of 2013 was approximately 29,500
  grams, representing an 11 percent increase in provider demand over the
  first quarter of 2012.¹
• Total operating expenses for the first quarter of 2013 declined 24
  percent compared to the same period in 2012 as the company remains
  focused on driving the business towards profitability.
• AMAG is beginning to see the positive financial impact of the change
  to a fully outsourced supply chain that occurred in the fourth quarter
  of 2012, with gross margin on sales of Feraheme increasing to more
  than 82 percent in the first quarter of 2013 driven by improvements in
  cost of goods sold (COGS).
• In March 2013, AMAG received notification that its supplemental new
  drug application (sNDA) was accepted for review by the U.S. Food and
  Drug Administration (FDA) and that the FDA is targeting October 21,
  2013 as the PDUFA action date for the filing. AMAG submitted the sNDA
  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.
• AMAG continues to prepare for the potential approval of its sNDA for
  Feraheme in patients with IDA, regardless of underlying cause, who
  cannot take oral iron. These activities include conducting physician
  market research and product message development and testing. Other
  related activities include corporate disease awareness initiatives and
  support for the presentations/publications of data from AMAG’s phase
  III IDA clinical program in medical journals and at medical
  conferences.

“We made several changes to the way we operate our business in 2012, and
we are now realizing the full benefit of those changes in our financial
results,” stated Frank Thomas, chief operating officer of AMAG. “The
nineteen percent increase in U.S. Feraheme sales versus 2012 was driven
by strong volume gains as well as an increase in net revenue per gram,
each of which we accomplished while maintaining a lower operating cost
structure in the first quarter.”

First Quarter 2013 Financial Results (unaudited)

Total revenues for the quarter ended March 31, 2013 were $17.9 million,
as compared to $15.5 million for the same period in 2012. The increase
in total revenues in the first quarter of 2013 was primarily due to
higher Feraheme product sales. Net U.S. Feraheme product sales for the
quarter ended March 31, 2013 were $15.6 million, as compared to $13.1
million (excluding a $0.5 million reduction of reserves for product
returns) for the same period in 2012.

Feraheme COGS in the first quarter of 2013 were $2.8 million, or 18
percent of global Feraheme product sales, compared to $2.6 million, or
23 percent of Feraheme product sales (excluding $0.5 million reduction
of reserves for product returns) in the first quarter of 2012. Total
operating expenses for the quarter ended March 31, 2013 were $19.4
million, compared to $25.6 million for the same period in 2012. The
decrease in operating expenses in the first quarter of 2013 versus the
first quarter of 2012 was primarily attributable to lower research and
development expenses due to the 2012 completion of AMAG’s phase III IDA
clinical program and a leaner internal R&D cost structure.

The company reported a net loss of $3.9 million, or a loss of $0.18 per
share, for the quarter ended March 31, 2013, as compared to a net loss
of $12.4 million, or a loss of $0.58 per share, for the same period in
2012.

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 percent and 18 percent of net Feraheme global
  product sales;
• Total operating expenses of between $78 million and $82 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.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with
slides today at 4:30 p.m. EDT, during which management will discuss the
company’s financial results, commercial progress and business
development initiatives. 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 7:30 p.m. EDT on April 23, 2013 through midnight April 30,
2013. To access a replay of the conference call, dial (855) 859-2056
from the United States or (404) 537-3406 for international access. The
pass code for the live call and the replay is 37544923.

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 7:30 p.m.
EDT on April 23, 2013 through midnight May 23, 2013.

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 March 2012, 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 revenues and profitability; our operating
expenses and cost of goods sold; expectations regarding the FDA’s review
of our sNDA for Feraheme; our expectations for revenue growth and the
expanded indication for Feraheme; AMAG’s pursuit of activities in
preparation for the potential approval of our sNDA; the impact of 2012
changes to our business; 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, and our dependence on
third parties for, 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 draft bioequivalence recommendation
for ferumoxytol, and (7) other risks identified in our Securities and
Exchange Commission filings, including our Annual Report on Form 10-K
for the year ended December 31, 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