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AMAG Pharmaceuticals Provides Business Update Announces Preliminary 2012 Financial Results and 2013 Financial Guidance

January 6, 2013 | Investor News, Press Releases

~ Submits sNDA for expanded indication for Feraheme® (ferumoxytol)
~

~ Achieves 14% growth in fourth quarter 2012 U.S. Feraheme product
revenues, compared to fourth quarter of 2011 ~

~ Ends 2012 with approximately $227 million in cash and
investments ~

LEXINGTON, Mass.–(BUSINESS WIRE)–Jan. 6, 2013–
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced a business
update, including preliminary fourth quarter 2012 financial results and
its outlook for 2013. The company will present further details at the 31st
Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday,
January 9, 2013 at 8:30 a.m. Pacific time.

“AMAG turned a corner in 2012, achieving all of our commercial and
development milestones for the year, which together have placed Feraheme
on a path to realize its full potential, both in the U.S. and abroad,”
stated William Heiden, president and chief executive officer of AMAG.
“Additionally, we believe, that the more efficient cost structure that
we established in 2012, coupled with continued top-line growth, will
help drive our company to profitability.”

Business Highlights and Estimated 2012 Financial Results (unaudited)

  • AMAG expects to report 2012 full year financial results in line with
    previous guidance, which was positively updated over the course of the
    year. The company ended 2012 with approximately $227 million in cash
    and investments.

    • For the fourth quarter of 2012, AMAG expects total revenues of
      between $21.1 million and $21.5 million, including between $14.4
      million and $14.8 million       of net U.S. Feraheme product revenues.
      The approximate 14% growth in U.S. net product revenues, compared
      to the fourth quarter of 2011, was driven by increased volume and
      an improving net effective price per gram for Feraheme.
    • Total operating expenses, excluding cost of goods sold, for the
      fourth quarter of 2012 are expected to be between $21.0 million
      and $22.5 million      , approximately 31% lower than the fourth quarter
      of 2011.
  • AMAG sold approximately 110,000 grams of Feraheme in the U.S. in 2012,
    representing record demand and more than 17% volume growth over 2011.
  • During the fourth quarter of 2012, AMAG’s partner, Takeda
    Pharmaceutical Company Limited    , launched ferumoxytol in Canada, under
    the brand name Feraheme, and in several European countries as Rienso®
    (ferumoxytol). During 2012, AMAG received $33 million in milestone
    payments related to ex-U.S. approvals and launches, $18 million of
    which it received in the fourth quarter. Additionally, during the
    fourth quarter of 2012, AMAG realized its first revenues from
    royalties and product sales in these regions.
  • AMAG submitted a supplemental new drug application (sNDA) for Feraheme
    to the U.S. Food and Drug Administration (FDA) in December 2012. The
    company is seeking to expand the label for Feraheme to include all
    patients with iron deficiency anemia, regardless of the underlying
    cause, who have failed or could not tolerate oral iron. The company
    believes that regulatory approval from the FDA for this broader
    patient population would double the market opportunity in the U.S. for
    Feraheme.

2013 Financial Outlook

“As we look to 2013, we plan to deliver accelerating revenue growth,
driven by both greater volume and increasing net revenue realized per
gram of Feraheme sold,” Heiden stated. “While we will continue to
operate as efficiently as possible, we do plan to make strategic
investments over the course of 2013 to maximize the commercial potential
of Feraheme and to ensure that we are positioned for success in the
broader IV iron market, in anticipation of potential regulatory approval
for the expanded IDA indication late in the year.”

The company expects to achieve the following in 2013:

  • Total revenues of between $73 million and $77 million, including:

    • Feraheme U.S. net product revenues of between $63 million and $67
      million      , driven by a combination of price and double-digit volume
      growth;
    • Royalties and product sales related to ex-U.S. sales of
      Feraheme/Rienso and recognition of milestones of approximately $10
      million      ;
  • Cost of goods sold (COGS) of between 14% and 18% of net product sales;
  • Total operating expenses, excluding COGS, of between $78 million and
    $82 million    , representing an approximate 10% reduction from 2012. The
    reduced operating expenses in 2013 will be driven by decreased
    clinical trial costs, offset in part by new investments in a
    lower-cost production process and pre-launch investments to support a
    potential expansion to Feraheme’s label. The company expects:

    • Research and development expenses of between $24 million and $27
      million      , representing an approximate 27% reduction from 2012;
    • Selling, general and administrative expenses of between $54
      million and $57 million      , representing an approximate 2% increase
      from 2012; and
  • A 2013 year-end cash and investments balance of between $206 million
    and $211 million    , not including the impact of business development
    transactions.

“AMAG is a different company than it was just 12 months ago – I believe
that we are now in a stronger position, both commercially and
financially. Feraheme is a on a solid growth trajectory and we are now
ready to add additional commercial products to our portfolio to leverage
these strengths,” concluded Heiden.

Webcast Information

A live audio webcast of the company’s presentation and the following
breakout session, along with the accompanying slide presentation at the
31st Annual J.P. Morgan Healthcare Conference will be
accessible through the Investors section of the company’s website at
www.amagpharma.com on January 9, 2013 at 8:30 a.m. P.T. (11:30 a.m.
E.T.). Following the conference, the webcast will be archived on the
AMAG Pharmaceuticals, Inc. website until February 9, 2013.

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.1 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.2

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.

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, our
presentation at the 31st Annual J.P. Morgan Healthcare
Conference; the market for Feraheme and our future profitability; our
estimates of fourth quarter 2012 total revenues, Feraheme net product
revenues, operating expenses and cost of goods sold; our efforts and
expectations regarding our supplemental new drug application for
Feraheme; revenue growth and plans for strategic investments, including
the addition of commercial products to our portfolio; our expectations
regarding Feraheme provider demand trends and the effective price per
gram for Feraheme; 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.

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

Rienso is a registered trademark of Takeda Pharmaceutical Company
Limited.

1 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.

2 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