AMAG Reports Third Quarter and Nine Month 2013 Financial Results

AMAG Reports Third Quarter and Nine Month 2013 Financial Results

                Another Quarter of Record U.S. Feraheme Sales
                 Company Achieves Cash-flow Positive Quarter
    Strong Performance Leads to Updated Full-year 2013 Financial Guidance

              Conference call scheduled for 8:00 a.m. EDT today

WALTHAM, Mass., Oct. 23, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc.
(Nasdaq:AMAG), a specialty pharmaceutical company, today reported unaudited
consolidated financial results for the third quarter and nine months ended
September 30, 2013. Total revenues for the third quarter of 2013 were $21.6
million, of which $19.3 million were U.S. net Feraheme® (ferumoxytol) sales,
the highest Feraheme quarterly sales since launch in 2009. AMAG generated
positive cash flows during the quarter and ended the third quarter with $213.5
million in cash and investments.

"Our ability to deliver another quarter of record growth as we entered the
fifth year of Feraheme's launch in the chronic kidney disease (CKD) patient
population is a testament to the features of the product, as well as the drive
and determination of the AMAG commercial team," said William Heiden, president
and chief executive officer. "Physicians across the U.S. recognize Feraheme as
the iron deficiency anemia (IDA) treatment of choice for their patients with
CKD and we will continue our efforts to drive growth in the CKD segment as we
seek regulatory approval to expand the indication for Feraheme."

Business Highlights

  *The company reported record U.S. net Feraheme product sales of $18.7
    million in the third quarter of 2013, compared to $14.1 million in the
    third quarter of 2012, representing a 33 percent increase; the product
    sales and growth figures for each period exclude the positive impact of
    the reduction of reserves for Medicaid rebates and product returns. The
    growth in product sales was primarily driven by increased volume across
    all segments of the non-dialysis market. Increasing net revenue per gram
    also contributed to the growth in net product sales, driven by the
    continued execution of AMAG's pricing strategy.
    
  *Total Feraheme provider demand for the third quarter of 2013 hit a record
    level for the second consecutive quarter at approximately 36,200 grams,
    compared to approximately 27,500 grams in the third quarter of
    2012.^1Several strategies led to the sales success during the third
    quarter of 2013, including an effective contracting strategy that provided
    incentives for physicians to have Feraheme in-stock and available,
    especially important in the face of a new competitor. Wholesaler inventory
    levels at the end of the third quarter of 2013 remained consistent with
    levels at the end of the second quarter of 2013.
    
  *During the third quarter of 2013, AMAG prepared for, and began promoting
    MuGard® Mucoadhesive Oral Wound Rinse, which the company licensed from
    Access Pharmaceuticals, Inc. in June 2013. The company revised the
    promotional messaging, developed new promotional materials, and trained
    its sales force.
    
  *In October 2013, AMAG announced that it had received notice of a 3-month
    extension of the PDUFA action date for the supplemental new drug
    application (sNDA) for Feraheme. The sNDA is seeking to expand the label
    for Feraheme to include all adult IDA patients who have failed or could
    not tolerate oral iron. The FDA informed the company of a new PDUFA action
    date of January 21, 2014, and a target date of December 23, 2013 to enter
    label discussions.

Third Quarter and Nine Month 2013 Financial Results (unaudited)

"The fundamentals of our business have improved every quarter for the past
year and a half," commented Frank Thomas, chief operating officer. "Now that
we have managed the business to positive cash flow levels this quarter, future
growth in revenue, combined with continuing operating expense discipline,
should provide positive earnings and drive further cash generation for AMAG to
deploy towards expanding our portfolio further."

The company reported record U.S. net Feraheme product sales of $18.7 million
(excluding a $0.6 million reduction of Medicaid reserves) for the third
quarter of 2013, compared to $14.1 million (excluding a $2.1 million reduction
of product return and Medicaid reserves) for the third quarter of 2012. For
the nine months ended September 30, 2013, AMAG reported U.S. net Feraheme
product sales of $51.8 million (excluding a $0.6 million reduction of Medicaid
reserves), compared to $40.7 million (excluding a $3.2 million reduction of
product return and Medicaid reserves) for the corresponding period in 2012.

Total revenues for the quarter ended September 30, 2013 were $21.6 million, as
compared to $17.7 million for the third quarter of 2012.For the nine months
ended September 30, 2013, AMAG reported total revenues of $59.1 million, as
compared to revenues of $64.2 million for the corresponding period in 2012;
the 2012 nine-month period was favorably impacted by the recognition of a $15
million milestone payment from Takeda Pharmaceutical Company Ltd. in June 2012
following the European regulatory approval of ferumoxytol for patients with
IDA and CKD.

Feraheme cost of goods sold (COGS) for the quarter ended September 30, 2013
was $2.5 million, or 13 percent of Feraheme net product revenues, compared to
$4.3 million, or 31 percent of Feraheme net product revenues for the quarter
ended September 30, 2012. For the nine months ended September 30, 2013,
Feraheme COGS were $8.4 million, or 16 percent of Feraheme net product
revenues, compared to $10.0 million, or 25 percent of Feraheme net product
revenues, for the corresponding period in 2012. COGS for the 2012 periods
included expenses associated with the closing of the company's Cambridge,
Massachusetts manufacturing facility.

Total operating expenses for the quarter ended September 30, 2013 were $19.5
million, compared to $18.0 million for the third quarter of 2012. The
increase in total operating expenses for the quarter ended September 30, 2013
was due to higher selling, general and administrative costs, including certain
one-time costs related to the company's relocation to a new corporate
headquarters, which is expected to result in lower annual rent expense over
the next several years. Total operating expenses for the nine months ended
September 30, 2013 were $58.1 million, 14 percent lower than 2012 nine-month
operating expenses of $67.5 million, including $1.6 million in restructuring
expenses. The decrease in total operating expenses in the nine months ended
September 30, 2013 was due primarily to decreased research and development
costs associated with the company's global IDA registration program and the
benefits of a leaner corporate infrastructure implemented in 2012.

The company reported a net loss of $0.1 million, or a loss of $0.01 per basic
and diluted share, for the quarter ended September 30, 2013, as compared to
net a loss of $4.0 million, or $0.19 per basic and diluted share, for the
third quarter of 2012. AMAG reported a net loss for the nine months ended
September 30, 2013 of $5.9 million, or $0.28 per basic and diluted share, as
compared to a net loss of $13.1 million, or $0.61 per basic and diluted share,
for the corresponding period in 2012.

As of September 30, 2013, the company's cash and investments totaled
approximately $213.5 million, reflecting net cash generated during the quarter
of approximately $1.1 million.

Improved 2013 Financial Outlook

The company has updated its financial guidance for the full year of 2013. AMAG
has:

  *Increased its total revenue forecast to between $78 million and $81
    million, including:

    *U.S. Feraheme net product sales of between $69 million and $71 million;
    *Revenues from other sources of between $9 million and $10 million,
      including ex-U.S. Feraheme/Rienso product sales, royalties and
      amortization of milestones as well as MuGard product sales;

  *Narrowed the range of forecasted Feraheme COGS to between 15 percent and
    17 percent of net Feraheme global product sales. Total COGS reported
    includes those associated with sales of MuGard;
  *Lowered its total operating expense forecast to between $76 million and
    $80 million; and
  *Increased its 2013 year-end cash and investments forecast to between $209
    million and $213 million, including the upfront costs of the MuGard
    licensing transaction, but excluding the impact of future business
    development transactions.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides
today at 8:00 a.m. EDT, during which management will discuss the company's
financial results and commercial progress. 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 11:00 a.m. EDT on October 23, 2013 through midnight on October
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 78527930.

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 11:00a.m. EDT on October 23, 2013 through
midnight November 22, 2013.


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except per share data)
                                                        
                                      Three Months Ended Nine months Ended
                                       September 30,      September 30,
                                      2013     2012      2013      2012
Revenues:                                                        
U.S. Feraheme product sales, net       $19,347 $16,186  $52,381  $43,906
Otherproduct sales and royalties      271      (10)      708       417
License fee and other collaboration    1,998   1,566    6,056    19,911
revenues
Total revenues                        21,616   17,742    59,145    64,234
Operating costs and expenses:                                    
Cost of product sales                  2,547    4,323     8,634     10,193
Research and development expenses      4,530    5,260     13,983    25,393
Selling, general and administrative    14,934   12,160   44,150   40,442
expenses
Restructuring expenses                --       562       --        1,620
Total operating costs and expenses     22,011   22,305    66,767    77,648
Operating loss                         (395)    (4,563)   (7,622)   (13,414)
Interest and dividend income, net      246      295       773       1,026
Gains on sale of assets                --       --        865       --
Gains (losses) on investments, net     4        2         36        (1,469)
Net loss before income taxes           (145)    (4,266)  (5,948)   (13,857)
Income tax benefit                     --       299       --        793
Net loss                               $(145)  $(3,967) $(5,948) $(13,064)
                                                                
Net loss per share                                               
Basic and diluted                      $(0.01) $(0.19)  $(0.28)  $(0.61)
                                                                
Weighted average shares outstanding                              
used to compute net loss per share:
Basic and diluted                      21,691   21,403    21,613    21,374



AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
                                                          
                                        September 30, 2013 December 31, 2012
Cash and cash equivalents                $30,946           $46,293
Short-term investments                   182,595            180,750
Accounts receivable, net                 8,778              6,410
Inventories                              14,694             12,451
Receivable from collaboration            250                263
Assets held for sale                     1,934              2,000
Other current assets                     6,360              6,673
Total current assets                     245,557            254,840
Property and equipment, net              1,741              3,297
Intangible assets, net                   16,866             --
Other assets                             400                --
Total assets                             $264,564          $258,137
                                                          
Accounts payable                         $1,001            $3,515
Accrued expenses                         20,032             20,338
Deferred revenues                        10,027             9,104
Total current liabilities                31,060             32,957
Deferred revenues                        44,428             50,350
Acquisition-related contingent           13,097             --
consideration, net
Other long-term liabilities              1,728              2,033
Total long-term liabilities              59,253             52,383
Total stockholders' equity               174,251            172,797
Total liabilities and stockholders'      $264,564          $258,137
equity

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets
Feraheme® (ferumoxytol) Injection and MuGard® Mucoadhesive Oral Wound Rinse in
the United States. Along with driving organic growth of its products, AMAG
intends to expand its portfolio with additional commercial-stage specialty
products. 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. MuGard is a registered trademark of Access
Pharmaceuticals, Inc. Rienso is a registered trademark of Takeda
Pharmaceutical Company Limited.

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: our efforts to drive growth in
the CKD segment; our plans for the third quarter launch of MuGard; the
potential expansion of Feraheme's labeled indication and our expectations
regarding the FDA's review of our sNDA for Feraheme; expectations regarding
our 2013 results, including our expected 2013 revenues, operating expenses and
cost of goods sold and our expected 2013 year-end cash and investments
balance; and our plans to drive organic growth and expand our product
portfolio with complementary products, 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 compete in the oral mucositis market in
the U.S., (3) 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 outside of
the US, including the EU, (4) the possibility that significant safety or drug
interaction problems could arise with respect to Feraheme/Rienso, and in turn
affect sales, regulatory approval or our ability to market the product both in
the U.S. and outside of the U.S., including the EU, (5) uncertainties
regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties
relating to our patents and proprietary rights, both in the U.S. and outside
of the U.S., (7) the risk of an Abbreviated New Drug Application (ANDA) filing
following the FDA's draft bioequivalence recommendation for ferumoxytol, (8)
the risk that we may not realize the anticipated benefits of our licensing
arrangement for and continued integration of MuGard and (9) other risks
identified in our Securities and Exchange Commission filings, including our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 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

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