Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2012 Financial Results

Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2012 Financial

CAMBRIDGE, Mass., Feb. 15, 2013 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals,
Inc. (Nasdaq:MNTA) today reported its financial results for the fourth quarter
and year ended December 31, 2012.

For the fourth quarter of 2012, the company reported a net loss of $(17.7)
million, or $(0.35) per share compared to a net loss of $(1.3) million, or
$(0.02) per share for the same period in 2011. For the year ended December 31,
2012, the company reported a net loss of $(58.6) million, or $(1.16) per share
compared to net income of $180.4 million, or $3.55 per diluted share, for the
same period in 2011. At December 31, 2012, the company had cash, cash
equivalents, and marketable securities of $340.6 million compared to $348.4
million at December 31, 2011.

"In 2012, we made significant advances across our development programs," said
Craig Wheeler, president and chief executive officer of Momenta
Pharmaceuticals. "We have invested in our capabilities to develop multiple
biosimilars, advanced an innovative sialylation technology that could have
broad applicability and initiated clinical studies of our novel drug M402 for
metastatic pancreatic cancer. The advancement of M356, our generic version of
Copaxone®, is a key priority and the FDA's review of the ANDA is moving
forward. We remain confident that the data submitted as part of the ANDA
support approval under the 505(j) pathway as an interchangeable generic

Mr. Wheeler continued, "Royalty revenues from sales of enoxaparin sodium
injection rebounded nicely in the fourth quarter and we believe will continue
to provide important cash flow to Momenta."

Fourth Quarter and Recent Events

Complex Generics Program:

M356, generic version of Copaxone® (glatiramer acetate injection)

  *The ANDA for M356 is under active review by the U.S. FDA.
  *In the patent litigation brought by Teva Pharmaceuticals against Momenta
    and Sandoz, appellate briefing is expected to be completed in the first
    quarter. Oral arguments are expected to be heard by the U.S. Court of
    Appeals for the Federal Circuit in the second quarter of 2013, with the
    appellate decision expected in the second half of the year.

Enoxaparin Sodium Injection

  *In the fourth quarter of 2012, Momenta earned $10.8 million in product
    revenues on net sales of enoxaparin sodium injection based on Sandoz
    reported net sales of $85 million.
  *In November 2012, the U.S. Court of Appeals for the Federal Circuit denied
    en banc review of its decision in Momenta Pharmaceuticals vs. Amphastar
    Pharmaceuticals, Inc. Momenta plans to file this month a petition for a
    writ of certiorari for a review by the Supreme Court.
  *The stay on the District Court proceedings has been lifted. Amphastar has
    filed a Motion for Summary Judgment and the Court has set a briefing

Biosimilars Program:

Baxter Collaboration

  *Three biosimilar products are being developed by Momenta under the
    collaboration -- M923 and M834, which are targeted for the treatment of
    autoimmune and other inflammatory indications, and M511, a monoclonal
    antibody for oncology. Momenta expects to submit an IND (Investigational
    New Drug) application in 2014 for its lead biosimilar, M923, and is also
    targeting achievement of development criteria that would generate a
    license payment or milestone payment for M511 and M834 in 2014.

Novel Drug Program:

M402 novel oncology candidate

  *Momenta is conducting a Phase 1/2 proof-of-concept trial for M402 in
    people with advanced metastatic pancreatic cancer. Data from Part A of the
    two-part study, which is designed to investigate the safety and antitumor
    activity of M402, are expected in 2013. M402 is a novel oncology candidate
    designed to inhibit tumor angiogenesis, progression, and metastasis.

Sialylation research program

  *Momenta continues to make significant research progress in demonstrating
    that the sialylation of Fc enhances anti-inflammatory effects. The company
    expects to generate more data in 2013 that will guide its research efforts
    toward optimizing a drug candidate to take into the clinic.

Fourth Quarter and Year End 2012 Financial Results

Total collaboration revenue for the fourth quarter of 2012 was $12.7 million
(including enoxaparin product revenue of $10.8 million), compared to $29.5
million (including enoxaparin product revenue of $26.1 million) for the same
period in 2011. Sandoz reported fourth quarter 2012 enoxaparin net sales of
$85 million versus $225 million for the fourth quarter 2011. The significant
decrease in enoxaparin product revenue reflects decreased unit sales due to
lower market share, as well as lower prices in response to competitor pricing
reductions on enoxaparin. For the year ended December 31, 2012, revenue was
$63.9 million, compared to $283.1 million for 2011. In January 2012, the
launch of a competitor's generic Lovenox® triggered a change in the revenue
Momenta receives from its collaborator, Sandoz, from a hybrid profit
share/royalty to a straight royalty structure. The fiscal year 2011 included
product revenue earned based on profit share through September 2011 and a
hybrid royalty/profit share for the fourth quarter of 2011, while the fiscal
year 2012 product revenue reflected the straight royalty structure after
January 2012.

Collaborative research and development revenue for the fourth quarter of 2012
was $1.9 million, which included $0.7 million expense reimbursement from
Sandoz under the enoxaparin and generic Copaxone® collaborations, $0.5 million
amortization of the equity premium received from the 2006 Sandoz
collaboration, and $0.7 million amortization of the $33 million payment paid
by Baxter.

Research and development expenses for the fourth quarter of 2012 were $21.5
million, compared to $21.2 million for the same period in 2011. For the year
ended December 31, 2012, research and development expenses were $80.3 million,
compared to $64.7 million for the year ended 2011. The increase of $15.6
million in research and development expenses from 2011 to 2012 resulted from
increases of $9.8 million in personnel and facilities-related expenses, $3.0
million in laboratory expenses, and $2.5 million in clinical trial expenses
associated with our M402 Phase 1/2 clinical study.

General and administrative expenses for the quarter ended December 31, 2012
were $9.4 million, compared with $9.7 million for the same period in 2011. For
the year ended December 31, 2012, general and administrative expenses were
$43.7 million, compared to $38.7 million for the year ended 2011. The increase
of $5.0 million in general and administrative expenses from 2011 to 2012 was
primarily due to increases of $6.4 million in professional fees, largely
related to enoxaparin patent litigation in the first half of 2012, $1.7
million in personnel-related expenses, and $1.7 million in share-based
compensation expense, offset by a decrease of $5.5 million in royalty fees
payable, primarily to the Massachusetts Institute of Technology, due to
reduced enoxaparin product revenue.

At December 31, 2012, Momenta had $340.6 million in cash, cash equivalents and
marketable securities. This cash position excludes restricted cash of $17.5
million, which serves as collateral for a security bond related to enoxaparin
legal proceedings, and $2.5 million of cash that is restricted in connection
with a facility lease letter of credit. 

Financial Guidance

Momenta confirmed its guidance provided November 7, 2012 for 2013 total
operating expenses, excluding stock-based compensation and net of
collaborative revenues, of approximately $30 million per quarter. For 2013,
Momenta is projecting that its net cash usage will average approximately $20
to $24 million per quarter for a total operating cash usage of approximately
$90 million.

Conference Call Information

Management will host a conference call and webcast today at 10:00 am ET to
discuss these results and provide an update on the company. A live webcast of
the conference call may be accessed on the "Investors" section of the
company's website, Please go to the site at least 15
minutes prior to the call in order to register, download, and install any
necessary software. An archived version of the webcast will be posted on the
Momenta website approximately two hours after the call and will be available
through March 1, 2013.

To access the call you may also dial (877) 224-9084 (domestic) or (720)
545-0022 (international) prior to the scheduled conference call time and
provide the access code 89671238. A replay of the call will be available
approximately two hours after the conclusion of the call and will be
accessible through November 14, 2013. To access the replay, please dial (855)
859-2056 (domestic) or (404) 537-3406 (international) and provide the access
code 89671238.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the
detailed structural analysis of complex mixture drugs and is headquartered in
Cambridge, MA. Momenta is applying its technology to the development of
generic versions of complex drugs, follow-on biologics and to the discovery
and development of novel drugs.

To receive additional information about Momenta, please visit the website at, which does not form a part of this press release.

Forward Looking Statements

Statements in this press release regarding management's future expectations,
beliefs, intentions, goals, strategies, plans or prospects, the Company's
revenue, expenses, including total operating expenses for 2013, comments
regarding fourth quarter revenue as indicative of future enoxaparin revenue,
anticipated achievement of milestones under the Baxter collaboration in 2014,
and cash usage, and other results of operations, our expected product
development and collaboration milestones and timing for clinical and
non-clinical results, our plans for future research and development
investment, and our other product development plans and expectations
constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995.Forward-looking statements can be
identified by terminology such as "anticipate," "believe," "could," "could
increase the likelihood," "hope," "target," "project," "goals," "potential,"
"predict," "might," "estimate," "expect," "intend," "is planned," "may,"
"should," "will," "will enable," "would be expected," "look forward," "may
provide," "would" or similar terms, variations of such terms or the negative
of those terms. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors referred to in the company's Quarterly
Report on Form10-Q for quarter ended September 30, 2012 filed with the
Securities and Exchange Commission under the section "Risk Factors," as well
as other documents that may be filed by Momenta from time to time with the
Securities and Exchange Commission. As a result of such risks, uncertainties
and factors, the Company's actual results may differ materially from any
future results, performance or achievements discussed in or implied by the
forward-looking statements contained herein. Momenta is providing the
information in this press release as of this date and assumes no obligations
to update the information included in this press release or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.

Our logo, trademarks, and service marks are the property of Momenta
Pharmaceuticals,Inc. All other trade names, trademarks, or service marks are
property of their respective owners.

Unaudited Condensed Consolidated Balance Sheets
(in thousands)
                                          December 31, December31,
                                           2012         2011
Cash and marketable securities             $340,603   $348,438
Accounts receivable                        10,811       28,171
Short-term and long-term restricted cash   19,971       17,500
Other assets                               35,244       26,800
Total assets                               $406,629   $420,909
Liabilities and Stockholders' Equity                   
Current liabilities                        $18,161    $16,028
Deferred revenue, net of current portion   27,269       1,608
Other long-term liabilities                712          195
Stockholders' equity                       360,487      403,078
Total liabilities and stockholders' equity $406,629   $420,909

Unaudited Condensed Statements of Comprehensive (Loss) Income
(in thousands, except per share amounts)
                                ThreeMonths Ended     Year Ended
                                 December 31,           December 31,
                                2012        2011       2012        2011
Collaboration revenues:                                          
Product revenues                 $10,812   $26,148  $54,772   $270,473
Research and development         1,916      3,307     9,149      12,595
Total revenues                   12,728     29,455    63,921     283,068
Operating expenses:                                              
Research and development*        21,540     21,239    80,345     64,657
General and administrative*      9,373      9,714     43,682     38,710
Total operating expenses         30,913     30,953    124,027    103,367
Operating (loss) income          (18,185)   (1,498)   (60,106)   179,701
Other income (expense):                                          
Interest income                  288        247       1,238      746
Interest expense                 --        (2)       --        (91)
Other income                     220        --       220        --
Total other income (expense)     508        245       1,458      655
Net (loss) income                $(17,677) $(1,253) $(58,648) $180,356
Net (loss) income per share:                                     
Basic                            $(0.35)   $(0.02)  $(1.16)   $3.62
Diluted                          $(0.35)   $(0.02)  $(1.16)   $3.55
Weighted average shares                                          
Basic                            50,547     50,128    50,411     49,852
Diluted                          50,547     50,128    50,411     50,823
Comprehensive (loss) income      $(17,737)  $(1,186)  $(58,456)  $180,291
*Includes the following
share-based compensation                                         
Research and development         $1,515    $1,369   $5,832    $4,919
General and administrative       $1,937    $1,753   $7,880    $6,219

CONTACT: Lora Pike
         Momenta Pharmaceuticals, Inc.
         (617) 395-5189
Press spacebar to pause and continue. Press esc to stop.