Momenta Pharmaceuticals, Inc.
Aug 1, 2013

Momenta Pharmaceuticals Reports Second Quarter 2013 Financial Results

CAMBRIDGE, Mass., Aug. 1, 2013 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended June 30, 2013.

For the second quarter of 2013, the company reported a net loss of $28.8 million, or ($0.57) per share, compared with a net loss of $10.2 million, or ($0.20) per share, for the same period in 2012. At June 30, 2013, the company had cash, cash equivalents, and marketable securities of $300.2 million, compared with $340.6 million at December 31, 2012.

"We are extremely pleased with the recent opinion by the Federal Circuit that found several Copaxone® patents Teva asserted against Momenta and Sandoz invalid," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "The Court's decision clears the path to potentially launch M356, generic Copaxone, in the U.S. after the remaining patents expire in May 2014, pending FDA approval.

"In addition to the favorable Federal Circuit ruling, our 2013 achievements include advancing our lead biosimilar product M923 toward a planned IND submission in 2014 and executing on objectives for our biosimilars and novel drug programs," continued Mr. Wheeler.

Second Quarter Highlights and Recent Progress

Complex Generics:

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

Enoxaparin Sodium Injection

Biosimilars and Potentially Interchangeable Biologics:

Novel Products:

M402 Phase 1/2 proof-of-concept study

Sialylation research program

Second Quarter 2013 Financial Results

Total revenue for the second quarter of 2013 was $4.4 million (including product revenue of $1.6 million), compared with $21.9 million (including product revenue of $19.4 million) for the same period in 2012. Sandoz reported second quarter enoxaparin net sales of $57 million. The decrease in product revenue from the prior year was due to decreased unit sales due to lower market share and lower prices in response to competitor pricing reductions on Enoxaparin Sodium Injection. In the second quarter of 2013 and 2012, Momenta's product revenue was reduced by $3.8 million and $3.9 million, respectively, for an annual adjustment to contractual share of certain development and other expenses for Enoxaparin Sodium Injection. Momenta second quarter 2013 revenues also include $2.7 million in research and development revenue, including $0.7 million in amortization of the $33 million payment received from the Baxter collaboration.

Research and development expenses, including stock-based compensation, for the second quarter of 2013 were $22.0 million, compared with $20.0 million, including stock-based compensation, for the same period in 2012. The increase was primarily due to personnel and related costs associated with increased headcount to support development of the company's pipeline as well as process development, manufacturing, and research costs related to the company's biosimilars program.

General and administrative expenses for the second quarter of 2013 were $11.5 million, including stock-based compensation, compared with $12.4 million, including stock-based compensation, for the same period in 2012. The decrease of $0.9 million from same period in 2012 was primarily due to a decrease in professional fees principally due to decreased legal fees relating to Enoxaparin Sodium Injection patent litigation.

At June 30, 2013, Momenta had $300.2 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 related to a facility lease letter of credit.

Financial Guidance

Momenta confirmed its guidance for 2013 for total operating expenses, excluding stock compensation and net of collaborative revenues, averaging 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 $80 to $90 million for 2013.

Conference Call Information

Management will host a conference call today, August 1, 2013 at 10:00 am EDT to discuss these results and provide an update on the company. To access the call, please dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 19648443. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through August 8, 2013. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 19648443.

A live audio webcast of the call will be available on the "Investors" section of the company's web site, www.momentapharma.com.  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 web site approximately two hours after the call and will be available through August 15, 2013.

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, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel products.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, 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 and other results of operations, including the quarter ended June 30, 2013, expectations regarding the review of the M356 ANDA by the FDA, expected achievement of product development milestones, the timing of legal developments and decisions, plans for future research and development investment, and other product development and research plans and expectations may 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 Form 10-Q for quarter ended March 31, 2013 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.

Momenta's 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.

MOMENTA PHARMACEUTICALS, INC.
Unaudited, Condensed Consolidated Balance Sheets
(in thousands)
     
  June 30,
2013
December 31,
2012
Assets    
Cash and marketable securities  $ 300,160  $ 340,603
Accounts receivable 3,099 10,811
Restricted cash 19,971 19,971
Other assets 34,529 35,244
Total assets  $ 357,759  $ 406,629
Liabilities and Stockholders' Equity    
Current liabilities  $ 16,829  $ 18,161
Deferred revenue, net of current portion 25,412 27,269
Other liabilities 602 712
Stockholders' equity 314,916 360,487
Total liabilities and stockholders' equity  $ 357,759  $ 406,629
 
 
MOMENTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)
         
  Three Months
Ended June 30,
Six Months
Ended June 30,
  2013 2012 2013 2012
Collaboration revenues:        
Product revenue $ 1,628 $ 19,352 $ 7,024 $ 41,382
Research and development revenue 2,733 2,511 4,940 4,709
Total collaboration revenue 4,361 21,863 11,964 46,091
         
Operating expenses:        
Research and development* 21,994 20,011 44,326 38,572
General and administrative* 11,516 12,353 21,233 23,310
Total operating expenses 33,510 32,364 65,559 61,882
         
Operating loss (29,149) (10,501) (53,595) (15,791)
         
Other income:        
Interest income 243 335 512 642
Other income 58 118
Total other income 301 335 630 642
         
Net loss $ (28,848) $ (10,166) $ (52,965) $ (15,149)
         
Basic and diluted net loss per share $ (0.57) $ (0.20) $ (1.04) $ (0.30)
         
Weighted average shares used in computing basic and diluted net loss per share  50,746 50,354 50,690 50,297
         
Comprehensive loss $ (28,872) $ (10,206) $ (53,054) $ (15,082)
         
* Non-cash share-based compensation expense included in operating expenses is as follows:
         
Research and development  $ 1,487  $ 1,432  $ 2,610  $ 2,786
General and administrative  $ 1,842  $ 2,025  $ 3,591  $ 3,925
CONTACT: Lora Pike

         Momenta Pharmaceuticals, Inc.

         lpike@momentapharma.com

         (617) 395-5189
Source: Momenta Pharmaceuticals

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