Momenta Pharmaceuticals, Inc.
Nov 5, 2014

Momenta Pharmaceuticals Reports Third Quarter 2014 Financial Results

CAMBRIDGE, Mass., Nov. 5, 2014 (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 third quarter ended September 30, 2014.

For the third quarter of 2014, the company reported a net loss of $29.1 million, or $(0.56) per share, compared to a net loss of $25.4 million, or $(0.50) per share for the same period in 2013. At September 30, 2014, the company had cash, cash equivalents, and marketable securities of $176.5 million.

"In the third quarter we continued to make important progress across our complex generics, biosimilars and novel drug programs," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We discussed this progress at our R&D day in early October where we announced encouraging top-line results from the Part A phase of our necuparanib trial and unveiled three promising novel autoimmune drug candidates that we expect to reach clinical stage in 2016. We also discussed the progress we made in our biosimilars portfolio and in building on that progress, we are pleased to report that a European clinical trial application has been filed for M923, our biosimilar version of Humira® (adalimumab) in collaboration with Baxter. In addition, we recently achieved an important milestone in the development of our second biosimilar candidate, M834, also in development with Baxter. 

"In a short amount of time our innovative technology platform has allowed us to develop a robust portfolio of product candidates that we believe have the potential to create significant value for our shareholders in the coming years and beyond," continued Mr. Wheeler.

Third Quarter Highlights and Recent Events

Complex Generics:
M356, generic version of COPAXONE® (glatiramer acetate injection)

Enoxaparin Sodium Injection

Biosimilar and Potentially Interchangeable Biologics:

Novel Drugs:
Necuparanib (novel oncology candidate)

Novel Autoimmune Drugs 
The Company announced it is advancing three novel autoimmune candidates toward clinical development over the next 18 to 24 months including:

Third Quarter 2014 Financial Results
Total revenues for the third quarter of 2014 were $9.3 million (including enoxaparin product revenue of $4.7 million), compared to $10.8 million (including enoxaparin product revenue of $4.8 million) for the same period in 2013. Sandoz reported third quarter 2014 enoxaparin net sales of $48 million, compared to $58 million for the third quarter of 2013.

Collaborative research and development revenue for the third quarter of 2014 was $4.6 million, compared to $6.0 million in the same quarter last year. The decrease of $1.4 million in collaborative revenue between comparable periods is due to lower reimbursable M923 research and development services and expenses incurred in connection with the Baxter Agreement. 

Research and development expenses for the third quarter of 2014 were $27.5 million, compared to $27.4 million for the same period in 2013.  The increase of $0.1 million from the 2013 period to the 2014 period resulted from increases of: $2.0 million in costs incurred to advance our research program; $1.2 million in necuparanib clinical costs incurred to complete the Part A dose escalation component of the Phase 1/2 trial; and $0.9 million in facility related costs due to additional subleased laboratory and office space. These increases were offset by a $4.0 million decrease in consulting, third-party process development and contract research costs related to the Company's biosimilars program.

General and administrative expenses for the third quarter ended September 30, 2014 were $11.1 million, compared with $9.0 million for the same period in 2013. The increase of $2.1 million in the third quarter of 2014 was due to: $0.9 million in professional fees, driven mainly by corporate and IP legal fees; $0.7 million in rent and facility-related costs due to additional subleased laboratory and office space; and $0.5 million in salary, salary-related and stock compensation.

At September 30, 2014, Momenta had $176.5 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings.

Financial Guidance
Today, Momenta confirmed its financial guidance for the second half of 2014: Momenta previously projected that total 2014 operating expenses, excluding stock-based compensation and net of collaborative revenues, would be $28 to $30 million per quarter and, in the first three quarters of 2014, the average amount per quarter was $30 million.  For the fourth quarter of 2014, the Company projects total operating expenses, excluding stock-based compensation and net of collaborative revenues, to be $30 to $32 million. Momenta previously projected that its net cash usage in 2014, excluding revenue from the potential launch of M356 and milestones earned from the Baxter biosimilars collaboration, would average approximately $26 million per quarter.  Through the first three quarters of 2014, net cash usage has averaged $23 million per quarter. Cash burn for the fourth quarter of 2014 is expected to be in line with our previous guidance and is projected to be partially offset by $19 million from milestone payments earned under the Baxter collaboration, although a portion of these milestone payments could be received in the first quarter of 2015.

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, 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 website approximately two hours after the call and will be available through November 12, 2014.

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 23751819. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through August 14, 2014.  To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 23751819.

About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex 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 therapeutics for oncology and autoimmune indications.

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

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.

Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about the Company's anticipated initiation of a European clinical trial, expected receipt or timing of milestone payments in its development programs with Baxter, future achievements and related value-creation in the Company's antibody research and development programs and product opportunities. 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 the quarter ended June 30, 2014 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 PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
     
  September 30, 2014 December 31, 2013
Assets    
Cash and marketable securities  $ 176,457  $ 245,682
Accounts receivable 7,649 13,095
Restricted cash 20,719 20,719
Other assets 36,710 37,319
Total assets  $ 241,535  $ 316,815
Liabilities and Stockholders' Equity    
Current liabilities  $ 18,615  $ 21,942
Deferred revenue, net of current portion 21,863 24,024
Other long-term liabilities 701 1,012
Stockholders' equity 200,356 269,837
Total liabilities and stockholders' equity  $ 241,535  $ 316,815
 
 
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Comprehensive Loss
(in thousands, except per share amounts)
         
  Three Months
Ended September 30,
Nine Months
Ended September 30,
  2014 2013 2014 2013
Collaboration revenues:        
Product revenue  $ 4,714  $ 4,774  $ 15,216  $ 11,798
Research and development revenue 4,622 5,977 15,855 10,918
Total collaboration revenue 9,336 10,751 31,071 22,716
         
Operating expenses:        
Research and development* 27,508 27,435 80,289 71,771
General and administrative* 11,103 8,977 34,039 30,202
Total operating expenses 38,611 36,412 114,328 101,973
         
Operating loss (29,275) (25,661) (83,257) (79,257)
         
Other income:        
Interest income 112 224 452 736
Other income 62 55 186 174
Total other income 174 279 638 910
         
Net loss $ (29,101) $ (25,382) $ (82,619) $ (78,347)
         
Basic and diluted net loss per share $ (0.56) $ (0.50) $ (1.61) $ (1.54)
         
Weighted average shares used in computing basic and diluted net loss per share 51,545 51,055 51,456 50,813
         
Comprehensive loss:        
Net loss $ (29,101) $ (25,382) $ (82,619) $ (78,347)
Net unrealized holding gains (losses) on available-for-sale marketable securities  (26)  98  (5)  9
Comprehensive loss $ (29,127) $ (25,284) $ (82,624) $ (78,338)
         
* Non-cash share-based compensation expense included in operating expenses is as follows:
         
Research and development  $ 1,509  $ 1,359  $ 4,755  $ 3,969
General and administrative  $ 1,890  $ 1,796  $ 5,760  $ 5,387
CONTACT: INVESTOR CONTACT:

         Sarah Carmody

         Momenta Pharmaceuticals

         1-617-395-5189

         IR@momentapharma.com



         MEDIA CONTACT:

         Karen Sharma

         MacDougall Biomedical Communications

         1-781-235-3060

         Momenta@macbiocom.com
Source: Momenta Pharmaceuticals

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