Momenta Pharmaceuticals, Inc.
MOMENTA PHARMACEUTICALS INC (Form: 8-K, Received: 02/11/2010 08:55:55)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported) February 11, 2010

 

Momenta Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-50797

 

04-3561634

(State or Other Jurisdiction

 

(Commission File Number)

 

(IRS Employer

of Incorporation)

 

 

 

Identification No.)

 

675 West Kendall Street, Cambridge, MA
(Address of Principal Executive Offices)

 

02142
(Zip Code)

 

(617) 491-9700

 (Registrant’s telephone number, including area code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):

 

o             Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o             Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o             Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o             Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02.  Results of Operations and Financial Condition

 

On February 11, 2010, Momenta Pharmaceuticals, Inc., a Delaware corporation, announced its financial results for the quarter and year ended December 31, 2009.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.  Financial Statements and Exhibits

 

(d)          Exhibits

 

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

99.1.  Press Release issued by Momenta Pharmaceuticals, Inc. on February 11, 2010.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

 

MOMENTA PHARMACEUTICALS, INC.

 

 

 

By:

/s/ Richard P. Shea

 

 

Richard P. Shea

 

 

Chief Financial Officer

 

 

(Principal Financial Officer)

 

Date: February 11, 2010

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Momenta Pharmaceuticals, Inc. on February 11, 2010.

 

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Exhibit 99.1

 

MOMENTA PHARMACEUTICALS, INC.

675 WEST KENDALL STREET

T: 617.491.9700   F: 617.621.0430

 

CAMBRIDGE, MA 02142

WWW.MOMENTAPHARMA.COM

 

 

Momenta Pharmaceuticals Reports

Financial Results for the Fourth Quarter and Year End 2009

 

CAMBRIDGE, MA — February 11,2010 — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the fourth quarter and year ended December 31, 2009.

 

For the fourth quarter of 2009 the Company reported a net loss of $14.7million, compared to a net loss of $18.4 millionfor the same period in 2008.  For the year ended December 31, 2009, the Company reported a net loss of $64.0 million compared to a net loss of $62.6 million for the same period in 2008.  At December 31, 2009, the Company had cash, cash equivalents, and marketable securities of $95.7 million, compared to $108.5 million at December 31, 2008.

 

“Momenta is poised for a pivotal year in 2010,” commented Craig A. Wheeler, President and Chief Executive Officer. “We continue to believe the FDA will approve the ANDA for generic Lovenox ® .Together with our collaborative partner Sandoz,we are prepared for a potential launch. The FDA review of the ANDA for the second complex mixture product in our pipeline, generic Copaxone ® , is also well underway.  Our novel drug candidates, products of Momenta’s proprietary analytical platform, are advancing. We begin 2010 financially strong and committed to developing needed medicationsthat will deliver value to patients,” he concluded.

 

2009 Highlights:

 

·                   In 2009the FDAcontinued to reviewthe ANDA for M-Enoxaparin, a generic version Lovenox.  During the year the agency inspected the manufacturing supply chain and,we believe, we have now satisfactorily resolved all of the outstanding technical and regulatory issues relating to approval.

 

·                   We made considerable progress in the regulatory, product and process development activities required to support the approval and commercialization for M356, a generic version of Copaxone.

 



 

·                   We announced positive Phase 2a studyresults for M118, Momenta’s novel anticoagulant, supporting its potential to become the baseline anticoagulant of choice forpatients with acute coronary syndromes (ACS).

 

·                   We presented preclinical data for M402, a novel oncology product candidate, at the American Association for Cancer Research meeting. M402, a rationally designed molecule with a novel mechanism of action, was shown to inhibit tumor metastasis in two murine models, providing a rationale for further clinical development.

 

·                   The Momenta Board of Directors was strengthenedwith the addition of Bruce L. Downey, former Chairman and CEO of Barr Laboratories.

 

·                   We completed a $46.8 million follow-on offering of Momenta stock.

 

Financial Results

Revenue for the fourth quarter of 2009 was $5.6 million, compared to $2.9 million for the same period in 2008.  For the year ended December 31, 2009, revenue was $20.2 million, compared to $14.6 million for2008.  The increase in revenue in both periods was a result of an increase in reimbursable expenses associated with the development of our M356 program.

 

Research and development expenses for the fourth quarter of 2009 were $14.2 million, compared to $15.4 million for the same period in 2008. The decrease in research and development expenses from fourth quarter 2008 to fourth quarter 2009 principally resulted from a decrease in clinical development costs associated with the completion of the M118Phase 2a clinical trial in June 2009. For the year ended December 31, 2009, research and development expenses were $60.6 million, compared to $55.3 million for 2008.  The year-over-year increase in research and development expenses was primarily due to increased manufacturing and third-party research and development expenditures associated with our M356 program.

 

General and administrative expenses for the fourth quarter of 2009 totaled $6.1 million, compared with $6.2 million for the same period in 2008.  For the year ended December 31, 2009, general and administrative expenses were $23.8 million, compared to $24.6 million for 2008.  The decrease in general and administrative expenses for the year was primarily due to a decrease in professional fees.

 

Conference Call Information

Management will host a conference call on Thursday, February 11, 2010 at 10:00 am EST to discuss these results and provide an update on the Company.  To access the call, please dial (877) 419-6603 (domestic) or (719) 325-4835(international) prior to the scheduled conference call time and provide the access code 9660744. A replay of the call will be available approximately two hours after the call and will be accessible through February 25, 2010.  To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 9660744.

 

A live audio webcast of the call will be available on the “Investors” section of the

 

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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 March 13, 2010.

 

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs.  Momenta was founded in 2001 based on technology initially developed at the Massachusetts Institute of Technology and is headquartered in Cambridge, MA.

 

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, including statements relating to the timing, review and inquiries regardinggeneric Lovenox  regulatory submissions, our product development plans, and the Company’s revenue, expenses and other results of operations, including the quarter and year ended December 31, 2009, current and future development efforts and commercialization efforts, 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 the quarter ended September 30, 2009 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.

 

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MOMENTA PHARMACEUTICALS, INC.

Unaudited, Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

December 31,
2009

 

December 31,
2008

 

Assets

 

 

 

 

 

Cash and marketable securities

 

$

95,650

 

$

108,531

 

Restricted cash

 

1,778

 

1,778

 

Other assets

 

21,023

 

21,892

 

Total assets

 

$

118,451

 

$

132,201

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

16,340

 

$

19,092

 

Other liabilities

 

7,949

 

13,604

 

Stockholders’ equity

 

94,162

 

99,505

 

Total liabilities and stockholders’ equity

 

$

118,451

 

$

132,201

 

 

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MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Statement of Operations

(in thousands, except per share amounts)

 

 

 

Three Months Ended
December  31,

 

Year Ended
December 31,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

5,646

 

$

2,941

 

$

20,249

 

$

14,570

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development*

 

14,232

 

15,377

 

60,612

 

55,301

 

General and administrative*

 

6,057

 

6,200

 

23,800

 

24,591

 

Total operating expenses

 

20,289

 

21,577

 

84,412

 

79,892

 

Loss from operations

 

(14,643

)

(18,636

)

(64,163

)

(65,322

)

Other income (expense), net

 

(46

)

266

 

151

 

2,685

 

Net loss

 

$

(14,689

)

$

(18,370

)

$

(64,012

)

$

(62,637

)

Basic and diluted net loss per share

 

$

(0.34

)

$

(0.50

)

$

(1.60

)

$

(1.74

)

Shares used in computing basic and diluted net loss per share

 

43,615

 

36,476

 

40,056 056

 

35,960

 

 


*Includes stock-based compensation of the following:

 

 

 

 

 

 

 

 

 

Research and development

 

$

1,072

 

$

382

 

$

4,377

 

$

3,124

 

General and administrative

 

$

1,443

 

$

1,663

 

$

6,378

 

$

6,090

 

 

CONTACT:

Momenta Pharmaceuticals, Inc.

Beverly Holley, Director of Investor Relations

bholley@momentapharma.com

(617) 395-5189

 

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