Momenta Pharmaceuticals, Inc.
MOMENTA PHARMACEUTICALS INC (Form: 8-K, Received: 05/07/2008 08:54:14)

 

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) May 7, 2008 (May 7, 2008)

 

Momenta Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
 (State or Other Jurisdiction
 of Incorporation)

 

000-50797
 (Commission File Number)

 

04-3561634
(IRS Employer

 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 May 7, 2008, Momenta Pharmaceuticals, Inc., a Delaware corporation, announced its financial results for the quarter ended March 31, 2008.  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 May 7, 2008.

 

2



 

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: May 7, 2008

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Momenta Pharmaceuticals, Inc. on May 7, 2008.

 

4


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 First Quarter of 2008

 

CAMBRIDGE, MA — May 7, 2008 — 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 March 31, 2008.

 

For the first quarter of 2008, the Company reported a net loss of $13.3 million, compared with a net loss of $17.0 million for the same period last year. At March 31, 2008, the Company had cash, cash equivalents, and marketable securities of $123.6 million, compared with $135.9 million at December 31, 2007.

 

“We are pleased that the FDA has clarified our path forward regarding the ANDA for M-Enoxaparin and anticipate submitting the amendment addressing the potential for immunogenicity in the third quarter of this year,”  commented Craig A. Wheeler, President and Chief Executive Officer. “During the quarter, we were particularly pleased to have been part of a scientific collaboration that worked with our co-founder, Dr. Ram Sasisekharan at M.I.T., to investigate the heparin contamination issue.  We believe our work with this team is a testament to the quality and capabilities of Momenta’s technology and people.”

 

First Quarter 2008 Financial Results

 

Revenue for the first quarter of 2008 was $4.2 million, compared to $2.2 million for the same period last year. The increase in revenue was a result of increased reimbursable expenses for the M-Enoxaparin program and increased amortization income.

 

Research and development expenses for the first quarter of 2008 were $12.9 million, compared to $13.8 million for the same period last year. The decrease in research and

 



 

development expenses was primarily due to decreases in manufacturing and process development costs in our M356, M-Enoxaparin and M118 programs and a decrease in stock-based compensation expense.

 

General and administrative expenses for the first quarter of 2008 totaled $5.8 million, compared with $7.7 million for the same period last year. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation expense and a reduction in professional fees and other legal expenses.

 

Recent Corporate Developments

 

On April 29, 2008, the Company announced that it had received regulatory guidance from the Food and Drug Administration (FDA) regarding the Abbreviated New Drug Application (ANDA) for M-Enoxaparin.  Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox®, in collaboration with Sandoz, the generics division of Novartis AG.  Based on the FDA’s guidance and the preliminary assessment by Sandoz and Momenta, the companies plan to submit an amendment to the ANDA in the third quarter of 2008.

 

On April 23, 2008, two peer-reviewed journal articles were released that were co-authored by scientists from the FDA, M.I.T., several other academic institutions and Momenta.  A publication in Nature Biotechnology , titled “Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events”, describes the identification of a contaminant in heparin associated with adverse clinical events.  A paper in the New England Journal of Medicine , titled “Contaminated heparin associated with adverse clinical events and activation of the contact system”, describes the biological and potential clinical effects of the contaminant identified in batches of heparin linked to adverse events.

 

On April 4, 2008, the Company presented clinical data from a Phase 1 study of M118 at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting in Orlando, Florida. One of the key findings was that an Activated Clotting Time (ACT) reading of greater than 200 seconds was achieved in the higher dose cohorts, suggesting that an intravenous bolus administration of M118 can produce ACT levels comparable to levels expected with standard heparin doses

 

 



 

used in conjunction with Percutaneous Coronary Intervention (PCI) procedures.

 

On March 4, 2008, Momenta announced that James M. Roach, M.D., had been appointed as the Company’s new Chief Medical Officer and Senior Vice President of Development.

 

Conference Call Information

 

Management will host a conference call on Wednesday, May 7, 2008 at 10:00 am EDT to discuss these results and provide an update on the Company.  To access the call, please dial (877) 419-6592 (domestic) or (719) 325-4878 (international) prior to the scheduled conference call time and provide the access code 7437817.  A replay of the call will be available approximately two hours after the call and will be accessible through May 14, 2008.  To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 7437817.

 

A live audio webcast of the call will be available 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 June 7, 2008.

 

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 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 FDA’s assessment of the ANDA for M-Enoxaparin or the timing of submission of the amendment to the M-Enoxaparin ANDA, and the Company’s participation in a scientific collaboration regarding heparin contamination 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 Annual Report on Form 10-K for the year ended December 31, 2007 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 obligation 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, trade names and service marks are the property of Momenta Pharmaceuticals, Inc. Other trademarks or service marks appearing in this press release are the property of their respective owners and are not the property of Momenta Pharmaceuticals, Inc. or its subsidiaries.

 

 



 

 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

 

March 31,
2008

 

December 31,
2007

 

Assets

 

 

 

 

 

Cash and marketable securities

 

$

123,558

 

$

135,937

 

Restricted cash

 

1,778

 

1,778

 

Other assets

 

23,306

 

30,583

 

Total assets

 

$

148,642

 

$

168,298

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

14,929

 

$

22,412

 

Other liabilities

 

17,168

 

18,346

 

Stockholders’ equity

 

116,545

 

127,540

 

Total liabilities and stockholders’ equity

 

$

148,642

 

$

168,298

 

 

 



 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Statement of Operations

(in thousands, except per share amounts)

 

 

 

Three Months Ended
March  31,

 

 

 

2008

 

2007

 

 

 

 

 

 

 

Collaboration revenue

 

$

4,152

 

$

2,242

 

Operating expenses:

 

 

 

 

 

Research and development*

 

12,913

 

13,772

 

General and administrative*

 

5,781

 

7,703

 

Total operating expenses

 

18,694

 

21,475

 

Loss from operations

 

(14,542

)

(19,233

)

Other income, net

 

1,204

 

2,270

 

Net loss

 

$

(13,338

)

$

(16,963

)

Basic and diluted net loss per share

 

$

(0.37

)

$

(0.48

)

Shares used in computing basic and diluted net loss per share

 

35,740

 

35,584

 


*Includes stock-based compensation of the following:

 

 

 

 

 

Research and development

 

$

736

 

$

1,256

 

General and administrative

 

$

1,266

 

$

2,259

 

 

Contact:

Beverly Holley

Momenta Pharmaceuticals, Inc.

617-395-5189