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) August 10, 2005

 

Momenta Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-50797

 

04-3561634

(State or Other Jurisdiction
of Incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

675 West Kendall Street, Cambridge, MA

 

02142

(Address of Principal Executive Offices)

 

(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 August 10, 2005, Momenta Pharmaceuticals, Inc., a Delaware corporation (the “Company”), announced its financial results for the quarter ended June 30, 2005.  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

 

(c) Exhibits

 

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

 

99.1                                            Press release issued by Momenta Pharmaceuticals, Inc. dated August 10, 2005.

 

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: August 10, 2005

 

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press release issued by Momenta Pharmaceuticals, Inc., dated August 10, 2005.

 

4


Exhibit 99.1

 

Press Release

 

 

MOMENTA PHARMACEUTICALS, INC.

 

675 WEST KENDALL STREET

 

T: 617.491.9700 F: 617.621.0431

 

 

CAMBRIDGE, MA 02142

 

WWW.MOMENTAPHARMA.COM

 

 

Momenta Pharmaceuticals Reports Financial Results for the Second Quarter of 2005

 

On Track to File ANDA for M-Enoxaparin in August

 

CAMBRIDGE, MA — August 10, 2005 – Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company developing drugs based on its proprietary sugar sequencing technology, today announced its financial results for the second quarter and six months ended June 30, 2005.

 

For the second quarter of 2005, the Company reported a net loss of $4.6 million compared with a net loss of $2.9 million for the same period last year.  For the six months ended June 30, 2005, the Company reported a net loss of $8.4 million compared with a net loss of $5.5 million for the six months ended June 30, 2004.

 

At June 30, 2005, the Company held cash, cash equivalents, and marketable securities of $46.9 million, compared with $53.6 million at December 31, 2004.

 

“We are finalizing our abbreviated new drug application (ANDA) for M-Enoxaparin, our generic version of Lovenox®,” said Alan Crane, Chief Executive Officer of Momenta.  “We reiterate our expectation that our ANDA will be filed during the month of August.”

 

“We believe that our proprietary technology provides us with the unique ability to thoroughly characterize the complex mixture of sugar chains that comprise Lovenox and to demonstrate that our generic product meets the FDA requirements for same active ingredients,” continued Mr. Crane.

 

M-Enoxaparin is a technology-enabled generic version of the low molecular weight heparin drug Lovenox.  Marketed by Sanofi-Aventis, Lovenox is widely prescribed for the prevention and treatment of deep vein thrombosis and treatment of acute coronary syndromes.  Worldwide sales of Lovenox in 2004 were reported to be approximately $2.4 billion, with a U.S. market share of approximately 85%.

 

“Subsequent to the close of the second quarter, we made the strategic decision to raise additional equity capital.  On July 21, 2005, we raised net proceeds of approximately $122.3 million through the issuance of approximately 4.8 million shares of common stock.  We believe this transaction provides us with a stronger capital base to pursue near term product opportunities where we can leverage our technology advantage, as well as to continue to fund our existing discovery and development programs,” concluded Mr. Crane.

 

Revenue for the second quarter of 2005 was $3.4 million, compared to $2.1 million for the second quarter of 2004.  For the six months ended June 30, 2005, revenue was $7.1 million compared to $3.2 million in the same period of 2004.  Revenue in all periods was earned under the Company’s collaborative agreement with Sandoz, an affiliate of Novartis AG.  Pursuant to the collaboration, Momenta and Sandoz have agreed to jointly develop, manufacture, and commercialize M-Enoxaparin, and Sandoz is responsible for funding substantially all of the development, regulatory, legal and commercialization costs associated with M-Enoxaparin.

 

Research and development expenses for the second quarter of 2005 were $5.0 million, compared to $3.5 million for the same period in 2004.  For the six months ended June 30, research and development expenses were $10.3 million in 2005 compared to $5.7 million in 2004.  The increase in research and development spending was primarily due to increased headcount and increased manufacturing and other research expenses.

 

General and administrative expenses for the second quarter of 2005 totaled $3.2 million, compared with $1.6 million for the same period in 2004.  For the six months ended June 30, general and administrative expenses were $5.8 million in 2005 compared to $3.0 million in 2004.  The increase in general and administrative spending was primarily due to increased professional fees, increased headcount, and additional insurance coverage and other public company costs.

 



 

Conference Call Information

 

Management will host a conference call on Wednesday, August 10, 2005 at 10:00 am EDT to provide an update on the Company and discuss second quarter results. To access the call, please dial 866-700-7173 (domestic) or 617-213-8838 (international) prior to the scheduled conference call time and provide the access code 19905356. A replay of the call will be available approximately two hours after the call and will be accessible through August 17, 2005. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and provide the access code 44855780.

 

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 September 10, 2005.

 

About Momenta

 

Momenta Pharmaceuticals, Inc. is a biotechnology company specializing in the detailed structural analysis and design of complex sugars for the development of improved versions of existing drugs, the development of novel drugs and the discovery of new biological processes.  Momenta is also utilizing its ability to sequence sugars to create technology-enabled generic versions of sugar-based and biologic drug products.  The Company’s most advanced product candidate is M-Enoxaparin, a technology-enabled generic version of Lovenox®.  Based on its understanding of complex sugars, Momenta has created a diversified pipeline of near-term product opportunities, novel development products and discovery candidates.  Momenta was founded in 2001 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 Momenta Pharmaceuticals Inc.’s future expectations, beliefs, goals, plans or prospects, including statements relating to results of operations, regulatory filings and current and future development efforts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Momenta’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in Momenta’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 filed with the Securities and Exchange Commission under the section ”Risk Factors That May Affect Results,” as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding Momenta’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “may”, “should”, “will”, and “would” or similar words.  Momenta assumes no obligations to update the information included in 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.

 



 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Balance Sheets

(in thousands)

 

 

 

June 30,
2005

 

December 31,
2004

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Cash and marketable securities

 

$

46,864

 

$

53,621

 

Restricted cash

 

1,485

 

1,485

 

Other assets

 

9,890

 

9,224

 

Total assets

 

$

58,239

 

$

64,330

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

6,339

 

$

5,962

 

Other liabilities

 

2,065

 

1,375

 

Stockholders’ equity

 

49,835

 

56,993

 

Total liabilities and stockholders’ equity

 

$

58,239

 

$

64,330

 

 



 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Statement of Operations

(in thousands, except per share amounts)

 

 

 

Three Months
Ended June  30,

 

Six Months
Ended June 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

3,364

 

$

2,115

 

$

7,137

 

$

3,151

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development*

 

4,999

 

3,508

 

10,288

 

5,748

 

General and administrative*

 

3,231

 

1,580

 

5,771

 

2,989

 

Total operating expenses

 

8,230

 

5,088

 

16,059

 

8,737

 

Loss from operations

 

(4,866

)

(2,973

)

(8,922

)

(5,586

)

Other income, net

 

286

 

83

 

572

 

114

 

Net loss

 

(4,580

)

(2,890

)

(8,350

)

(5,472

)

 

 

 

 

 

 

 

 

 

 

Deemed dividend related to beneficial conversion feature of Series C redeemable convertible preferred stock

 

 

 

 

(20,389

)

Dividends and accretion to redemption value of redeemable convertible preferred stock

 

 

(1,034

)

 

(1,852

)

Net loss attributable to common stockholders

 

$

(4,580

)

$

(3,924

)

$

(8,350

)

$

(27,713

)

Basic and diluted net loss per share attributable to common stockholders

 

$

(0.18

)

$

(0.79

)

$

(0.33

)

$

(7.28

)

Shares used in computing basic and diluted net loss per share attributable to common stockholders

 

25,116

 

4,985

 

24,992

 

3,808

 

 

 

 

 

 

 

 

 

 

 


*Includes stock-based compensation of the following:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

157

 

$

108

 

$

271

 

$

199

 

General and administrative

 

418

 

635

 

731

 

953

 

Total stock-based compensation

 

$

575

 

$

743

 

$

1,002

 

$

1,152

 

 

Contact:

Michael A. Lawless

Momenta Pharmaceuticals, Inc.

617-395-5189