Momenta Pharmaceuticals, Inc.
MOMENTA PHARMACEUTICALS INC (Form: 8-K, Received: 11/01/2010 08:30:30)

 

 

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) November 1, 2010

 

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 November 1, 2010, Momenta Pharmaceuticals, Inc., a Delaware corporation, announced its financial results for the quarter ended September 30, 2010.  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 November 1, 2010.

 

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: November 1, 2010

 

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Momenta Pharmaceuticals, Inc. on November 1, 2010.

 

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 Third Quarter of 2010

 

CAMBRIDGE, MA — November 1, 2010 — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced its financial results for the quarter ended September 30, 2010.

 

For the third quarter of 2010, the Company reported a net income of $32.1 million, or $0.70 per diluted share, compared with a net loss of $14.6 million, or $0.38 per share, for the same period last year. At September 30, 2010, the Company had cash, cash equivalents, and marketable securities of $65.7 million, compared with $95.7 million at December 31, 2009.

 

“Momenta reached profitability in the third quarter thanks to a very strong enoxaparin launch by our collaboration partner, Sandoz,” commented Craig A. Wheeler, President and Chief Executive Officer. “For the nine weeks in the quarter that enoxaparin was on the market, Momenta earned $44.2 million in profit share in addition to a $5.0 million milestone payment,” he continued.  “Sales continue to be strong, and because the Sandoz product continues to be the only approved source of generic Lovenox ® , Momenta continues to earn a significant profit share on product sales,” Wheeler concluded.

 

Third Quarter 2010 Financial Results

 

Revenue for the third quarter of 2010 was $52.0 million, compared to $4.0 million for the same period last year.  The increase in revenue in the current year’s quarter was due to $44.2 million of profit share earned from commercial sales of enoxaparin sodium injection and the $5.0 million regulatory milestone earned upon FDA marketing approval of enoxaparin sodium injection in July of 2010.

 

Research and development expenses for the third quarter of 2010 were $12.5 million, compared to $12.9 million for the same period last year. The decrease in research and development expenses principally resulted from a decrease in manufacturing, process development and third-party research costs in support of our M356 program.

 

General and administrative expenses for the third quarter of 2010 totaled $7.3 million, compared with $5.6 million for the same period last year. The increase in general and administrative expenses was due to an increase in royalty and license fees associated with the product revenues of enoxaparin sodium injection and an increase in personnel and

 



 

related costs primarily due to performance payments made in connection with the regulatory approval of enoxaparin sodium injection.

 

Quarterly Highlights

 

·   Approval by FDA and successful launch of enoxaparin sodium injection on July 23, 2010.

 

·   Ongoing regulatory review of generic Copaxone ANDA; Copaxone patent litigation heading toward trial.

 

·   Two new patents issued relating to chain mapping of enoxaparin sodium injection.

 

·   M118 named a Top Ten CV/Metabolic Project to Watch by Windhover Information and the publishers of In Vivo and Startup.

 

Conference Call Information

 

Management will host a conference call on Tuesday, November 1, 2010 at 11:00 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 15660292.  A replay of the call will be available approximately two hours after the call and will be accessible through November 14, 2010.  To access the replay, please dial (800) 642-1687 (domestic) or (706) 645-9291 (international) and provide the access code 15660292.

 

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 November 14, 2010.

 

About Momenta

 

Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, 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.

 

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 our beliefs regarding the potential sales of enoxaparin sodium injection, revenue associated with enoxaparin sodium injection, the Copaxone litigation with Teva, and the development and commercialization

 

2



 

opportunity for our development product candidates, 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 June 30, 2010    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, 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.

 

3



 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

As of
September 30,
2010

 

As of
December 31,
2009

 

Assets

 

 

 

 

 

Cash and marketable securities

 

$

65,686

 

$

95,650

 

Accounts receivable

 

44,188

 

 

Restricted cash

 

1,778

 

1,778

 

Other assets

 

16,496

 

21,023

 

Total assets

 

$

128,148

 

$

118,451

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities

 

$

13,486

 

$

16,340

 

Other liabilities

 

4,431

 

7,949

 

Stockholders’ equity

 

110,231

 

94,162

 

Total liabilities and stockholders’ equity

 

$

128,148

 

$

118,451

 

 

4



 

MOMENTA PHARMACEUTICALS, INC.

Unaudited Condensed Statement of Operations

(in thousands, except per share amounts)

 

 

 

Three Months
Ended September 30,

 

Nine Months
Ended September 30,

 

 

 

2010

 

2009

 

2010

 

2009

 

Collaboration revenues:

 

 

 

 

 

 

 

 

 

Product revenues

 

$

44,188

 

$

 

$

44,188

 

$

 

Research and development revenues

 

7,773

 

4,008

 

14,258

 

14,603

 

Total revenues

 

51,961

 

4,008

 

58,446

 

14,603

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development*

 

12,488

 

12,912

 

36,521

 

46,380

 

General and administrative*

 

7,325

 

5,633

 

20,759

 

17,743

 

Total operating expenses

 

19,813

 

18,545

 

57,280

 

64,123

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

32,148

 

(14,537

)

1,166

 

(49,520

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

46

 

131

 

132

 

748

 

Interest expense

 

(74

)

(136

)

(266

)

(447

)

Other expense

 

 

(104

)

 

(104

)

Total other income (expense)

 

(28

)

(109

)

(134

)

197

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

32,120

 

$

(14,646

)

$

1,032

 

$

(49,323

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.72

 

$

(0.38

)

$

0.02

 

$

(1.27

)

Diluted

 

$

0.70

 

$

(0.38

)

$

0.02

 

$

(1.27

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

44,719

 

39,014

 

44,183

 

38,855

 

Diluted

 

46,032

 

39,014

 

45,708

 

38,855

 

 


*Includes the following share-based compensation expense:

 

 

 

 

 

 

 

 

 

Research and development

 

$

808

 

$

1,117

 

$

3,291

 

$

3,305

 

General and administrative

 

$

1,392

 

$

1,568

 

$

5,462

 

$

4,935

 

 

Contact:

Beverly Holley

Momenta Pharmaceuticals, Inc.

bholley@momentapharma.com

617-395-5189

 

###

 

5