-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Kh+SW5Z4fKf6qfZNjHpMVoVE3PHhWnp3KV8oEIj7HcY0cHbgV6awF+y7TDF3+RdR Jle9tiTuGfTHOFLy3ambWw== 0001104659-08-049729.txt : 20080805 0001104659-08-049729.hdr.sgml : 20080805 20080805074221 ACCESSION NUMBER: 0001104659-08-049729 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080805 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080805 DATE AS OF CHANGE: 20080805 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NITROMED INC CENTRAL INDEX KEY: 0000927829 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223159793 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50439 FILM NUMBER: 08989675 BUSINESS ADDRESS: STREET 1: 12 OAK PARK DR CITY: BEDFORD STATE: MA ZIP: 01730 BUSINESS PHONE: 7816859700 MAIL ADDRESS: STREET 1: 12 OAK PARK DR CITY: BEDFORD STATE: MA ZIP: 01730 8-K 1 a08-18612_28k.htm 8-K

 

 

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 5, 2008

 

NITROMED, INC.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-50439

 

22-3159793

(State or Other Jurisdiction of

 

(Commission File Number)

 

(IRS Employer Identification No.)

Incorporation)

 

 

 

 

 

 

 

 

 

45 Hayden Avenue, Suite 3000

 

 

Lexington, Massachusetts

 

02421

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (781) 266-4000

 

 

(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):

 

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

 

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

 

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

 

¨                                    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 5, 2008, NitroMed, Inc. announced its financial results for the quarter ended June 30, 2008. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in Item 2.02 of this Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 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

 

Exhibit No.

 

Description

99.1

 

Press Release issued by NitroMed, Inc. on August 5, 2008.

 

2



 

SIGNATURE

 

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.

 

 

 

NITROMED, INC.

 

 

Date: August 5, 2008

By:

/s/ Kenneth M. Bate

 

 

 

 

 

Kenneth M. Bate

 

 

President, Chief Executive Officer and

 

 

Interim Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press release issued by NitroMed, Inc. on August 5, 2008.

 

4


EX-99.1 2 a08-18612_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

 

NITROMED, INC.
45 HAYDEN AVENUE, SUITE 3000
LEXINGTON, MA 02421
t. 781.266.4000
f. 781.274.8080

 

 

www.nitromed.com

 

NitroMed Reports Financial Results for Second Fiscal Quarter 2008

 - Conference Call and Webcast to be Held Today at 8:00 AM ET -

 

LEXINGTON, MA—(August 5, 2008) — NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for its second fiscal quarter and year to date ended June 30, 2008. NitroMed is the maker of BiDil® (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine approved in the United States for the treatment of heart failure in self-identified black patients.

 

Total revenues for the three months ended June 30, 2008 were $3.8 million, compared to $3.7 million for the same period in 2007, an increase of $0.1 million, or 3%. For the six months ended June 30, 2008, total revenues were $7.8 million, compared to $7.3 million for the same period in 2007, an increase of $0.5 million, or 7%. Sales of BiDil accounted for all revenues during both periods.

 

Total operating expenses for the three months ended June 30, 2008, excluding cost of product sales, were $2.4 million, compared to $9.6 million for the same period in 2007, a decrease of $7.2 million, or 75%. For the six months ended June 30, 2008, total operating expenses, excluding cost of product sales, were $10.8 million, compared to $22.5 million for the same period in 2007, a decrease of $11.7 million, or 52%. The decrease in operating expenses for both periods is primarily due to the Company’s restructuring in January 2008.

 

The Company’s net income for the quarter ended June 30, 2008 was $1.0 million, or $0.02 per common share, compared to a net loss of $6.2 million, or ($0.16) per common share, for the same quarter in 2007.  For the six months ended June 30, 2008, the Company’s net loss was $4.2 million, or ($0.09) per common share, compared to a net loss of $16.4 million, or ($0.42) per common share, for the same period in 2007.  Although the Company recorded net income in the second quarter of 2008, the Company has not been profitable in any prior quarter, has discontinued active promotion of BiDil, and may incur losses in future periods.

 

At June 30, 2008, the Company had cash, cash equivalents and short-term marketable securities totaling $18.8 million, which excludes $1.6 million of securities classified as long-term marketable securities.  The Company believes that its existing cash, plus cash it expects to generate from sales of BiDil, will be sufficient to fund its current business plan for at least the next twelve months.

 

“We were pleased that total prescriptions of BiDil generally held steady through the second quarter, despite our discontinuation of active promotional efforts related to BiDil at the beginning of 2008. During the second quarter, we continued to carefully manage expenses following our January 2008 restructuring.  As previously announced, we continue to evaluate strategic alternatives intended to maximize shareholder value,” said Kenneth M. Bate, NitroMed’s President, Chief Executive Officer and Interim Chief Financial Officer. “As a result of the continued implementation of our January 2008 restructuring, we are lowering our

 



 

expense guidance range by $2 million. For the year ending December 31, 2008, we expect to incur approximately $14 to $16 million in operating expenses, including share-based compensation expense related to SFAS 123R but excluding cost of product sales and charges related to our January 2008 restructuring.”

 

Webcast and Conference Call

 

NitroMed will host a webcast and conference call, including an open question and answer session to discuss second quarter 2008 financial results and Company progress.

 

Date:

Tuesday, August 5, 2008

Time:

8:00 a.m. Eastern Time

Access

by Conference Call:

 

Domestic callers:

Dial 800-356-4123

 

International callers:

Dial 617-597-5393

 

Participant passcode:

32967472

Access

by Webcast:

 

Go to www.nitromed.com for live webcast link.

 

An audio replay of the earnings conference call will be available two hours after the call and through September 5, 2008.  The replay can be accessed by dialing 888-286-8010.  International callers should dial 617-801-6888. The replay passcode for all callers is 86745157.  The webcast will be archived on the Company’s website for an indefinite period of time following the earnings call.

 

About NitroMed, Inc.

 

NitroMed of Lexington, Massachusetts is the maker of BiDil® (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine available in the United States for the treatment of heart failure in self-identified black patients.  In this population, BiDil is indicated as an adjunct to current standard therapies such as angiotensin converting enzyme (ACE) inhibitors and beta blockers.  There is little experience in patients with New York Heart Association Class IV heart failure.  BiDil was approved by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company’s landmark A-HeFT (African American Heart Failure Trial) clinical trial.

 

For full prescribing information, visit: www.BiDil.com.  BiDil is a registered trademark of NitroMed, Inc.

 

Cautionary Note Concerning Forward Looking Statements

 

Statements in this press release about future expectations, plans and prospects for the Company, including the Company’s expectations regarding cash management and operating expenses in 2008 and its plans to evaluate strategic alternatives intended to maximize shareholder value, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the Company’s ability to generate sufficient capital to continue funding its operating expenses; the Company’s ability to successfully execute on its first quarter 2008 restructuring plan, including, without limitation, the Company’s ability to retain the employees necessary to oversee its continuing operations and its ability to achieve anticipated cost reductions; unplanned difficulties with respect to continued sales of BiDil and the ongoing development of an extended release formulation of

 

2



 

BiDil, known as BiDil XR™; the Company’s ability to identify and enter into strategic transactions and, through any such transactions, maximize shareholder value; the Company’s ability to obtain or maintain intellectual property protection and required licenses; unanticipated operating expenses; general economic and market conditions; and other important factors discussed in the Section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, which has been filed with the SEC. The forward-looking statements included in this press release represent the Company’s views as of the date of this release.  The Company anticipates that subsequent events and developments will cause the Company’s views to change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

 

Contact:

 

P: 781.266.4220

C: 781.640.8499

Source: NitroMed, Inc.

 

-   Financial Tables Follow –

 

3



 

NITROMED, INC.

SELECTED FINANCIAL INFORMATION

(in thousands, except per share amounts)

 

CONDENSED BALANCE SHEETS

As of June 30, 2008 and December 31, 2007

(Unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2008

 

2007

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Cash and marketable securities

 

$

18,753

 

$

31,400

 

Accounts receivable, net

 

1,796

 

1,929

 

Inventories

 

1,535

 

1,401

 

Other assets

 

1,958

 

837

 

 

 

 

 

 

 

Total assets

 

$

24,042

 

$

35,567

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

4,885

 

$

13,342

 

Stockholders’ equity

 

19,157

 

22,225

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

24,042

 

$

35,567

 

 

CONDENSED STATEMENTS OF OPERATIONS

For the three and six months ended June 30, 2008 and 2007

(Unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2008

 

2007

 

2008

 

2007

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

3,831

 

$

3,715

 

$

7,764

 

$

7,283

 

 

 

 

 

 

 

 

 

 

 

Cost and operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

536

 

637

 

1,515

 

1,591

 

Research and development

 

509

 

2,931

 

2,139

 

5,938

 

Sales, general and administrative

 

1,906

 

6,634

 

5,904

 

15,582

 

Restructuring charge

 

 

 

2,725

 

1,004

 

 

 

 

 

 

 

 

 

 

 

Total cost and operating expenses

 

2,951

 

10,202

 

12,283

 

24,115

 

 

 

 

 

 

 

 

 

 

 

Net Income (loss) from operations

 

880

 

(6,487

)

(4,519

)

(16,832

)

 

 

 

 

 

 

 

 

 

 

Non-operating income, net

 

102

 

251

 

317

 

482

 

 

 

 

 

 

 

 

 

 

 

Net Income (loss)

 

$

982

 

$

(6,236

)

$

(4,202

)

$

(16,350

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net income (loss) per common share

 

$

0.02

 

$

(0.16

)

$

(0.09

)

$

(0.42

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

46,029

 

40,100

 

45,910

 

38,689

 

Diluted

 

46,033

 

40,100

 

45,910

 

38,689

 

 

4


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