-----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, BssiYvikGdUIDNiwoRcX+hIIar985L3/qBRW/cyVXL6XwBsE09QLv26cxlUIfrAR NbjKHwS+76jTOXH/5gqnRg== 0001104659-08-030502.txt : 20080507 0001104659-08-030502.hdr.sgml : 20080507 20080507071628 ACCESSION NUMBER: 0001104659-08-030502 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080507 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080507 DATE AS OF CHANGE: 20080507 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: 08808172 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 a08-13590_18k.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): May 7, 2008

 

NITROMED, INC.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-50439

 

22-3159793

(State or Other Jurisdiction of
Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

 

 

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):

 

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, NitroMed, Inc. 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 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 May 7, 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:  May 7, 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 May 7, 2008.

 

4


EX-99.1 2 a08-13590_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

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 First Fiscal Quarter 2008

 

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

 

LEXINGTON, MA—(May 7, 2008)—NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for the fiscal quarter ended March 31, 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 March 31, 2008 were $3.9 million compared to $3.6 million for the same period in 2007, an increase of $0.3 million, or 10%.  Sales of BiDil accounted for all revenues during both periods.

 

Total operating expenses for the three months ended March 31, 2008, excluding cost of product sales, were $8.4 million, compared to $13.0 million for the same period in 2007, which represents a decrease of $4.6 million, or 36%.  The year-over-year decrease in operating expenses is primarily the result of the Company’s January 2008 restructuring.

 

The Company’s net loss for the quarter ended March 31, 2008 was $5.2 million, or $0.11 per common share, compared to a net loss of $10.1 million, or $0.27 per common share, for the same quarter in 2007.

 

At March 31, 2008, the Company had cash, cash equivalents and short-term marketable securities totaling $21.2 million, which excludes $1.6 million of auction rate securities classified as long-term marketable securities.

 

“Although the company discontinued active promotional efforts related to BiDil just two weeks into January, total prescriptions of BiDil have generally held steady during the first quarter of 2008. Approximately 32,500 BiDil prescriptions were generated in the first quarter of 2008, representing an increase of 6% over the fourth quarter of 2007. As previously announced, we are continuing to evaluate our strategic alternatives in order to maximize shareholder value,” said Kenneth M. Bate, NitroMed’s President, Chief Executive Officer and Interim Chief Financial Officer.  “Based on the sales trends for BiDil during a challenging quarter, we continue to believe that BiDil is an attractive and valuable asset, especially with the continued development of a planned extended release formulation of BiDil, known as BiDil XR™.”

 

“Expenses during the first quarter were carefully managed as we implemented our January 2008 restructuring plan,” Mr. Bate commented.  “Going forward for the year 2008, we to expect to incur approximately $16 to $18 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 first quarter 2008 financial results and Company progress.

 

Date:       Wednesday, May 7, 2008

Time:      8:00 am ET

 

Access by Conference Call:

 

Domestic callers:

Dial 888-713-4218

 

 

International callers:

Dial 617-213-4870

 

 

Participant passcode:

24676784

 

Access by Webcast:

 

Go to www.nitromed.com for live webcast link or https://www.theconferencingservice.com/prereg/key.process?key=PQLTPTPLG

 

An audio replay of the earnings conference call will be available two hours after the call and through June 7, 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 64165398.  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.

 

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, its expectations for BiDil’s value as an asset and the planned clinical development and commercialization of BiDil XR, 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: difficulties in successfully developing, obtaining regulatory approval for, manufacturing and commercializing BiDil XR; the Company’s ability to successfully execute on its first quarter 2008 restructuring plan, including, without limitation, the Company’s ability to retain key employees and ability to achieve anticipated cost reductions; the Company’s ability to identify

 

2



 

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 expenses related to the Company’s restructuring plan; 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 March 31, 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:

Jane A. Kramer

P: 781.266.4220

C: 781.640.8499

 

(Selected Financial Statements Follow)

 

3



 

NITROMED, INC.

 

SELECTED FINANCIAL INFORMATION

 

(in thousands, except per share amounts)

 

CONDENSED BALANCE SHEETS

As of March 31, 2008 and December 31, 2007

(Unaudited)

 

 

 

 

March 31,
2008

 

December 31,
2007

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Cash and short-term marketable securities

 

$

21,242

 

$

31,400

 

Accounts receivable, net

 

1,733

 

1,929

 

Inventories

 

1,260

 

1,401

 

Long-term marketable securities

 

1,594

 

 

Other assets

 

741

 

837

 

 

 

 

 

 

 

Total assets

 

$

26,570

 

$

35,567

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

8,311

 

$

13,342

 

Deferred revenue

 

 

 

Long-term debt

 

 

 

Stockholders’ equity

 

18,259

 

22,225

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

26,570

 

$

35,567

 

 

CONDENSED STATEMENTS OF OPERATIONS

For the three months ended March 31, 2008 and 2007

(Unaudited)

 

 

 

Three Months Ended
March 31,

 

 

 

2008

 

2007

 

Revenues:

 

 

 

 

 

Product revenue

 

$

3,933

 

$

3,568

 

 

 

 

 

 

 

Cost and operating expenses:

 

 

 

 

 

Cost of product sales

 

979

 

954

 

Research and development

 

1,630

 

3,007

 

Sales, general and administrative

 

3,998

 

8,948

 

Restructuring charge

 

2,725

 

1,004

 

 

 

 

 

 

 

Total cost and operating expenses

 

9,332

 

13,913

 

 

 

 

 

 

 

Loss from operations

 

(5,399

)

(10,345

)

 

 

 

 

 

 

Non-operating income, net

 

215

 

231

 

 

 

 

 

 

 

Net loss

 

$

(5,184

)

$

(10,114

)

 

 

 

 

 

 

 Basic and diluted net loss per common share

 

$

(0.11

)

$

(0.27

)

 

 

 

 

 

 

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

 

45,792

 

37,263

 

 

4


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-----END PRIVACY-ENHANCED MESSAGE-----