-----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, A9+7JYeHL/2eKZdG5XI5EXizWU3i0JHyd7ZdK+8bDECXtJhEWD76RfxBtYei0D14 ScjztKoqIBzjJd5JwQJ6Ug== 0001104659-04-023725.txt : 20040811 0001104659-04-023725.hdr.sgml : 20040811 20040811075401 ACCESSION NUMBER: 0001104659-04-023725 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040811 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20040811 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: 04965744 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 a04-9344_18k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 11, 2004

 

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.)

 

 

 

 

 

125 Spring Street  Lexington, Massachusetts

 

02421

(Address of Principal Executive
Offices)

 

(Zip Code)

 

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

 

12 Oak Park Drive, Bedford, Massachusetts, 01730

(Former Name or Former Address, if Changed Since Last Report)

 

 



 

Item 12.    Results of Operations and Financial Condition.

 

On August 11, 2004, NitroMed, Inc. announced its financial results for the quarter ended June 30, 2004. 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 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.

 

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.

 

Date:  August 11, 2004

NITROMED, INC.

 

 

 

 

 

By:

/s/ Joseph Grimm

 

 

 

Joseph Grimm

 

 

Senior Vice President, Business
Development and Chief Financial
Officer, Treasurer and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

99.1

 

Press release of NitroMed, Inc. dated August 11, 2004

 

 

4


EX-99.1 2 a04-9344_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Contact for

Media and Investor Relations:

Kathleen O’Donnell

NitroMed, Inc.

781-266-4192

 

FOR IMMEDIATE RELEASE

 

NITROMED REPORTS FINANCIAL RESULTS FOR THE SECOND QUARTER 2004

 

Company Accelerates Preparations for Anticipated Launch of BiDil®

 

 Conference Call Today, August 11 at 9:00 a.m. Eastern Time

 

Lexington, MA – August 11, 2004 – NitroMed, Inc. (NASDAQ: NTMD), today reported financial results for the second quarter ended June 30, 2004. The company also reported on recent corporate achievements, including the early halt to its Phase III clinical trial of BiDil, its lead drug in development for the treatment of African Americans with heart failure. The trial was stopped in July 2004 because of the significant survival benefit seen with the drug.

 

The company also announced today that it has entered into a letter of intent to finalize an agreement with Publicis Selling Solutions of New Jersey to establish a NitroMed sales force.  Publicis will assist NitroMed in creating a specialized sales force of up to approximately 200 people, which is expected to be on board in the first quarter of 2005 and ready to launch BiDil as soon as it is approved for marketing by the FDA.

 

Total revenue for the three months ended June 30, 2004 was $2.3 million compared to $1.7 million for the three months ended June 30, 2003. The $0.6 million, or 38 % increase in revenue in the 2004 period is primarily attributable to milestone revenue recognized from the agreement with Merck to develop nitric-oxide enhanced COX-2 inhibitors, which is being recognized ratably over the collaboration period.  For the six months ended June 30, 2004 revenue totaled $4.7 million compared to $3.4 million for the comparable period last year. The $1.3 million, or 38%, increase in revenue in the six months ended June 30, 2004 was primarily due to milestone revenue recognized from the Merck collaboration, which is being recognized ratably over the collaboration period.

 

Research and development expense for the three months ended June 30, 2004 was $5.1 million compared to $4.2 million for the three months ended June 30, 2003.  The $0.9 million, or 20 % increase in research and development expense is primarily due to additional costs of $0.9 million associated with the BiDil clinical program, which reflects an increase in the number of clinical sites and the enrollment of additional patients in the trial.   For the six months ended June 30, 2004 research and development expense totaled $10.7 million compared to $8.7 million for the comparable period last year.  The $2.0 million, or 22%, increase in research and development

 

-MORE-

 



 

expenses in the six months ended June 30, 2004 is primarily due to additional costs of $1.8 million associated with the BiDil clinical program, which reflects an increase in the number of clinical sites and the enrollment of additional patients in the trial.

 

General and administrative expense for the three months ended June 30, 2004 was $2.3 million compared to $0.7 million for the three months ended June 30, 2003. The $1.6 million, or 230% increase is primarily attributable to increased costs of approximately $0.8 million associated with operating as a public company and approximately $0.6 million associated with expenses relating to preparing for the possible launch of BiDil.  For the six months ended June 30, 2004 general and administrative expense totaled $3.8 million compared to $1.3 million for the comparable period last year.  The $2.5 million, or 192% increase in general and administrative expenses in the six months ended June 30, 2004 is primarily due to increased costs of approximately $1.5 million associated with operating as a public company and approximately $0.9 million associated with expenses relating to preparing for the possible launch of BiDil.

 

The Company’s net loss attributable to common shareholders for the quarter ended June 30, 2004 was $4.7 million or $0.18 loss per share compared to a loss of $3.8 million or $3.88 loss per share for the same period in 2003.  For the six months ended June 30, 2004 the net loss attributable to common shareholders totaled $9.3 million or $0.36 loss per share compared to a loss of $7.7 million or $7.80 loss per share for the comparable period last year.

 

At June 30, 2004, the Company had cash, cash equivalents and marketable securities of $82.5 million.

 

Highlights of other recent corporate events include:

 

                  The independent Data and Safety Monitoring Board (DSMB) of the A-HeFT confirmatory Phase III clinical trial unanimously recommended in July 2004 that the trial be stopped early because of the statistically significant survival benefit observed with BiDil.

 

                  The preliminary A-HeFT data also indicated that:

 

                  the statistically significant survival benefit seen with BiDil was consistent with and confirmed by the primary composite endpoint of mortality, hospitalization and quality of life.

 

                  serious adverse events and cardiovascular events in particular, were also less frequently observed in the BiDil arm of the trial.

 

                  The company named Mark Pavao, a former Bristol Myers Squibb marketing executive, Senior Vice President of Marketing and Sales.

 

2



 

                  The company’s partner, Merck, advanced NitroMed’s lead nitric oxide-enhancing COX 2 inhibitor into Phase II clinical trials.  NitroMed and Merck are engaged in three-year collaboration to develop proprietary nitric oxide COX-2 inhibitors to treat pain and inflammation and other conditions and diseases.

 

                  The company continued the preclinical development of a nitric oxide-enhanced paclitaxel coated stent with Boston Scientific.

 

Commenting on the company’s recent achievements, Michael D. Loberg, Ph.D., President and Chief Executive Officer, NitroMed said, “The last few weeks have been exciting times for NitroMed as we move closer toward the commercialization of BiDil – that’s about a year earlier than we had anticipated.  Our team is working hard to move us to the final steps of the regulatory process and to be ready for a successful product launch, assuming the FDA approves BiDil.  We are confident in our ability to be able to launch BiDil and ensure its market exclusivity.  In addition to our great news about BiDil, we are continuing to make important strides with our Merck and Boston Scientific partnerships.  Merck has advanced our lead COX-2 inhibitor into Phase II clinical trials.  Indeed, we have had exciting and welcome outcomes.”

 

The Company’s projected business outlook and financial guidance for 2004 and Q1 2005 includes:

 

                  Data analysis of the A-HeFT clinical trial to be available in Q4 of 2004.

                  The commercial resources and sales force to be in place in Q1 of 2005, ready to launch BiDil if and when the FDA approves it for marketing.

                  The company remains on track with respect to achieving total R&D revenue of $8-10 million for the year ended December 31, 2004.  The company expects that total operating expenses will be higher than previously forecast and year-end cash will be lower than previously forecast as a result of the accelerated commercial activities it is undertaking to support an expected earlier than previously planned product launch of BiDil.

 

CONFERENCE CALL TODAY – INFORMATION

 

NitroMed will hold a conference call today, August 11, 2004 at 9:00 a.m. Eastern to discuss the second quarter earnings and corporate developments and answer questions. The conference may be heard live via the investor relations section of the NitroMed website at www.nitromed.com.

 

In the United States, the call can also be accessed by dialing 800-295-3991. The participant passcode is 47967503.

 

The international dial in number is 617-614-3924. The participant passcode is 47967503.

 

A replay of the call will be available by dialing in the United States 888-286-8010.  The international dial in number for replay is 617-801-6888.  The replay passcode is 11601557.

 

3



 

About NitroMed, Inc.

NitroMed is an emerging pharmaceutical company that discovers, develops and seeks to commercialize proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide. The Company uses its expertise in nitric oxide biology and chemistry in an effort to develop both novel drugs, as well as safer, more effective versions of existing drugs. Research and development efforts focus on major diseases that are characterized by a deficiency in nitric oxide, such as cardiovascular and inflammatory diseases. BiDil®, the Company’s lead product in development, is an orally administered nitric oxide-enhancing medicine being investigated for the treatment of heart failure in African Americans. Because of the significant survival benefit seen with BiDil, NitroMed prematurely halted its confirmatory phase III clinical trial of the drug. The action was taken on July 19, 2004 and followed the unanimous recommendations of both the trial’s independent Data and Safety Monitoring Board (DSMB) and its Steering Committee.  Over 1,000 patients in 162 sites across the United States were enrolled in the double blind placebo controlled trial, known as the African American Heart Failure Trial or A-HeFT. The Association of Black Cardiologists is a joint sponsor of the study. Collaborative partnerships are a key element of the Company’s business strategy. NitroMed has agreements with Merck to jointly develop nitric oxide COX-2 inhibitors and with Boston Scientific to jointly develop nitric oxide coated cardiovascular stents.

 

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company’s plans for the launch of BiDil® in 2005, its financial forecasts, its ability to establish a sales force by the first quarter of 2005 as well as statements containing the words “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” and similar expressions, 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 or delays relating to required regulatory approvals to develop, market and sell BiDil and the Company’s other products under development; the Company’s ability to develop or successfully contract for the sales, marketing and manufacturing competencies required to launch BiDil and any other product candidates for which it may receive regulatory approval; the Company’s ability to successfully complete clinical trials of its products under development; the Company’s dependence on corporate collaborators to develop, manufacture, market and sell products based upon its technologies; the Company’s failure to obtain or maintain intellectual property protection and required licenses for its technologies and products under development; the Company’s ability to obtain the substantial additional funding required to conduct research and development, manufacturing, marketing and sales of its products under development; and other factors discussed in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2004, which is filed with the SEC. In addition, 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.

 

4



 

NitroMed, Inc. selected financial information follows.

 

NitroMed, Inc. - Second Quarter 2004 Results

 

NitroMed, Inc.

 

SELECTED FINANCIAL INFORMATION

(in thousands, except per share amounts)

 

CONDENSED BALANCE SHEETS

As of June 30, 2004 and December 31, 2003

 

 

 

June 30,
2004

 

December 31,
2003

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and marketable securities

 

$

82,543

 

$

97,088

 

 

 

 

 

Other assets

 

3,898

 

2,082

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

86,441

 

$

99,170

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

10,079

 

$

10,446

 

 

 

 

 

Long term portion of deferred revenue

 

3,462

 

6,925

 

 

 

 

 

Stockholders’ equity

 

72,900

 

81,799

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

86,441

 

$

99,170

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONDENSED STATEMENTS OF OPERATIONS
For the three and six months ended June 30, 2004 and 2003

 

 

 

Three Months Ended
June 30

 

Six Months Ended
June 30

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

(Unaudited)

 

(Unaudited)

 

(Unaudited)

 

(Unaudited)

 

Revenues:

 

 

 

 

 

 

 

 

 

Research and development

 

$

2,331

 

$

1,694

 

$

4,662

 

$

3,388

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

5,085

 

4,242

 

10,713

 

8,677

 

General and administrative

 

2,261

 

687

 

3,797

 

1,252

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

7,346

 

4,929

 

14,510

 

9,929

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(5,015

)

(3,235

)

(9,848

)

(6,541

)

 

 

 

 

 

 

 

 

 

 

Other income, net

 

315

 

85

 

592

 

204

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(4,700

)

(3,150

)

(9,256

)

(6,337

)

 

 

 

 

 

 

 

 

 

 

Dividends and accretion to redemption value of redeemable convertible preferred stock

 

 

(675

)

 

(1,349

)

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(4,700

)

$

(3,825

)

$

(9,256

)

$

(7,686

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(0.18

)

$

(3.88

)

$

(0.36

)

$

(7.80

)

 

 

 

 

 

 

 

 

 

 

Average common shares outstanding, basic and diluted

 

25,696

 

985

 

25,648

 

985

 

 

5


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