-----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, KODeAlvTCeqJAPrNeFSwOkYJHAgc/mgLNO0mtGzcMCIe6oZ43CxJZqtnsTEq+uUh GigxryUgMICgjKbHOsWY7g== 0001104659-06-030019.txt : 20060502 0001104659-06-030019.hdr.sgml : 20060502 20060502080933 ACCESSION NUMBER: 0001104659-06-030019 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060502 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060502 DATE AS OF CHANGE: 20060502 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: 06797216 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 a06-10834_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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 2, 2006

 

NITROMED, INC.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-50439

 

22-3159793

(State or Other Juris-
diction 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

 

 

(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 May 2, 2006, NitroMed, Inc. announced its financial results for the quarter ended March 31, 2006. 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 2, 2006.

 

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 2, 2006

By:

/s/ James Ham III

 

 

James Ham III

 

Vice President of Finance

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release issued by NitroMed, Inc. on May 2, 2006.

 

4


EX-99.1 2 a06-10834_1ex99d1.htm EX-99

Exhibit 99.1

 

GRAPHIC

 

 

NITROMED, INC.

 

125 SPRING STREET

 

LEXINGTON, MA 02421

 

 

t. 781.266.4000

f. 781.274.8080

 

www.nitromed.com

 

 

NitroMed Reports Financial Results for First Quarter 2006

 - Conference Call and Webcast to be Held Today at 9:00 AM ET-

 

LEXINGTON, Mass—May 2, 2006—NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for the first quarter ended March 31, 2006.

 

Total revenue for the three months ended March 31, 2006 was $2.3 million compared to $0.4 million for the same period in 2005, an increase of $1.9 million. Product sales of BiDil® (isosorbide dinitrate/hydralazine hydrochloride) accounted for all of the Company’s revenue during the first quarter of 2006, and license fees accounted for all of the Company’s revenue during the first quarter of 2005.

 

Total operating expenses for the three months ended March 31, 2006, excluding cost of product sales of $0.9 million, were $27.8 million, compared to $20.8 million for the same period in 2005, a 34% increase of $7.0 million. The increase in operating expenses for the first three months of 2006 versus the comparable period in 2005 is primarily due to: an increase in sales, general and administrative (SG&A) expense of $6.5 million related to the commercial launch of BiDil; a $2.0 million restructuring charge related to the discontinuation of discovery research and the elimination of approximately one-third of the Company’s workforce; and stock-based compensation expense of $1.7 million, related to the Company’s adoption of the Financial Accounting Standard Board’s (FASB) Statement of Financial Accounting Standards No. 123 (revised 2004), Shareholder Based Payment (SFAS 123R) on January 1, 2006.

 

SG&A expenses for the three months ended March 31, 2006 were $19.6 million, compared to $13.1 million for the same period in 2005, an increase of $6.5 million or 50%. The increase in SG&A expenses for the first three months of 2006 versus the comparable period in 2005 was primarily related to the commercial launch of BiDil, including: costs related to the Company’s contract sales force agreement with Publicis Selling Solutions, Inc.; the hiring of sales and marketing personnel; and BiDil advertising and promotional expenses.

 

Research and Development (R&D) expenses for the three months ended March 31, 2006 were $6.2 million, compared to $7.7 million for the same period in 2005, a decrease of $1.5 million, or 19%. The decrease in R&D expenses for the first quarter of 2006 versus the comparable period in 2005 was primarily due to reduced medical spending supporting the commercialization of BiDil, partially offset by increases in stock-based compensation expenses.

 

The Company’s net loss attributable to common shareholders for the quarter ended March 31, 2006 was $25.9 million or $0.75 per basic and diluted common share compared to a net loss of $19.6 million or $0.65 per basic and diluted share for the same quarter in 2005.

 



 

At March 31, 2006, the Company had cash, cash equivalents and marketable securities of $93.9 million, including net proceeds of $58.6 million from a registered direct offering that closed on January 26, 2006.

 

Kenneth M. Bate, Chief Operating Officer and Chief Financial Officer for NitroMed said, “With the restructuring of research and development now completed, and plans in place to internalize the sales force, we are now resetting guidance for the year. We now expect operating expenses for 2006 to be in the range of $95 - $110 million, which includes SFAS 123R related expenses as well as restructuring charges and excludes cost of product sales. Regarding revenue, we expect to see demand for BiDil continue to grow and are projecting net product sales of approximately $20 million for 2006.”

 

Argeris N. Karabelas, Ph.D., Chairman and interim Chief Executive Officer for NitroMed, commented, “Our first and foremost priority is to accelerate BiDil sales. We’re encouraged by BiDil prescription numbers for the first quarter of 2006, which increased 50% over the previous quarter. March was a particularly strong month and we expect to continue to make this kind of progress as we seek to improve productivity by moving the sales force in-house and focus on reimbursement and partnering initiatives. I look forward to reporting to you on our key objectives during today’s conference call, and on the actions being taken to maximize the potential for success of BiDil and NitroMed.”

 

Webcast and Conference Call

NitroMed will host a webcast and conference call, including an open question and answer session to discuss first quarter 2006 financial results, Company progress and updated guidance.

 

Date:

Tuesday, May 2, 2006

Time:

9:00 am ET

 

 

To access by conference call:

 

Domestic callers:

Dial 800-901-5226

 

International callers:

Dial 617-786-4513

 

Participant passcode:

65922817

 

 

 

To access by webcast:

 

Go to http://www.nitromed.com and follow instructions for the live webcast.

 

Participants may register in advance.

 

An audio replay of this event, available by two hours after the call, can be accessed by dialing 888-286-8010 (domestic) or 617-801-6888 (international). The replay passcode ID for all callers is 88414065. In addition, an audio webcast of this event will be archived on NitroMed’s website for an indefinite period of time.

 

About NitroMed, Inc.

NitroMed of Lexington, Massachusetts is an emerging pharmaceutical company and 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/or 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, and is marketed by NitroMed through a nationwide, dedicated sales force.

 

2



 

Forward Looking Statements

Statements in this press release about future expectations, plans and prospects for the Company, including the Company’s guidance regarding operating expenses and revenue for fiscal year 2006 and its statements regarding the Company’s expectations concerning increasing demand and prescriptions for BiDil, 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: patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; the Company’s ability to obtain preferential reimbursement treatment for BiDil, if at all, and the impact of obtaining such preferential reimbursement treatment on BiDil sales, if any; the Company’s ability to effectively and efficiently transition its contract sales force to NitroMed within the time frame expected, if at all; the Company’s ability to successfully market and sell BiDil with reduced sales force representation; the impact, if any, of practice guidelines and peer-reviewed publications on market acceptance of BiDil; the effectiveness of the Company’s marketing and sales strategy; the Company’s ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; unanticipated difficulties in maintaining regulatory approvals to market and sell BiDil; adverse side effects experienced by patients taking BiDil; the Company’s ability to obtain or maintain intellectual property protection and required licenses; the Company’s ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil; unanticipated operating expenses for the remainder of the fiscal year 2006 and other factors discussed in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, which has been 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.

 

For full prescribing information, visit: www.BiDil.com.

 

BiDil is a registered trademark of NitroMed, Inc.

 

Contacts:

Sondra Newman, Investor Relations

P: 781.266.4197

C: 781.640.3088

 

Jane Kramer, Media

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 March 31, 2006 and December 31, 2005

(Unaudited)

 

 

 

March 31,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Cash and marketable securities

 

$

93,892

 

$

61,541

 

Accounts receivable, net

 

702

 

4,078

 

Inventories

 

3,156

 

3,247

 

Other assets

 

6,381

 

7,655

 

 

 

 

 

 

 

Total assets

 

$

104,131

 

$

76,521

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

27,051

 

$

29,351

 

Deferred revenue

 

520

 

3,451

 

Long term portion of notes payable

 

8,986

 

10,653

 

Stockholders’ equity

 

67,574

 

33,066

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

104,131

 

$

76,521

 

 

CONDENSED STATEMENTS OF OPERATIONS

For the three months ended March 31, 2006 and 2005

(Unaudited)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2006

 

2005

 

Revenues:

 

 

 

 

 

Product sales

 

$

2,316

 

$

 

Research and development

 

 

398

 

 

 

 

 

 

 

Total revenues

 

2,316

 

398

 

 

 

 

 

 

 

Cost and operating expenses:

 

 

 

 

 

Cost of product sales

 

896

 

 

Research and development

 

6,152

 

7,696

 

Sales, general and administrative

 

19,632

 

13,063

 

Restructuring charge

 

2,038

 

 

 

 

 

 

 

 

Total cost and operating expenses

 

28,718

 

20,759

 

 

 

 

 

 

 

Loss from operations

 

(26,402

)

(20,361

)

 

 

 

 

 

 

Non-operating income, net

 

478

 

772

 

 

 

 

 

 

 

Net loss

 

$

(25,924

)

$

(19,589

)

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(0.75

)

$

(0.65

)

 

 

 

 

 

 

Average common shares outstanding, basic and diluted

 

34,597

 

30,234

 

 


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