-----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, OKD4fVDU8xHHSeOKrXxMacmELVCIByAopcchj8meQfLixC7lAPeOQqYZoH3hZiiZ KhB42Wu8yTRCE62NIMMFdA== 0001104659-07-078284.txt : 20071031 0001104659-07-078284.hdr.sgml : 20071030 20071031074135 ACCESSION NUMBER: 0001104659-07-078284 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071031 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071031 DATE AS OF CHANGE: 20071031 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: 071201115 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 a07-27780_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): October 31, 2007

 

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 October 31, 2007, NitroMed, Inc. announced its financial results for the quarter ended September 30, 2007. 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 October 31, 2007.

 

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: October 31, 2007

By:

/s/ James G. Ham, III

 

 

 

 

 

 

 

James G. Ham, III
Vice President, Chief Financial Officer,
Treasurer and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release issued by NitroMed, Inc. on October 31, 2007.

 

4


EX-99.1 2 a07-27780_1ex99d1.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 Third Quarter 2007

 

 - Conference Call and Webcast Today at 8:30 AM EDT -

 

LEXINGTON, MA—(October 31, 2007)—NitroMed, Inc. (NASDAQ: NTMD), an emerging pharmaceutical company and 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, today reported financial results for its third fiscal quarter and year to date ended September 30, 2007.

 

Total revenues for the three months ended September 30, 2007 were $3.8 million compared to $3.4 million for the same period in 2006, an increase of $0.4 million or 10%. For the nine months ended September 30, 2007, total revenues were $11.0 million, compared to $8.6 million for the same period during 2006, an increase of $2.4 million, or 28%. Sales of BiDil accounted for all revenues during both periods.

 

Total operating expenses for the three months ended September 30, 2007, excluding cost of product sales, were $11.9 million, compared to $19.1 million for the same period in 2006, a decrease of $7.2 million or 38%. For the nine months ended September 30, 2007, total operating expenses, excluding cost of product sales, were $34.5 million, compared to $68.0 million for same period during 2006, a decrease of $33.5 million or 49%.

 

The substantial year-over-year decreases in operating expenses are primarily the result of the Company’s restructuring actions in March and October of 2006, which reduced costs and employee headcount in the areas of research and discovery, and sales and marketing, respectively; and decreased advertising and medical affairs expenditures that had supported the commercial launch of BiDil in 2006.

 

The Company’s net loss for the quarter ended September 30, 2007 was $8.4 million or $0.18 per common share, compared to a net loss of $16.5 million or $0.45 per common share for the same quarter in 2006. For the nine months ended September 30, 2007, the Company’s net loss was $24.7 million or $0.60 per common share, compared to a net loss of $60.7 million or $1.68 per common share for the same period in 2006.

 

At September 30, 2007, the Company had cash, cash equivalents and marketable securities totaling $38.2 million, a decrease of $3.9 million from December 31, 2006. In May 2007, the Company raised net proceeds of $18.2 million in a registered direct offering of its common stock.

 

“During the third quarter, we succeeded in expanding the size of our field sales organization, as planned, with an experienced group of cardiovascular sales professionals,” said Kenneth M. Bate, NitroMed’s President and Chief Executive Officer. “We welcome these newest members of the BiDil team, who are focused on pull-through efforts at the local physician level. Broadly aiding our field efforts, in September

 



 

we placed a series of nationwide BiDil advertisements in the leading cardiovascular journals. In addition, we launched an information-rich website, BiDil.com, that includes a BiDil sample-ordering option for physicians. These efforts, combined with affordable reimbursement for BiDil on a substantial majority of health care plans, provide strong impetus for building the BiDil market, and we look forward to monitoring their impact on fourth quarter sales.”

 

James G. Ham, III, NitroMed’s Chief Financial Officer, commented, “During the third quarter, we continued to aggressively manage our cash burn to a rate of $6.2 million, which was a slight decrease from second quarter burn. For the year 2007, we project operating expenses to be approximately $50 million, including share-based compensation expense related to SFAS 123R but excluding cost of product sales.”

 

Corporate Highlights

 

Accomplishments realized by NitroMed during the third quarter of 2007 include:

 

                  The publication in the September issue of Clinical Pharmacokinetics, a peer-reviewed scientific journal, demonstrating that two different combinations of individual isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD), used in the Vasodilator-Heart Failure Trials (V-HeFT) I and II are not bioequivalent to BiDil, the fixed-dose combination of ISDN and HYD, used in the African American Heart Failure Trial (A-HeFT). The study compared identical amounts of the formulations of ISDN and HYD used in V-HeFT I and II, and BiDil, the proprietary fixed dose combination, used in A-HeFT and demonstrated that the formulations used in V-He FT I and V-HeFT II are neither bioequivalent to each other, nor to BiDil. Generic formulations of ISDN and HYD have not been shown to be bioequivalent to BiDil and there is no basis to conclude that the clinical efficacy and outcomes results of generic ISDN and HYD will be the same as BiDil.

 

                  The presentation in September of five abstracts at the 11th Annual Scientific Meeting of the Heart Failure Society of America. The new data broadens the clinical understanding of BiDil by a dding to the body of evidence that BiDil represents important adjunct therapy in the treatment of black heart failure patients. The data presented regarding mortality in high risk heart failure patients with atrial fibrillation, BiDil’s use in the elderly and with concomitant therapies, and genetic results will help heart failure specialists deliver optimal care to their patients.

 

                  Improvement in preferred reimbursement for BiDil and inclusion of BiDil on key hospital formu laries. Preferred reimbursement denotes a preferential level of reimbursement at which patient co-pays range from approximately $15.00 to $30.00 per prescription.

 

                  The doubling of the Company’s BiDil field organization through the deployment of approximately 30 additional professionals with extensive cardiovascular sales, marketing and/or management experience at the end of the third quarter.

 

                  The introduction of new BiDil marketing support, including:

 

                  Advertising placement in key cardiovascular medical journals.

                  The launch of BiDil.com (www.bidil.com), an information rich resource for cardiovascular health professionals, physicians, and black heart failure patients.

 

Webcast and Conference Call

 

NitroMed will host a webcast and conference call, including an open question and answer session to discuss third quarter 2007 financial results and Company progress.

 

2



 

Date:      Wednesday, October 31, 2007

Time:     8:30 a.m. Eastern Time

Access by Conference Call:

Domestic callers:               Dial 800-299-8538

International callers:          Dial 617-786-2902

Participant passcode:         40599135

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 November 7, 2007. The replay can be accessed by dialing 888-286-8010. International callers should dial 617-801-6888. The replay passcode for all callers is 56024019. 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 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 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 specialty medicines sales organization.

 

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 2007, its positioning to achieve the Company’s goals and objectives in 2007, the expected benefit of its current sales organization expansion, its plans to build the market for the BiDil brand, the expected impact of such efforts in the fourth quarter of 2007 and beyond, and its plans to develop an extended release formulation of BiDil, known as BiDil XR™, 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, including the Company’s ability to maintain third-party relationships for the development and manufacture of clinical and commercial quantities of BiDil XR on favorable terms, if at all; the Company’s ability to execute on its revised sales and marketing strategy for BiDil, including, without limitation, the Company’s ability to achieve anticipated cost reductions, the Company’s ability to successfully market and increase the sales of BiDil with limited sales force support and centralized marketing efforts, the Company’s ability to recruit the specialized sales representatives necessary to execute on this strategy, and the Company’s ability to successfully enter into a co-promotion agreement for BiDil on favorable terms, if at all; the Company’s ability to enter into collaboration or licensing arrangements with strategic partners related to its product candidate portfolio on favorable terms, if at all; the Company’s ability to obtain the substantial additional funding required to execute its business strategies; patient, physician and third-party payor acceptance of BiDil and/or BiDil XR, if successfully developed, as safe and effective therapeutics; the Company’s ability to obtain or maintain intellectual property protection and required licenses; unanticipated operating expenses for the remainder of fiscal year 2007 and beyond; 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 September 30, 2007, which has been filed with the SEC, and in the other filings that the Company makes with the SEC from time to time. 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

 

3



 

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

Source: NitroMed, Inc.

 

-                    Financial Tables Follow –

 

4



 

NITROMED, INC.

SELECTED FINANCIAL INFORMATION

(in thousands, except per share amounts)

 

CONDENSED STATEMENTS OF OPERATIONS

For the three and nine months ended September 30, 2007 and 2006

(Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Revenues:

 

 

 

 

 

 

 

 

 

Product revenue

 

$

3,759

 

$

3,427

 

$

11,042

 

$

8,598

 

 

 

 

 

 

 

 

 

 

 

Cost and operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

560

 

1,310

 

2,151

 

2,827

 

Research and development

 

3,807

 

4,074

 

9,745

 

14,590

 

Sales, general and administrative

 

8,127

 

15,022

 

23,709

 

51,386

 

Restructuring charge

 

 

 

1,004

 

2,038

 

 

 

 

 

 

 

 

 

 

 

Total cost and operating expenses

 

12,494

 

20,406

 

36,609

 

70,841

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(8,735

)

(16,979

)

(25,567

)

(62,243

)

 

 

 

 

 

 

 

 

 

 

Non-operating income, net

 

381

 

459

 

863

 

1,519

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,354

)

$

(16,520

)

$

(24,704

)

$

(60,724

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.18

)

$

(0.45

)

$

(0.60

)

$

(1.68

)

 

 

 

 

 

 

 

 

 

 

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

 

45,180

 

37,090

 

40,877

 

36,146

 

 

CONDENSED BALANCE SHEETS

As of September 30, 2007 and December 31, 2006

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Cash and marketable securities

 

$

38,224

 

$

42,153

 

Accounts receivable, net

 

1,515

 

1,370

 

Inventories

 

2,696

 

2,846

 

Other assets

 

1,072

 

2,336

 

 

 

 

 

 

 

Total assets

 

$

43,507

 

$

48,705

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

15,488

 

$

15,898

 

Long-term debt

 

 

3,728

 

Stockholders’ equity

 

28,019

 

29,079

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

43,507

 

$

48,705

 

 

5


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