-----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, LsGutF1XIy1khOrJpxUApTYmGCoaVBSuKv43DWuM5k8nSRZFD3Y+SbqBjPE13HoV F++i8WyvR09i9lG4YTmtnA== 0001104659-07-017426.txt : 20070308 0001104659-07-017426.hdr.sgml : 20070308 20070308162602 ACCESSION NUMBER: 0001104659-07-017426 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070308 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070308 DATE AS OF CHANGE: 20070308 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: 07681228 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 a07-5783_38k.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): March 8, 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.)

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):

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 March 8, 2007, NitroMed, Inc. announced its financial results for the quarter and year ended December 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 March 8, 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: March 8, 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 March 8, 2007.

 

                                                                                      

4



EX-99.1 2 a07-5783_3ex99d1.htm EX-99.1

 

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 Fourth Quarter and Full Year 2006

 - Conference Call and Webcast to be Held Today at 4:30 PM ET-

LEXINGTON, MA—(March 8, 2007)—NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for the fourth quarter and the year ended December 31, 2006.

Total revenues for the three months ended December 31, 2006 were $3.5 million compared to $3.7 million for the same period in 2005, a decrease of $0.2 million. BiDil® (isosorbide dinitrate/hydralazine hydrochloride) revenues for the fourth quarter were also $3.5 million, an increase of $0.2 million over the comparable 2005 period. For the year ended December 31, 2006, the Company reported total revenues of $12.1 million compared to $6.0 million for the same period in 2005, an increase of $6.1 million or just over 100%. All revenues for the full year ended December 31, 2006 came from sales of BiDil, representing a $7.6 million or 169% year-on-year increase in BiDil revenue. Revenues reported for 2005 include research and development collaboration revenues, in addition to BiDil revenues. These collaboration revenues totaled $0.4 million and $1.6 million for the fourth quarter and year-ended December 31, 2005, respectively.

For the three months ended December 31, 2006, cost of product sales were $0.7 million, compared to $5.1 million for the same period in 2005, a decrease of $4.4 million or 86%. For the year ended December 31, 2006, cost of product sales were $3.6 million, down from $8.0 million in 2005, a decrease of $4.4 million or 56%. The decreases in cost of product sales for both the three- and twelve-month periods of 2006 versus 2005 were primarily due to reduced inventory impairment charges, which declined by $5.6 million for the full year 2006.

Total operating expenses for the three months ended December 31, 2006, excluding cost of product sales, were $13.7 million, compared to $30.4 million for the same period in 2005, a decrease of $16.7 million or 55%. For the full year ended December 31, 2006, total operating expenses, excluding cost of product sales, were $81.7 million, compared to $105.9 million for the same period in 2005, a decrease of $24.2 million or 23%.

The decrease in operating expenses for the three-month period ended December 31, 2006 versus the comparable period in 2005 was primarily due to a $6.1 million or 72% reduction in research and development (R&D) expenses and a $13.8 million or 63% reduction in sales, general and administrative (SG&A) expenses, partially offset by a $3.2 million restructuring charge. The decrease in operating expenses for the twelve-month period ended December 31, 2006 versus the comparable period in 2005 was primarily due to a decrease of $14.3 million, or 46%, in R&D expenses and a reduction of $15.2 million, or 20%, in SG&A expenses, partially offset by a $5.3 million restructuring charge.




 

The year-over-year decrease in both R&D and SG&A operating expenses is primarily attributable to two restructuring events that resulted in substantial reductions in employee headcount. In March 2006, the Company discontinued its discovery research operations, and in October 2006, the then current generalist sales force was replaced with a smaller specialty sales force. In addition, SG&A expenses were favorably impacted by the termination of a contract sales agreement with Publicis, while R&D expenses were favorably impacted by decreased clinical and medical expenses subsequent to the completion of the African American Heart Failure Trial (A-HeFT) and the approval of BiDil. The decreases were partially offset by restructuring charges of $5.3 million and an increase in the amount of $8.0 million for stock-based compensation expense related to the adoption of SFAS 123R in January 2006.

The Company’s net loss for the quarter ended December 31, 2006 was $10.6 million or $0.29 per basic and diluted common share, compared to a net loss of $31.6 million or $1.04 per basic and diluted share for the same quarter in 2005. Net loss for the twelve months ended December 31, 2006 was $71.3 million or $1.96 per basic and diluted share, compared to a net loss of $105.9 million or $3.49 per basic and diluted share for comparable period in 2005.

At December 31, 2006, the Company had cash, cash equivalents and marketable securities totaling $42.2 million.

“In 2006, we incurred operating expenses of approximately $82 million, bettering our earlier estimates, while continuing our investment in the ongoing commercial launch of BiDil and the planned development of BiDil extended release,” said James G. Ham, III, NitroMed’s Chief Financial Officer. “For the year 2007, we will continue to tightly manage expenses and expect operating expenses to be approximately $55 million, excluding cost of product sales but including stock-based compensation charges that will be recorded under SFAS 123R. The decrease in projected expense is due primarily to ongoing savings resulting from the restructuring events of 2006.”

NitroMed’s Corporate Highlights for 2006:

·                  Preferred reimbursement for BiDil dramatically improved; by year end nearly 60% of African Americans with heart failure had functional, affordable access to BiDil.

·                  Early clinical development of a next-generation, extended release formulation of BiDil (BiDil XR™) was initiated i n the fourth quarter.

·                  The U.S. Food and Drug Administration (FDA) confirmed in a May 3, 2006 letter that there is no substitutable drug or any product therapeutically equivalent to BiDil.

·                  Approximately 84,000 cumulative BiDil prescriptions were recorded in 2006, written by nearly 12,000 physicians.

·                  The Heart Failure Society of America (HFSA) issued its Comprehensive Heart Failure Guidelines for 2006, which state that, “A strong recommendation now exists for the addition of the fixed combination of isosorbide dinitrate (ISDN) and hydralazine to the standard medical regimen for African Americans with heart failure.” BiDil is the only fixed-dose combination of ISDN /hydralazine available.

2




 

·                  New A-HeFT clinical data were presented at the major cardiovascular medical meetings; the annual meetings of the American College of Cardiology (ACC) in March, the HFSA in September, and the American Heart Association (AHA) in November. The findings presented included but were not limited to:

·                  Data demonstrating that BiDil’s clinical benefits are independent of its blood pressure lowering effect.

·                  Data demonstrating that BiDil is clinically beneficial in both women and men. Notably, A-HeFT set records for the largest proportion of women studied in a clinical trial. Of the 1,050 African American heart failure patients observed, an unprecedented 40% were women.

·                  Data from the Company’s ongoing pharmacogenomics Genetic Risk Assessment in Heart Failure sub-studies (GRAHF) identifying genotypes that are important in cardiovascular diseases and are associated with a positive clinical effect of BiDil in A-HeFT, suggesting there may be genetic markers in heart failure patients that affect their response to BiDil.

·                  Data from an extension trial (X-A-HeFT) that demonstrated a high level of compliance, a duplication of the low mortality, and an improvement in the safety and tolerability of treatment with BiDil previously seen in A-HeFT.

·                  Data demonstrating BiDil’s clinical benefits in postmenopausal women.

·                  Data showing the mode of death in A-HeFT.

NitroMed’s President and Chief Executive Officer, Kenneth M. Bate observed, “During 2006, NitroMed made substantial improvements in preferred access to BiDil for the 750,000 African American patients with heart failure in the United States, and advanced BiDil extended release from the Company’s development pipeline into the clinic. To date in 2007, our efforts to maintain and possibly expand utilization of BiDil are well underway, and the BiDil XR™ program is progressing on schedule. We expect our team of cardiovascular sales specialists, managed care account specialists and field based medical experts to further develop the market for BiDil by solidifying key thought leader and institutional support. Paramount is their experience and their commitment to making the BiDil brand a commercial success.”

Webcast and Conference Call

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

Date:   Thursday, March 8, 2007

 

Time:   4:30 pm ET

 

Access by Conference Call:

 

 

 

      Domestic callers:

 

Dial 866-831-6272

 

      International callers:

 

Dial 617-213-8859

 

      Participant passcode:

 

45737741

 

3




 

Access by Webcast:

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

An audio replay of the earnings conference call will be available two hours after the call and through March 15, 2007. The replay can be accessed by dialing 888-286-8010. International callers should dial 617-801-6888. The replay passcode ID for all callers is 52408843.

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 the effect of its operational restructurings, its expectations regarding cash management and operating expenses in 2007, its positioning to achieve the Company’s goals and objectives in 2007, and its plans to increase value for the Company and its stockholders, 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 including without limitation, the Company’s inability 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 conduct manufacturing, marketing and sales of BiDil and to develop, conduct clinical trials for and, if approved, commercialize BiDil XR™; patient, physician and third-party payer acceptance of BiDil and/or BiDil XR™ as a safe and effective therapeutic; 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 Annual Report on Form 10-K for the year ended December 31, 2006, 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.

4




 

Contact:

Jane Kramer
P: 781.266.4220
C: 781.640.8499

Source: NitroMed, Inc.

-                    Financial Tables Follow —

5




NITROMED, INC.

SELECTED FINANCIAL INFORMATION
(in thousands, except per share amounts)

CONDENSED BALANCE SHEETS
As of December 31, 2006 and 2005
(Unaudited)

 

 

December 31,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

Cash and marketable securities

 

$

42,153

 

$

61,541

 

Accounts receivable, net

 

1,370

 

4,078

 

Inventories

 

2,846

 

3,247

 

Other assets

 

2,336

 

7,655

 

Total assets

 

$

48,705

 

$

76,521

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

$

15,692

 

$

29,351

 

Deferred revenue

 

206

 

3,451

 

Long-term debt

 

3,728

 

10,653

 

Stockholder equity

 

29,079

 

33,066

 

Total liabilities and stockholders’ equity

 

$

48,705

 

$

76,521

 

 

CONDENSED STATEMENTS OF OPERATIONS
For the three months and years ended December 31, 2006 and 2005
(Unaudited)

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

3,488

 

$

3,338

 

$

12,086

 

$

4,455

 

Research and development

 

 

398

 

 

1,592

 

Total revenues

 

3,488

 

3,736

 

12,086

 

6,047

 

Cost and operating expenses

 

 

 

 

 

 

 

 

 

Cost of product sales

 

733

 

5,132

 

3,560

 

8,009

 

Research and development

 

2,439

 

8,547

 

17,029

 

31,340

 

Sales, general and administrative

 

8,017

 

21,837

 

59,403

 

74,596

 

Restructuring charges

 

3,245

 

 

5,283

 

 

Total cost and operating expenses

 

14,434

 

35,516

 

85,275

 

113,945

 

Loss from operating expenses

 

(10,946

)

(31,780

)

(73,189

)

(107,898

)

Non-operating income, net

 

333

 

213

 

1,852

 

2,046

 

Net loss

 

$

(10,613

)

$

(31,567

)

$

(71,337

)

$

(105,852

)

Basic and diluted net loss per common share

 

$

(0.29

)

$

(1.04

)

$

(1.96

)

$

(3.49

)

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

 

37,147

 

30,486

 

36,399

 

30,355

 

 

6



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