-----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, DxBu82r0pm8Phkx7D0wnbgDh/k0WTUElsQRKPTiwrsK+XPqE3llgxk+CYC9Og33P y4cldkmvl4wL5dDTpAmzfg== 0001104659-06-070655.txt : 20061102 0001104659-06-070655.hdr.sgml : 20061102 20061102143829 ACCESSION NUMBER: 0001104659-06-070655 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20061102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061102 DATE AS OF CHANGE: 20061102 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: 061182186 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 a06-22886_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): November 2, 2006

 

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 November 2, 2006, NitroMed, Inc. announced its financial results for the quarter ended September 30, 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 November 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: November 2, 2006

 

By:

 

/s/ KENNETH M. BATE

 

 

 

 

 

 

 

 

 

Kenneth M. Bate

 

 

 

 

Chief Operating Officer, Chief Financial
Officer, Treasurer and Secretary

 

3




 

EXHIBIT INDEX

Exhibit No.

 

Description

 

 

 

 

 

99.1

 

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

 

4



EX-99.1 2 a06-22886_1ex99d1.htm EX-99

GRAPHIC 

 


Exhibit 99.1

 

 

 

 

 

 

 

NITROMED, INC.

 

125 SPRING STREET

 

LEXINGTON, MA 02421

 

t. 781.266.4000

 

f. 781.274.8080

 

www.nitromed.com

 

NitroMed Reports Financial Results for Third Quarter 2006
 - Conference Call and Webcast Today at 4:00 PM ET-

LEXINGTON, Mass — November 2, 2006—NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for the three- and nine-month periods ended September 30, 2006.

Total revenue for the three-month period ended September 30, 2006 was $3.4 million compared to $1.5 million for the same period in 2005, an increase of $1.9 million.  Total revenue for the nine-month period ended September 30, 2006 was $8.6 million compared to $2.3 million for the same period in 2005, an increase of $6.3 million.  Net sales of BiDil® (isosorbide dinitrate/hydralazine hydrochloride) accounted for all of the Company’s revenue during the first nine months of 2006, and $1.1 million of the Company’s revenue during the three and nine-month periods ended September 30, 2005.  License fees accounted for the remainder of the Company’s revenue during the first nine months of 2005.

Total operating expenses for the three-month period ended September 30, 2006, excluding cost of product sales of $1.3 million, were $19.1 million, a decrease of $11.9 million or 38% compared to the same period in 2005.  For the nine-month period ended September 30, 2006, total operating expenses, excluding cost of product sales of $2.8 million, were $68.0 million, a decrease of $7.6 million or 10% compared to the same period in 2005.

The decrease in operating expenses for the three-month period ended September 30, 2006 versus the comparable period in 2005 was primarily due to: a $3.0 million or 41% decrease in research and development (R&D) expense; and a $8.9 million or 38% decrease in sales, general and administrative (SG&A) expense.  The decrease in operating expenses for the nine-month period ended September 30, 2006 versus the comparable period in 2005 was primarily due to: an $8.2 million or 35% decrease in R&D expense; and a $1.4 million or 3% decrease in SG&A expense, partially offset by a $2.0 million restructuring charge.

The decrease in SG&A expenses and the decrease in R&D expenses during the reported periods are primarily due to the launch of BiDil in July 2005 and the restructuring of the Company’s discovery research group in March 2006.

The Company’s net loss attributable to common shareholders for the quarter ended September 30, 2006 was $16.5 million or $0.45 per basic and diluted common share, compared to a net loss of $32.1 million or $1.05 per basic and diluted common share for the same quarter in 2005.  Net loss for the nine months ended September 30, 2006 was $60.7 million or $1.68 per basic and diluted common share, compared to a net loss of $74.3 million or $2.45 per basic and diluted common share for the comparable period in 2005.




 

At September 30, 2006, the Company had cash, cash equivalents and marketable securities of $54.6 million.

Kenneth M. Bate, Chief Operating Officer and Chief Financial Officer for NitroMed said, “Due to the restructuring that was recently announced on October 11th and expense controls that have been in place during the year, we are lowering our operating expense guidance for 2006.  We now expect total operating expenses for the year to be in the range of $85 to $95 million. This includes SFAS 123R related expenses as well as restructuring charges, and excludes cost of product sales.  We expect to record charges of approximately $3.0 million related to this restructuring in the fourth quarter of 2006.  We expect to end the year with approximately $35 million in cash.  Looking ahead to 2007, as a result of the revised business strategy that we announced last month, we expect to realize approximately $30 million in additional operating expense savings as compared to 2006 levels.”

NitroMed’s key accomplishments during the third quarter 2006 include:

1. Strong improvement in patient access to BiDil

·                  The Company entered into final agreements to place BiDil on preferred formularies of 2 of the nation’s 5 largest Medicare Part D payors

·                  By October 1, based on the Company’s best estimates using external and internal data sources, over 50% of insured African Americans over age 45 had access to BiDil at a favorable co-pay

2.               The launch of a direct-to-consumer (DTC) advertising campaign to drive patient demand for BiDil

·                  Radio and print in Houston, Detroit, Washington DC

·                  Educational website, www.HeartHealthHeritage.com, launched nationwide

3.               The presentation of new clinical data at the annual meeting of the Heart Failure Society of America (HFSA), including but not limited to:

·                  Results of 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

·                  As part of the Company’s Genetic Risk Assessment in Heart Failure (GRAHF) study, the identification of a fifth genotype prevalent in African Americans and characterized by pronounced clinical effect of BiDil in A-HeFT

4.               The initiation of BiDil extended release (BiDil XR™) clinical studies

·                  After the close of the quarter, in October, the Company initiated its first pharmacokinetic (PK) study of BiDil XR™, consistent with the Company’s decision to accelerate the development of this once-daily formulation

Subsequent to the end of the third quarter, the Company announced a revision of its strategy and business model in a move intended to focus its resources on the accelerated development of BiDil XR™.  The Company believes this revised strategy will allow it to conserve the cash required to accelerate development of BiDil XR™ while refocusing the market presence of the current BiDil formulation. The strategic shift involved eliminating NitroMed’s sales force and replacing it with a small team of highly experienced senior cardiovascular specialists, whose efforts are being directed toward regional and national thought-leader physicians, current BiDil prescribers, as well as key institutions in major metropolitan centers that treat, and influence the treatment of, large numbers of African-

2




 

Americans diagnosed with heart failure. Additional marketing methods will be utilized to reach the broader number of existing and potential BiDil prescribers.

“Substantial improvements in access to BiDil were made during the third quarter, and a direct-to-consumer advertising campaign was initiated.  We also received positive preclinical results during the quarter on BiDil XR™.  Despite this progress, we determined that the rate of BiDil prescription sales growth required a strategic shift to refocus our market presence through alternative, less costly marketing methods and redirect our resources to accelerating development of our new, once-daily formulation of BiDil”, commented Argeris N. Karabelas, Ph.D., Chairman and Chief Executive Officer for NitroMed.  He continued, “With this redirection behind us, we are proceeding according to our plan.  The development of BiDil XR™ has been accelerated, and pharmacokinetic work is underway.  A team of senior cardiovascular specialists is being assembled and we are working to roll out new, centralized marketing initiatives.  And finally, we continue to consider co-promotion opportunities for BiDil and to pursue potential partnerships for our IND-ready cardiovascular agent NMI-3377.”

Webcast and Conference Call
NitroMed will host a conference call and webcast this afternoon to discuss Company progress and financial results for its third quarter ended September 30, 2006.   Details follow.

Event Date:

Thursday, November 2, 2006

Event Time:

4:00 p.m. ET

Dial-in Access Numbers:

 

Domestic:

866-770-7146

International:

617-213-8068

Participant passcode:

59015566

Webcast Access:

 

Go to www.nitromed.com. 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 41833992.  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 study, 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,

3




 

including the Company’s expectations regarding the effect of its operational restructuring and revised sales and marketing strategy, its current development plans for BiDil XR™, its expectations regarding the benefit of BiDil XR™ to patients, if approved, its co-promotion and out-licensing strategies, and its financial guidance with respect to operating expenses and available cash, 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 successfully contract 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 sell 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 2006 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 period ended September 30, 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.

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

4




 

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

CONDENSED BALANCE SHEETS
As of September 30, 2006 and December 31, 2005
(Unaudited)

 

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

Cash and marketable securities

 

$

54,595

 

$

61,541

 

Accounts receivable, net

 

1,578

 

4,078

 

Inventories

 

3,053

 

3,247

 

Other assets

 

3,684

 

7,655

 

Total assets

 

$

62,910

 

$

76,521

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

$

19,133

 

$

29,351

 

Deferred revenue

 

 

3,451

 

Long-term debt

 

5,525

 

10,653

 

Stockholders’ equity

 

38,252

 

33,066

 

Total liabilities and stockholders’ equity

 

$

62,910

 

$

76,521

 

 

CONDENSED STATEMENTS OF OPERATIONS
For the three and nine months ended September 30, 2006 and 2005
(Unaudited)

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

3,427

 

$

1,117

 

$

8,598

 

$

1,117

 

Research and development

 

 

398

 

 

1,194

 

Total revenues

 

3,427

 

1,515

 

8,598

 

2,311

 

Cost and operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

1,310

 

2,877

 

2,827

 

2,877

 

Research and development

 

4,400

 

7,393

 

15,215

 

23,391

 

Sales, general and administrative

 

14,696

 

23,614

 

50,761

 

52,161

 

Restructuring charge

 

 

 

2,038

 

 

Total cost and operating expenses

 

20,406

 

33,884

 

70,841

 

78,429

 

Loss from operations

 

(16,979

)

(32,369

)

(62,243

)

(76,118

)

Non-operating income, net

 

459

 

297

 

1,519

 

1,833

 

Net loss

 

$

(16,520

)

$

(32,072

)

$

(60,724

)

$

(74,285

)

Basic and diluted net loss per common share

 

$

(0.45

)

$

(1.05

)

$

(1.68

)

$

(2.45

)

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

 

37,090

 

30,421

 

36,146

 

30,311

 

 

5



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