-----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, BYTlPTaxTBDEdUVP/z2+R/j/Xg54GXG/hVaPGZazgqvIN7dA60bdHtz80TADHDko RYZFTEpI5AgEUcLFLRGh9g== 0001104659-06-050936.txt : 20060803 0001104659-06-050936.hdr.sgml : 20060803 20060803085103 ACCESSION NUMBER: 0001104659-06-050936 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060803 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060803 DATE AS OF CHANGE: 20060803 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: 061000114 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 a06-17148_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):  August 3, 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 August 3, 2006, NitroMed, Inc. announced its financial results for the quarter ended June 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 August 3, 2006.

 




 

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: August 3, 2006

 

By:

 

/s/ KENNETH M. BATE

 

 

 

 

Kenneth M. Bate

 

 

 

 

Chief Operating Officer, Chief Financial Officer, Treasurer and Secretary

 




 

EXHIBIT INDEX

Exhibit No.

 

Description

99.1

 

Press release issued by NitroMed, Inc. on August 3, 2006.

 



EX-99.1 2 a06-17148_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 Second Quarter 2006

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

LEXINGTON, Mass - August 3, 2006—NitroMed, Inc. (NASDAQ: NTMD) today reported financial results for the three- and six-month periods ended June 30, 2006.

Total revenue for the three-month period ended June 30, 2006 was $2.9 million compared to $0.4 million for the same period in 2005, an increase of $2.5 million.  Total revenue for the six-month period ended June 30, 2006 was $5.2 million compared to $0.8 million for the same period in 2005, an increase of $4.4 million.  Product sales of BiDil® (isosorbide dinitrate/hydralazine hydrochloride) accounted for all of the Company’s revenue during the first half of 2006.  License fees accounted for all of the Company’s revenue during the first half of 2005.  BiDil was commercially launched in July 2005.

Total operating expenses for the three-month period ended June 30, 2006, excluding cost of product sales of $621,000, were $21.1 million, compared to $23.8 million for the same period in 2005, a decrease of $2.7 million or 11.3%.  For the six-month period ended June 30, 2006, total operating expenses, excluding cost of product sales of $1.5 million, were $48.9 million, compared to $44.5 million for the same period in 2005, an increase of $4.4 million or 9.9%.  The decrease in operating expenses for the three-month period ended June 30, 2006 versus the comparable period in 2005 was due to a $3.6 million decrease in research and development (R&D) expense, partially offset by an increase in sales, general and administrative (SG&A) expense of $949,000.  The increase in operating expenses for the six-month period ended June 30, 2006 versus the comparable period in 2005 was due to an increase in SG&A expense of $7.5 million and a $2.0 million restructuring charge related to the discontinuation of discovery research, partially offset by a $5.2 million decrease in R&D expense.

SG&A expenses for the three months ended June 30, 2006 were $16.4 million, compared to $15.5 million for the same period in 2005, an increase of $949,000 or 6.1%.  SG&A expenses for the six-month period ended June 30, 2006 were $36.1 million, compared to $28.5 million for the comparable period in 2005, and increase of $7.6 million or 26.7%.  R&D expenses for the three months ended June 30, 2006 were $4.7 million, compared to $8.3 million for the same period in 2005, a decrease of $3.6 million or 43.4%.  For the six-month period ended June 30, 2006, R&D expenses were $10.8 million, compared to $16.0 million for the comparable period in 2005, a decrease of $5.2 million or 32.5%.  The respective increase in SG&A expenses and the decrease in R&D expenses in 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 June 30, 2006 was $18.3 million or $0.50 per basic and diluted common share, compared to a net loss of $22.6 million or $0.75 per basic and diluted share for the same quarter in 2005.  Net loss for the six months ended




 

June 30, 2006 was $44.2 million or $1.24 per basic and diluted share, compared to a net loss of $42.2 million or $1.40 per basic and diluted share for the comparable period in 2005.

At June 30, 2006, the Company had cash, cash equivalents and marketable securities of $71.7 million, including net proceeds of $58.5 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 respect to guidance, we expect to end the year toward the lower end of our previous guidance of $95 - $110 million in operating expenses. This includes SFAS 123R related expenses as well as restructuring charges but excludes cost of product sales.  We are optimistic about our second quarter achievements in the priority areas of reimbursement and sales force productivity.  However, because of the difficulty at this time of quantifying the impact of those achievements on BiDil prescription growth, as well as the variability in prescription numbers to date, we are withdrawing our previous net sales guidance of $20 million for 2006, at least until we are able to base such a projection on more consistent trends.”

NitroMed events and key accomplishments during the second quarter of 2006 include:

1. Strong improvement in patient access to BiDil.

·                  The Company entered into final agreements to transition BiDil to preferred formulary status for commercial participants with the two largest Pharmacy Benefit Managers (PBMs) in the nation.

·                  By July 1, based on the Company’s best estimates using external and internal data sources, 40% to 50% of insured African Americans over age 45 had access to BiDil at a co-pay of $25 or less.

2.               Prescription growth of approximately 20% over the previous quarter.

3.               The complete internalization of the BiDil sales force, previously retained on a contract basis, into NitroMed.

“Upon setting our access and sales force objectives at the start of the quarter, the organization acted urgently to record strong gains in preferred access to BiDil and to boost sales force productivity,” commented Argeris N. Karabelas, Ph.D., Chairman and interim Chief Executive Officer for NitroMed.

“On the reimbursement front, our team has significantly increased BiDil’s preferred Tier 2 coverage by commercial insurance plans.  And externally, we are encouraged by the heightened attention to Medicare Part D implementation by the Centers for Medicaid and Medicare Services (CMS), in collaboration with patient advocacy and medical groups, specifically as related to African Americans with heart failure,” Dr. Karabelas said.  “We have now fully internalized our BiDil reps into NitroMed.  Clear expectations are set, and direct lines of communication are established.  The process culminated late in June with the launch of the NitroMed sales force at our National Sales Meeting.  We believe our BiDil sales force is now well prepared to support BiDil in their territories.  While we expect that our second quarter achievements will contribute to improved prescription growth moving forward in 2006, there remain considerable opportunities and challenges ahead and we are not relaxing our efforts to realize both near and long-term gains for BiDil and the Company,” concluded Dr. Karabelas.

Webcast and Conference Call
NitroMed will host a webcast and conference call, including an open question and answer session to provide a corporate update and discuss second quarter 2006 financial results.  Details follow.

2




 

Event Date:           Thursday, August 3, 2006

Event Time:           9:00 a.m. ET

Dial-in Access Numbers:

Domestic:              866-713-8307

International:        617-597-5307

Participant passcode:          56015494

Webcast Access at 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 59548775.  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.

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 guidance regarding operating expenses and revenue for fiscal year 2006 and its statements regarding the Company’s expectation that its reimbursement access and sales force objectives will contribute to improved prescription growth 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 successfully market and sell BiDil; the effectiveness of the Company’s marketing and sales strategy and efforts; the Company’s ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to 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 the section titled “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

3




 

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 June 30, 2006 and December 31, 2005
(Unaudited)

 

June 30,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

Cash and marketable securities

 

$

71,698

 

$

61,541

 

Accounts receivable, net

 

466

 

4,078

 

Inventories

 

3,250

 

3,247

 

Other assets

 

4,979

 

7,655

 

 

 

 

 

 

 

Total assets

 

$

80,393

 

$

76,521

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

$

20,364

 

$

29,351

 

Deferred revenue

 

109

 

3,451

 

Long-term debt

 

7,277

 

10,653

 

Stockholders’ equity

 

52,643

 

33,066

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

80,393

 

$

76,521

 

 

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

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$2,855

 

$—

 

$5,171

 

$—

 

Research and development

 

 

398

 

 

796

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

2,855

 

398

 

5,171

 

796

 

 

 

 

 

 

 

 

 

 

 

Cost and operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

621

 

 

1,517

 

 

Research and development

 

4,663

 

8,302

 

10,815

 

15,998

 

Sales, general and administrative

 

16,433

 

15,484

 

36,065

 

28,547

 

Restructuring charge

 

 

 

2,038

 

 

 

 

 

 

 

 

 

 

 

 

Total cost and operating expenses

 

21,717

 

23,786

 

50,435

 

44,545

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(18,862

)

(23,388

)

(45,264

)

(43,749

)

 

 

 

 

 

 

 

 

 

 

Non-operating income, net

 

582

 

764

 

1,060

 

1,536

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$(18,280

)

$(22,624

)

$(44,204

)

$(42,213

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$(0.50

)

$(0.75

)

$(1.24

)

$(1.40

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss

 

36,724

 

30,275

 

35,667

 

30,255

 

 

5



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