-----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, ORsXmUsf9LPVRBQHd8zBJbICKs60TqMw9Bcb0kTUJUQQsrPUnMKMXMhZcQu+2jOj dB2sXaXhPBy1dxwi6ZTvdw== 0001012870-03-001800.txt : 20030416 0001012870-03-001800.hdr.sgml : 20030416 20030416161226 ACCESSION NUMBER: 0001012870-03-001800 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030416 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030416 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CV THERAPEUTICS INC CENTRAL INDEX KEY: 0000921506 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 431570294 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21643 FILM NUMBER: 03652740 BUSINESS ADDRESS: STREET 1: 3172 PORTER DR CITY: PALO ALTO STATE: CA ZIP: 94304 BUSINESS PHONE: 6503848500 MAIL ADDRESS: STREET 1: 3172 PORTER DRIVE CITY: PALO ALTO STATE: CA ZIP: 94304 8-K 1 d8k.htm CURRENT REPORT ON FORM 8-K Current Report on Form 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): April 16, 2003

 


 

CV THERAPEUTICS, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware

 

0-21643

 

43-1570294

(State or other jurisdiction

of incorporation)

 

(Commission File No.)

 

(I.R.S. Employer

Identification No.)

 

3172 Porter Drive

Palo Alto, California 94304

(Address of Principal Executive Offices, including Zip Code)

 

(650) 384-8500

(Registrant’s Telephone Number, including Area Code)

 



 

ITEM 5.    OTHER EVENTS

 

On April 16, 2003, the Registrant publicly disseminated a press release announcing certain financial results for the financial quarter ended March 31, 2003.

 

The foregoing description is qualified in its entirety by reference to the Registrant’s Press Release dated April 16, 2003, a copy of which is attached hereto as Exhibit 99.1.

 

ITEM 7.    FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS

 

(c)    Exhibits.

 

99.1

  

Registrant’s Press Release dated April 16, 2003.

 

ITEM 9.    REGULATION FD DISCLOSURE (INFORMATION PROVIDED UNDER ITEM 12—DISCLOSURE OF RESULTS OF

                 OPERATIONS AND FINANCIAL CONDITION)

 

Pursuant to Securities and Exchange Commission Release No. 33-8216, dated March 27, 2003, the information provided herein is being furnished under Item 12 of Form 8-K.

 

On April 16, 2003, the Registrant publicly disseminated a press release announcing certain financial results for the financial quarter ended March 31, 2003.

 

The foregoing description is qualified in its entirety by reference to the Registrant’s Press Release dated April 16, 2003, a copy of which is attached hereto as Exhibit 99.1.

 

Forward-Looking Statements.    This report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements relate to future events or our future clinical or product development or financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of those terms and other comparable terminology. These statements reflect only management’s current expectations. Important factors that could cause actual results to differ materially from the forward-looking statements we make or incorporate by reference in this report are set forth under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as may be updated from time to time by our future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

 

2


 

SIGNATURES

 

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.

 

Date: April 16, 2003

     

CV THERAPEUTICS, INC.

           

By:

 

/s/    DANIEL K. SPIEGELMAN        


               

Daniel K. Spiegelman

Senior Vice President and Chief Financial Officer

EX-99.1 3 dex991.htm PRESS RELEASE DATED 04/16/2003 Press Release dated 04/16/2003

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

 

Investor Contacts:

 

Media Contact:

Dan Spiegelman

 

John Bluth

SVP & Chief Financial Officer

 

Director, Corporate Communications

(650) 384-8509

 

(650) 384-8850

Christopher Chai

   

Treasurer & Executive Director, Investor Relations

   

(650) 384-8560

   

 

CV THERAPEUTICS REPORTS FIRST QUARTER

 

FINANCIAL RESULTS FOR 2003

 

PALO ALTO, Calif., April 16, 2003—CV Therapeutics, Inc. (Nasdaq: CVTX) today announced financial results for the first quarter ended March 31, 2003. For the quarter ended March 31, 2003, the Company reported a net loss of $20.7 million, or $0.75 per share, compared to a net loss of $21.9 million, or $0.86 per share, for the same quarter in 2002.

 

Operating expenses for the quarter ended March 31, 2003 decreased to approximately $23.3 million, from $25.0 million for the same quarter in 2002, primarily due to decreased clinical trial expenses (consistent with the fluctuation in clinical trial activity of our late stage programs) and decreased general and administrative outside service expenses. These decreases were partially offset by increased pre-commercialization marketing and manufacturing expenses.

 

The Company recognized collaborative research revenue of $1.8 million for the quarter ended March 31, 2003, compared to $1.2 million for the same quarter in 2002. The revenue recognized for both periods relates to the reimbursement of certain development costs from collaborative partners and amortization of up-front milestone payments earned.

 

At March 31, 2003, the Company had cash, cash equivalents and marketable securities of approximately $401.3 million, compared to $410.9 million at December 31, 2002.

 

Company management will webcast a conference call on Wednesday, April 16, 2003 at 5:30 p.m. EDT, 2:30 p.m. PDT, on the Company’s website. To access the live webcast, please log on to the company’s website at www.cvt.com and go to the Investor Information section. Alternatively, domestic callers may participate in the conference call by dialing (888) 370-6121, and international callers may participate in the conference call by dialing (706) 679-7163. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Domestic callers can access the replay by dialing (800) 642-1687, and international callers can access the replay by dialing (706) 645-9291; the PIN access number is 9393956.


 

CV Therapeutics, Inc., headquartered in Palo Alto, Calif., is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics currently has four compounds in clinical trials. Ranexa(TM) (ranolazine) is the first in a new class of compounds that partially inhibit fatty acid oxidation (pFOX). If approved by the FDA, Ranexa would represent the first new class of anti-anginal therapy in more than 20 years. Tecadenoson, an A1-adenosine receptor agonist, is being developed for the potential reduction of rapid heart rate during atrial arrhythmias. CVT-3146, a selective A2A-adenosine receptor agonist, is being developed for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies. Adentri(TM), an A1-adenosine receptor antagonist for the potential treatment of acute and chronic congestive heart failure, is licensed to Biogen, Inc.

 

Except for the historical information contained herein, the matters set forth in this press release, including statements as to development and commercialization of the company’s products, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including, early stage of development; the timing of clinical trials; approval and commercialization of our products; the dependence on collaborative and licensing agreements; and other risks detailed from time to time in CVT’s SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2002. CVT disclaims any intent or obligation to update these forward-looking statements.

 

– Tables to follow –


 

CV Therapeutics, Inc.

CONSOLIDATED STATEMENT OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

    

Three months ended

March 31,


 
    

2002 (A)


    

2003


 

Revenues:

                 

Collaborative research

  

$

1,214

 

  

$

1,797

 

Operating expenses:

                 

Research and development

  

 

19,461

 

  

 

16,878

 

Sales and marketing

  

 

1,339

 

  

 

2,859

 

General and administrative

  

 

4,198

 

  

 

3,516

 

    


  


Total operating expenses

  

 

24,998

 

  

 

23,253

 

    


  


Loss from operations

  

 

(23,784

)

  

 

(21,456

)

Interest and other income (expense), net

  

 

1,918

 

  

 

730

 

    


  


Net loss

  

$

(21,866

)

  

$

(20,726

)

    


  


Basic and diluted net loss per share

  

$

(0.86

)

  

$

(0.75

)

    


  


Shares used in computing basic & diluted net loss per share

  

 

25,522

 

  

 

27,476

 

    


  


CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

    

December 31, 2002 (B)


    

March 31, 2003


 

Assets:

                 

Cash, cash equivalents, and marketable securities

  

$

410,913

 

  

$

401,307

 

Other current assets

  

 

8,952

 

  

 

7,705

 

    


  


Total current assets

  

 

419,865

 

  

 

409,012

 

Property and equipment, net

  

 

15,934

 

  

 

15,992

 

Other assets

  

 

5,203

 

  

 

4,910

 

    


  


Total assets

  

$

441,002

 

  

$

429,914

 

    


  


Liabilities and stockholders’ equity:

                 

Current liabilities

  

$

20,907

 

  

$

11,306

 

Long-term obligations

  

 

201,130

 

  

 

201,071

 

Stockholders’ equity

  

 

218,965

 

  

 

217,537

 

    


  


Total liabilities and stockholders’ equity

  

$

441,002

 

  

$

429,914

 

    


  


 


(A)   Certain reclassifications of prior year amounts have been made to conform with the current year presentation.
(B)   Derived from the audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2002.
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