-----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, C+btYK/pAkoByyE0NrbXetEi659N4QkYrKOW+7fVoif4pRHKguAhYBcO6cDyzd4U 0/hg3pHHMkAiRSkm+Wql0w== 0001012870-03-002017.txt : 20030424 0001012870-03-002017.hdr.sgml : 20030424 20030424161921 ACCESSION NUMBER: 0001012870-03-002017 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030424 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030424 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TULARIK INC CENTRAL INDEX KEY: 0000889057 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943148800 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28397 FILM NUMBER: 03662548 BUSINESS ADDRESS: STREET 1: TWO CORPORATE DRIVE CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 6508257300 MAIL ADDRESS: STREET 1: TWO CORPORATE DRIVE CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 d8k.htm FORM 8-K 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 24, 2003

   

 

Tularik Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware


 

000-28347


 

94-3248800


(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

Two Corporate Drive, South San Francisco, CA


 

94080


(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:

 

(650) 825-7000

   

 

 


(Former name or former address, if changed since last report)

 


 

Item 7.   Financial Statements, Pro Forma Financial Information and Exhibits.

 

(c)   Exhibits

 

  99.1   Press Release entitled “Tularik Reports 2003 First Quarter Financial Results,” dated April 24, 2003.

 

Item 9.   Regulation FD Disclosure (Information Provided under Item 12, Disclosure of Results of Operations and Financial Condition)

 

Pursuant to the 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 24, 2003, the Registrant publicly disseminated a press release announcing certain financial results for the quarter ended March 31, 2003.

 

The foregoing description is qualified in its entirety by references to the Registrant’s press release dated April 24, 2003, a copy of which is attached hereto as Exhibit 99.1.


 

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.

 

   

TULARIK INC.

 

/s/    William J. Rieflin


Date: April 24, 2003

 

William J. Rieflin

Executive Vice President, Administration

Acting Chief Financial Officer

 


 

Exhibit Index

 

Number


  

Description


99.1

  

Press Release entitled “Tularik Reports 2003 First Quarter Financial Results,” dated April 24, 2003.

 

EX-99.1 3 dex991.htm PRESS RELEASE Press Release

 

Exhibit 99.1

 

[LOGO OF TULARIK]

 

Contacts:   Tularik Inc.  
Traci McCarty  
650-825-7182

 

Tularik Reports 2003 First Quarter Financial Results

 

South San Francisco, Calif., April 24, 2003—Tularik Inc. (Nasdaq: TLRK) today reported results for the first quarter ended March 31, 2003. Revenue for the quarter was $6.7 million, compared to 2002 first quarter revenue of $6.2 million. Net losses for the quarter were $24.2 million, or $0.44 per share, compared to a net loss of $20.6 million, or $0.41 per share, for the same period in 2002. At March 31, 2003, Tularik had $156.3 million in cash, cash equivalents and marketable securities, including $17.7 million from Tularik’s majority-owned subsidiary, Cumbre Inc.

 

First Quarter Highlights:

 

    Tularik announced the initiation of its pivotal trial with T67 for the first-line treatment of hepatocellular carcinoma (HCC), a leading cause of cancer death worldwide. T67 is an anti-cancer drug candidate with a novel chemical structure that binds to ß-tubulin, a known anti-cancer drug target. Tularik is conducting a 750-patient, two-arm, randomized, global study to compare the survival of patients who receive T67 versus those receiving doxorubicin. Doxorubicin is the current systemic chemotherapy standard of care for HCC, although the FDA has not approved it for this indication. The Company will provide an enrollment update at year-end.

 

    The Company’s second anti-cancer drug candidate, T607, is an analog of T67. Tularik is currently conducting Phase 2 studies with T607 for the treatment of HCC, ovarian cancer, gastric cancer and esophageal cancer. During the quarter, Tularik halted the non-Hodgkin’s lymphoma arm of the study for a number of reasons including cost-containment, low patient enrollment and limited market opportunity. At the end of the year, the Company will provide an update on further development plans for T607.

 

    Tularik initiated a multiple, ascending-dose Phase 1 study with T487, its novel drug candidate for the treatment of inflammatory diseases. T487 is an antagonist to CXCR3, a chemokine receptor implicated in rheumatoid arthritis, psoriasis, inflammatory bowel disease and other conditions. The Company expects to complete Phase 1 studies and initiate Phase 2 proof-of-concept studies later in 2003.

 

    Tularik’s drug candidate for the treatment of type 2 diabetes, T131, began Phase 1 studies during the quarter. T131 acts through PPARg (peroxisome proliferator-activated receptor gamma), a target involved in the body’s ability to respond to insulin. T131 has a novel chemical structure and interacts with PPARg differently from currently approved drugs, including Actos® and Avandia®. Preclinical studies comparing T131 to Avandia® demonstrate that T131 has equal efficacy and a better side effect profile. The Company intends to complete Phase 1 studies and initiate Phase 2 proof-of-concept studies later in 2003.

 

    Tularik scientists published a paper in the March 2003 edition of Cancer Cell describing the discovery of a novel, amplified oncogene, KCNK9. This gene is expressed at abnormally high levels in nearly 50% of the breast cancer specimens examined in their study. Led by Scott Powers of Tularik’s genomics division, the researchers used a variety of criteria to determine that the KCNK9 gene plays a role in cancer. Expression of the KCNK9 gene was increased at least five-fold and up to over 100-fold above normal levels in 28 out of 64 breast cancer specimens (44%).


 

Financial Results

 

Revenues for the first quarter of 2003 totaled $6.7 million, compared to revenues of $6.2 million for the same period in 2002. 2003 first quarter revenues were comprised of $5.1 million from collaborative research and development and $1.6 million from technology license fees. Collaborative research revenues were primarily derived from research collaborations with Japan Tobacco Inc., Medarex, Inc. and Sankyo Company, Limited. Revenues from technology licenses for the first quarter of 2003 related to the receipt of preferred stock of a private company in exchange for a license to certain technology and the assignment of certain patents.

 

Total research and development expenses for the first quarter of 2003 increased 12%, to $28.3 million from $25.2 million for the same period in 2002, due to increased clinical development costs, increased research spending at Cumbre and increased headcount.

 

Total general and administrative expenses for the first quarter of 2003 increased by 11% to $3.0 million from $2.7 million for the same period in 2002, due to higher legal and accounting expenses.

 

Interest income decreased to $0.8 million for the first quarter of 2003 from $1.6 million for the first quarter last year. The decrease was due to lower cash and investment balances as well as lower yields on our investment portfolio.

 

Total net losses for the first quarter of 2003 were $24.2 million, or $0.44 per share, compared to a net loss of $20.6 million, or $0.41 per share, for the same period in 2002.

 

About Tularik

 

Tularik is engaged in the discovery and development of a broad range of novel and superior orally available medicines that act through the regulation of gene expression. Tularik’s scientific platform is focused on three therapeutic areas: cancer, immunology and metabolic disease. The Company currently has four drug candidates in clinical trials. In the cancer area, Tularik is currently conducting a pivotal study of T67 for the treatment of HCC and Phase 2 trials with T607 for the treatment of HCC, ovarian cancer, gastric cancer and esophageal cancer. T487, for the treatment of inflammatory diseases, and T131, for the treatment of type 2 diabetes, are in Phase 1 trials to evaluate safety and pharmacokinetic profile. For more information, visit Tularik’s Internet website at www.tularik.com.

 

This press release contains “forward-looking” statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause the results of Tularik to differ materially from those indicated by these forward-looking statements, including, among others, risks detailed from time to time in Tularik’s SEC reports, including the report on Form 10-K for the year ended December 31, 2002. Tularik does not undertake any obligation to update forward-looking statements.


 

TULARIK INC.

 

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

 

    

Three months ended

March 31,


 
    

2003


    

2002


 
    

(unaudited)

    

(unaudited)

 

Revenue:

                 

Collaborative research and development

  

$

5,061

 

  

$

6,176

 

Technology license fee

  

 

1,600

 

  

 

—  

 

    


  


    

 

6,661

 

  

 

6,176

 

    


  


Operating expenses:

                 

Research and development

  

 

28,329

 

  

 

25,244

 

General and administrative

  

 

2,976

 

  

 

2,714

 

    


  


    

 

31,305

 

  

 

27,958

 

    


  


Loss from operations

  

 

(24,644

)

  

 

(21,782

)

Interest and other income

  

 

839

 

  

 

1,619

 

Interest expense

  

 

(406

)

  

 

(392

)

    


  


Net loss

  

$

(24,211

)

  

$

(20,555

)

    


  


Basic and diluted amounts per share:

                 

Net loss

  

$

(0.44

)

  

$

(0.41

)

    


  


Weighted-average shares used in computing basic and diluted net loss per share

  

 

55,103,415

 

  

 

50,008,537

 

    


  


 

Condensed Consolidated Balance Sheets

(In thousands)

 

    

March 31,

2003


  

December 31,

2002


    

(unaudited)

  

(Note)

Cash and cash equivalents

  

$

85,669

  

$

95,670

Investments

  

 

70,631

  

 

81,030

Other current assets

  

 

5,399

  

 

4,600

    

  

Total current assets

  

 

161,699

  

 

181,300

    

  

Property and equipment, net

  

 

30,393

  

 

31,188

Non-current and restricted investments

  

 

7,905

  

 

17,359

Other assets

  

 

6,803

  

 

6,460

    

  

Total assets

  

$

206,800

  

$

236,307

    

  

Liabilities and stockholders’ equity:

             

Current liabilities

  

$

29,398

  

$

33,786

Long-term obligations

  

 

25,783

  

 

27,539

Minority interest

  

 

26,250

  

 

26,250

Stockholders’ equity

  

 

125,369

  

 

148,732

    

  

Total liabilities and stockholders’ equity

  

$

206,800

  

$

236,307

    

  


(Note): Derived from audited consolidated financial statements at that date.

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