-----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, KfYJK6AsbJr3FK1L64lgs5c/Jlmd4ggLQb4NeFyFtqbbyqMwlpqn8PJP8ogm27iu 4h4jM9+XuX6woMTebmOicw== 0001341004-06-002994.txt : 20061113 0001341004-06-002994.hdr.sgml : 20061110 20061113131231 ACCESSION NUMBER: 0001341004-06-002994 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061113 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061113 DATE AS OF CHANGE: 20061113 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENELABS TECHNOLOGIES INC /CA CENTRAL INDEX KEY: 0000874443 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943010150 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19222 FILM NUMBER: 061207405 BUSINESS ADDRESS: STREET 1: 505 PENOBSCOT DR CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 6503969500 MAIL ADDRESS: STREET 1: 505 PENOBSCOT DR CITY: REDWOOD CITY STATE: CA ZIP: 94063 8-K 1 genelabs8k11-13.htm

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 13, 2006

 

Genelabs Technologies, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

California

0-19222

94-3010150

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

 

505 Penobscot Drive, Redwood City, California

94063

(Address of principal executive offices)

(Zip Code)

 

 

Registrant’s telephone number, including area code: (650) 369-9500

 

 

(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 obligations of the registrant under any of the following provisions:

 

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 13, 2006, Genelabs Technologies, Inc. announced its financial results for the third quarter and first nine months of 2006. A copy of the related press release is furnished as Exhibit 99.1 hereto.

 

The information in this Form 8-K (including Exhibit 99.1) 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

 

(c) Exhibits

 

Exhibit Number

Description

 

99.1

 

Press Release of Registrant, dated November 13, 2006, entitled "Genelabs Technologies, Inc. Reports Financial Results for the Third Quarter and First Nine Months of 2006."

 

 


 

 

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.

 

 

 

Genelabs Technologies, Inc.

 

 

Date: November 13, 2006

By:

/s/ James Smith

 

Name:

James Smith

 

Title:

Chief Executive Officer

 

 

 


 

 

EXHIBIT INDEX

 

Exhibit Number

Description

 

99.1

 

Press Release of Registrant, dated November 13, 2006, entitled "Genelabs Technologies, Inc. Reports Financial Results for the Third Quarter and First Nine Months of 2006."

 

 

 

 

 

 EX-99 2 gene99-1.htm EXHIBIT 99.1 - PRESS RELEASE

Exhibit 99.1

 

 

 

 

 

Contact:

James A. D. Smith

President and Chief Executive Officer

 

Phone: 650-562-1424

 

FOR IMMEDIATE RELEASE:

 

GENELABS TECHNOLOGIES, INC. REPORTS FINANCIAL RESULTS

FOR THE THIRD QUARTER AND FIRST NINE MONTHS OF 2006

 

REDWOOD CITY, Calif. – November 13, 2006 – Genelabs Technologies, Inc. (Nasdaq:GNLB) today reported revenues of $3.6 million and a net loss of $0.6 million, or $0.03 per share, for the third quarter ended September 30, 2006. This compares to revenues of $1.7 million and a net loss of $2.8 million, or $0.16 per share for the third quarter of 2005. Revenues for the first nine months of 2006 were $7.6 million and the net loss was $8.3 million, or $0.42 per share, compared to revenues of $5.1 million and a net loss of $8.6 million, or $0.48 per share, for the same period in 2005.

 

The increase in revenue in the third quarter of 2006 compared to the third quarter of 2005 resulted primarily from our non-nucleoside collaboration with Novartis Institutes for BioMedical Research, Inc. targeted at hepatitis C virus, or HCV, which commenced in June 2006. Third quarter revenue associated with this collaboration includes on-going research funding as well as a portion of a $12.5 million up-front license fee which is being recognized on a straight line basis over the three-year term of our potential obligations under the collaboration. During the third quarter we also recorded revenue from our ongoing nucleoside HCV collaboration with Gilead Sciences, Inc.

 

“Chronic infection with hepatitis C virus has emerged as an important worldwide public health threat for which the currently available treatments are generally accepted to be sub-optimal,” stated James A. D Smith, Genelabs President and Chief Executive Officer. “Many experts believe future HCV treatment could evolve to include multiple direct antiviral drugs that function by different mechanisms, both to overcome anticipated viral resistance as well as to improve overall response rates. Genelabs has established itself as a significant player in HCV drug discovery, having established premier partnerships with Novartis and Gilead for our non-nucleoside and nucleoside HCV programs, respectively. We have also retained a third HCV program targeted at NS5a for ourselves and are evaluating additional approaches to inhibit the replication of this virus. Taking multiple mechanistic approaches to HCV drug discovery diversifies the inherent risk in any one program, and at the same time if multi-drug regimens ultimately emerge as the standard for treating HCV, these different programs have the potential to be complementary.”

 

 


 

 

During the third quarter we also recorded revenue from our collaborations for the development and commercialization of Prestara™ with Watson Pharmaceuticals, Inc. and Tanabe Seiyaku Co., Ltd.

 

“With PrestaraTM, we continue to make progress with the FDA toward finalizing a protocol for a new phase III clinical trial designed to support an indication for the treatment of lupus.” stated Mr. Smith.

 

Total operating expenses were $4.5 million and $4.7 million for the third quarters of 2006 and 2005, respectively, and $16.4 million and $14.1 million for the nine months ended September 30, 2006 and 2005, respectively. The increase in operating expenses for the nine months ended September 30, 2006 is primarily the result of costs recorded in the 2006 period for which there is no comparable expense in the 2005 period. This includes incentive-based compensation recorded after the Company met board-specified criteria in the second quarter of 2006, non-cash stock-based compensation charges following the adoption of SFAS 123R in 2006 and a fee paid to a financial advisor in the second quarter of 2006 related to the collaboration with Novartis. Incentive-based compensation and non-cash stock-based compensation charges recorded in the third quarter of 2006 were offset by a decrease in general and administrative expenses, including legal, finance and facilities related costs, resulting in a net decrease when compared to the third quarter of 2005.

 

At September 30, 2006, Genelabs had cash and cash equivalents of $20.8 million.

 

About Genelabs Technologies

Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery capabilities that can support various research and development projects. Genelabs is currently concentrating these capabilities on discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program, while also developing a late-stage product for lupus. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.

 

Note: Genelabs® and the Genelabs logo are registered trademarks and Prestara™ is a trademark of Genelabs Technologies, Inc.

 

 


 

 

NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains forward-looking statements including statements regarding the advancement of the Company’s HCV drug discovery programs and the protocol for a new clinical trial of Prestara for lupus. These forward-looking statements are based on Genelabs’ current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, delisting of Genelabs common stock from the Nasdaq Capital Market; potential development failures or setbacks in our HCV research programs or in our collaborations with Novartis and/or Gilead; progress and announcements by competitors regarding their HCV programs; regulatory problems or delays regarding Prestara™, including an adverse response from the FDA or a determination to discontinue development of Prestara; and increases in expenses and Genelabs’ capital requirements. Please see the information appearing in Genelabs’ filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions “Risk Factors” and “Forward-Looking Statements” for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.

 

-Financials to follow-

 


 

 

 

GENELABS TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

 

September 30,

 

December 31,

 

2006

 

2005

 

(Unaudited)

 

Note 1

ASSETS

Cash and cash equivalents

$

20,758

 

$

10,061

Other current assets

1,344

 

689

Property and equipment

976

 

951

Long-term investment and other assets

1,110

 

960

 

$

24,188

 

$

12,661

 

 

 

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

Accounts payable and accrued liabilities

$

2,913

 

$

2,356

Unearned contract revenue

18,106

 

7,958

Shareholders' equity

3,169

 

2,347

 

$

24,188

 

$

12,661

 

 

 

 

 

 

 

Note 1: Derived from audited financial statements

 


 

 

GENELABS TECHNOLOGIES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended

 

For the nine months ended

 

September 30,

 

September 30,

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

Contract

$

3,422

 

$

1,556

 

$

7,133

 

$

4,664

Royalty

180

 

142

 

493

 

466

Total revenue

3,602

 

1,698

 

7,626

 

5,130

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

3,231

 

2,944

 

10,878

 

9,425

General and administrative

1,299

 

1,720

 

5,552

 

4,640

 

 

 

 

 

 

 

 

Total operating expenses

4,530

 

4,664

 

16,430

 

14,065

 

 

 

 

 

 

 

 

Operating loss

(928)

 

(2,966)

 

(8,804)

 

(8,935)

Interest income, net

295 

 

121 

 

484 

 

364 

 

 

 

 

 

 

 

 

Net loss

$

(633)

 

$

(2,845)

 

$

(8,320)

 

$

(8,571)

 

 

 

 

 

 

 

 

 

 

Net loss per common share –
basic and diluted

$

(0.03)

 

$

(0.16)

 

$

(0.42)

 

$

(0.48)

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding to calculate basic and diluted net loss per common share

 

24,050

 

 

17,774

 

 

19,941

 

17,725

 

 

 

 

 

 

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