-----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, LpVkuliMvQpDXXLGaKnf1vroH8eCyAkzUTnOsJUJ5AoahxM7/umU/c+NbDVsZVUT LcKS3AUmL0QJCCq8RQEJnA== 0001341004-06-001654.txt : 20060608 0001341004-06-001654.hdr.sgml : 20060608 20060608060559 ACCESSION NUMBER: 0001341004-06-001654 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060602 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060608 DATE AS OF CHANGE: 20060608 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: 06892749 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 pa207430.txt 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): June 2, 2006 Genelabs Technologies, Inc. (Exact Name of Registrant as Specified in its Charter) California 0-19222 94-3010150 - ------------------------------ ---------------------- ---------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) 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: |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 1.01. Entry into a Material Definitive Agreement On June 2, 2006, Genelabs Technologies, Inc. entered into a License and Research Collaboration Agreement with Novartis Institutes for BioMedical Research, Inc., for the research, development and commercialization of non-nucleoside compounds targeting the hepatitis C virus (HCV) NS5b polymerase. Under the agreement, the parties will collaborate to develop one or more compounds for the treatment of HCV. Novartis will have exclusive worldwide rights to develop and commercialize such compounds for HCV infection and other potential disease indications, as well as other compounds developed by Genelabs in the research program. Under the collaboration, Genelabs will receive upfront payments of $12.5 million and research funding of approximately $3 million to $4 million per year over a planned two-year research program. The amount of the research funding depends on the number of Genelabs' scientists working on the program. Novartis has the right to extend the research program and funding for an additional year. Genelabs could also receive over $175 million for achievement of specified development, regulatory and sales milestones if multiple compounds are commercialized and all potential clinical, regulatory and sales milestones are met. Research under the collaboration will be overseen by a committee with equal representation by the parties, with Novartis having the final decision right. If a product is approved for sale, Genelabs is also eligible to receive royalties on net sales of that product. In addition, Genelabs has granted Novartis an exclusive option to negotiate, for a limited period of time, for exclusive license rights to Genelabs' HCV NS5a program, in which compounds are currently in the lead optimization phase. Subject to the parties' mutual obligation to negotiate in good faith, Genelabs is not obligated to enter into a license with Novartis for its NS5a program. Under the License and Research Collaboration Agreement, each party may terminate the agreement if the other party commits an uncured material breach of its obligations. Novartis may also terminate the agreement without cause after the termination of the research program. In the event of a change of control of Genelabs involving a potential competitor, Novartis has the option to either terminate the Agreement or terminate only the research program, in which event the other provisions of the agreement will remain in effect, including Novartis' licenses and its obligations to make royalty and milestone payments. Novartis may also terminate the research program if Genelabs is unable to perform its research obligations due to lack of specified personnel or facilities. Lazard acted as financial advisor to Genelabs. Forward-Looking Statements This report on Form 8-K contains forward-looking statements regarding the future collaboration with Novartis and payments that may be received under the collaboration with Novartis. 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, the failure to commercialize multiple compounds or any compounds, that all or some of the potential clinical, regulatory and sales milestones are not met, failures or setbacks in Genelabs' HCV research and development programs; problems in the collaboration with Novartis; progress and announcements by competitors regarding their HCV programs; the potential delisting of Genelabs common stock from the Nasdaq Capital Market, failure by Genelabs to raise additional funds, or lease termination. Please see the information appearing in Genelabs' filings with the Securities and Exchange Commission, including our most recent Quarterly Report on Form 10-Q, under the captions "Item 1A - Risk Factors" and "Forward-Looking Statements," for more discussion regarding uncertainties and risks 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 report on Form 8-K. Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing On June 5, 2006, Genelabs received a staff determination letter from The Nasdaq Stock Market, Inc. ("Nasdaq") stating that the minimum bid price of Genelabs' common stock does not meet the requirements of Nasdaq Marketplace Rule 4310(c)(4). That rule, in conjunction with Rule 4310(c)(8)(D), requires that the minimum bid price for Genelabs' common stock not remain below $1.00 per share for a period of 30 consecutive business days. The 30 consecutive business day period with respect to Genelabs' common stock ended on June 2, 2006, the last trading day before Genelabs announced the HCV collaboration with Novartis described under Item 1.01 above. Genelabs will regain compliance with Rule 4310(c)(4) if the bid price of Genelabs' common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days. Genelabs has until December 4, 2006 to regain compliance or its common stock may be delisted. On each of the three business days since Genelabs received the letter from Nasdaq, shares of Genelabs' common stock closed with a bid price greater than or equal to $1.83 per share. Item 7.01. Regulation FD Disclosure A copy of the Company's press release announcing its License and Research Collaboration Agreement with Novartis Institutes for BioMedical Research, Inc. is filed herewith and attached as Exhibit 99.1. Item 9.01. Financial Statements and Exhibits (c) Exhibits Exhibit Number Description - -------------- ----------- 99.1 Press Release of Registrant, dated June 5, 2006, entitled "Genelabs Announces Collaboration for Development and Commercialization of HCV Non-Nucleoside Drug Candidates" 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: June 8, 2006 By: /s/ Matthew M. Loar ------------------------ Name: Matthew M. Loar Title: Chief Financial Officer EXHIBIT INDEX Exhibit Number Description - -------------- ----------- 99.1 Press Release of Registrant, dated June 5, 2006, entitled "Genelabs Announces Collaboration for Development and Commercialization of HCV Non-Nucleoside Drug Candidates" EX-99 2 genepr6-5.txt EXHIBIT 99.1 - PRESS RELEASE Exhibit 99.1 Contact: Matthew M. Loar Chief Financial Officer Phone: 650-562-1424 FOR IMMEDIATE RELEASE: - --------------------- GENELABS ANNOUNCES COLLABORATION FOR DEVELOPMENT AND COMMERCIALIZATION OF HCV NON-NUCLEOSIDE DRUG CANDIDATES REDWOOD CITY, Calif. - June 5, 2006 - Genelabs Technologies, Inc. (Nasdaq:GNLB) announced today that it has entered into a license and collaboration agreement with Novartis for the development and commercialization of compounds from Genelabs' Hepatitis C Virus (HCV) non-nucleoside drug discovery program. "I am delighted that Genelabs and Novartis are entering into this collaboration. This collaboration links us with a partner that has the scope, scale, expertise and commitment to make a major impact on the future treatment of HCV infection," stated James A.D. Smith, President and Chief Executive Officer. "The Genelabs non-nucleosides covered by this collaboration have the potential to be complementary with other HCV drugs being developed by Novartis, and I believe Novartis is well positioned to move this project forward efficiently." Under the terms of the agreement, Genelabs is eligible to receive approximately $20 million over a planned two-year research program, including initial up-front payments of $12.5 million. If all potential clinical, regulatory and sales milestones are met, additional payments to Genelabs could exceed $175 million. Genelabs is also entitled to a royalty on net sales of products covered by the collaboration. "This is the second major collaboration for Genelabs based on our HCV drug discovery platform, and we are very pleased to have Novartis as our partner," stated Ronald C. Griffith, Ph.D., Chief Scientific Officer. "I am proud of the highly skilled and dedicated scientists working at Genelabs, who have all contributed to our HCV drug discovery successes." About the Hepatitis C Virus - --------------------------- Hepatitis C is a viral liver disease caused by infection with the Hepatitis C Virus. Worldwide, 170 million people are estimated to be infected with the hepatitis C virus. Liver disease resulting from chronic HCV infection is now recognized as the leading cause of liver failure and liver transplantation in the United States. Currently, there is no vaccine that can protect against HCV infection. -more- Genelabs Announces Collaboration for Development and Commercialization of HCV Non-Nucleoside Drug Candidates Page 2 About the Collaboration - ----------------------- Under the terms of the agreement, Genelabs is responsible for drug discovery research and Novartis is responsible for development and commercialization. Novartis has an option to extend the research funding for a third year and has a right of first negotiation for Genelabs' HCV NS5a drug discovery compounds. Lazard acted as financial advisor to Genelabs. 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(R) and the Genelabs logo are registered trademarks and Prestara(TM) 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 progress of the Company's HCV drug discovery programs, including the preclinical development status and future development of compounds that may result from the collaboration with Novartis. It also contains forward-looking statements regarding Genelabs' NS5a program, the Company's business strategy, and payments that may be received under the collaboration with Novartis. 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, the potential delisting of Genelabs common stock from the Nasdaq Capital Market; fluctuations in Genelabs' stock price; failures or setbacks in our HCV research and development programs or in our collaboration with Gilead; progress and announcements by competitors regarding their HCV programs; regulatory problems or delays regarding Prestara(TM), including an adverse response from the FDA or a determination to discontinue development of Prestara; lease termination; increases in expenses and Genelabs' capital requirements and history of operating losses. 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. -end- -----END PRIVACY-ENHANCED MESSAGE-----