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
November 14, 2005
Date of Report (date of earliest event reported)
VIVUS, INC.
(Exact name of registrant as specified in charter)
Delaware |
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0-23490 |
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94-3136179 |
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(Commission File Number) |
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(I. R. S. Employer
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1172 Castro Street, Mountain View, California 94040 |
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(Address of principal executive offices) |
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Registrants telephone number, including area code: (408) 435-9600 |
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N/A |
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(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:
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 1.01 Entry into a Material Definitive Agreement.
On November 15, 2005, Vivus Real Estate LLC (Real Estate LLC), a wholly owned subsidiary of VIVUS, Inc. (the Company), entered into two agreements to purchase from its landlord the Companys principal manufacturing facility, which is currently leased. Under the agreements between Real Estate LLC and 735 Airport Road, LLC and 745 Airport Road, LLC (collectively Seller), Real Estate LLC agreed to pay $7,100,000 for the property located at 735 Airport Road and 745 Airport Road in Lakewood, New Jersey (the Facility). Upon the signing of the agreements, Real Estate LLC deposited $355,000 into an escrow account. Should the transactions close, Seller shall release to the Company $3,324,143 currently being held by Seller as cash collateral for renovations to the Facility upon the termination of the lease (the Collateral). The Company expects that the purchase price will be funded in part by the Collateral, its cash and borrowed funds, if available at reasonable terms. The transactions are expected to close on or about December 31, 2005. The Company has also entered into a conditional amendment of the lease whereby the lease shall be extended until February 15, 2012 should the transactions fail to close.
Item 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.
On November 16, 2005, VIVUS, Inc. announced the appointment of Wesley W. Day, Ph.D., as Vice President, Clinical Development. Dr. Day, age 42, has held a variety of positions from 1993 to October 2005 with Pfizer Inc., a research-based global pharmaceutical company, most recently serving as Senior Director- Safety and Risk Management from September 2003 until his departure in October 2005. He was Senior Associate Director- Worldwide Regulatory Affairs from August 2001 to 2003 and Associate Director II- Worldwide Regulatory Affairs from 2000 to 2001.
Dr. Day and VIVUS entered into that certain Change of Control Agreement dated November 14, 2005, whereby Dr. Day is eligible to receive certain benefits if within the twenty-four month period following a change of control of VIVUS he is terminated by VIVUS or its successor other than for cause or voluntarily. Upon such qualifying termination, Dr. Day will become entitled to receive: (i) monthly severance payments at a rate equal to his monthly base salary for a period of twenty-four months; (ii) monthly severance payments at a rate equal to 1/12th of his target bonus for the fiscal year in which the termination occurs for a period of twenty-four months; (iii) the pro-rated amount of his target bonus for the fiscal year in which the termination occurs; (iv) continuation of employee benefits for a period of twenty-four months; (v) outplacement services; and (vi) accelerated vesting of 100% of his then unvested shares under his option.
Dr. Day will be provided with VIVUS standard indemnification agreement for officers of VIVUS, which provides, among other things, that VIVUS will indemnify Dr. Day, under certain circumstances set forth therein, for defense expenses, damages, judgments, fines and settlements incurred by him in connection with actions or proceedings to which he may be a party as a result of his position as an officer, employee, agent or fiduciary of VIVUS, and otherwise to the full extent permitted under the bylaws and Delaware law.
A copy of the press release announcing the appointment of Dr. Day is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
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(c) Exhibits. |
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Exhibit No. |
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Description |
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99.1 |
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Press Release issued by VIVUS, Inc. dated November 16, 2005 |
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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.
Dated: November 16, 2005 |
VIVUS, INC. |
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/s/ Timothy E. Morris |
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Timothy E. Morris |
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EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by VIVUS, Inc. dated November 16, 2005 |
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Exhibit 99.1
For more information:
VIVUS Inc.
Timothy E. Morris
Chief Financial Officer
650-934-5200
VIVUS Appoints Wesley W. Day, Ph.D.
as Vice President of Clinical Development
Mountain View, Calif. (November 16, 2005) VIVUS Inc. (Nasdaq:VVUS) today announced the appointment of Wesley W. Day, Ph.D., as Vice President of Clinical Development. Dr. Day will be responsible for leading and directing clinical activities for VIVUS, including clinical trials, clinical research and data collection, as well as overseeing the strategies for developing and implementing clinical protocols, data collection systems, and trial site management. Dr. Day will report to Peter Tam, VIVUS Senior Vice President of Product and Corporate Development.
Dr. Day comes to VIVUS after more than 12 years experience with Pfizer, Inc. where he was instrumental in the creation and development of compounds designed to treat womens health issues including sexual dysfunction. Dr. Day is also an inventor on several issued and pending patents for a variety of womens health treatments. Most recently, he served as a Senior Director and Therapeutic Area Head of oncology and ophthalmology. His group was responsible for operational delivery of clinical submissions supporting new drug applications (NDAs) worldwide. Prior to this role, as a clinical pharmacologist, Dr. Day oversaw and directed the clinical safety activities supporting various drug candidates for Pfizer in La Jolla, California. In addition to his work in womens health, oncology and ophthalmology, Dr. Day has functioned in various roles on numerous clinical development teams, supporting drugs to treat several cardiovascular and metabolic diseases. Dr. Day holds a Ph.D. in pharmacology and toxicology from the University of Maryland at Baltimore, a B.S. from University of Texas Pan American, and he is a Diplomate of the American Board of Toxicology. Dr. Day has been an Adjunct Assistant Professor at the University of Maryland at Baltimore since 1995 and has also been an Adjunct Assistant Professor for Temple University.
We are pleased to have Dr. Day join VIVUS as the Vice President of Clinical Development, stated Leland F. Wilson, VIVUS President and Chief Executive Officer. His expertise and experience in designing and running clinical trials focused on a variety of sexual dysfunction disorders will greatly benefit all of our late stage clinical trial programs.
As a leader in sexual dysfunction clinical research and development, VIVUS represents a tremendous opportunity, commented Wesley W. Day. I believe VIVUS pipeline of product candidates may result in effective treatments for important medical conditions.
About VIVUS
VIVUS Inc. is a pioneer in the research and development of proprietary products to restore sexual function for men and women. VIVUS current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated its Phase 2B programs with ALISTA for female sexual arousal disorder, and Evamist for the alleviation of menopausal symptoms. VIVUS has completed Phase 2 development for Testosterone MDTS® for the treatment of HSDD. The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs through the skin. For men, VIVUS is developing avanafil for erectile dysfunction, which is currently in a Phase 2 program. VIVUS currently markets MUSE®(alprostadil) suppository for the treatment of erectile dysfunction in the U.S. and internationally through distributors. For more information on clinical trials and products, please visit the Companys web site at www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, forecast, estimated and intend, among others. These forward-looking statements are based on VIVUS current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS Form 10-K for the year ended December 31, 2004 and periodic reports filed with the Securities and Exchange Commission.