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)

October 26, 2005

 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-23490

 

94-3136179

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

1172 Castro Street
Mountain View, CA 94040

(Address of principal executive offices, including zip code)

 

 

 

 

 

(650) 934-5200

(Registrant’s telephone number, including area code)

 

Not Applicable

(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 2.02.              Results of Operations and Financial Condition

 

On October 26, 2005, Vivus, Inc. issued a press release regarding its financial results for the third quarter ended September 30, 2005 and certain other information.  The full text of the press release concerning the foregoing is furnished herewith as Exhibit 99.1.

 

The information in this Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item  9.01.           Financial Statements and Exhibits.

 

(c) Exhibits.

 

Exhibit Number

 

Description

 

 

 

99.1

 

Text of press release issued by Vivus, Inc., dated October 26, 2005, reporting the results of operations for the third quarter ended September 30, 2005 and certain other information (furnished herewith)

 

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.

 

 

VIVUS, INC.

 

 

 

 

 

/s/ Timothy E. Morris

 

 

Timothy E. Morris

 

Vice President and Chief Financial Officer

 

Date:  October 26, 2005

 

3



 

EXHIBIT INDEX

 

Exhibit Number

 

Description

 

 

 

99.1

 

Text of press release issued by Vivus, Inc., dated October 26, 2005, reporting the results of operations for the third quarter ended September 30, 2005 and certain other information (furnished herewith)

 


 

EXHIBIT 99.1

 

 

For more information:

VIVUS, Inc.

Timothy E. Morris

650-934-5200

 

FOR IMMEDIATE RELEASE

 

 

VIVUS REPORTS THIRD QUARTER 2005
FINANCIAL RESULTS AND PRODUCT DEVELOPMENT HIGHLIGHTS

 

Mountain View, Calif. (October 26, 2005) – VIVUS, Inc. (Nasdaq:VVUS), a specialty pharmaceutical company focused on the research, development and commercialization of products to restore sexual function in women and men, today announced its accomplishments for the third quarter 2005 and financial results for the three and nine months ended September 30, 2005.

 

“The third quarter was marked by significant progress with the clinical development of Evamist and obtaining FDA input on the continued clinical development of Testosterone MDTS,” commented Leland Wilson, President and Chief Executive Officer of VIVUS. “In addition, the details of the Phase 2 study for Testosterone MDTS for the treatment of Hypoactive Sexual Desire Disorder in premenopausal women were presented by the lead investigator at the North American Menopause Society meeting. Furthermore, five abstracts have been accepted for presentation at the Sexual Medicine Society of North America 2005 fall meeting.  These abstracts detail much of the development work completed through Phase 2 for avanafil, our investigational PDE5 inhibitor for male erectile dysfunction.”

 

Third Quarter 2005 Highlights

 

The quarter ended September 30, 2005 highlights included:

 

                  Completion of enrollment in a pivotal Phase 3 clinical study of the investigational drug Evamistä (Estradiol MDTSâ), an estradiol spray being developed for the treatment of vasomotor symptoms associated with menopause. This Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Evamist.  The primary endpoint is the reduction in the frequency and severity of moderate-to-severe vasomotor symptoms associated with menopause at weeks 4 and 12 of the study. Over 400 patients were enrolled at 43 centers throughout the United States. The study was initiated in December 2004 under a Special Protocol Assessment (“SPA”) with the Food and Drug Administration (“FDA”).

 

                  Presentation of positive results from a Phase 2 study evaluating the safety and efficacy of Testosterone MDTS® (Metered Dose Transdermal Spray), an

 

 



 

investigational transdermal testosterone spray for the treatment of low libido in premenopausal women.  The presentation was made by Susan R. Davis, M.D., Ph.D., Professor of Women’s Health at Monash University and Principal Investigator for the study, at The North American Menopause Society’s 16th Annual Meeting.  The study found that patients treated with the Testosterone MDTS more than doubled their number of satisfactory sexual events as compared to baseline and placebo.

 

                  An End of Phase 2 meeting was held with the FDA regarding Testosterone MDTS, which is being developed for the treatment of Hypoactive Sexual Desire Disorder (“HSDD”). On September 12, 2005, we met with the FDA and although final Phase 3 protocols have not been agreed upon, the FDA was able to give us guidance on the size and duration requirements that would be necessary to support regulatory approval for the use of testosterone to treat HSDD.

 

                  Acceptance of five abstract presentations at the Sexual Medicine Society of North America’s (SMSNA) 2005 fall meeting for avanafil.  These abstracts summarize the important attributes of avanafil based on its unique pharmacokinetic and high-selectivity profile.  These abstracts will be presented during the meeting, which will be held in New York November 17th through 20th.

 

Financial Results for the Third Quarter

 

For the three months ended September 30, 2005, total revenue was $3.3 million, compared to $4.3 million for the three months ended September 30, 2004. Domestic sales of MUSE were lower in the third quarter of 2005 due to the decline in the demand for MUSE and a reduction in inventory at the wholesale level.  We estimate that the inventory at the wholesale level has continued to decrease since the beginning of 2005.

 

The net loss for the third quarter of 2005 was  $6.0 million, or $0.13 per share, compared to $4.9 million, or $0.13 per share, in the third quarter of 2004. The increased loss was principally due to decreased revenues and increased expenses from continuing clinical activities related to the company’s development programs.

 

For the nine months ended September 30, 2005, total revenue was $5.6 million, compared to $9.5 million for the nine months ended September 30, 2004.  The net loss for the first nine months of 2005 was $23.4 million, or $0.55 per share, compared to $20.7 million, or $0.54 per share in the same prior year nine-month period.  The decreased revenue and increased net loss in the first nine months of 2005 resulted primarily from lower product sales.

 

Cash, Cash Equivalents and Available-for-Sale Securities

 

At September 30, 2005, VIVUS had cash, cash equivalents and available-for-sale securities of $33.5 million, as compared to $39.5 million at June 30, 2005.

 

Exclusive of the $19.6 million in net proceeds from the sale of common stock in the first quarter of 2005, the decrease in cash, cash equivalents and available-for-sale securities since December 31, 2004 was $16.0 million.

 



 

Third Quarter Investigational Product Pipeline Update

 

We continued the development of our late stage clinical candidates.  Highlights for each of the major programs in the third quarter are as follows:

 

                  ALISTAä - Recruitment of patients and enrollment continues in the current clinical trial of ALISTA, an investigational drug being developed for the treatment of Female Sexual Arousal Disorder (“FSAD”).  Our goal is to complete enrollment in this trial by the end of 2005.

 

                  Testosterone MDTS - Based on the recent meeting and discussion with the FDA, we obtained guidance on the size and duration of the clinical trials necessary to complete the development of this product.  We will continue to work with the FDA to finalize the Phase 3 safety and efficacy studies for Testosterone MDTS to treat HSDD.

 

                  Evamist - We completed the enrollment in the pivotal Phase 3 trial.  We intend to complete the current trial and prepare the New Drug Application by mid 2006.

 

                  Avanafil- We have requested an End of Phase 2 meeting with the FDA to discuss the details of our Phase 3 development program. The meeting is planned for November 2005.  We also completed an independent research report that reveals the market potential for avanafil. This report may serve as a key component for the partnering effort for this product candidate.

 

About VIVUS

VIVUS, Inc. is a pioneer in the research and development of proprietary products to restore sexual function for women and men. VIVUS’ current product pipeline includes four investigational products in late stage clinical development.  For women, VIVUS has initiated a Phase 2B program with ALISTAä for female sexual arousal disorder and a Phase 3 program for Evamistä for the alleviation of menopausal symptoms. Testosterone MDTS® for the treatment of hypoactive sexual desire disorder has completed Phase 2 development.  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 has completed Phase 2 development.  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 Company’s web site at www.vivus.com.

 

Conference Call Information

As previously announced, VIVUS will hold a conference call to discuss the third quarter accomplishments and financial results today, October 26, 2005, beginning at 4:00 p.m. Eastern Time.  You can listen to this call by dialing 877-660-0983 and entering conference ID #1836976.  The call will be available for replay through November 25, 2005, by calling 800-642-1687, conference ID #1836976.

 

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; litigation and legislation; 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.

 

Financial Tables Follow

 



 

VIVUS, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

September 30,

 

September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

US product, net

 

$

2,538

 

$

3,665

 

$

4,255

 

$

6,697

 

International product

 

688

 

629

 

1,235

 

2,666

 

Other revenue

 

41

 

37

 

122

 

112

 

 

 

 

 

 

 

 

 

 

 

Total revenue

 

3,267

 

4,331

 

5,612

 

9,475

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of goods sold and manufacturing

 

2,477

 

2,634

 

6,616

 

7,238

 

Research and development

 

4,154

 

3,856

 

14,080

 

14,629

 

Selling, general and administrative

 

2,826

 

2,863

 

8,941

 

8,685

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

9,457

 

9,353

 

29,637

 

30,552

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(6,190

)

(5,022

)

(24,025

)

(21,077

)

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

232

 

105

 

601

 

386

 

 

 

 

 

 

 

 

 

 

 

Loss before provision for income taxes

 

(5,958

)

(4,917

)

(23,424

)

(20,691

)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

(2

)

 

(23

)

(5

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(5,960

)

$

(4,917

)

$

(23,447

)

$

(20,696

)

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.13

)

$

(0.13

)

$

(0.55

)

$

(0.54

)

 

 

 

 

 

 

 

 

 

 

Shares used in per share computation:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

44,526

 

38,048

 

42,824

 

37,986

 

 



 

VIVUS, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amount)

 

 

 

September 30

 

December 31

 

 

 

2005

 

2004*

 

 

 

(unaudited)

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

15,725

 

$

8,304

 

Available-for-sale securities

 

17,725

 

16,739

 

Accounts receivable

 

1,822

 

9,544

 

Inventories

 

5,126

 

3,855

 

Prepaid expenses and other assets

 

1,576

 

1,459

 

Total current assets

 

41,974

 

39,901

 

Property and equipment

 

5,348

 

6,394

 

Restricted cash

 

3,324

 

3,324

 

Available-for-sale securities, non-current

 

 

4,770

 

Total assets

 

$

50,646

 

$

54,389

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,476

 

$

3,120

 

Accrued and other liabilities

 

11,911

 

11,315

 

Total current liabilities

 

14,387

 

14,435

 

 

 

 

 

 

 

Notes payable

 

4,929

 

3,239

 

Accrued and other long-term liabilities

 

4,009

 

5,993

 

Total liabilities

 

23,325

 

23,667

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

Common stock; $.001 par value; shares authorized 200,000; shares outstanding - 44,527 at September 30, 2005; 38,127 at December 31, 2004

 

44

 

38

 

Additional paid-in capital

 

173,306

 

153,275

 

Accumulated other comprehensive loss

 

(39

)

(48

)

Accumulated deficit

 

(145,990

)

(122,543

)

Total stockholders’ equity

 

27,321

 

30,722

 

Total liabilities and stockholder’s equity

 

$

50,646

 

$

54,389

 

 


*The Condensed Consolidated Balance Sheet at December 31, 2004 has been derived from the Company’s audited financial statements at that date.