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 8, 2010

 

VIVUS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-33389

 

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)

 

N/A

(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 November 8, 2010, VIVUS, Inc. issued a press release regarding its financial results for the third quarter and the nine month period ended September 30, 2010 and certain other information.  A copy of the press release is attached hereto 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.

 

(d) Exhibits.

 

Exhibit Number

 

Description

99.1

 

Press release dated November 8, 2010, titled “VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results.”

 

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/ Lee B. Perry

 

Lee B. Perry

 

Vice President and Chief Accounting Officer

 

Date:  November 8, 2010

 

3



 

EXHIBIT INDEX

 

Exhibit Number

 

Description

 

 

 

99.1

 

Press release dated November 8, 2010, titled “VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results.”

 

4


Exhibit 99.1

 

 

CONTACT:

 

VIVUS, Inc.

 

 

 

Investor Relations:

 

The Trout Group

Timothy E. Morris

 

 

 

 

 

Brian Korb

Chief Financial Officer

 

 

 

 

 

646-378-2923

650-934-5200

 

 

 

 

 

 

 

VIVUS Reports Third Quarter and First Nine Months 2010 Financial Results

 

MOUNTAIN VIEW, Calif., November 8, 2010 VIVUS, Inc. (NASDAQ: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the third quarter and nine months ended September 30, 2010.

 

Third Quarter Highlights

 

On September 21, 2010, we announced top-line results from a two-year study of Qnexa which showed significant and sustained weight loss of greater than 10% over two years. Patients taking top- and mid-dose Qnexa achieved and maintained weight loss over two years of 11.4% and 10.4% of their initial body weight, respectively, as compared to placebo-treated patients with 2.5% weight loss (ITT-LOCF, p<0.0001). The findings come from the SEQUEL study (OB-305), a 52-week extension study for a subset of patients who completed the previously reported 56-week CONQUER study. The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients, all of whom had two or more weight related co-morbidities, and an average baseline BMI of 36.1. Consistent with the first year experience, QNEXA therapy was well tolerated, with no new or unexpected adverse events. The most common side effects seen were constipation, tingling, dry mouth, altered taste and insomnia.

 

On October 1, 2010, we entered into a definitive asset purchase agreement with Meda to transfer our rights and assets related to MUSE, transurethral alprostadil, for the treatment of erectile dysfunction (ED).The acquisition price was $23.5 million, which includes an upfront cash payment of $22 million. The Company is eligible to receive a one-time milestone payment of $1.5 million based on future sales of MUSE. Meda has been our European distributor of MUSE since 2002. The assets sold include the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey. The sale will allow VIVUS to focus on the approval and commercialization of QNEXA and the development of avanafil.  This transaction closed on November 5, 2010.  Prior to the closing, VIVUS regained all the rights to MUSE and avanafil held by Deerfield Management Company, L.P. and affiliates

 

VIVUS, Inc. 1172 Castro Street, Mountain View, CA 94040 Tel 650-934-5200   Fax 650-934-5389  www.vivus.com

 



 

and by Crown Bank, N. A.  The financial results for MUSE are accounted for as discontinued operations.

 

Third Quarter Results

 

For the three months ended September 30, 2010, we reported a net loss of $18 million, or $0.22 net loss per share, as compared to a net loss of $21.1 million, or $0.30 net loss per share, during the same period in 2009. The decrease in net loss in the second quarter of 2010 as compared to the second quarter of 2009 primarily results from the decrease in research and development spending due to the completion of the Phase 3 clinical trials for Qnexa for the treatment of obesity, partially offset by increased general and administrative expenses, primarily due to Qnexa pre-commercialization activities in the third quarter 2010.

 

Nine Months Results

 

For the nine months ended September 30, 2010, we reported a net loss of $59.6 million, or $0.74 net loss per share, as compared to a net loss of $41.1 million, or $0.59 net loss per share, during the same period in 2009. The increase in net loss in the nine months ended September 30, 2010 as compared to the nine months ended September 30, 2009 results from the completion of the recognition of the Evamist deferred revenue in 2009 and increased general and administrative expenses, primarily due to Qnexa pre-commercialization activities, partially offset by decreased research and development spending due to the completion of the pivotal phase 3 clinical trials for Qnexa for the treatment of obesity.

 

Cash, Cash Equivalents and Available-for-Sale Securities

 

VIVUS had cash, cash equivalents and available-for-sale securities of $158.2 million at September 30, 2010, as compared to $206.8 million at December 31, 2009.  The decrease in cash, cash equivalents and available-for-sale securities of $48.6 million is primarily due to cash used in operations and other net cash uses offset by proceeds of $2.4 million from the exercise of common stock options and ESPP purchases.

 

Qnexa Regulatory Update

 

On October 28, 2010, we received a Complete Response Letter (CRL) from the FDA regarding the Qnexa NDA.  The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.  At the present time, we are preparing a written response to the FDA’s requests for information in the CRL.

 

  “As demonstrated by the results of the two-year SEQUEL study, Qnexa patients continue to see weight loss greater than 10%.  We received the Qnexa CRL on October 28, 2010.  In response to the FDA’s requests, we are working to submit the final study report from SEQUEL and address their requests in a written response to the CRL,” stated Leland Wilson, chief executive officer of VIVUS. “In addition to the release of the SEQUEL data, in the third quarter of 2010 we announced the sale of MUSE to Meda.  This transaction closed on November 5, 2010.  The MUSE transaction marks the end of an era and I wish to thank the hundreds of employees that

 



 

have been involved in the MUSE business since its inception and approval in 1996. The balance sheet remains strong and through the remainder of 2010 we are focused on the written response to the CRL for Qnexa, the filing for approval of Qnexa in the European Union and additional phase 3 trial results from avanafil.”

 

About VIVUS

 

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead product in clinical development, Qnexa(R), completed phase 3 clinical trials for the treatment of obesity and an NDA was filed and accepted by the FDA. VIVUS received a Complete Response Letter (CRL) from the FDA and is preparing a written response to address the FDA’s requests for information included in the CRL. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of male sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction.

 

For more information about the company, please visit www.vivus.com.

 

Note to Investors

 

As previously announced, VIVUS will hold a conference call and an audio webcast to discuss the third quarter financial results today, November 8, 2010, beginning at 1:30 p.m. Pacific Time.  You can listen to this call by dialing 1-877-359-2916 and outside the U.S. 1-224-357-2386.  A webcast replay will be available for 30 days and can be accessed at http://ir.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, the timing and substance of VIVUS’ written response to the FDA’s complete response letter; the FDA’s interpretation of the data VIVUS submits relating to the teratogenicity and cardiovascular safety; the FDA’s interpretation of the data from our SEQUEL study (OB-305) and our sleep apnea study (OB-204); that we may be required to conduct additional clinical trials; our history of losses and variable quarterly results; substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; 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 our response to the FDA’s complete response letter will be sufficient to satisfy the FDA’s safety concerns, that the FDA will not require us to conduct additional clinical studies 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, 2009 and periodic reports filed with the Securities and Exchange Commission.

 

###

 



 

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

 

 

 

2010

 

2009

 

2010

 

2009

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

License and other revenue

 

$

 

$

 

$

 

$

31,395

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

10,091

 

17,149

 

33,878

 

57,398

 

General and administrative

 

6,747

 

3,447

 

18,661

 

10,398

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

16,838

 

20,596

 

52,539

 

67,796

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(16,838

)

(20,596

)

(52,539

)

(36,401

)

 

 

 

 

 

 

 

 

 

 

Interest (expense) income, net of other-than-temporary loss on impaired securities

 

(1,323

)

(617

)

(3,802

)

(1,629

)

 

 

 

 

 

 

 

 

 

 

Loss before provision for income taxes

 

(18,161

)

(21,213

)

(56,341

)

(38,030

)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

(1

)

(1

)

(1

)

(1

)

 

 

 

 

 

 

 

 

 

 

Loss from continuing operations

 

(18,162

)

(21,214

)

(56,342

)

(38,031

)

 

 

 

 

 

 

 

 

 

 

Income (loss) from discontinued operations

 

183

 

148

 

(3,212

)

(3,048

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(17,979

)

$

(21,066

)

$

(59,554

)

$

(41,079

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share:

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(0.22

)

$

(0.30

)

$

(0.70

)

$

(0.55

)

Discontinued operations

 

0.00

 

0.00

 

(0.04

)

(0.04

)

Net loss per share

 

$

(0.22

)

$

(0.30

)

$

(0.74

)

$

(0.59

)

 

 

 

 

 

 

 

 

 

 

Shares used in per share computation:

 

 

 

 

 

 

 

 

 

Basic

 

81,172

 

70,942

 

80,926

 

70,149

 

Diluted

 

82,966

 

73,324

 

80,926

 

70,149

 

 



 

VIVUS, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value amount)

 

 

 

September 30

 

December 31

 

 

 

2010

 

2009*

 

 

 

(unaudited)

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

29,036

 

$

40,533

 

Available-for-sale securities

 

129,162

 

166,241

 

Inventories, net

 

1,803

 

 

Prepaid expenses and other assets

 

2,306

 

3,968

 

Current assets of discontinued operations

 

7,786

 

12,620

 

Total current assets

 

170,093

 

223,362

 

Property and equipment, net

 

240

 

290

 

Non-current assets of discontinued operations

 

5,595

 

6,380

 

Total assets

 

$

175,928

 

$

230,032

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,677

 

$

8,082

 

Accrued and other liabilities

 

10,405

 

6,891

 

Current liabilities of discontinued operations

 

5,330

 

7,537

 

Total current liabilities

 

20,412

 

22,510

 

 

 

 

 

 

 

Notes payable-net of current portion

 

15,255

 

15,255

 

Non-current liabilities of discontinued operations

 

5,068

 

5,541

 

Total liabilities

 

40,735

 

43,306

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock; $.001 par value; shares authorized 200,000; shares outstanding - 81,206 at September 30, 2010; 80,607 at December 31, 2009, respectively

 

81

 

81

 

Additional paid-in capital

 

428,703

 

420,708

 

Accumulated other comprehensive income (loss)

 

23

 

(3

)

Accumulated deficit

 

(293,614

)

(234,060

)

Total stockholders’ equity

 

135,193

 

186,726

 

Total liabilities and stockholders’ equity

 

$

175,928

 

$

230,032

 

 


*  The Condensed Consolidated Balance Sheet at December 31, 2009 has been derived from the Company’s audited financial statements at that date.