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 22, 2004
VIVUS, INC
(EXACT NAME OF REGISTRANT AS SPECIFIED IN
ITS CHARTER)
COMMISSION FILE NUMBER: 0–23490
| DELAWARE (STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION) |
94–3136179 (I.R.S. EMPLOYER IDENTIFICATION NO.) |
| 1172 CASTRO STREET MOUNTAIN VIEW, CA (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES |
94040 (ZIP CODE) |
(650) 934–5200
(REGISTRANT’S TELEPHONE NUMBER, INCLUDING
AREA CODE)
N/A
(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR, IF
CHANGED SINCE LAST REPORT)
Item 2.02. Results of Operations and Financial Condition.
The information in this section, including the information contained in the press release included as Exhibit 99.1 hereto, is being furnished pursuant to this Item 2.02 and shall not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. In addition, this information shall not be deemed to be incorporated by reference into any of the Registrant’s filings with the Securities and Exchange Commission, except as shall be expressly set forth by specific reference in any such filing.
On October 20, 2004, VIVUS, Inc. issued a press release announcing its financial results for the fiscal quarter and nine month period ended September 30, 2004. A copy of the October 20, 2004 press release is included as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release dated October 20, 2004 regarding financial results for the three and nine months ended September 30, 2004. |
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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 thereunto duly authorized.
Date: October 22, 2004
| VIVUS, INC. | ||
/s/ LELAND F. WILSON Leland F. Wilson President and Chief Executive Officer |
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VIVUS, INC.
INDEX TO EXHIBITS
The following exhibits are filed herewith:
| Exhibit | Description | |
| 99.1 | Press Release dated October 20, 2004 regarding financial results for the three and nine months ended September 30, 2004 and certain other information. |
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Exhibit 99.1
For more information:
Investors
Fleishman-Hillard
Nina Ferrari
415/318-4286
or
Marie Villalba
415/318-4254
FOR IMMEDIATE RELEASE
VIVUS Reports Third Quarter and Nine Month Financial Results
MOUNTAIN VIEW, Calif. (October 20, 2004) — VIVUS, Inc. (Nasdaq NM: VVUS), today announced third quarter and nine months ended September 30, 2004 financial results.
For the three months ended September 30, 2004, VIVUS’ total revenues increased to $4.3 million from the $3.2 million reported in the three months ended June 30, 2004. Total revenues for last year’s third quarter were $5.5 million (not including $5.0 million in other revenue due to the settlement of the Janssen arbitration claim). The net loss for the 2004 third quarter was ($4.9) million, or ($0.13) per share, compared to net income of $3.9 million, or $0.10 per share, in the same prior year period. Net income in the third quarter of 2003 was principally due to $5.0 million in other revenue due to the settlement of the Janssen arbitration claim. Clinical activities related to the Company’s four primary development programs increased during the third quarter of 2004 as compared to the same period last year.
At September 30, 2004, VIVUS had cash, cash equivalents and available-for-sale securities of $34.1 million, as compared to $48.3 million at December 31, 2003. Net cash used during the quarter was $4.1 million. During the first quarter of 2004, the Company signed an agreement for a line of credit with Tanabe Seiyaku Co., Ltd. This facility allows VIVUS to borrow up to $8.5 million to be used for development of avanafil, a treatment for erectile dysfunction. As of the end of the third quarter, borrowing against this facility totaled $2.2 million.
“The third quarter was a positive one for VIVUS. All of VIVUS’ clinical programs advanced as expected during the third quarter and we were pleased to initiate the Phase 3 study of ALISTA for Female Sexual Arousal Disorder in early September. We continue to expect to initiate Phase 3 studies with Estradiol MDTS® during the fourth quarter of this year,” said Leland Wilson, president and CEO of VIVUS. “Phase 3 studies with avanafil and Testosterone MDTS® are expected to be initiated during the first half of 2005.”
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VIVUS Third Quarter
Financial Results
October 20, 2004
For the nine months ended September 30, 2004, VIVUS sales totaled $9.5 million compared to $13.4 million reported for the nine months ended September 30, 2003 (not including $5.0 million in other revenue due to the settlement of the Janssen arbitration claim). The net loss for the first nine months of 2004 was ($20.7) million, or ($0.54) per share compared to ($2.2) million, or ($0.06) per share in the same prior year nine-month period.
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 products in late stage clinical
development. For women, VIVUS has initiated its Phase 3 program with ALISTA™ for
sexual arousal disorder, and will enter Phase 3 studies with testosterone and estradiol
for the treatment of sexual desire disorder and menopausal syndrome via its novel Metered
Dose Transdermal Spray (MDTS®). The MDTS system is a next generation,
patient-preferred transdermal drug delivery technology that delivers drugs through the
skin safely and non-invasively. For men, VIVUS is developing avanafil for erectile
dysfunction in a Phase 2 program. VIVUS currently markets MUSE® in the
US for the treatment of erectile dysfunction. For more information on clinical trials,
products and corporate goals, please visit the Company’s 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 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, 2003 and periodic reports filed with the Securities and Exchange Commission.
Financial Tables Follow
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VIVUS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SEPTEMBER 30 | SEPTEMBER 30 | SEPTEMBER 30 | SEPTEMBER 30 | |||||||||||
| 2004 | 2003 | 2004 | 2003 | |||||||||||
| (UNAUDITED) | (UNAUDITED) | (UNAUDITED) | (UNAUDITED) | |||||||||||
| Revenue | ||||||||||||||
| United States product | $ | 4,017 | $ | 4,443 | $ | 7,357 | $ | 11,212 | ||||||
| International product | 666 | 1,426 | 2,778 | 3,264 | ||||||||||
| Other | — | 5,033 | — | 5,033 | ||||||||||
| Returns provision | (352 | ) | (372 | ) | (660 | ) | (1,062 | ) | ||||||
| Total revenue | 4,331 | 10,530 | 9,475 | 18,447 | ||||||||||
| Cost of goods sold | 2,634 | 3,002 | 7,238 | 8,210 | ||||||||||
| Gross profit | 1,697 | 7,528 | 2,237 | 10,237 | ||||||||||
| 1,697 | 7,528 | 2,237 | 10,237 | |||||||||||
| Operating expenses: | ||||||||||||||
| Research and development | 3,856 | 1,821 | 14,629 | 5,951 | ||||||||||
| Selling, general and administrative | 2,863 | 2,255 | 8,685 | 7,319 | ||||||||||
| Total operating expenses | 6,719 | 4,076 | 23,314 | 13,270 | ||||||||||
| (Loss) income from operations | (5,022 | ) | 3,452 | (21,077 | ) | (3,033 | ) | |||||||
| Interest and other income: | ||||||||||||||
| Interest income | 155 | 177 | 471 | 537 | ||||||||||
| Gain on disposal of property and equipment | — | 20 | 1 | 19 | ||||||||||
| Foreign exchange (loss) gain | (2 | ) | 5 | 5 | 15 | |||||||||
| Interest expense | (48 | ) | — | (91 | ) | — | ||||||||
| (Loss) income before benefit (provision) for income taxes | (4,917 | ) | 3,654 | (20,691 | ) | (2,462 | ) | |||||||
| Benefit (Provision) for income taxes | — | 219 | (5 | ) | 219 | |||||||||
| Net (loss) income | $ | (4,917 | ) | $ | 3,873 | $ | (20,696 | ) | $ | (2,243 | ) | |||
| Net (loss) income per share: | ||||||||||||||
| Basic | $ | (0.13 | ) | $ | 0.10 | $ | (0.54 | ) | $ | (0.06 | ) | |||
| Diluted | $ | (0.13 | ) | $ | 0.10 | $ | (0.54 | ) | $ | (0.06 | ) | |||
| Shares used in per share computation: | ||||||||||||||
| Basic | 38,048 | 37,653 | 37,986 | 35,263 | ||||||||||
| Diluted | 38,048 | 38,064 | 37,986 | 35,263 | ||||||||||
VIVUS, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
(In thousands, except par value)
ASSETS
| SEPTEMBER 30 | DECEMBER 31 | |||||||
|---|---|---|---|---|---|---|---|---|
| 2004 | 2003 * | |||||||
| (UNAUDITED) | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,960 | $ | 13,097 | ||||
| Available-for-sale securities | 23,362 | 21,488 | ||||||
| Accounts receivable, net | 3,053 | 2,623 | ||||||
| Inventories, net | 3,316 | 3,109 | ||||||
| Prepaid expenses and other assets | 1,707 | 1,108 | ||||||
| Total current assets | 37,398 | 41,425 | ||||||
| Property and equipment, net | 6,863 | 8,220 | ||||||
| Restricted cash | 3,324 | 3,324 | ||||||
| Available-for-sale securities, non-current | 4,797 | 13,763 | ||||||
| Total assets | $ | 52,382 | $ | 66,732 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,483 | $ | 2,917 | ||||
| Accrued and other liabilities | 10,458 | 8,409 | ||||||
| Total current liabilities | 12,941 | 11,326 | ||||||
| Notes payable | 2,205 | — | ||||||
| Accrued and other long-term liabilities | 5,894 | 4,171 | ||||||
| Total liabilities | 21,040 | 15,497 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; $1.00 par value; shares authorized 5,000; shares issued and | ||||||||
| outstanding - 0 at September 30, 2004 and December 31, 2003 | — | — | ||||||
| Common stock; $.001 par value; shares authorized 200,000; shares issued | ||||||||
| and outstanding - 38,048 at September 30, 2004, and 37,788 at | ||||||||
| December 31, 2003 | 38 | 38 | ||||||
| Additional paid-in capital | 152,980 | 152,093 | ||||||
| Accumulated other comprehensive (loss) income | (20 | ) | 64 | |||||
| Accumulated deficit | (121,656 | ) | (100,960 | ) | ||||
| Total stockholders’ equity | 31,342 | 51,235 | ||||||
| Total liabilities and stockholders’ equity | $ | 52,382 | $ | 66,732 | ||||
- The Condensed Consolidated Balance Sheet at December 31, 2003 has been derived from the Company’s audited financial statements at that date.
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