MOUNTAIN VIEW, Calif., Feb. 23 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a leading specialty pharmaceutical company focused on the development and commercialization of novel products to restore sexual function in women and men, today announced its accomplishments for 2005 and financial results for the fourth quarter and year ended December 31, 2005.
Fiscal Year 2005 Accomplishments
2005 was an important year for VIVUS. We achieved key clinical milestones with each program, and secured financing to advance each program. Some of the company's most significant 2005 highlights include:
"2005 was an important clinical year for VIVUS," commented Leland Wilson, president and chief executive officer of VIVUS. "During the year, we saw positive clinical results with each of our product candidates spanning multiple health indications. As we begin 2006, we are increasingly enthusiastic about the continued progress of these clinical programs, and the potential commercialization of ALISTA, Evamist, Testosterone MDTS and avanafil."
Financial Results for the Quarter Ended December 31, 2005
Total revenues for the fourth quarter of 2005 were $9.0 million compared to $10.1 million in the fourth quarter of 2004. Net loss for the fourth quarter of 2005 was $1.0 million or $0.02 per share, compared to a net loss of $887,000 or $0.02 per share for the same period last year. Decreased U.S. product revenues of $2.3 million were partially offset by increased international product revenues of $1.2 million in the fourth quarter of 2005 as compared to the fourth quarter of 2004. The decrease in U.S. product revenues is primarily due to decreased purchases made by U.S. wholesalers in advance of a price increase late in the fourth quarter of 2005 as compared to the strategic buying which took place late in the fourth quarter of 2004. The increased net loss in the fourth quarter of 2005 as compared to 2004 is attributable to the decline in product revenues partially offset by decreased expenses, mainly research and development, primarily due to the completion of the Phase 2 avanafil trial, completion of the initial formulation work for Testosterone MDTS and completion of patient enrollment in the Phase 2B trial for ALISTA.
Financial Results for the Year Ended December 31, 2005
For 2005, total revenues were $14.7 million, compared to $19.6 million for 2004. Net loss for 2005 was $24.5 million or $0.57 per share, compared to a net loss of $21.6 million or $0.57 per share, for 2004. The increase in the net loss in 2005 is primarily due to lower product revenue, as a result of decreased strategic buying in the fourth quarter of 2005 for MUSE and increased clinical activities related to the Company's four primary clinical development programs which were more than offset by $5.1 million in licensing fees included in research and development expenses in 2004.
VIVUS had cash, cash equivalents and available-for-sale securities of $27.0 million at December 31, 2005, a decrease of $2.8 million from December 31, 2004.
Worldwide product revenues from the sales of MUSE were $14.5 million in 2005, a decrease of $5.0 million from the worldwide sales of MUSE in 2004. The change in revenues is mainly due to destocking of inventory at the wholesale level that occurred prior to the fourth quarter of 2005. Demand for MUSE, as measured by independent third-party prescription data, has begun to stabilize, but is down from the demand in 2004. Similar to prior years, wholesalers made purchases in the fourth quarter of 2005 that were greater than the current demand. Based on the fourth quarter demand for MUSE, we estimate purchases made by wholesalers in the fourth quarter of 2005 represent approximately 4 months of excess demand. Given the stabilization of the demand and the strategic buying in the fourth quarter of 2005 we anticipate worldwide revenues of MUSE in 2006 will remain consistent with those seen in 2005.
Outlook for 2006
In 2006, VIVUS plans to continue the advancement of each of our product candidates. Specific goals include:
"In recent years, VIVUS has made significant progress with the development of multiple promising compounds," commented Peter Tam, senior vice president of product and corporate development. "Such efforts have resulted in the broad pipeline we have today. With late-stage clinical products addressing multiple sexually-related indications, we believe VIVUS has emerged as a leader in this growing market. We look forward to continued clinical success as we bring these products closer to the market."
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 3 program for Evamist for the treatment of vasomotor symptoms associated with menopause and a Phase 2B program with ALISTA for female sexual arousal disorder. Additionally, the company has completed Phase 2 development of Testosterone MDTS® for the treatment of hypoactive sexual desire disorder (HSDD). The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs directly through the skin.
For men, VIVUS has completed Phase 2 development of avanafil for erectile dysfunction. The company 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.
Note to Investors
As previously announced, VIVUS will hold a conference call to discuss the fourth quarter and full-year financial results today, February 23, 2006, beginning at 4:30 p.m. Eastern Time. You can listen to this call by dialing (877) 660-0983 and entering reservation number 5317282. A live webcast and 30-day archive of the call can be accessed at www.vivus.com.
A telephone replay of the conference call will be available for 24 hours beginning February 23rd at approximately 7:30 p.m. (EST) by dialing (800)-642-1687 and entering reservation number 5317282.
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; 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 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.
CONTACT: VIVUS, Inc. Vida Communication Timothy E. Morris Stephanie Diaz & Tim Brons Chief Financial Officer 415-675-7400 650-934-5200 Tables to follow VIVUS, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Three Months Ended Year Ended December 31, December 31, December 31, December 31, 2005 2004 2005 2004 (unaudited) (unaudited) (unaudited) Revenue: US product, net $7,442 $9,722 $11,697 $16,419 International product 1,559 364 2,794 3,030 Other revenue 41 40 163 152 Total revenue 9,042 10,126 14,654 19,601 Operating expenses: Cost of goods sold and manufacturing 4,402 4,045 11,018 11,283 Research and development 2,925 4,047 17,005 18,676 Selling, general and administrative 2,975 3,045 11,916 11,730 Total operating expenses 10,302 11,137 39,939 41,689 Loss from operations (1,260) (1,011) (25,285) (22,088) Interest and other income, net 225 125 826 511 Loss before provision for income taxes (1,035) (886) (24,459) (21,577) Provision for income taxes (2) (1) (25) (6) Net loss $(1,037) $(887) $(24,484) $(21,583) Net loss per share: Basic and diluted $(0.02) $(0.02) $(0.57) $(0.57) VIVUS, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except par value amount) December 31, December 31, 2005 2004* (unaudited) Current assets: Cash and cash equivalents $22,236 $8,304 Available-for-sale securities 4,770 16,739 Accounts receivable 7,604 9,544 Inventories 4,504 3,855 Prepaid expenses and other assets 1,024 1,459 Total current assets 40,138 39,901 Property and equipment 9,144 6,394 Restricted cash -- 3,324 Available-for-sale securities, non-current -- 4,770 Total assets $49,282 $54,389 Current liabilities: Accounts payable $3,779 $3,120 Accrued and other liabilities 12,790 11,315 Total current liabilities 16,569 14,435 Notes payable 5,164 3,239 Accrued and other long-term liabilities 948 5,993 Total liabilities 22,681 23,667 Stockholders' equity: Common stock; $.001 par value; shares authorized 200,000; shares outstanding - 44,642 at December 31, 2005; 38,127 at December 31, 2004 45 38 Additional paid-in capital 173,613 153,275 Accumulated other comprehensive loss (30) (48) Accumulated deficit (147,027) (122,543) Total stockholders' equity 26,601 30,722 Total liabilities and stockholders' equity $49,282 $54,389
*The Condensed Consolidated Balance Sheet at December 31, 2004 has been derived from the Company's audited financial statements at that date.
SOURCE VIVUS, Inc.
CONTACT: Timothy E. Morris, Chief Financial Officer of VIVUS, Inc., +1-650-934-5200; or Stephanie Diaz & Tim Brons, both of Vida Communication, +1-415-675-7400, for VIVUS, Inc.
Web site: http://www.vivus.com