MOUNTAIN VIEW, Calif., March 8 /PRNewswire-FirstCall/ -- VIVUS, Inc. today reported its financial results for the fourth quarter and year ended December 31, 2009.
“This past year was transformational for VIVUS given the significant achievements in both the Qnexa and avanafil investigational product programs, which are being developed to address the obesity and erectile dysfunction markets with highly differentiated products that address unmet needs,” stated Leland Wilson, chief executive officer of VIVUS. “We look forward to continued clinical and regulatory momentum in 2010 as we continue to work with the FDA during the review of the Qnexa NDA and as we report additional avanafil pivotal data.”
Fourth Quarter Results
Product revenues from the sale of MUSE in the fourth quarter of 2009 were $8.5 million as compared to $7.8 million in the fourth quarter of 2008, primarily due to a modest increase in shipments and an increase in domestic prices in 2009. Total revenue for the fourth quarter of 2009 was $8.6 million, as compared to $28.8 million for the fourth quarter of 2008. The decrease in total revenue in the fourth quarter of 2009 compared to the fourth quarter last year was primarily due to the inclusion of deferred license revenue from the sale of Evamist in the fourth quarter of 2008. There was no deferred license revenue recognized in the fourth quarter of 2009 as the monthly Evamist deferred revenue recognition ended in May 2009.
Net loss for the fourth quarter of 2009 was $13.2 million, or $0.16 per share, compared to $6.7 million, or $0.10 per share, for the same period last year. The increase in net loss in the fourth quarter of 2009 as compared to the fourth quarter of 2008 predominantly results from the completion of the monthly recognition of the Evamist deferred revenue in 2009 and to a lesser extent, decreased research and development spending due to the completion of the phase 3 clinical trials for Qnexa for the treatment of obesity. In the fourth quarter of 2009, VIVUS also recorded a $2.4 million benefit for income taxes primarily due to a carryback claim of losses generated in 2008 that allowed us to obtain a refund of Federal income taxes paid in 2007.
Year End Results
MUSE revenues of $18.2 million for 2009 were consistent with the $18.1 million recognized in 2008. For 2009, total revenues were $50 million, as compared to $102.2 million for 2008. The decrease in total revenues is mainly due to the last portion of K-V deferred license revenue from the sale of Evamist being recognized in 2009 as compared to 2008, where the company recognized a full year of deferred revenue. Net loss for 2009 was $54.3 million, or $0.75 per share, compared to a net loss of $9.9 million, or $0.16 per share, for 2008. The increase in the net loss is primarily due to a decrease in license and other revenue related to the Evamist transaction. The decrease in operating expenses in 2009 as compared to 2008 was primarily attributable to reduced spending on Qnexa for obesity clinical trials, partially offset by increased spending related to the company’s phase 3 clinical trials of avanafil for the treatment of erectile dysfunction, increased selling, general and administrative expense primarily due to Qnexa pre-commercialization expenses and an increase in non-cash share-based compensation expense. In addition, VIVUS had a reduction in other-than-temporary impairment losses in 2009 as compared to 2008.
Cash, Cash Equivalents and Available-for-Sale Securities
VIVUS had cash, cash equivalents and available-for-sale securities of $207 million at December 31, 2009, as compared to $189.2 million at December 31, 2008. The increase in cash, cash equivalents and available-for-sale securities of $17.8 million consists of $102.7 million in net proceeds from the underwritten public offering of our common stock and $10 million in cash from the Deerfield financing offset by cash used in operations and other net cash uses of $94.9 million.
Recent Clinical Development Highlights:
“The milestones achieved in 2009 are evidence of VIVUS’ commitment to executing on our well-defined business strategy,” added Peter Tam, president of VIVUS. “In 2010, we will focus on advancing our pre-commercial and business development initiatives along with executing our clinical and regulatory development plans in both the U.S. and abroad.”
About VIVUS
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. The company’s lead investigational product in clinical development, Qnexa(R), has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of October 28, 2010. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already commercially available and generating revenue for VIVUS. 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 fourth quarter and year end financial results today, March 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, 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, 2008 and periodic reports filed with the Securities and Exchange Commission.
CONTACT: Timothy E. Morris, Chief Financial Officer of VIVUS, Inc.,
+1-650-934-5200; or Investor Relations: Brian Korb of The Trout Group,
+1-646-378-2923; or Media Relations: Sheryl Seapy of Pure Communications,
Inc., +1-949-608-0841
Web site: http://www.vivus.com/
