MOUNTAIN VIEW, Calif., Aug. 11 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the second quarter ended June 30, 2009.
Second Quarter Results
Net loss for the second quarter of 2009 was $13.2 million, or $0.19 per share, as compared to net income of $3.6 million, or $0.06 per share, for the second quarter of 2008. The net loss in the second quarter of 2009 as compared to the net income in the second quarter of 2008 is primarily due to a decrease in license and other revenue as a result of the last portion of K-V Pharmaceutical ("K-V") deferred license revenue being recognized in the second quarter of 2009, and increased operating expenses. The increase in operating expenses, as compared to the second quarter of 2008, was primarily attributable to spending related to our phase 3 clinical trials of avanafil, our investigational product candidate for the treatment of erectile dysfunction. Spending on Qnexa, our investigational product for obesity, was consistent quarter over quarter.
Total revenue for the second quarter of 2009 was $14.7 million, as compared to $25.3 million for the second quarter of 2008. Product revenues from the sale of MUSE in the second quarter of 2009 were $4.1 million, as compared to $4.2 million in the second quarter of 2008. License and other revenue of $10.6 million and $21 million in the second quarters of 2009 and 2008, respectively, primarily relates to the sale in 2007 of Evamist to K-V. All of the deferred revenue related to the sale of Evamist has now been recognized. Since we had received the $150 million in cash from the sale of Evamist and we had no related contingencies, the recognition of license revenue and the corresponding reduction of deferred revenue related to the Evamist sale had no impact on our cash flows from operations in 2009 or 2008.
Six Month Results
Net loss for the six months ended June 30, 2009 was $20 million, or $0.29 per share, compared to a net loss of $3.5 million or $0.06 per share for the same period in 2008. The increase in the net loss in the six months ended June 30, 2009 as compared to the same period in 2008 is primarily due to the decrease in K-V deferred license revenue, an increase in operating expenses primarily due to our phase 3 clinical trials of avanafil and increased legal expenses and costs related to the Acrux arbitration and a decrease in interest income. With the completion of the Acrux arbitration, legal expenses are expected to decrease in the second half of 2009. For the six-month period ending June 30, 2009, total revenues were $37 million, compared to $48 million for the same period in 2008. The decrease in total revenues is primarily due to the reduction in K-V deferred license revenue in the six months ended June 30, 2009.
Cash, Cash Equivalents and Available for Sale Securities
VIVUS had cash, cash equivalents and available-for-sale securities of $144.2 million at June 30, 2009, as compared to $189.2 million at December 31, 2008. The decrease in cash, cash equivalents and available-for-sale securities of $45 million is the net result of cash used for operating and investing activities partially offset by cash provided by financing activities, including $6.7 million in cash from the Deerfield financing received in the first six months of 2009.
The phase 3 Qnexa development program remains on schedule. In total, over 3,750 patients were enrolled in two 56-week studies. The EQUIP study (OB-302) will determine the impact of Qnexa on patients that are considered morbidly obese (BMI>35). The CONQUER study (OB-303) enrolled patients that are considered overweight (BMI>27) with at least two co-morbidities including high blood pressure, high cholesterol and type 2 diabetics. Top-line results for both of these studies are expected in the third quarter of 2009.
"The highlight of the second quarter was the two podium presentations of Qnexa at this year's American Diabetes Association Scientific Session. The medical and scientific communities have long recognized the link between obesity and type 2 diabetes. Now they are beginning to recognize the importance of weight loss in the treatment of type 2 diabetes. The top-line results from the year-long studies of Qnexa for the treatment of obesity are expected in the third quarter of 2009. Progress on the preparation of the NDA for Qnexa in obesity also remains on schedule for an expected filing by the end of 2009," stated Leland Wilson, president and chief executive officer of VIVUS. "Pivotal studies for avanafil for the treatment of erectile dysfunction are also in process, with results expected in the fourth quarter of 2009."
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address obesity, diabetes and sexual health. The company's lead product in clinical development, Qnexa(TM), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor, and in phase 3 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD). For more information about the company, please visit www.vivus.com.
Note to Investors
As previously announced, VIVUS will hold a conference call to discuss the second quarter financial results today, August 11, 2009, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing 1-877-548-7907 and outside the U.S. 1-719-325-4848. A 30-day archive of the call 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 or regulatory submissions 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: VIVUS, Inc. Investor Relations: The Trout Group Timothy E. Morris Brian Korb Chief Financial Officer 646-378-2923 650-934-5200 Media Relations: Pure Communications, Inc. Sheryl Seapy 949-608-0841
VIVUS, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, June 30, June 30, 2009 2008 2009 2008 (unaudited)(unaudited)(unaudited)(unaudited) Revenue: US product, net $ 3,368 $ 2,923 $ 4,261 $ 4,011 International product 776 1,300 1,069 1,854 License and other revenue 10,581 21,046 31,627 42,092 Total revenue 14,725 25,269 36,957 47,957 Operating expenses: Cost of goods sold and manufacturing 2,877 2,929 5,480 5,716 Research and development 20,258 15,335 40,327 38,706 Selling, general and administrative 4,555 4,345 9,966 8,597 Total operating expenses 27,690 22,609 55,773 53,019 Income (loss) from operations (12,965) 2,660 (18,816) (5,062) Interest (expense) income, net of other-than-temporary loss on impaired securities (239) 924 (1,191) 1,559 Income (loss) before provision for income taxes (13,204) 3,584 (20,007) (3,503) Provision for income taxes - (5) (6) (10) Net income (loss) $ (13,204) $ 3,579 $ (20,013) $ (3,513) Net income (loss) per share: Basic and diluted $ (0.19) $ 0.06 $ (0.29) $ (0.06) Shares used in per share computation: Basic 69,805 60,351 69,746 59,616 Diluted 69,805 61,850 69,746 59,616
VIVUS, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except par value amount) June 30 December 31 2009 2008* (unaudited) Current assets: Cash and cash equivalents $ 27,820 $ 66,121 Available-for-sale securities 116,404 121,789 Accounts receivable, net 3,395 4,157 Inventories, net 2,662 3,041 Prepaid expenses and other assets 3,443 3,744 Total current assets 153,724 198,852 Property and equipment, net 6,287 6,726 Restricted cash 700 700 Available-for-sale securities - 1,344 Total assets $ 160,711 $ 207,622 Current liabilities: Accounts payable $ 9,632 $ 17,205 Deferred revenue 462 31,858 Accrued and other liabilities 17,940 14,909 Total current liabilities 28,034 63,972 Notes payable-net of current portion 16,809 11,177 Deferred revenue 1,029 1,260 Total liabilities 45,872 76,409 Commitments and contingencies Stockholders' equity: Common stock; $.001 par value; shares authorized 200,000; shares outstanding - 69,960 at June 30, 2009; 69,667 at December 31, 2008 70 70 Additional paid-in capital 314,282 310,558 Accumulated other comprehensive income 269 354 Accumulated deficit (199,782) (179,769) Total stockholders' equity 114,839 131,213 Total liabilities and stockholders' equity $160,711 $207,622 *The Condensed Consolidated Balance Sheet at December 31, 2008 has been derived from the Company's audited financial statements at that date.
|SOURCE VIVUS, Inc.|
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