VIVUS Reports First Quarter 2007 Financial Results and Accomplishments
First Quarter 2007 Results
Total revenues for the first quarter of 2007 were $1.7 million, as compared to $1.3 million for the first quarter of 2006. The increase in revenues in the first quarter of 2007 as compared to the same period last year is mainly due to the timing of international orders from our European distribution partner. Net loss for the first quarter of 2007 was $7.4 million or $0.13 per share, compared to a net loss of $8.8 million or $0.20 per share for the same period last year.
The lower net loss in the first quarter of 2007 as compared to 2006 is the result of the increase in revenues and lower operating expenses. Lower operating expenses were attributable to decreased cost of goods sold due to an inventory write-down in the first quarter of 2006 related to the purchase of alprostadil, considered to be in excess of production needs, a net overall reduction in research and development spending offset by increased selling, general and administrative expense due to higher non-cash stock compensation expenses. For the first quarter of 2007, the stock compensation expense under FAS 123R is $906,000 as compared to $490,000 in the same period last year. This amount has been allocated to cost of goods sold and manufacturing, research and development, and selling, general and administrative expenses, accordingly.
Effective January 1, 2007, VIVUS implemented FIN No. 48, Accounting for Uncertainty in Income Taxes, which resulted in a $1.2 million decrease to the opening accumulated deficit as of January 1, 2007.
VIVUS had cash, cash equivalents and available-for-sale securities of $55.6 million at March 31, 2007, as compared to $58.9 million at December 31, 2006.
"As we enter 2007, I am excited about the prospects for the company," stated Leland Wilson, president and chief executive officer of VIVUS. "The sale of the EvaMist rights to KV Pharmaceuticals at the end of the first quarter provides us with a solid financial base on which to initiate the Phase 3 trials for Qnexa."
First Quarter 2007 Highlights
The highlights of the first quarter of 2007 included:
-- Agreement to Sell EvaMist Rights to KV Pharmaceutical - In
March 2007, VIVUS executed an agreement to transfer its
exclusive rights and assets related to EvaMist(TM), an
investigational metered dose transdermal estradiol spray for
the treatment of menopause symptoms, to KV Pharmaceutical
Company. The closing of the transaction is expected to occur
by mid 2007 following the satisfaction of various closing
conditions as well as the completion of a review by the
Federal Trade Commission under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976. Under the terms of the transaction,
VIVUS is eligible to receive an upfront payment of $10 million
upon the closing and an additional $140 million upon the
approval of the New Drug Application ("NDA") for EvaMist
currently under review by the Food and Drug Administration.
VIVUS may also receive milestone payments of up to $30 million
based on sales of EvaMist through the term of the agreement.
Upon the closing of the transaction, KV Pharmaceutical will be responsible for the manufacturing, selling, marketing and regulatory requirements once the product is approved. VIVUS previously submitted the NDA for EvaMist on September 29, 2006. The PDUFA date is July 29, 2007. KV Pharmaceutical will also assume all additional expenses and liabilities associated with EvaMist.
-- VIVUS Appoints Vice President and Chief Accounting Officer -
In February, VIVUS promoted Lee B. Perry, to the position of
Vice President and Chief Accounting Officer. His
responsibilities will include oversight of the company's
accounting operations and systems, external reporting,
financial planning and analysis, cost accounting, internal
controls, taxation and risk management. Mr. Perry has over 30
years experience in corporate finance and operations and
public accounting. For the past twenty years he has held
senior financial positions in life sciences and manufacturing
industries.
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three products that are positioned to enter Phase 3 clinical trials, and one product currently under NDA review by the FDA. The pipeline includes: Qnexa, for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS®, for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist, for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; and avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE® is approved and currently on the market for the treatment of ED. 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 first quarter financial results today, April 26, 2007, beginning at 4:30 p.m. Eastern Time. You can listen to this call by dialing 1-800-573-4752, and outside the U.S. 1-617-224-4324, and entering passcode 95635542. A live webcast and 30-day archive of the call can be accessed at http://ir.vivus.com/.
A replay of the conference call will be available beginning at 6:30 p.m. ET on April 26, 2007 through 6:30 p.m. ET on May 3, 2007. Access numbers for this replay are: 1-888-286-8010 (U.S./Canada) and 1-617-801-6888 (international). The access code for the replay is 50583319.
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 the EvaMist NDA submission will be approved in a timely basis, or at all. 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, 2006 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
-----------------------
March 31, March 31,
2007 2006
-----------------------
(unaudited) (unaudited)
Revenue:
US product, net $ 460 $ 963
International product 1,113 188
Other revenue 116 116
----------- -----------
Total revenue 1,689 1,267
Operating expenses:
Cost of goods sold and manufacturing 2,571 3,020
Research and development 3,011 3,560
Selling, general and administrative 4,105 3,672
----------- -----------
Total operating expenses 9,687 10,252
----------- -----------
Loss from operations (7,998) (8,985)
Interest and other income, net 613 165
----------- -----------
Loss before provision for income taxes (7,385) (8,820)
Provision for income taxes (6) (6)
----------- -----------
Net loss $(7,391) $(8,826)
=========== ===========
Net loss per share:
Basic and diluted $ (0.13) $ (0.20)
Shares used in per share computation:
Basic and diluted 58,242 44,642
VIVUS, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value amount)
March 31 December 31
2007 2006*
----------- -----------
(unaudited)
Current assets:
Cash and cash equivalents $ 43,838 $ 44,628
Available-for-sale securities 11,786 14,243
Accounts receivable, net 1,041 4,359
Inventories, net 3,312 3,327
Assets held for sale 543 -
Prepaid expenses and other assets 2,202 2,408
----------- -----------
Total current assets 62,722 68,965
Property and equipment, net 8,087 8,549
Restricted cash 700 700
----------- -----------
Total assets $ 71,509 $ 78,214
=========== ===========
Current liabilities:
Accounts payable $ 1,853 $ 2,102
Accrued and other liabilities 7,156 9,299
----------- -----------
Total current liabilities 9,009 11,401
Notes payable 11,835 11,488
Deferred revenue 2,070 2,185
----------- -----------
Total liabilities 22,914 25,074
----------- -----------
Commitments and contingencies
Stockholders' equity:
Common stock; $.001 par value; shares
authorized 200,000; shares outstanding
58,351 at March 31, 2007;
58,144 at December 31, 2006 58 58
Additional paid-in capital 223,380 221,744
Accumulated other comprehensive loss (7) (11)
Accumulated deficit (174,836) (168,651)
----------- -----------
Total stockholders' equity 48,595 53,140
----------- -----------
Total liabilities and stockholders'
equity $ 71,509 $ 78,214
=========== ===========
* The Condensed Consolidated Balance Sheet at December 31, 2006 has
been derived
from the Company's audited financial statements at that
date.
CONTACT: VIVUS, Inc.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
or
The Trout Group
Ian Clements (SF)415-392-3385
Brian Korb (NYC)646-378-2923
SOURCE: VIVUS, Inc.