VIVUS Reports Third Quarter and First Nine Months 2012 Financial Results

VIVUS Reports Third Quarter and First Nine Months 2012 Financial Results

MOUNTAIN VIEW, Calif., Nov. 6, 2012 (GLOBE NEWSWIRE) -- VIVUS,Inc.
(Nasdaq:VVUS), a biopharmaceutical company dedicated to the development and
commercialization of novel therapeutic products, today reported its financial
results for the third quarter and nine months ended September 30, 2012.

On September 17, 2012, we announced the U.S. market availability of Qsymia™
and, later that week, we formally introduced Qsymia to healthcare
professionals at The Obesity Society's Annual Scientific Meeting in San
Antonio, Texas. We launched Qsymia in September for distribution to eligible
patients through the home delivery networks of two pharmacies, CVS Pharmacy
and Walgreens. Since then we have expanded the distribution of Qsymia to
include the home delivery networks of Express Scripts and a large closed model
health maintenance organization, or HMO.

"The U.S. commercial launch of Qsymia marks the beginning of a new era in the
treatment of obesity," stated Leland Wilson, chief executive officer of VIVUS.
"We look forward to continuing to introduce Qsymia to healthcare professionals
and, ultimately, bringing this drug to those afflicted with this serious

Third Quarter Financial Results

For the third quarter, we recognized net product revenues of $41,000 from
prescriptions shipped from certified pharmacies to patients. Given the lack of
history in selling Qsymia, VIVUS will recognize revenue on the sell-through
method, that is, revenue is recognized as prescriptions are shipped to
patients. We obtain the prescription shipment data directly from the
pharmacies to determine the amount of revenue to recognize. We will continue
to recognize revenue for Qsymia based upon prescription sell-through until we
have sufficient historical information to reliably estimate product returns
from our certified pharmacies.

For the three months ended September 30, 2012, VIVUS reported a net loss of
$40.4 million, or $0.40 per share, as compared to a loss of $8.6million, or
$0.10 per share, for the same period last year. The increase in net loss is
primarily attributable to increased selling, general and administrative
expenses related to pre-commercialization and commercialization activities for
Qsymia. In addition, research and development expenses increased due to the
start-up costs associated with the post-approval studies for Qsymia and

First Nine Months Financial Results

Net loss for the first nine months of 2012 is $83.2 million, or $0.85 per
share, as compared to a loss of $34.7 million, or $0.42 per share, for the
same period in 2011. The increase is primarily due to higher selling, general
and administrative expenses incurred for the Qsymia launch.

Qsymia Regulatory Update

On October 17, 2012, we submitted an amendment to the Risk Evaluation and
Mitigation Strategy, or REMS, for Qsymia proposing a REMS modification that
would allow us to dispense Qsymia through select retail pharmacies to increase
access while meeting all requirements of the REMS. The REMS modification was
made at the mutual request of VIVUS and the United States Food and Drug
Administration, or FDA, as documented in the FDA approval letter.

On December 17, 2010, we filed a Marketing Authorization Application, or MAA,
with the European Medicines Agency, or EMA, to market Qsymia in the European
Union, or EU, for the treatment of obesity. The approved trade name for Qsymia
in the EU is Qsiva™. On October 18, 2012, we received the formal opinion from
the EMA's Committee for Medicinal Products for Human Use, or CHMP,
recommending against approval of the MAA for Qsiva in the EU due to concerns
over the potential cardiovascular and central nervous system effects
associated with long-term use, teratogenic potential and use by patients for
whom Qsiva would not have been indicated. We have notified the CHMP that we
will appeal this opinion and request a re-examination of the decision by the
CHMP. If approved upon CHMP's re-examination, we intend to commercialize Qsiva
in the EU through a collaboration arrangement with a third party. We also
intend to seek approval for Qsymia in other territories outside the United
States and EU, and we intend to commercialize Qsymia in territories where we
obtain approval through collaboration agreements with third parties.

About Qsymia

Qsymia was approved with a REMS with the goal of informing prescribers and
patients of reproductive potential about an increased risk of orofacial clefts
in infants exposed to Qsymia during the first trimester of pregnancy, the
importance of pregnancy prevention for females of reproductive potential
receiving Qsymia, and the need to discontinue Qsymia immediately if pregnancy
occurs. The Qsymia REMS program includes a Medication Guide, Healthcare
Provider training, distribution through certified home delivery pharmacies,
implementation system and a time table for assessments.

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased
physical activity for chronic weight management in adult patients with an
initial body mass index, or BMI, of 30 kg/m2 or greater (obese), or 27 kg/m2
or greater (overweight) in the presence of at least one weight-related
comorbidity such as hypertension, type 2 diabetes mellitus, or
dyslipidemia.The effect of Qsymia on cardiovascular morbidity and mortality
has not been established.The safety and effectiveness of Qsymia in
combination with other products intended for weight loss, including
prescription and over-the-counter drugs and herbal preparations, have not been

Qsymia can cause fetal harm. Data from pregnancy registries and epidemiology
studies indicate that a fetus exposed to topiramate, a component of Qsymia, in
the first trimester of pregnancy has an increased risk of oral clefts (cleft
lip with or without cleft palate).Qsymia must not be used by women who are
pregnant; by patients with eye problems (glaucoma); by patients who have been
told they have an overactive thyroid; by patients taking a type of
anti-depressant called MAOI; or by patients who are allergic to phentermine,
topiramate, or any of the ingredients in Qsymia.The most common side effects
seen in Qsymia clinical studies were tingling in the hands and feet,
dizziness, change in taste, trouble sleeping, constipation, and dry mouth.

For more information about Qsymia, go to or for full
prescribing information go to


Our drug, STENDRA (avanafil), was approved by the FDA on April 27, 2012 for
the treatment of erectile dysfunction, or ED. STENDRA is a phosphodiesterase
5, or PDE5, inhibitor indicated for the treatment of ED.

In March 2012, we submitted and the European Medicines Agency, or EMA,
accepted our Marketing Authorization Application, or MAA, for avanafil. The
approved trade name for STENDRA in the EU is SPEDRA™. In July 2012, we
received the Day 120 List of Questions from the EMA. The Day 120 List of
Questions covers a broad range of topics including, without limitation,
questions relating to clinical relevance in certain populations as well as
questions regarding drug-drug interaction and pharmacokinetics. We are in the
process of preparing our response to the CHMP.

Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation, or MTPC. VIVUS
has development and commercial rights to avanafil for the treatment of sexual
dysfunction worldwide with the exception of certain Asian Pacific Rim
countries. Through collaboration arrangements with third parties, we intend to
commercialize STENDRA in the United States and, if approved, in the EU and
other territories outside the United States.

Administration of STENDRA with any form of organic nitrates, either regularly
and/or intermittently, is contraindicated.STENDRA is contraindicated in
patients with a known hypersensitivity to any component of the tablet.The
most common adverse reactions include headache, flushing, nasal congestion,
nasopharyngitis, and back pain.

For more information about STENDRA, go to or for full
prescribing information go to

Note to Investors

As previously announced, VIVUS will hold a conference call and an audio
webcast to discuss the third quarter financial results today, November 6,
2012, beginning at 8:45 a.m. Eastern Time. Investors can listen to this call
by dialing 1-877-359-2916 and outside the U.S. 224-357-2386. A webcast replay
will be available for 30 days and can be accessed at


VIVUS is a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health for U.S., Europe and other world markets.
Qsymia is also in phase 2 clinical development for the treatment of type 2
diabetes and obstructive sleep apnea.For more information about the company,
please visit

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," "estimate," "expect," "intend," "likely,"
"may," "plan," "potential," "predict," "opportunity" and "should," among
others. 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, our lack of commercial experience
with Qsymia in the U.S.; the timing of initiation and completion of the
clinical studies required as part of the approval of Qsymia by the United
States Food and Drug Administration, or FDA; the response from the FDA to the
data that VIVUS will submit relating to post-approval clinical studies; the
impact of the indicated uses and contraindications contained in the Qsymia
label and the REMS requirements; the impact of distribution of Qsymia through
a certified pharmacy network; whether or not the FDA approves our amendment to
the REMS for Qsymia, which, if approved, would allow dispensing through select
retail pharmacies to increase access while meeting all requirements of the
REMS; that we may be required to provide further analysis of previously
submitted clinical trial data; our appeal of the negative opinion of the
European Medicines Agency's, or EMA, Committee for Medicinal Products for
Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for
Qsymia; our ability to successfully commercialize or establish a marketing
partnership for avanafil, which will be marketed in the U.S. under the name
STENDRA, or the ability of our partners to maintain regulatory approvals to
manufacture and adequately supply our products to meet demand; our history of
losses and variable quarterly results; substantial competition; risks related
to the failure to protect our intellectual property and litigation in which we
may become involved; uncertainties of government or third party payer
reimbursement; our reliance on sole source suppliers; our limited sales and
marketing and manufacturing experience; our reliance on third parties and our
collaborative partners; our failure to continue to develop innovative
investigational drug candidates and drugs; risks related to the failure to
obtain FDA or foreign authority clearances or approvals and noncompliance with
FDA or foreign authority regulations; our ability to demonstrate through
clinical testing the safety and effectiveness of our investigational drug
candidates; the timing of initiation and completion of clinical trials and
submissions to foreign authorities; the volatility and liquidity of the
financial markets; our liquidity and capital resources; and our expected
future revenues, operations and expenditures. As with any pharmaceutical in
development, there are significant risks in the development, the regulatory
approval, and commercialization of new products. There are no guarantees that
our products will receive regulatory approval outside the United States for
any indication or prove to be commercially successful. VIVUS does not
undertake an obligation to update or revise any forward-looking statements.
Investors should read the risk factors set forth in VIVUS' Form 10-K for the
year ending December 31, 2011, and periodic reports filed with the Securities
and Exchange Commission.

(in thousands, except per share amounts)

                          Three Months Ended       Nine Months Ended
                          September 30 September 30 September 30 September 30
                          2012         2011         2012         2011
Net product revenue        $41        $--        $41        $--
Operating expenses:                                            
Cost of goods sold         4            --          4           --
Research and development   9,300       3,738       24,307      19,253
Selling, general and       31,269      5,203       59,351      15,934
Total operating expenses   40,573      8,941       83,662      35,187
Loss from operations       (40,532)    (8,941)     (83,621)    (35,187)
Interest and other income, 59          132         130         210
Loss from continuing
operations before income   (40,473)    (8,809)     (83,491)    (34,977)
Provision for income taxes (3)         (3)         (13)        (6)
Loss from continuing       (40,476)    (8,812)     (83,504)    (34,983)
Income from discontinued   80          185         282         306
Net loss                   $(40,396)  $(8,627)   $(83,222)  $(34,677)
Basic and diluted net loss                                     
per share:
Continuing operations      $(0.40)    $(0.10)    $(0.85)    $(0.42)
Discontinued operations    --          --          --          --
Net loss per share         $(0.40)    $(0.10)    $(0.85)    $(0.42)
Shares used in per share                                       
Basic and diluted          100,438      84,818       97,505       82,866

(in thousands)

                                             September 30     December 31
                                             2012             2011*
Current assets:                                               
Cash and cash equivalents                     $62,274        $39,554
Available-for-sale securities                212,204         107,282
Accounts receivable, net                      516             --
Inventories                                   14,650          3,107
Prepaid expenses and other assets             17,437          1,793
Total current assets                          307,081         151,736
Property and equipment, net                   1,419           320
Total assets                                  $308,500       $152,056
Current liabilities:                                          
Accounts payable                              $22,772        $2,940
Accrued and other liabilities                 11,208          6,392
Current liabilities of discontinued           518             1,640
Total current liabilities                     34,498          10,972
Commitments and contingencies                                 
Stockholders' equity:                                         
Common stock and additional paid-in capital   703,452          487,324
Accumulated other comprehensive income       37              25
Accumulated deficit                          (429,487)       (346,265)
Total stockholders' equity                    274,002         141,084
Total liabilities and stockholders' equity    $308,500       $152,056
* The Condensed Consolidated Balance Sheet at December 31, 2011 has been
derived from our audited financial statements as of that date.

         Timothy E. Morris
         Chief Financial Officer
         Investor Relations:
         The Trout Group
         Brian Korb
Press spacebar to pause and continue. Press esc to stop.