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VIVUS Reports 2012 Fourth Quarter and Full-Year Financial Results



VIVUS Reports 2012 Fourth Quarter and Full-Year Financial Results

MOUNTAIN VIEW, Calif., Feb. 25, 2013 (GLOBE NEWSWIRE) -- VIVUS,Inc.
(Nasdaq:VVUS), a biopharmaceutical company commercializing and developing
innovative, next-generation therapies to address unmet needs in obesity, sleep
apnea, diabetes and sexual health, today provided a business update and
reported its financial results for the fourth quarter and year ended December
31, 2012.

"We believe in the long-term value of our franchise, and are focused on
retaining and enhancing that value for our stockholders," stated Leland
Wilson, chief executive officer of VIVUS. "In 2012, we obtained FDA approval
for Qsymia^TM and STENDRA^TM and launched Qsymia in the U.S. Since approval,
we have dedicated resources and been actively engaged in the process of
educating physicians and creating awareness for Qsymia. In order to expand
access to Qsymia, we submitted to FDA in mid-October 2012 a modification of
the REMS that, pending approval, would allow patients to access Qsymia through
select certified retail pharmacies. We continue to make substantial progress
in obtaining reimbursement coverage. Our goals for 2013 include expanding both
access and reimbursement for Qsymia as well as securing partnerships for
STENDRA."

Recent Highlights

  * In February 2013, VIVUS announced the publication of a study concluding
    that weight loss resulting from treatment with Qsymia led to significant
    improvements in cholesterol, blood pressure and triglycerides in obese and
    overweight patients experiencing one or more of these associated
    conditions.
     
  * In December 2012, VIVUS announced an agreement with Express Scripts, which
    manages the pharmacy benefit for approximately 26.3 million lives in the
    U.S., adding Qsymia as a standard benefit option to the Express Scripts
    National Formulary.
     
  * In September 2012, VIVUS launched Qsymia in the U.S., the first
    FDA-approved, once-daily combination therapy and the first new medication
    available in 13 years for the treatment of obesity.

Fourth Quarter 2012 Results

For the three months ended December 31, 2012, the company reported a net loss
of $56.7 million, or $0.56 per share, compared to a net loss of $11.5 million,
or $0.13 per share, for the same period the prior year.  The increase in net
loss was primarily attributable to higher selling, general and administrative
expenses related to commercialization activities for Qsymia.  In the fourth
quarter of 2012, the company recognized net product revenues of $2.0 million
from sales of Qsymia.

Year End 2012 Results

For the year ended December 31, 2012, the company reported a net loss of
$139.9 million, or $1.42 per share, compared to a loss of $46.1 million, or
$0.55 per share, for the year ended December 31, 2011.  The increase was
primarily due to higher selling, general and administrative expenses incurred
for the commercialization of Qsymia.

Mr. Wilson continued, "We are executing a commercialization strategy focused
on driving awareness of Qsymia and the important role it can play in the
medical obesity treatment paradigm. There is an addressable patient population
in the U.S. of approximately 100 million people, and less than 2% are
currently being treated with pharmacotherapy for obesity. We believe that
Qsymia can change this dynamic. Qsymia is the first-ever and only FDA-approved
oral medication shown to achieve more than 10% average weight loss, and we
believe there is a significant opportunity to improve patient care and drive
value for our shareholders. Throughout 2013, our strategy is focused on
enhancing the infrastructure necessary to support Qsymia's broad distribution
and expand reimbursement access."

Note to Investors

As previously announced, VIVUS will hold a conference call and an audio
webcast to discuss the fourth quarter and full-year financial results today,
February 25, 2013, beginning at 4:30 pm 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
http://ir.vivus.com/.

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 established.

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, visit www.Qsymia.com or for full
prescribing information see http://www.vivus.com/docs/QsymiaPI.pdf.

About STENDRA

STENDRA (avanafil), was approved by 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 EMA accepted our 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, visit www.STENDRA.com, or for full
prescribing information see
http://www.stendra.com/assets/pdf/STENDRA-avanafil-tablets-full-PI.pdf.

About VIVUS

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 www.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," "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 limited 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 Risk Evaluation and Mitigation Strategy, or REMS, requirements;
the impact of distribution of Qsymia through a certified home delivery
pharmacy network; whether or not the FDA approves our amendment to the REMS
for Qsymia, which, if approved, would allow dispensing through select
certified 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; 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™; the ability of our
partners to obtain and 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 results of post-marketing studies are
not favorable; compliance with post-marketing regulatory standards is not
maintained; 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 the
commercialization of new products. There are no guarantees that the product
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's Form 10-K for the year ending December 31,
2011, 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          Years Ended
                        December 31   December 31   December 31   December 31
                        2012          2011          2012          2011*
                        (unaudited)   (unaudited)   (unaudited)    
Revenue:                                                           
Net product revenue      $ 1,971       $ --          $ 2,012       $ --
                                                                   
Operating expenses:                                                
Cost of goods sold      183            --           187            --
Research and             7,758         5,351         32,065        24,604
development
Selling, general and     50,314        6,538         109,665       22,472
administrative
                                                                   
Total operating          58,255        11,889        141,917       47,076
expenses
                                                                   
Loss from operations     (56,284)      (11,889)      (139,905)     (47,076)
                                                                   
Interest and other       69            30            199           240
income, net
                                                                   
Loss from continuing
operations before        (56,215)      (11,859)      (139,706)     (46,836)
income taxes
                                                                   
Provision for income     (14)          (184)         (27)          (190)
taxes
                                                                   
Loss from continuing     (56,229)      (12,043)      (139,733)     (47,026)
operations
                                                                   
(Loss) income from       (430)         580           (148)         886
discontinued operations
                                                                   
Net loss                 $ (56,659)    $ (11,463)    $ (139,881)   $ (46,140)
                                                                   
Basic and diluted net
income (loss) per                                                  
share:
Continuing operations    $ (0.56)      $ (0.14)      $ (1.42)      $ (0.56)
Discontinued operations  (0.00)        0.01          (0.00)        0.01
Net loss per share       $ (0.56)      $ (0.13)      $ (1.42)      $ (0.55)
                                                                   
Shares used in per                                                 
share computation:
Basic and diluted       100,626       88,921        98,289        84,392
                                                                   
*The Condensed Consolidated Statement of Operations at December 31, 2011 has
been derived from the Company's audited financial statements at that date.

                                                                
VIVUS, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value amount)
                                                                
                                               December 31     December 31
                                               2012            2011*
                                               (unaudited)      
Current assets:                                                 
Cash and cash equivalents                       $ 58,605        $ 39,554
Available-for-sale securities                   155,981         107,282
Accounts receivable, net                        2,778           --
Inventories                                     25,353          3,107
Prepaid expenses and other assets               19,446          1,793
Total current assets                            262,163         151,736
Property and equipment, net                     1,951           320
Total assets                                    $ 264,114       $ 152,056
                                                                
Current liabilities:                                            
Accounts payable                                $ 25,375        $ 2,940
Accrued and other liabilities                   13,777          6,392
Deferred revenue                                1,150           --
Current liabilities of discontinued operations  903             1,640
Total current liabilities                       41,205          10,972
                                                                
Commitments and contingencies                                   
                                                                
Stockholders' equity:                                           
Common stock and additional paid-in capital     709,022         487,324
Accumulated other comprehensive income          33              25
Accumulated deficit                             (486,146)       (346,265)
Total stockholders' equity                      222,909         141,084
Total liabilities and stockholders' equity      $ 264,114       $ 152,056
 
*The Condensed Consolidated Balance Sheet at December 31, 2011 has been
derived from the Company's audited financial statements at that date.

CONTACT: Financial Media Relations:
         Joele Frank, Wilkinson Brimmer Katcher
         Eric Bonach
         ebonach@joelefrank.com
         212-355-4449
        
         Investor Relations:
         The Trout Group
         Brian Korb
         bkorb@troutgroup.com
         646-378-2923
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