Vanda Pharmaceuticals Reports Third Quarter 2013 Results

           Vanda Pharmaceuticals Reports Third Quarter 2013 Results

PR Newswire

WASHINGTON, Nov. 7, 2013

WASHINGTON, Nov.7, 2013 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA), a biopharmaceutical company focused on the development and
commercialization of products for the treatment of central nervous system
disorders, today announced financial and operational results for the third
quarter ended September 30, 2013.

Key Highlights:

  oOn July 29, 2013 Vanda announced that the U.S. Food and Drug
    Administration (FDA) accepted the filing of and granted priority review
    classification to Vanda's New Drug Application (NDA) for tasimelteon, a
    circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in
    the totally blind.
  oThe FDA has scheduled a Peripheral and Central Nervous System Drugs
    Advisory Committee Meeting on November 14, 2013, for the review of Vanda's
    NDA for tasimelteon, proposed trade name HETLIOZ™, for the treatment of
    Non-24.
  oThe FDA determined the action target date under the Prescription Drug User
    Fee Act (PDUFA-V) for tasimelteon to be January 31, 2014.
  oOn August 7, 2013 Vanda completed the public offering of 4.68 million
    shares of common stock resulting in net proceeds of $48.6 million.
  oVanda recorded third quarter 2013 revenue of $8.7 million including
    royalties of $2.0 million. Fanapt® prescriptions, as reported by IMS,
    were approximately 43,600 for the third quarter of 2013. This represents
    a 13% increase over third quarter 2012 prescriptions and a 5% increase
    over second quarter 2013 prescriptions.

THIRD QUARTER 2013 REPORTED RESULTS

Total revenues for the third quarter of 2013 were $8.7 million, compared to
$8.3 million for the same period in 2012. Third quarter 2013 revenues
included $2.0 million in Fanapt^® royalties received from Novartis as compared
to royalties of $1.5 million for the third quarter of 2012.

Total operating expenses for the third quarter of 2013 were $14.1 million,
compared to $13.7 million for the third quarter of 2012. Third quarter 2013
research and development expenses of $8.0 million includes $3.5 million in
milestones associated with the FDA acceptance of the tasimelteon filing. The
primary driver of the lower research and development expenses in the third
quarter of 2013 as compared to $10.2 million in the third quarter of 2012 was
the completion of the tasimelteon Non-24 and Major Depressive Disorder
efficacy studies. General and administrative expenses of $5.7 million for the
third quarter of 2013 were $2.6 million higher than the third quarter of 2012
and reflect the increased commercial activity in preparation for a potential
tasimelteon commercial launch in the United States.

Vanda recorded a net loss of $5.4 million for the third quarter of 2013,
compared to a net loss of $5.3 million for the same period in 2012. Diluted
net loss per share for the third quarter of 2013 was $0.17, compared to a
diluted net loss per share of $0.19 for the third quarter of 2012.

Cash, cash equivalents and marketable securities (Cash) increased by $38.5
million to $142.2 million as of September 30, 2013, primarily as a result of
the sale of common stock in Vanda's public offering in August 2013.

Year to Date September 30, 2013 Key
Financial Figures^1
                             Nine Months Ended
                             September 30  September 30
($ in thousands, except per  2013          2012           Change ($)   Change
share amounts)                                                          (%)
Total revenues               $         $         $        1%
                             25,096        24,807        289
Research & development      21,968        34,829        (12,861)       (37%)
expenses
General & administrative     14,743        10,657        4,086          38%
expenses
Non-cash stock-based         3,321         3,171         150            5%
compensation^2
Net loss                     (12,632)      (21,295)      8,663          41%
Diluted net loss per share   $        $        $         43%
                             (0.43)       (0.75)       0.32
Third Quarter 2013 Key Financial
Figures^1
                             Three Months Ended
                             September 30  June 30
($ in thousands, except per  2013          2013           Change ($)   Change
share amounts)                                                          (%)
Total revenues               $        $        $        5%
                             8,709         8,319         390
Research & development      8,026         5,982         2,044          34%
expenses
General & administrative     5,711         5,074         637            13%
expenses
Non-cash stock-based         1,539         830           709            85%
compensation^2
Net loss                     (5,380)       (3,079)       (2,301)        (75%)
Diluted net loss per share   $        $        $          (55%)
                             (0.17)       (0.11)       (0.06)
Select Cash Flow Data^1
                             Nine Months Ended
                             September 30  September 30
($ in thousands)             2013          2012
Net cash provided by (used
in)
Operating activities         $ (27,439)    $ (31,068)
Investing activities         31,421        47,660
Financing activities         49,418        -
Select Balance Sheet Data^1
                             September 30  June 30       September 30
($ in thousands)             2013          2013          2012
Total cash and marketable    $          $          $  
securities                   142,172       103,633       134,404
(1) Unaudited
(2) Non-cash stock-based compensation is allocated to both Research &
development and General & administrative expenses



OPERATIONAL HIGHLIGHTS

On July 29, 2013, Vanda announced that the FDA accepted the filing of and
granted a priority review classification to Vanda's NDA for tasimelteon, a
circadian regulator for the treatment of Non-24 in the totally blind.
Currently, there is no approved treatment for Non-24 and tasimelteon has the
potential to address this unmet medical need. The FDA has scheduled a
Peripheral and Central Nervous System Drugs Advisory Committee Meeting on
November 14, 2013, for the review of Vanda's NDA for tasimelteon, proposed
trade name HETLIOZ™, for the treatment of Non-24. The FDA determined the
action target date under the Prescription Drug User Fee Act (PDUFA-V) for
tasimelteon to be January 31, 2014.

Vanda recorded third quarter 2013 revenue of $8.7 million including $6.7
million in licensing revenue related to the amortization of the upfront
payment received from Novartis for U.S. and Canadian commercial rights to
Fanapt® and Fanapt® royalties of $2.0 million. Fanapt® prescriptions, as
reported by IMS, were approximately 43,600 for the third quarter of 2013.
This represents a 13% increase over third quarter 2012 prescriptions and a 5%
increase versus second quarter 2013 prescriptions.

2013 FINANCIAL GUIDANCE

2013 expenses are expected to reflect lower research and development spending
as compared to 2012 and an increase in commercial spending. Reflecting the
recent public offering and year to date expenditures, Vanda now expects that
it will end the year with between $130.0 and $135.0 million in Cash. Total
2013 operating expenses are expected to be between $50.0 and $55.0 million and
decrease in Cash, excluding the impact of the recent public offering, is
expected to be between $35.0 and $40.0 million.

CONFERENCE CALL

Vanda has scheduled a conference call for today, Thursday, November 7, 2013,
at 10:00 AM ET. During the call, Vanda's management will discuss the third
quarter 2013 financial results and other corporate activities. Investors can
call 1-888-895-5271 (domestic) and 1-847-619-6547 (international) and use
passcode 35919679. A replay of the call will be available beginning Thursday,
November 7, 2013 at 12:00 PM ET and will be accessible until Thursday,
November 14, 2013, at 5:00 PM ET. The replay call-in number is 1-888-843-7419
for domestic callers and 1-630-652-3042 for international callers. The access
number is 35919679.

The conference call will be broadcast simultaneously on Vanda's website,
www.vandapharma.com. Investors should click on the Investor Relations tab and
are advised to go to the website at least 15 minutes early to register,
download, and install any necessary software or presentations. The call will
also be archived on Vanda's website for a period of 30 days.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders. For more on Vanda, please visit
www.vandapharma.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the
securities laws. Words such as, but not limited to, "believe," "expect,"
"anticipate," "estimate," "intend," "plan," "project," "target," "goal,"
"likely," "will," "would," and "could," or the negative of these terms and
similar expressions or words, identify forward-looking statements.
Forward-looking statements are based upon current expectations that involve
risks, changes in circumstances, assumptions and uncertainties. Important
factors that could cause actual results to differ materially from those
reflected in the company's forward-looking statements include, among others:
Vanda's failure to obtain, or any delay in obtaining, regulatory approval for
tasimelteon for the treatment of Non-24-Hour Disorder or to comply with
ongoing regulatory requirements; the costs and effects of current or potential
litigation and other factors that are described in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the fiscal year
ended December 31, 2012 which is on file with the SEC and available on the
SEC's website at www.sec.gov and Vanda's quarterly report on Form 10-Q for the
quarter ended September 30, 2013 to be filed with the SEC. In addition to the
risks described above and in Vanda's annual report on Form 10-K and quarterly
reports on Form 10-Q, other unknown or unpredictable factors also could affect
Vanda's results. There can be no assurance that the actual results or
developments anticipated by Vanda will be realized or, even if substantially
realized, that they will have the expected consequences to, or effects on,
Vanda. Therefore, no assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Vanda or any
person acting on its behalf are expressly qualified in their entirety by the
cautionary statements contained or referred to herein. Vanda cautions
investors not to rely too heavily on the forward-looking statements Vanda
makes or that are made on its behalf. The information in this release is
provided only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or revise
publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.

VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
                        Three Months Ended          Nine Months Ended
                        September 30  September 30  September 30  September 30
($ in thousands, except 2013          2012          2013          2012
per share amounts)
Revenues:
    Licensing agreement $ 6,753       $ 6,753       $ 20,037      $ 20,037
    Royalty               1,956         1,535         5,059         4,770
    revenue
           Total          8,709         8,288         25,096        24,807
           revenues
Operating expenses:
    Research and          8,026         10,159        21,968        34,829
    development
    General and           5,711         3,147         14,743        10,657
    administrative
    Intangible asset      377           377           1,118         1,118
    amortization
           Total
           operating      14,114        13,683        37,829        46,604
           expenses
Loss from operations      (5,405)       (5,395)       (12,733)      (21,797)
    Other income          25            69            101           502
Loss before tax benefit   (5,380)       (5,326)       (12,632)      (21,295)
    Tax benefit           -             -             -             -
Net loss                $ (5,380)     $ (5,326)     $ (12,632)    $ (21,295)
Net loss per share:
    Basic               $ (0.17)      $ (0.19)      $ (0.43)      $ (0.75)
    Diluted             $ (0.17)      $ (0.19)      $ (0.43)      $ (0.75)
Shares used in
calculations of net
loss
    per share:
    Basic                 31,332,993    28,226,743    29,363,162    28,226,743
    Diluted               31,332,993    28,226,743    29,363,162    28,226,743



VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
($ in thousands)                            September 30,     December 31,
                                            2013              2012
ASSETS
 Current assets:
       Cash and cash equivalents            $   142,172       $   88,772
       Marketable securities                    -                 31,631
       Accounts receivable                      1,956             1,168
       Prepaid expenses and other current       2,412             3,967
       assets
       Restricted cash, current                 530               430
            Total current assets                147,070           125,968
 Property and equipment, net                    2,106             2,348
 Intangible asset, net                          5,414             6,532
 Restricted cash, non-current                   500               600
            Total assets                    $   155,090       $   135,448
LIABILITIES AND STOCKHOLDERS' EQUITY
 Current liabilities:
       Accounts payable                     $   369           $   287
       Accrued liabilities                      4,532             5,187
       Deferred rent, current                   215               -
       Deferred revenues, current               26,789            26,789
            Total current                       31,905            32,263
            liabilities
       Deferred rent, non-current               2,945             3,005
       Deferred revenues, non-current           70,238            90,275
            Total liabilities                   105,088           125,543
 Stockholders' equity:
       Common stock                             33                28
       Additional paid-in capital               353,708           300,974
       Accumulated other comprehensive          -                 10
       income
       Accumulated deficit                      (303,739)         (291,107)
            Total stockholders' equity          50,002            9,905
            Total liabilities and           $   155,090       $   135,448
            stockholders' equity

INVESTOR CONTACT:
Chad Rubin
Vice President
The Trout Group
(646) 378-2947
crubin@troutgroup.com

SOURCE Vanda Pharmaceuticals Inc.

Website: http://www.vandapharma.com
 
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