Vanda Pharmaceuticals Reports Second Quarter 2013 Results

          Vanda Pharmaceuticals Reports Second Quarter 2013 Results

PR Newswire

WASHINGTON, July 31, 2013

WASHINGTON, July 31, 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 second
quarter ended June 30, 2013.

Key Highlights:

  oOn July 29, 2013 Vanda announced that the U.S. Food and Drug
    Administration (FDA) accepted the filing 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 determined the action target date under Prescription Drug User Fee
    Act (PDUFA-V) to be January 31, 2014. The FDA has also tentatively
    scheduled an advisory committee meeting to discuss the tasimelteon
    application on November 14, 2013.
  oFull year 2013 decrease in cash, cash equivalents and marketable
    securities (Cash) is expected to be between $45.0 and $50.0 million,
    consistent with prior guidance.
  oVanda recorded second quarter 2013 revenue of $8.3 million including
    royalties of $1.6 million. Fanapt® prescriptions, as reported by IMS,
    were approximately 41,400 for the second quarter of 2013. This represents
    a 11% increase over second quarter 2012 prescriptions and a 7% increase
    over first quarter 2013 prescriptions.

SECOND QUARTER 2013 REPORTED RESULTS

Total revenues for the second quarter of 2013 were $8.3 million, compared to
$8.4 million for the same period in 2012. Second quarter 2013 revenues
included $1.6 million in Fanapt^® royalties received from Novartis as compared
to royalties of $1.7 million for the second quarter of 2012.

Total operating expenses for the second quarter of 2013 were $11.4 million,
compared to $16.5 million for the second quarter of 2012. The primary driver
of the lower expenses in the second quarter of 2013 was the completion of the
tasimelteon Non-24 and Major Depressive Disorder efficacy studies.

Vanda recorded a net loss of $3.1 million for the second quarter of 2013,
compared to a net loss of $8.0 million for the same period in 2012. Diluted
net loss per share for the second quarter of 2013 was $0.11, compared to a
diluted net loss per share of $0.28 for the second quarter of 2012.

Cash, cash equivalents and marketable securities (Cash) decreased by $7.3
million in the second quarter of 2013, compared to decreases of $12.5 million
in the second quarter of 2012 and $9.5 million in the first quarter of 2013.
Vanda's Cash as of June 30, 2013 totaled $103.6 million. 

Year to Date June 30, 2013 Key Financial Figures^1

                           

                           Six Months Ended
                           June 30      June 30
($ in thousands, except    2013         2012          Change ($)   Change (%)
per share amounts)
Total revenues             $        $        $        (1%)
                           16,387       16,519       (132)
Research & development    13,942       24,670       (10,728)       (43%)
expenses
General & administrative   9,032        7,510        1,522          20%
expenses
Non-cash stock-based       1,782        2,595        (813)          (31%)
compensation^2
Net loss                   (7,252)      (15,969)     8,717          55%
Diluted net loss per share $       $       $        54%
                           (0.26)      (0.57)      0.31



Second Quarter 2013 Key Financial Figures^1

                            

                            Three Months Ended
                            June 30      March 31
($ in thousands, except per 2013         2013          Change ($)  Change (%)
share amounts)
Total revenues              $       $       $        3%
                            8,319        8,068         251
Research & development     5,982        7,960        (1,978)       (25%)
expenses
General & administrative    5,074        3,958        1,116         28%
expenses
Non-cash stock-based        830          952          (122)         (13%)
compensation^2
Net loss                    (3,079)      (4,173)      1,094         26%
Diluted net loss per share  $       $       $        27%
                            (0.11)      (0.15)       0.04



Select Cash Flow Data^1

                               Six Months Ended
                               June 30            June 30
($ in thousands)               2013               2012
Net cash provided by (used in)
Operating activities           $    (17,168)  $    (20,904)
Investing activities           31,428             27,369
Financing activities           601                -



Select Balance Sheet Data^1

                                  June 30              March 31      June 30
($ in thousands)                  2013                 2013          2012
Total cash and marketable         $    103,633      $          $   
securities                                             110,932       144,701
(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 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 determined the action target date
under Prescription Drug User Fee Act (PDUFA-V), to be January 31, 2014. The
FDA has also tentatively scheduled an advisory committee meeting to discuss
the tasimelteon application on November 14, 2013.

Vanda continues to expand its activities in support of Non-24 disease
awareness and education with professional, advocacy and patient groups. In
June 2013, Vanda presented data from the SET and RESET studies at the 27th
Annual Meeting of the Associated Professional Sleep Societies, SLEEP 2013, and
the 95^th Annual Endocrine Society Meeting, ENDO 2013. 

Vanda recorded second quarter 2013 revenue of $8.3 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 $1.6 million. Fanapt^® prescriptions, as
reported by IMS, were approximately 41,400 for the second quarter of 2013.
This represents a 11% increase over second quarter 2012 prescriptions and a 7%
increase versus first quarter 2013 prescriptions.

AFFIRMS 2013 FINANCIAL GUIDANCE

Consistent with prior guidance, 2013 expenses are expected to reflect lower
research and development spending as compared to 2012 and an increase in
commercial spending.

  oFull year 2013 decrease in Cash is expected to be between $45.0 and $50.0
    million, compared to $47.5 million for 2012.
  oTotal 2013 operating expenses are expected to be between $57.0 and $62.0
    million. This includes Fanapt^® intangible asset amortization of $1.5
    million and $4.0 to $6.0 million of non-cash stock based compensation.
    Total 2012 operating expenses were $61.0 million.
  o2013 operating expense guidance includes $3.5 million in milestone
    payments due upon the acceptance by the FDA of a tasimelteon NDA
    submission and assumes $4.0 to $5.0 million in NDA filing-related
    expenses.

CONFERENCE CALL

Vanda has scheduled a conference call for today, Wednesday, July 31, 2013, at
10:00 AM ET. During the call, Vanda's management will discuss the second
quarter 2013 financial results and other corporate activities. Investors can
call 1-888-895-5479 (domestic) and 1-847-619-6250 (international) and use
passcode 35347357. A replay of the call will be available beginning
Wednesday, July 31, 2013 at 12:00 PM ET and will be accessible until
Wednesday, August 7, 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 35347357.

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. 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          Six Months Ended
                        June 30       June 30       June 30       June 30
($ in thousands, except 2013          2012          2013          2012
per share amounts)
Revenues:
  Licensing agreement   $ 6,678       $ 6,678       $ 13,284      $ 13,284
  Royalty revenue         1,641         1,700         3,103         3,235
       Total              8,319         8,378         16,387        16,519
       revenues
Operating expenses:
  Research and            5,982         12,490        13,942        24,670
  development
  General and             5,074         3,601         9,032         7,510
  administrative
  Intangible asset        372           372           741           741
  amortization
       Total
       operating          11,428        16,463        23,715        32,921
       expenses
Loss from                 (3,109)       (8,085)       (7,328)       (16,402)
operations
  Other income            30            78            76            433
Loss before tax           (3,079)       (8,007)       (7,252)       (15,969)
benefit
  Tax benefit             -             -             -             -
Net loss                $ (3,079)     $ (8,007)     $ (7,252)     $ (15,969)
Net loss per share:
  Basic                 $ (0.11)      $ (0.28)      $ (0.26)      $ (0.57)
  Diluted               $ (0.11)      $ (0.28)      $ (0.26)      $ (0.57)
Shares used in
calculations of net
loss
  per share:
  Basic                  28,377,254    28,226,743    28,361,340    28,226,743
  Diluted                 28,377,254    28,226,743    28,361,340    28,226,743





VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
($ in thousands)                              June 30, 2013  December 31, 2012
ASSETS
 Current assets:
   Cash and cash equivalents                  $  103,633     $    88,772
   Marketable securities                         -                31,631
   Accounts receivable                           1,641            1,168
   Prepaid expenses and other current assets     2,651            3,967
   Restricted cash, current                      430              430
       Total current assets                      108,355          125,968
 Property and equipment, net                     2,208            2,348
 Intangible asset, net                           5,791            6,532
 Restricted cash, non-current                    600              600
       Total assets                           $  116,954     $    135,448
LIABILITIES AND STOCKHOLDERS' EQUITY
 Current liabilities:
   Accounts payable                           $  1,167       $    287
   Accrued liabilities                           3,770            5,187
   Deferred rent, current                        209              -
   Deferred revenues, current                    26,789           26,789
       Total current liabilities                 31,935           32,263
   Deferred rent, non-current                    3,002            3,005
   Deferred revenues, non-current                76,991           90,275
       Total liabilities                         111,928          125,543
 Stockholders' equity:
   Common stock                                  28               28
   Additional paid-in capital                    303,357          300,974
   Accumulated other comprehensive income        -                10
   Accumulated deficit                           (298,359)        (291,107)
       Total stockholders' equity                5,026            9,905
       Total liabilities and stockholders'    $  116,954     $    135,448
       equity



COMPANY CONTACT:
Jim Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

SOURCE Vanda Pharmaceuticals Inc.

Website: http://www.vandapharma.com
 
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