Vanda Pharmaceuticals Reports First Quarter 2013 Results

           Vanda Pharmaceuticals Reports First Quarter 2013 Results

PR Newswire

WASHINGTON, May 9, 2013

WASHINGTON, May 9, 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 first
quarter ended March 31, 2013.

Key Highlights:

  oOn March 25, 2013, Vanda announced that it held a successful Pre-New Drug
    Application meeting with the U.S. Food and Drug Administration (FDA). The
    FDA confirmed that the efficacy and safety data proposed by Vanda to be
    submitted in a tasimelteon New Drug Application (NDA) for Non-24-Hour
    Disorder (Non-24) is adequate to support filing. Vanda is targeting an NDA
    submission for tasimelteon for Non-24 in mid-2013.
    
  oVanda and Bristol-Myers Squibb (BMS) entered into an amendment to the
    tasimelteon licensing agreement. Subsequent to this amendment, BMS waived
    its option to re-acquire rights to develop and commercialize tasimelteon.
    
  oFull year 2013 decrease in cash, cash equivalents and marketable
    securities (Cash) is expected to be between $45.0 and $50.0 million,
    compared to $47.5 million for 2012. 2013 expenses are expected to reflect
    lower research and development spending as compared to 2012 and an
    increase in commercial spending that is commensurate to progress with the
    tasimelteon NDA filing.
    
  oDuring the first quarter of 2013, Vanda withdrew its Marketing
    Authorization Application (MAA) for Fanaptum™ (oral iloperidone tablets)
    in the European Union.
    
  oOn April 18, 2013, Vanda announced that Paolo Baroldi, M.D., Ph.D. joined
    its management team as Senior Vice President, Chief Medical Officer.

FIRST QUARTER 2013 REPORTED RESULTS

Total revenues for the first quarter of 2013 and 2012 were each $8.1 million.
The total revenues for the first quarter of 2013 and 2012 each included $1.5
million in Fanapt^® royalties received from Novartis.

Total operating expenses for the first quarter of 2013 were $12.3 million,
compared to $16.5 million for the first quarter of 2012. The primary driver
of the lower expenses in the first quarter of 2013 was the completion of the
tasimelteon Non-24 and Major Depressive Disorder efficacy studies.

Vanda recorded a net loss of $4.2 million for the first 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 first quarter of 2013 was $0.15, compared to a
diluted net loss per share of $0.28 for the first quarter of 2012.

Cash decreased by $9.5 million in the first quarter of 2013, compared to
decreases of $10.6 million in the first quarter of 2012 and $14.0 million in
the fourth quarter of 2012. Vanda's Cash as of March 31, 2013 totaled $110.9
million.

First Quarter 2013 Key Financial Figures^1
                            Three Months Ended
                            March 31     December 31
(in thousands, except per   2013         2012          Change ($)  Change (%)
share amounts)
Total revenues              $       $       $        2%
                            8,068        7,920         148
Research & development     7,960        10,617       (2,657)       (25%)
expenses
General & administrative    3,958        3,225        733           23%
expenses
Non-cash stock-based        952          923          29            3%
compensation^2
Net loss                    (4,173)      (6,369)      2,196         34%
Diluted net loss per share  $       $       $        35%
                            (0.15)      (0.23)       0.08



Select Cash Flow Data^1
                                        Three Months Ended
                                        March 31            March 31
(in thousands)                          2013                2012
Net cash provided by (used
in) 
 Operating activities                  $     (9,125)  $     (8,690)
 Investing activities                  30,477              28,861
Financing activities                  (193)               -



Select Balance Sheet Data^1
                                      March 31      December 31     March 31
(in thousands)                        2013          2012            2012
Total cash and marketable             $          $            $   
securities                 110,932       120,403         157,250
(1) Unaudited
(2) Non-cash stock-based compensation is allocated to both Research &
development and General &

 administrative expenses

OPERATIONAL HIGHLIGHTS

On March 25, 2013, Vanda announced that it held a pre-NDA meeting with the
Division of Neurology Products of the FDA to discuss the regulatory path for
filing an NDA for tasimelteon, a circadian regulator, for the treatment of
Non-24. At the pre-NDA meeting, the FDA confirmed that the efficacy and
safety data proposed by Vanda to be submitted in the tasimelteon NDA for
Non-24 is adequate to support filing. The NDA supporting package that
includes data from clinical pharmacology, pre-clinical pharmacology program,
chemistry and manufacturing was also deemed adequate to support filing. Based
on this successful completion of the pre-NDA meeting, Vanda is targeting an
NDA submission for tasimelteon in mid-2013. Non-24 is a serious, rare
circadian rhythm disorder that affects a majority of totally blind
individuals. Currently there is no FDA approved treatment for Non-24.

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 will present data from the SET and RESET studies at the 27th
Annual Meeting of the Associated Professional Sleep Societies, SLEEP 2013, and
the 95th Annual Endocrine Society Meeting, ENDO 2013. In addition, Vanda
continues to build its registry of individuals who have the potential to be
Non-24 patients. The U.S. based registry has over 1,500 individuals and was
created to facilitate the recruitment of patients for the tasimelteon Non-24
clinical studies.

On April 25, 2013, Vanda and Bristol-Myers Squibb (BMS) entered into an
amendment to the tasimelteon licensing agreement. Subsequent to this
amendment, BMS waived its option to re-acquire rights to develop and
commercialize tasimelteon in countries not covered by a third party
development and commercialization agreement.

Vanda plans to initiate a proof of concept study for VLY-686 in Treatment
Resistant Pruritus in Atopic Dermatitis in the second half of 2013. VLY-686
is a small molecule neurokinin-1 receptor (NK-1R) antagonist currently at the
clinical stage of development. An inappropriate NK-1R activation either in
nervous tissue or peripherally could result in pathological conditions such as
substance dependence, anxiety, nausea/vomiting, and pruritus. An NK-1R
antagonist may possess the ability to reduce this over-stimulation of the
NK-1R, and as a result address the underlying pathophysiology of the symptoms
in these conditions.

During the first quarter of 2013, Vanda withdrew its MAA submitted to the
European Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) for Fanaptum™ for the treatment of adult patients with
schizophrenia. This withdrawal was based on a request by the
CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing
relapse prevention, randomized iloperidone-placebo withdrawal study in
patients with schizophrenia. The results of this study will not be available
in the timeframe allowed by the EMA's Centralised Procedure. Vanda intends to
reassess its European regulatory strategy for Fanaptum™ once the results from
the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) being
conducted by Novartis, become available.

Vanda recorded first quarter 2013 revenue of $8.1 million including Fanapt®
royalties of $1.5 million. Fanapt® prescriptions, as reported by IMS, were
approximately 38,900 for the first quarter of 2013. This represents a 9%
increase over first quarter 2012 prescriptions and a 2% increase versus fourth
quarter 2012 prescriptions.

On April 18, 2013, Vanda announced that Paolo Baroldi, M.D., Ph.D. joined its
management team as Senior Vice President, Chief Medical Officer. He had
assumed the role of Vanda's acting Chief Medical Officer in October 2012. Dr.
Baroldi previously served as Vanda's Senior Vice President and Chief Medical
Officer from July 2006 through January 2009. He has also served in senior
clinical development positions at Galileo Research, Supernus Pharmaceuticals,
Chiesi Famaceutici SpA, and Novartis.

2013 FINANCIAL GUIDANCE

2013 financial guidance assumes a mid-year NDA submission for tasimelteon for
Non-24 is accepted by the FDA for Standard Review. 2013 expenses are expected
to reflect lower research and development spending as compared to 2012 and an
increase in commercial spending that is commensurate to progress with the
tasimelteon NDA filing.

  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 assumes $4.3 million in milestone payments
    due upon the acceptance by the FDA of a tasimelteon NDA submission and
    $3.0 to $4.0 million in NDA filing-related expenses.

CONFERENCE CALL

Vanda has scheduled a conference call for today, Thursday, May 9, 2013, at
10:00 AM ET. During the call, Vanda's management will discuss the first
quarter 2013 financial results and other corporate activities. Investors can
call 1-877-280-4962 (domestic) and 1-857-244-7319 (international) and use
passcode 32610810. A replay of the call will be available beginning Thursday,
May 9, 2013 at 12:00 PM ET and will be accessible until Thursday, May 16,
2013, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic
callers and 1-617-801-6888 for international callers. The access number is
47460221.

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 regulatory approval for tasimelteon for the
treatment of Non-24-Hour Disorder or to comply with ongoing regulatory
requirements; 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
                                                    March 31      March 31
(in thousands, except for share and per share       2013          2012
amounts)
Revenues:
Licensing agreement                                 $ 6,606       $ 6,606
Royalty revenue                                       1,462         1,535
Total revenues                                        8,068         8,141
Operating expenses:
Research and development                              7,960         12,180
General and administrative                            3,958         3,909
Intangible asset amortization                         369           369
Total operating expenses                              12,287        16,458
Loss from operations                                  (4,219)       (8,317)
Other income                                          46            355
Loss before tax benefit                               (4,173)       (7,962)
Tax benefit                                           -             -
Net loss                                            $ (4,173)     $ (7,962)
Net loss per share:
Basic                                               $ (0.15)      $ (0.28)
Diluted                                             $ (0.15)      $ (0.28)
Shares used in calculations of net loss
per share:
Basic                                                28,345,555    28,226,743
Diluted                                               28,345,555    28,226,743



VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(in thousands)                              March 31, 2013  December 31, 2012
ASSETS
Current assets:
Cash and cash equivalents                   $   109,931     $    88,772
Marketable securities                           1,001            31,631
Accounts receivable                             1,462            1,168
Prepaid expenses and other current assets       3,288            3,967
Restricted cash, current                        430              430
Total current assets                            116,112          125,968
Property and equipment, net                     2,264            2,348
Intangible asset, net                           6,163            6,532
Restricted cash, non-current                    600              600
Total assets                                $   125,139     $    135,448
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable                            $   1,113       $    287
Accrued liabilities                             3,874            5,187
Deferred rent, current                          197              -
Deferred revenues, current                      26,789           26,789
Total current liabilities                       31,973           32,263
Deferred rent, non-current                      3,016            3,005
Deferred revenues, non-current                  83,669           90,275
Total liabilities                               118,658          125,543
Stockholders' equity:
Common stock                                    28               28
Additional paid-in capital                      301,733          300,974
Accumulated other comprehensive income          -                10
Accumulated deficit                             (295,280)        (291,107)
Total stockholders' equity                      6,481            9,905
Total liabilities and stockholders' equity  $   125,139     $    135,448

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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