Vanda Pharmaceuticals Reports Fourth Quarter 2013 and Full Year 2013 Results

 Vanda Pharmaceuticals Reports Fourth Quarter 2013 and Full Year 2013 Results

PR Newswire

WASHINGTON, Feb. 13, 2014

WASHINGTON, Feb. 13, 2014 /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 fourth
quarter and full year ended December 31, 2013.

"The recent FDA approval of HETLIOZ™ marks an important advancement in the
treatment of Non-24," said Mihael H. Polymeropoulos, M.D., Vanda's President
and Chief Executive Officer. "We are excited by the opportunity to help
Non-24 patients and are committed to providing much needed support and
facilitating access to this new therapeutic option."

Key Highlights:

  oOn January 31, 2014, Vanda announced that the U.S. Food and Drug
    Administration (FDA) approved HETLIOZ™ (tasimelteon) 20mg capsules for the
    treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Non-24 affects the
    majority of totally blind individuals and it is estimated that
    approximately 80,000 Americans have the disorder.
  oHETLIOZ™ is the first and only FDA approved medication for Non-24. Vanda
    expects HETLIOZ™ to be available to patients in the second quarter of
    2014.
  oVanda is preparing to file a Marketing Authorization Application (MAA) for
    tasimelteon for the treatment of Non-24 with the European Medicines Agency
    (EMA) during 2014.

FULL YEAR 2013 REPORTED RESULTS
Total revenues for the full year 2013 were $33.9 million, compared to $32.7
million for 2012. Full year 2013 revenues included $7.1 million in Fanapt^®
royalties received from Novartis as compared to royalties of $5.9 million for
the prior year. Both 2013 and 2012 revenues include $26.8 million recognized
from the $200.0 million upfront payment previously received from Novartis for
Fanapt^® U.S. and Canadian rights.

Total operating expenses for 2013 were $54.3 million, compared to $61.0
million for 2012. Full year 2013 research and development expenses of $28.2
million included $3.5 million in milestone payments associated with the FDA
acceptance of the HETLIOZ™ New Drug Application. The primary driver of the
lower research and development expenses in 2013 as compared to $45.4 million
in 2012 was the completion of the HETLIOZ™ Non-24 and Major Depressive
Disorder efficacy studies. General and administrative expenses of $24.6
million for 2013 were $10.7 million higher than for 2012 and reflect the
increased commercial activity in preparation for the launch of HETLIOZ™in the
United States.

Vanda recorded a net loss of $20.3 million for 2013, compared to a net loss of
$27.7 million for 2012. Diluted net loss per share for 2013 was $0.67,
compared to a diluted net loss per share of $0.98 for 2012.

Cash, cash equivalents and marketable securities (Cash) were $130.4 million as
of December 31, 2013.

FOURTH QUARTER 2013 REPORTED RESULTS
Total revenues for the fourth quarter of 2013 were $8.8 million, compared to
$7.9 million for the fourth quarter of 2012. Fourth quarter 2013 revenues
included $2.0 million in Fanapt^® royalties received from Novartis as compared
to royalties of $1.2 million for the fourth quarter of 2012.

Total operating expenses for the fourth quarter of 2013 were $16.5 million,
compared to $14.3 million for the fourth quarter of 2012. Vanda recorded a
net loss of $7.6 million for the fourth quarter of 2013, compared to a net
loss of $6.4 million for the fourth quarter of 2012. Diluted net loss per
share for the fourth quarter of 2013 and 2012 was $0.23 per share.

Full Year December 31, 2013 Key Financial Figures^1

                               

                               Twelve Months Ended
                               December 31  December 31
($ in thousands, except per    2013         2012          Change ($)   Change
share amounts)                                                          (%)
Total revenues                 $        $        $         4%
                               33,879       32,727       1,152
Research & development        28,190       45,446       (17,256)       (38%)
expenses
General & administrative       24,594       13,882       10,712         77%
expenses
Non-cash stock-based           4,604        4,094        510            12%
compensation^2
Net loss                       (20,255)     (27,664)     7,409          27%
Diluted net loss per share     $       $       $        32%
                               (0.67)      (0.98)      0.31



Fourth Quarter 2013 Key Financial Figures^1

                               

                               Three Months Ended
                               December 31  September 30
($ in thousands, except per    2013         2013           Change ($)  Change
share amounts)                                                          (%)
Total revenues                 $       $        $        1%
                               8,783        8,709           74
Research & development        6,222        8,026         (1,804)       (22%)
expenses
General & administrative       9,851        5,711         4,140         72%
expenses
Non-cash stock-based           1,283        1,539         (256)         (17%)
compensation^2
Net loss                       (7,623)      (5,380)       (2,243)       (42%)
Diluted net loss per share     $       $        $        (35%)
                               (0.23)      (0.17)       (0.06)



Select Cash Flow Data^1

                               Twelve Months Ended
                               December 31        December 31
($ in thousands)               2013               2012
Net cash provided by (used in)
 Operating activities        $    (39,592)  $    (44,917)
 Investing activities        (34,275)           45,754
 Financing activities        49,859             12



Select Balance Sheet Data^1

                                December 31       September 30     December 31
($ in thousands)                2013              2013             2012
Total cash and marketable       $    130,350   $    142,172  $   
securities                                                         120,403


(1) Unaudited
(2) Non-cash stock-based compensation is allocated to both Research &
development and General & administrative expenses

OPERATIONAL HIGHLIGHTS
On January 31, 2014, Vanda announced that the FDA approved HETLIOZ™
(tasimelteon) 20mg capsules for the treatment of Non-24. HETLIOZ™ is the
first FDA approved medication for Non-24. Non-24 was first described more
than 60 years ago, and is a chronic, circadian rhythm disorder resulting from
the misalignment of the endogenous master body clock to the 24-hour day,
disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind
individuals and it is estimated that approximately 80,000 Americans have the
disorder.

Vanda recorded full year 2013 revenue of $33.9 million including Fanapt^®
royalties of $7.1 million and $26.8 million in licensing revenue related to
the amortization of the upfront payment received from Novartis for U.S. and
Canadian commercial rights to Fanapt^®. Fanapt^® prescriptions, as reported
by IMS, were approximately 43,400 for the fourth quarter of 2013. This
represents a 1% decrease versus third quarter 2013 prescriptions and a 14%
increase over fourth quarter 2012 Fanapt^® prescriptions.

KEY 2014 CORPORATE ACTIVITIES

During fiscal 2014, Vanda expects to focus on the following corporate
initiatives:

  oCommercial launch of HETLIOZ™ in the U.S., which is currently expected in
    the second quarter of 2014
  oFile a MAA for tasimelteon for the treatment of Non-24 in the European
    Union

Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com

CONFERENCE CALL
Vanda has scheduled a conference call for today, Thursday, February 13, 2014,
at 10:00 AM ET. During the call, Vanda's management will discuss the fourth
quarter and full year 2013 financial results and other corporate activities.
Investors can call 1-888-895-5271 (domestic) and 1-847-619-6547
(international) and use passcode 36518617. A replay of the call will be
available beginning Thursday, February 13, 2014 at 12:30 PM ET and will be
accessible until Thursday, February 20, 2014, at 11:59 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 36518617.

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 ability to successfully commercialize HETLIOZ™ for the treatment of
Non-24-Hour Sleep-Wake Disorder in the U.S., the regulatory status of
tasimelteon in Europe, Vanda's ability to successfully complete or achieve its
2014 commercial initiatives 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 annual report on
Form 10-K for the year ended December 31, 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, current reports on Form 8-K and
other filings with the SEC, 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          Twelve Months Ended
                        December 31   December 31   December 31   December 31
($ in thousands, except 2013          2012          2013          2012
per share amounts)
Revenues:
  Licensing agreement   $ 6,752       $ 6,752       $ 26,789      $ 26,789
  Royalty revenue         2,031         1,168         7,090         5,938
       Total              8,783         7,920         33,879        32,727
       revenues
Operating expenses:
  Cost of sales           -             129           -             129
  Research and            6,222         10,617        28,190        45,446
  development
  General and             9,851         3,225         24,594        13,882
  administrative
  Intangible asset        377           377           1,495         1,495
  amortization
       Total
       operating          16,450        14,348        54,279        60,952
       expenses
Loss from                 (7,667)       (6,428)       (20,400)      (28,225)
operations
  Other income            44            59            145           561
Loss before tax           (7,623)       (6,369)       (20,255)      (27,664)
benefit
  Tax benefit             -             -             -             -
Net loss                $ (7,623)     $ (6,369)     $ (20,255)    $ (27,664)
Net loss per share:
  Basic                 $ (0.23)      $ (0.23)      $ (0.67)      $ (0.98)
  Diluted               $ (0.23)      $ (0.23)      $ (0.67)      $ (0.98)
Shares used in
calculations of net
loss
  per share:
  Basic                  33,283,705    28,233,409    30,351,353    28,228,409
  Diluted                 33,283,705    28,233,409    30,351,353    28,228,409



VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
($ in thousands)                          December 31, 2013  December 31, 2012
ASSETS
 Current assets:
   Cash and cash equivalents              $    64,764        $    88,772
   Marketable securities                       65,586             31,631
   Accounts receivable                         2,031              1,168
   Prepaid expenses and other current          2,703              3,967
   assets
   Restricted cash, current                    530                430
        Total current assets                   135,614            125,968
 Property and equipment, net                   2,198              2,348
 Intangible asset, net                         5,037              6,532
 Restricted cash, non-current                  500                600
        Total assets                      $    143,349       $    135,448
LIABILITIES AND STOCKHOLDERS' EQUITY
 Current liabilities:
   Accounts payable                       $    661           $    287
   Accrued liabilities                         5,180              5,187
   Deferred rent, current                      221                -
   Deferred revenues, current                  26,789             26,789
        Total current liabilities              32,851             32,263
   Deferred rent, non-current                  2,888              3,005
   Deferred revenues, non-current              63,486             90,275
        Total liabilities                      99,225             125,543
 Stockholders' equity:
   Common stock                                33                 28
   Additional paid-in capital                  355,432            300,974
   Accumulated other comprehensive             21                 10
   income
   Accumulated deficit                         (311,362)          (291,107)
        Total stockholders' equity             44,124             9,905
        Total liabilities and             $    143,349       $    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
 
Press spacebar to pause and continue. Press esc to stop.