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