Vanda Pharma Reports Fourth Quarter 2017 and Full Year 2017 Financial Results

Vanda Pharma today announced financial and operational results for the fourth quarter and full year ended December 31, 2017.

Full year 2017 total revenues grew to $165.1 million, a 13% increase compared to 2016

 
[14-February-2018]
 
 

WASHINGTON, Feb. 14, 2018 /PRNewswire/ -- Vanda Pharmaceuticals, Inc. (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2017.

Key Highlights:

  • Total net product sales from HETLIOZ® and Fanapt® were $44.3 million in the fourth quarter of 2017, a 7% increase compared to $41.3 million in the third quarter of 2017 and a 16% increase compared to $38.2 million in the fourth quarter of 2016.

HETLIOZ® (tasimelteon)

  • HETLIOZ® net product sales were $25.0 million in the fourth quarter of 2017, a 12% increase compared to $22.3 million in the third quarter of 2017 and a 30% increase compared to $19.3 million in the fourth quarter of 2016.

Fanapt® (iloperidone)

  • Fanapt® net product sales were $19.3 million in the fourth quarter of 2017, a 1% increase compared to $19.1 million in the third quarter of 2017 and a 2% increase compared to $18.9 million in the fourth quarter of 2016.
  • Fanapt® prescriptions, as reported by IQVIA, were 28,159 in the fourth quarter of 2017, a 1% increase compared to the third quarter of 2017, which represents the first quarter to demonstrate sequential growth since the second quarter of 2014.

Research and Development

Tradipitant

  • A tradipitant for atopic dermatitis Phase III clinical study is expected to begin in the first half of 2018.
  • A tradipitant clinical study for the treatment of gastroparesis is ongoing. Results are expected by the end of 2018.

HETLIOZ®

  • HETLIOZ® studies for the treatment of jet lag disorder (2102 and 3107) have each completed enrollment. Results from the jet lag disorder clinical program are expected in the first quarter of 2018.
  • Enrollment in a pharmacokinetic study of the HETLIOZ® pediatric liquid formulation was completed in the fourth quarter of 2017.
  • Enrollment in the Smith-Magenis Syndrome clinical study is ongoing. Results are expected by the end of 2018.

VTR-297 (histone deactetylase (HDAC) inhibitor)

  • A VTR-297 Phase I study (1101) in patients with hematologic malignancies is expected to start in the second half of 2018.

Cash, cash equivalents and marketable securities (Cash) were $143.4 million as of December 31, 2017, representing an increase to Cash of $2.1 million during 2017.

Non-GAAP Financial Results

Non-GAAP net income was $1.4 million for the fourth quarter of 2017, or $0.03 per share, compared to a Non-GAAP net income of $3.6 million, or $0.08 per share, for the fourth quarter of 2016. Vanda Non-GAAP net loss was $3.4 million for the full year 2017, compared to a Non-GAAP net income of $1.5 million for the full year 2016.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information" for more detailed information regarding Non-GAAP financial information.

2018 Financial Guidance

Vanda expects to achieve the following financial objectives in 2018:

    Full Year 2018                               Full Year 2018
                                                    Guidance
    Financial Objectives
    --------------------

    Combined net product sales from
     both HETLIOZ(R) and Fanapt(R)               $180 to $200 million
    -------------------------------              --------------------

    HETLIOZ(R) net product sales                 $108 to $118 million
    ----------------------------                 --------------------

    Fanapt(R) net product sales                    $72 to $82 million
    ---------------------------                    ------------------

    Non-GAAP Operating expenses,
     excluding Cost of goods sold(1)             $163 to $173 million
    --------------------------------             --------------------

    Intangible asset amortization                        $1.7 million
    -----------------------------                        ------------

    Stock-based compensation                       $11 to $15 million
    ------------------------                       ------------------

    Year-end 2018 Cash(2)                        $115 to $125 million
    --------------------                         --------------------

 

    (1) Non-GAAP Operating expenses,
     excludes Cost of goods sold,
     intangible asset amortization and
     stock-based compensation.

    (2) Year-end 2018 Cash includes the
     expected payment of a $25 million
     milestone obligation based on
     cumulative HETLIOZ(R) net product
     sales.

Conference Call

Vanda has scheduled a conference call for today, Wednesday, February 14, 2018, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2017 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 46291578. A replay of the call will be available on Wednesday, February 14, 2018, beginning at 7:00 PM ET and will be accessible until Wednesday, February 21, 2018, 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 passcode number is 46291578.

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.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda's business and reflect how it manages the business internally and sets operational goals. Vanda's "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda's "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda's use of financial resources and its long-term performance.

This press release includes a projection of 2018 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading "2018 Financial Guidance." This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda's financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.

About Vanda Pharmaceuticals Inc.

Vanda is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release, including, but not limited to, the guidance provided under "2018 Financial Guidance" above, are "forward-looking statements" under the securities laws. 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 Vanda's forward-looking statements include, among others, Vanda's assumptions regarding its ability to continue to grow its business in the U.S. through the HETLIOZ® to Psychiatrists Initiative, among other means, Vanda's ability to complete the clinical development and obtain regulatory approval of tradipitant for the treatment of atopic dermatitis, Vanda's ability to successfully commercialize HETLIOZ® in Europe 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, 2016 and quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2017, which are on file with the SEC and available on the SEC's website at www.sec.gov. Additional factors may be described in those sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018. 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

                                                                                                   (in thousands, except for share and per share amounts)

                                                                          (unaudited)


                                                                                             Three Months Ended                                          Year Ended
                                                                                             ------------------                                          ----------

                                                                                                 December 31                                       December 31              December 31            December 31

                                                                                                           2017                                            2016                               2017           2016
                                                                                                           ----                                            ----                               ----           ----

    Revenues:

                                HETLIOZ(R) product sales, net                                           $25,010                                                     $19,295                              $89,978                    $71,671

                                Fanapt(R) product sales, net                                             19,266                                                      18,949                               75,105                     74,346

                                Total revenues                                                                                            44,276                                           38,244                          165,083                   146,017


    Operating expenses:

                                Cost of goods sold excluding amortization              4,791                                                5,272                                           17,848                           24,712

                                Research and development                                                 10,154                                                       7,614                               38,547                     29,156

                                Selling, general and administrative                   31,049                                               23,907                                          123,841                           99,787

                                Intangible asset amortization                                               432                                                       2,105                                1,750                     10,933

                                Total operating expenses                                                 46,426                                                      38,898                              181,986                    164,588
                                                                                                         ------                                                      ------                              -------                    -------


    Loss from operations                                                                                                              (2,150)                                           (654)                        (16,903)                 (18,571)

                                Other income                                                                                                 399                                              154                            1,472                       665


    Loss before income taxes                                                                                                          (1,751)                                           (500)                        (15,431)                 (17,906)

                                Provision for income taxes                                                   87                                                         104                                  136                        104

    Net loss                                                                                                                         $(1,838)                                          $(604)                       $(15,567)                $(18,010)
                                                                                                                                      =======                                            =====                         ========                  ========


    Net loss per share, basic and diluted                                                                                           $(0.04)                                         $(0.01)                         $(0.35)                  $(0.41)


    Weighted average shares outstanding, basic and diluted                                                                      44,930,832                                       43,968,730                       44,735,146                43,449,441

 

 

                                                                  VANDA PHARMACEUTICALS INC.

                                                             CONDENSED CONSOLIDATED BALANCE SHEETS

                                                                        (in thousands)

                                                                          (unaudited)


                                                                                                   December 31     December 31
                                                                                                              2017                2016
                                                                                                              ----                ----

     ASSETS

     Current assets:

     Cash and cash equivalents                                                          $33,627                                $40,426

     Marketable securities                                                              109,786                                100,914

     Accounts receivable, net                                                            17,601                                 20,268

     Inventory                                                                              840                                    779

     Prepaid expenses and other current assets                                            8,003                                 11,788
                                                                                          -----                                 ------

                                               Total current assets                                        169,857                        174,175


     Property and equipment, net                                                                           5,306                          5,015

     Intangible assets, net                                                                               26,069                         27,819

     Non-current inventory and other                                                                       4,193                          3,365

                                               Total assets                                               $205,425                       $210,374
                                                                                                          ========                       ========



     LIABILITIES AND STOCKHOLDERS' EQUITY

     Current liabilities:

     Accounts payable and accrued liabilities                                           $20,335                                $16,196

     Accrued government and other rebates                                                23,028                                 34,124

      Milestone obligations under license
      agreements                                                                         27,000                                      -

                                               Total current liabilities                                    70,363                         50,320


      Milestone obligations under license
      agreements                                                                              -                                25,000

     Other non-current liabilities                                                        3,675                                  3,724

                                               Total liabilities                                            74,038                         79,044


     Stockholders' equity:

     Common stock                                                                            45                                     44

     Additional paid-in capital                                                         492,802                                477,087

      Accumulated other comprehensive income
      (loss)                                                                               (34)                                    58

     Accumulated deficit                                                                                 (361,426)                     (345,859)

                                               Total stockholders' equity                                  131,387                        131,330
                                                                                                           -------                        -------

                                                Total liabilities and
                                                stockholders' equity                                      $205,425                       $210,374
                                                                                                          ========                       ========

 

 

                                                                                           VANDA PHARMACEUTICALS INC.

                                                                            Reconciliation of GAAP to Non-GAAP Financial Information

                                                                             (in thousands, except for share and per share amounts)

                                                                                                   (unaudited)


                                                       Three Months Ended                           Year Ended
                                                       ------------------                           ----------

                                                           December 31                       December 31                          December 31                     December 31

                                                                     2017                            2016                                          2017                     2016
                                                                     ----                            ----                                          ----                     ----

    Net loss                                                                 $(1,838)                                                      $(604)                                $(15,567)               $(18,010)

    Adjustments:

                           Stock-based
                           compensation          2,782                                            2,103                                                    10,465                                  8,543

                           Intangible asset
                           amortization            432                                            2,105                                                     1,750                                 10,933

    Non-GAAP Net income (loss)                                                 $1,376                                                       $3,604                                  $(3,352)                  $1,466
                                                                               ======                                                       ======                                   =======                   ======


    Non-GAAP Net income (loss) per share,
     basic                                                                      $0.03                                                        $0.08                                   $(0.07)                   $0.03


    Weighted average shares outstanding, basic                            44,930,832                                                   43,968,730                                44,735,146               43,449,441


    Operating expenses                                                        $46,426                                                      $38,898                                  $181,986                 $164,588

    Adjustments:

                           Cost of goods sold
                           excluding
                           amortization        (4,791)                                         (5,272)                                                 (17,848)                              (24,712)

                           Stock-based
                           compensation        (2,782)                                         (2,103)                                                 (10,465)                               (8,543)

                           Intangible asset
                           amortization          (432)                                         (2,105)                                                  (1,750)                              (10,933)


    Non-GAAP Operating expenses excluding

                          Cost of goods sold   $38,421                                          $29,418                                                  $151,923                               $120,400



    Research and development                                                  $10,154                                                       $7,614                                   $38,547                  $29,156

    Adjustment:

                           Stock-based
                           compensation          (194)                                           (535)                                                  (1,152)                               (2,087)

    Non-GAAP Research and development                                          $9,960                                                       $7,079                                   $37,395                  $27,069
                                                                               ======                                                       ======                                   =======                  =======


    Selling, general and administrative                                       $31,049                                                      $23,907                                  $123,841                  $99,787

    Adjustment:

                           Stock-based
                           compensation        (2,588)                                         (1,568)                                                  (9,313)                               (6,456)

    Non-GAAP Selling, general and
     administrative                                                           $28,461                                                      $22,339                                  $114,528                  $93,331
                                                                              =======                                                      =======                                  ========                  =======

 

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

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SOURCE Vanda Pharmaceuticals Inc.

 
 
Company Codes: NASDAQ-NMS:VNDA
 
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