SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act
Date of Report (Date of earliest event reported): February 14, 2012
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction of incorporation)
|(Commission File No.)
||(IRS Employer Identification No.)|
9605 Medical Center Drive
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (240) 599-4500
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
||Results of Operations and Financial Condition. |
On February 14, 2012, Vanda Pharmaceuticals Inc. (the Company or Vanda) issued a press release and is holding a conference call regarding its results of operations and
financial condition for the fourth quarter and year ended December 31, 2011. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Various statements to be made during the conference call are forward-looking statements under the securities laws. Words such
as, but not limited to, believe, expect, anticipate, estimate, project, intend, plan, target, 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
Important factors that could cause actual results to differ materially from those reflected in the
Companys forward-looking statements include, among others: the extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives; Vandas ability to successfully commercialize Fanapt®
outside of the U.S. and Canada; delays in the completion of Vandas and its partners clinical trials; a failure of Vandas products, product candidates or partnered products to be demonstrably safe and effective; Vandas failure
to obtain regulatory approval for its products or product candidates or to comply with ongoing regulatory requirements; a lack of acceptance of Vandas products, product candidates or partnered products in the marketplace, or a failure to
become or remain profitable; Vandas expectations regarding trends with respect to its revenues, costs, expenses and liabilities; Vandas inability to obtain the capital necessary to fund additional research and development activities;
Vandas failure to identify or obtain rights to new products or product candidates; Vandas failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; limitations on
Vandas ability to utilize some or all of its prior net operating losses and research and development credits; a loss of any of Vandas key scientists or management personnel; losses incurred from product liability claims made against
Vanda; a loss of rights to develop and commercialize Vandas products or product candidates under its license and sublicense agreements and other factors that are described in the Risk Factors and Managements Discussion
and Analysis of Financial Condition and Results of Operations sections of Vandas Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which is on file with the SEC and available on the SEC website at www.sec.gov.
Additional information will also be set forth in those sections of Vandas Annual Report on Form 10-K for the fiscal year ended December 31, 2011, which will be filed with the SEC in the first quarter of 2012. In addition to the risks
described above and in Vandas Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, other unknown or unpredictable factors also could affect Vandas 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 conveyed on the conference call will be provided only as of the date of the call, and the Company undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements made during
the call after the date thereof, whether as a result of new information, future events, or otherwise.
The information in
Item 2.02 of this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a
||Financial Statements and Exhibits. |
||Press release of Vanda Pharmaceuticals Inc. dated February 14, 2012.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
VANDA PHARMACEUTICALS INC.
/s/ James Kelly
||Name: James Kelly|
||Title: Chief Financial Officer|
Dated: February 14, 2012