UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 10, 2011
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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001-34186
(Commission File No.)
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03-0491827
(IRS Employer Identification No.) |
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (240) 599-4500
Not Applicable
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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| Item 2.02. |
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Results of Operations and Financial Condition. |
On February 10, 2011, 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, 2010. 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,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” and “could,” 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: the extent and effectiveness of the
development, sales and marketing and distribution support Fanapt® receives; Vanda’s ability to
successfully commercialize Fanapt® outside of the U.S. and Canada; delays in the completion of
Vanda’s clinical trials; a failure of Vanda’s products to be demonstrably safe and effective;
Vanda’s failure to obtain regulatory approval for its products or to comply with ongoing regulatory
requirements for its products; a lack of acceptance of Vanda’s products in the marketplace, or a
failure to become or remain profitable; Vanda’s expectations regarding trends with respect to its
costs and expenses; Vanda’s inability to obtain the capital necessary to fund additional research
and development activities; Vanda’s failure to identify or obtain rights to new products; Vanda’s
failure to develop or obtain sales, marketing and distribution resources and expertise or to
otherwise manage its growth; a loss of any of Vanda’s key scientists or management personnel;
losses incurred from product liability claims made against Vanda; a loss of rights to develop and
commercialize Vanda’s products under its license and sublicense agreements 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, 2009 and Quarterly Report on Form 10-Q for the fiscal quarter ended
September 30, 2010, which are 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 Vanda’s Annual Report on Form
10-K for the fiscal year ended December 31, 2010, which will be filed with the SEC in the first
quarter of 2011. 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 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 filing.