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): November 3, 2010
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 November 3, 2010, 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 third quarter ended September 30, 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 inability to
utilize a substantial portion of its prior net operating losses and research and development
credits; 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 will be filed with the SEC in the
fourth quarter of 2010. 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 to
update 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.