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): March 9, 2010
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
|
|
|
001-34186
|
|
03-0491827 |
(Commission File No.)
|
|
(IRS Employer Identification No.) |
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrants 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:
o |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
|
o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure
Vanda Pharmaceuticals Inc. (the Company or Vanda) will be making a presentation
regarding the Company at the Cowen and Company 30th Annual Health Care Conference on
March 9, 2010. The slides that will be used for such presentation are furnished as Exhibit 99.1 to
this Form 8-K. In addition, the slides will be posted on the Companys Web site
http://www.vandapharma.com.
Various statements to be made in the presentation, including statements in the slides
furnished as Exhibit 99.1 to this Form 8-K, 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
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 clinical trials; a failure of Vandas products to be demonstrably safe and effective;
Vandas failure to obtain regulatory approval for its products or to comply with ongoing regulatory
requirements for its products; a lack of acceptance of Vandas products in the marketplace, or a
failure to become or remain profitable; Vandas expectations regarding trends with respect to its
costs and expenses; Vandas inability to obtain the capital necessary to fund its research and
development activities; Vandas failure to identify or obtain rights to new products; Vandas
failure to develop or obtain sales, marketing and distribution resources and expertise or to
otherwise manage its growth; 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 under its license and sublicense agreements and other factors that
are described in the Risk Factors section (Part II, Item 1A) of Vandas quarterly report on Form
10-Q for the fiscal quarter ended September 30, 2009 (File No. 001-34186). In addition to the
risks described above and in Part II, Item 1A of Vandas quarterly report 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 in the slides attached as
Exhibit 99.1 to this Form 8-K will be provided only as of the date on which such slides are
presented, and the Company undertakes no obligation to update any forward-looking statements
contained in such slides from and after the date of such presentation whether as a result of new
information, future events or otherwise.
The information in Item 7.01 of this Form 8-K and the slides attached as Exhibit 99.1 to this
Form 8-K shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of
1934 (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.