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): May 6, 2008
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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000-51863
(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)
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:
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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)) |
Item 7.01. Regulation FD disclosure
Vanda
Pharmaceuticals Inc. (the Company) made presentations regarding the Companys two
late-stage product candidates,
FanaptaTM and tasimelteon,
as well as certain of the
Companys ongoing and planned commercialization and development activities and strategies, to
medical professionals, analysts, investors and others at the Annual Meeting of the American
Psychiatric Association (the APA Meeting) on May 6,
2008. The slides that were used for such
presentations are furnished as Exhibit 99.1 to this Form 8-K. In addition, the slides, as well as
the posters referenced in certain of the slides, will be posted on the Companys Web site
http://www.vandapharma.com.
On May 6, 2008,
the Company issued a press release regarding its participation at the APA
Meeting and disclosing certain of the data to be presented by the Company at the APA Meeting. The
full text of this press release is furnished as Exhibit 99.2 to this Form 8-K.
Various statements made in the presentations, including statements in the slides
furnished as Exhibit 99.1 to this Form 8-K, and statements made in the press release furnished as
Exhibit 99.2 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. The Company is at an early
stage of development and may not ever have any products that generate significant revenue.
Important factors that could cause actual results to differ materially from those reflected in the
Companys forward-looking statements include, among others: delays in the completion of the
Companys clinical trials; a failure of the Companys product candidates to be demonstrably safe
and effective; the Companys failure to obtain regulatory approval for its products or to comply
with ongoing regulatory requirements; a lack of acceptance of the Companys product candidates in
the marketplace, or a failure to become or remain profitable; the Companys inability to obtain the
capital necessary to fund its research and development activities; the Companys failure to
identify or obtain rights to new product candidates; the Companys failure to develop or obtain
sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss
of any of the Companys key scientists or management personnel; losses incurred from product
liability claims made against the Company; and a loss of rights to develop and commercialize the
Companys products under its license and sublicense agreements.
The Company encourages investors to read the discussion and analysis of its financial
condition and its consolidated financial statements contained in the Companys annual report on
Form 10-K for the fiscal year ended December 31, 2007 (the 10-K). The Company also encourages
investors to read Item 1A of the 10-K, entitled Risk Factors, which contains a more complete
discussion of the risks and uncertainties associated with the Companys business. In addition to
the risks described above and in Item 1A of the 10-K, other unknown or unpredictable factors also
could affect the Companys results. There can be no assurance that the actual results or
developments anticipated by the Company will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, the Company. Therefore, no assurance
can be given that the outcomes stated in such forward-looking statements and estimates will be
achieved.
The information in the slides attached as Exhibit 99.1 to this Form 8-K, the information in
the posters referenced in such slides and the information in the press release attached as Exhibit
99.2 to this Form 8-K will be provided only as of the applicable dates on which such slides and
posters are presented and such press release is issued, and the Company undertakes no obligation to
update any forward-looking statements contained in such slides, posters or press release from and
after the dates of such presentations or issuance whether as a result of new information, future
events or otherwise.
The information in Item 7.01 of this Form 8-K, the slides attached as Exhibit 99.1 to this
Form 8-K and the press release attached as Exhibit 99.2 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.