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): September 8, 2011
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
001-34186
|
|
03-0491827 |
|
|
|
|
|
(State or other Jurisdiction of
|
|
(Commission File No.)
|
|
(IRS Employer Identification No.) |
Incorporation) |
|
|
|
|
|
|
|
9605 Medical Center Drive |
|
|
Suite 300 |
|
|
Rockville, Maryland
|
|
20850 |
|
|
|
(Address of Principal Executive Offices)
|
|
(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
Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda
Pharmaceuticals Inc. (the Company or Vanda) will be making a corporate presentation at the
Stifel Nicolaus Global Healthcare Conference (the Global Healthcare Conference) in Boston, MA on
Thursday, September 8, 2011 at 4:25 p.m. Eastern Time. The slides that will be used for such
presentation are furnished as Exhibit 99.1 to this Current Report on Form 8-K. Vanda issued a
press release on August 31, 2011 announcing the Companys participation at the Global Healthcare
Conference, which is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
Various statements to be made during 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, 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
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, 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
costs and expenses; 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 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, which are on file with the SEC
and available on the SEC website at www.sec.gov. 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 during the
presentation and in the slides attached as Exhibit 99.1 to this Form 8-K will be provided only as
of the date of the Global Healthcare Conference, and the Company undertakes no obligation, and
specifically declines any obligation, to update or revise publicly any forward-looking statements
contained in such slides or presentation from and after the date of the Global Healthcare
Conference whether as a result of new information, future events or otherwise.
The information in Item 7.01 of this Current Report on Form 8-K and the Exhibits 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.