Item 2.02.
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Results of Operations and Financial Condition.
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On July 27, 2016, Vanda
Pharmaceuticals Inc. (Vanda) issued a press release and is holding a conference call regarding its results of operations and financial condition for the quarter ended June 30, 2016. The full text of the press release which includes
information regarding Vandas use of Non-GAAP financial measures, is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Various statements to be made during the conference call are forward-looking statements under the securities laws, including, but
not limited to, Vandas financial guidance for 2016. Words such as, but not limited to, believe, expect, anticipate, estimate, intend, plan, project,
target, goal, 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 Vandas forward-looking statements include, among others: Vandas ability to successfully commercialize
HETLIOZ
®
for the treatment of Non-24 in the U.S. and Europe; uncertainty as to the market awareness of Non-24 and the market acceptance of
HETLIOZ
®
; Vandas ability to generate U.S. sales of Fanapt
®
for the treatment of schizophrenia; the timing and costs of
Vandas establishment of a sales and marketing, supply chain, distribution, pharmacovigilance, compliance and safety infrastructure to promote Fanapt
®
in the U.S.; Vandas dependence
on third-party manufacturers to manufacture HETLIOZ
®
and Fanapt
®
in sufficient quantities and quality; Vandas limited sales and
marketing infrastructure; the regulatory status of Fanapt
®
in Europe; Vandas ability to successfully commercialize HETLIOZ
®
and
Fanapt
®
outside the U.S.; Vandas ability to prepare, file, prosecute, defend and enforce any patent claims and other intellectual property rights; Vandas ability to obtain the
capital necessary to fund its research and development or commercial activities; a loss of rights to develop and commercialize Vandas products under its license agreements; the ability to obtain and maintain regulatory approval of Vandas
products, and the labeling for any approved products; the timing and success of preclinical studies and clinical trials conducted by Vanda or its development partners; a failure of Vandas products to be demonstrably safe and effective; the
size and growth of the potential markets for Vandas products and the ability to serve those markets; Vandas expectations regarding trends with respect to its revenues, costs, expenses and liabilities; the timing and costs of complying
with the remaining post-marketing commitments and post-marketing requirements established in connection with the FDAs approval of Fanapt
®
; the scope, progress, expansion, and costs of
developing and commercializing Vandas products; Vandas failure to identify or obtain rights to new products; a loss of any of Vandas key scientists or management personnel; limitations on Vandas ability to utilize some or all
of its prior net operating losses and orphan drug and research and development credits; the costs and effects of litigation; losses incurred from product liability claims made against Vanda; use of existing cash, cash equivalents and marketable
securities 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, 2015 and quarterly report on Form 10-Q for the quarter ended March 31, 2016, which are on file with the SEC and available on the SECs website at www.sec.gov. Additional factors may be described in those
sections of Vandas quarterly report on Form 10-Q for the quarter ended June 30, 2016, to be filed with the SEC in the third quarter of 2016. In addition to the risks described above and in Vandas annual report on Form 10-K and
quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, 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 on the
conference call will be provided only as of the date of the call, and Vanda 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.