Item 2.02.
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Results of Operations and Financial Condition.
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On August 2, 2017, 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, 2017. 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 2017. 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 assumptions regarding its ability to continue to grow its business in the U.S., Vandas ability to successfully commercialize HETLIOZ
®
in Europe and
review by the European Medicines Agencys Committee for Medicinal Products for Human Use of the negative opinion of oral Fanaptum
®
,
Vandas ability to prepare, file, prosecute, defend and enforce any patent claims and other intellectual property rights, 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, 2016 and quarterly report on Form
10-Q
for the quarter ended March 31, 2017,
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, 2017, to be filed with the SEC in the third quarter of 2017. 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.