Item 2.02.
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Results of Operations and Financial Condition.
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On May 1, 2019, 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 March 31, 2019. 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 2019. 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 complete the clinical development and obtain regulatory approval of tradipitant for the treatment of gastroparesis and/or the treatment of chronic pruritus in atopic dermatitis, the outcome of the lawsuit initiated by Vanda against the FDA
relating to tradipitant, the ability of HETLIOZ
®
to provide significant benefit in the treatment of the symptoms of jet lag disorder, Vandas ability to obtain marketing approval for the
use of HETLIOZ
®
in the treatment of jet lag disorder, Vandas ability to complete the clinical development, submit an supplemental new drug application and obtain regulatory approval of
tasimelteon for the treatment of sleep disorders in patients with Smith-Magenis Syndrome 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, 2018, which is on file with the SEC and available on the SECs website at www.sec.gov.
Additional factors may be set forth in those sections of Vandas quarterly report on Form
10-K
for the quarter ended March 31, 2019, to be filed with the SEC in the second quarter of 2019. 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.