Item 2.02. Results of Operations and Financial Condition.
On November 2, 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 September 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 June 30, 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 September 30, 2016, to be filed with the SEC in the fourth 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.