WASHINGTON, Jan. 9, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical
company focused on the development and commercialization of novel
therapies addressing high unmet medical needs, today announced
preliminary unaudited financial results for the fourth quarter and
full year 2016 and its financial guidance for 2017.
Preliminary Full Year 2016 Results
- Vanda expects to report 2016 total net product sales from
HETLIOZ® and Fanapt® of approximately
$146 million, consistent with Vanda's
prior guidance of between $143 million and
$153 million.
- HETLIOZ® net product sales for 2016 are expected to
be approximately $72 million, as
compared to Vanda's prior guidance of between $73 million and $78 million.
- Fanapt® net product sales for 2016 are expected to
be approximately $74 million, as
compared to Vanda's prior guidance of between $70 million and $75 million.
- Vanda ended 2016 with approximately $141
million in cash, cash equivalents and marketable securities
("Cash"), representing a decrease to Cash of approximately
$2 million in 2016.
Preliminary Fourth Quarter 2016 Results
- Vanda expects to report fourth quarter 2016 total net product
sales from HETLIOZ® and Fanapt® of
approximately $38 million.
- HETLIOZ® fourth quarter net product sales are
expected to be approximately $19
million.
- Fanapt® fourth quarter net product sales are
expected to be approximately $19
million.
2017 Financial Guidance
Vanda expects to achieve the
following financial objectives in 2017:
- Net product sales from both HETLIOZ® and
Fanapt® of between $165 million
and $175 million.
- HETLIOZ® net product sales of between $88 million and $93 million.
- Fanapt® net product sales of between $77 million and $82 million.
- Non-GAAP Operating expenses, excluding cost of goods sold, of
between $162 million and $172
million. The primary drivers of the expected increase over
the prior year are investments in the U.S. Fanapt®
commercial business and funding of the ongoing tradipitant and
HETLIOZ® clinical studies.
- Non-GAAP Operating expenses also excludes intangible asset
amortization expense of $1.7 million
and stock-based compensation of between $9
million and $12 million.
- Cash is expected to decrease by less than $20 million during 2017.
Non-GAAP Financial Information
This press release
contains financial information and performance measures determined
by methods other than in accordance with accounting principles
generally accepted in the United States
of America ("GAAP"). Vanda's management believes these
non-GAAP measures provide a greater understanding of ongoing
operations and enhance comparability of results with prior periods
as well as demonstrate the effects of significant gains and charges
in the current period.
Vanda believes that a meaningful analysis of its financial
performance requires an understanding of the factors underlying
that performance. Vanda's management believes that these non-GAAP
metrics are useful supplements for it and investors to Vanda's GAAP
financial information because these measures exclude significant
elements which management believes are not reflective of Vanda's
operating results. These disclosures should not be viewed as a
substitute for financial measures determined in accordance with
GAAP, nor are they necessarily comparable to non-GAAP performance
measures that may be presented by other companies. In addition, it
is subject to inherent limitations as it reflects the exercise of
judgments by management in determining this non-GAAP financial
measure.
This press release includes a projection of 2017 non-GAAP
Operating expenses, excluding cost of goods sold, a forward-looking
non-GAAP financial measure under the heading "2017 Financial
Guidance". This non-GAAP financial measure is determined by
excluding cost of goods sold, stock-based compensation and
intangible asset amortization. Vanda is unable to reconcile
this non-GAAP guidance to GAAP because it is difficult to predict
the future impact of these adjustments.
This non-GAAP financial measure, as presented, may not be
comparable to similarly titled measures reported by other companies
since not all companies may calculate these measures in an
identical manner and, therefore, they are not necessarily an
accurate measure of comparison between companies.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals
Inc. is a biopharmaceutical company focused on the development and
commercialization of novel therapies addressing high unmet medical
needs. For more on Vanda, please visit
www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING
STATEMENTS
Various statements in this release, including,
but not limited to, statements regarding the preliminary financial
results for the fourth quarter of 2016 and full year 2016, and the
2017 financial guidance provided in the subheading to this release
and under "2017 Financial Guidance" above, are "forward-looking
statements" under the securities laws. 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 Vanda's forward-looking statements include, among
others, the fact that Vanda's preliminary financial results are
unaudited and changes in such results may be required by Vanda's
accountants following their audit of the results, Vanda's
assumptions regarding its ability to continue to grow its business
in the U.S., Vanda's ability to successfully commercialize
HETLIOZ® in Europe and
other factors that are described in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Vanda's 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
September 30, 2016, which are on file
with the SEC and available on the SEC's website at www.sec.gov.
Additional factors may be described in those sections of Vanda's
annual report on Form 10-K for the fiscal year ended December 31, 2016, to be filed with the SEC in
the first quarter of 2017. In addition to the risks described above
and in Vanda's annual report on Form 10-K and quarterly reports on
Form 10-Q, other unknown or unpredictable factors also could affect
Vanda's 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 in this release is provided
only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events or otherwise.
Corporate Contact:
Jim
Kelly
Senior Vice President and Chief Financial
Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.