WASHINGTON, Jan. 11, 2016 /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 2015 and its financial guidance for 2016.
Preliminary Fourth Quarter 2015 Results
- Vanda expects to report fourth quarter 2015 total net product
sales from HETLIOZ® and Fanapt® of
approximately $31.8 million.
- HETLIOZ® net product sales are expected to be
approximately $15.1 million.
- Fanapt® net product sales are expected to be
approximately $16.7 million.
Preliminary Full Year 2015 Results
- Vanda expects to report 2015 total net product sales from
HETLIOZ® and Fanapt® of approximately
$109.9 million, consistent with
Vanda's prior guidance of between $100 and
$115 million.
- HETLIOZ® net product sales for 2015 are expected to
be approximately $44.3 million,
consistent with Vanda's prior guidance of between $40 and $45 million.
- Fanapt® net product sales for 2015 are expected to
be approximately $65.6 million,
consistent with Vanda's prior guidance of between $60 and $70 million.
- Vanda ended 2015 with approximately $143
million in cash, cash equivalents and marketable securities
("Cash"), representing an increase to Cash of approximately
$13 million in 2015.
2016 Financial Guidance
Vanda expects to achieve the following financial objectives in
2016:
- Net product sales from both HETLIOZ® and
Fanapt® of between $143 and $153
million.
- HETLIOZ® net product sales of between $73 and $78 million.
- Fanapt® net product sales of between $70 and $75 million.
- Non-GAAP Operating expenses, excluding cost of goods sold, of
between $125 and $135 million. The
primary drivers of the expected increase over the prior year are
investments in the U.S. Fanapt® and European
HETLIOZ® commercial businesses.
- Non-GAAP Operating expenses also excludes intangible asset
amortization expense of $10.9 million
and stock-based compensation of between $9
and $11 million.
- Cash is expected to decrease by less than $20 million during 2016.
Non-GAAP Financial Information
Vanda believes that the Non-GAAP financial information provided
in this press release can assist investors in understanding and
assessing the ongoing economics of Vanda's business and reflect how
it manages the business internally and sets operational goals.
Vanda believes that excluding the impact of these items better
reflects the recurring economic characteristics of its business, as
well as Vanda's use of financial resources and its long-term
performance.
This press release includes a projection of 2016 Non-GAAP
Operating expenses, excluding cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2016 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.
The presentation of this Non-GAAP financial measure is not
intended to be considered in isolation or as a substitute for
guidance prepared in accordance with GAAP. The principal limitation
of this Non-GAAP financial measure is that they exclude significant
elements that are required by GAAP to be recorded in Vanda's
financial statements. In addition, it is subject to inherent
limitations as it reflects the exercise of judgments by management
in determining this Non-GAAP financial measure.
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 2015 and full year 2015, and the 2016 financial
guidance provided in the subheading to this release and under "2016
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, 2014 and quarterly report on Form
10-Q for the quarter ended September 30,
2015, 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, 2015,
to be filed with the SEC in the first quarter of 2016. 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
Media Contact:
Laney Landsman
Assistant
Vice President
Makovsky
(212) 508-9642
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.