WASHINGTON, Jan. 7, 2018 /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 2017 and its financial guidance for 2018.
Preliminary Full Year 2017 Results
- Vanda expects to report 2017 total net product sales from
HETLIOZ® and Fanapt® of approximately
$165 million, consistent with Vanda's
prior guidance of between $163
million and $169 million.
- HETLIOZ® net product sales for 2017 are expected to
be approximately $90 million,
consistent with Vanda's prior guidance of between $89 million and $92
million.
- Fanapt® net product sales for 2017 are expected to
be approximately $75 million,
consistent with Vanda's prior guidance of between $74 million and $77
million.
- Vanda ended 2017 with approximately $143
million in cash, cash equivalents and marketable securities
(Cash), representing an increase to Cash of approximately
$2 million in 2017.
Preliminary Fourth Quarter 2017 Results
- Vanda expects to report fourth quarter 2017 total net product
sales from HETLIOZ® and Fanapt® of
approximately $44 million.
- HETLIOZ® fourth quarter 2017 net product sales are
expected to be approximately $25
million.
- Fanapt® fourth quarter 2017 net product sales are
expected to be approximately $19
million.
2017 Financial Guidance
In addition to the preliminary
2017 results announced today, Vanda expects to achieve the
following financial objectives in 2017:
- Non-GAAP Operating expenses, excluding cost of goods sold, of
between $150 million and $157 million.
- 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.
2018 Financial Guidance
Vanda expects to achieve the
following financial objectives in 2018:
- Net product sales from both HETLIOZ® and
Fanapt® of between $180
million and $200 million.
- HETLIOZ® net product sales of between $108 million and $118
million.
- Fanapt® net product sales of between $72 million and $82
million.
- Non-GAAP Operating expenses, excluding cost of goods sold, of
between $163 million and $173 million. The primary drivers of the expected
increase over the prior year are clinical investments including
studies of tradipitant in atopic dermatitis and gastroparesis.
- Non-GAAP Operating expenses also excludes intangible asset
amortization expense of $1.7 million
and stock-based compensation of between $11
million and $15 million.
- Year-end 2018 Cash is expected to be between $115 and $125
million. This includes the expected payment of a
$25 million milestone obligation
based on cumulative HETLIOZ® net product sales.
Select 2018 Research and Development
Objectives
Tradipitant
- A Phase III clinical study of tradipitant for atopic dermatitis
is expected to begin in the first half of 2018.
- A tradipitant Phase II clinical study for the treatment of
gastroparesis is ongoing. Results are expected by the end of
2018.
HETLIOZ®
- Jet Lag clinical program results are expected in the first
quarter of 2018.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing. Results are expected by the end of 2018.
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's "Non-GAAP
Operating expenses, excluding cost of goods sold" exclude
stock-based compensation and intangible asset amortization.
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 2017 Non-GAAP
Operating expenses, excluding cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2017 Financial
Guidance" and a projection of 2018 Non-GAAP Operating expenses,
excluding cost of goods sold, a forward-looking Non-GAAP financial
measure under the heading "2018 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 this measure in an identical
manner and, therefore, it is 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 it excludes significant
elements that are required by GAAP to be recorded in Vanda's
financial statements. In addition, it is subject to inherent
limitations as they reflect the exercise of judgments by management
in determining this Non-GAAP financial measure. Vanda is unable to
reconcile this non-GAAP guidance to GAAP because it is difficult to
predict the future impact of these adjustments.
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 2017 and full year 2017, and the
2018 financial guidance provided in the subheading to this release
and under "2018 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, the
timing of filings with the FDA for new indications or new potential
therapies 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, 2016 and quarterly report on Form
10-Q for the quarter ended September 30,
2017, which are on file with the Securities and Exchange
Commission (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, 2017, to be filed with the SEC in
the first quarter of 2018. 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
Executive Vice President and Chief Financial
Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.