WASHINGTON, July 27, 2016 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced
financial and operational results for the second quarter ended
June 30, 2016.
"Vanda's commercial business continues to demonstrate strong
progress and growth," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "We look
forward to our planned launch of HETLIOZ in Germany in the third quarter and the
opportunity to bring an important therapy to Non-24 patients in
Europe."
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $36.0 million
during the second quarter of 2016, an 8% increase compared to
$33.3 million in the first quarter of
2016 and a 31% increase compared to $27.6
million in the second quarter of 2015.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $17.5 million in the second quarter of 2016, an
8% increase compared to $16.2 million
in the first quarter of 2016 and a 74% increase compared to
$10.0 million in the second quarter
of 2015.
- A HETLIOZ® product launch in Germany is planned for the third quarter of
2016.
- Enrollment in the Smith-Magenis Syndrome (SMS) open label
interventional study is ongoing. An SMS placebo controlled Phase
III study is expected to begin in the second half of 2016.
- The Pediatric Non-24 pharmacokinetic study of the
HETLIOZ® liquid formulation is enrolling. A Phase III
study is expected to begin in 2017.
- The screening of patients for a Jet Lag Disorder (JLD) Phase II
proof of concept study began during the second quarter of 2016.
Results from the JLD study are expected in the first half
2017.
Fanapt® (iloperidone)
- Fanapt® net product sales were $18.6 million for the second quarter of 2016, a
9% increase compared to $17.1 million
in the first quarter of 2016 and a 6% increase compared to
$17.6 million in the second quarter
of 2015.
- In May 2016, the U.S. Food and
Drug Administration (FDA) approved Vanda's supplemental New Drug
Application (sNDA) for Fanapt®, modifying and expanding
the prescribing information for the use of Fanapt® as a
maintenance treatment for schizophrenia in adults. The FDA granted
three years of marketing exclusivity for the changes related to the
approval of the sNDA.
- A review of the Marketing Authorization Application for oral
Fanaptum® tablets by the European Medicines Agency (EMA)
for the treatment of schizophrenia in adults is ongoing. An opinion
by the EMA's Committee for Medicinal Products for Human Use (CHMP)
is expected in the first quarter of 2017.
Tradipitant
- Enrollment in a tradipitant Phase II proof of concept study for
the treatment of chronic pruritus in patients with atopic
dermatitis is ongoing. Results are expected in the first half of
2017.
- A tradipitant Phase II proof of concept study for the treatment
of gastroparesis is expected to begin enrolling patients in the
fourth quarter of 2016. Results are expected in the second half of
2017.
Cash, cash equivalents and marketable securities (Cash) were
$136.0 million as of June 30, 2016, representing a decrease to Cash of
$2.3 million in the second quarter of
2016.
Non-GAAP Financial Results
For the second quarter of 2016, Non-GAAP net income was
$0.4 million, compared to a Non-GAAP
net loss of $0.4 million, for the
second quarter of 2015.
Vanda provides Non-GAAP financial information, which it believes
can enhance an overall understanding of its financial performance
when considered together with GAAP figures. Refer to the sections
of this press release entitled "Non-GAAP Financial Information" and
"Reconciliation of GAAP to Non-GAAP Financial Information."
2016 Financial Guidance
Vanda reiterates its prior 2016 financial guidance with an
update to stock-based compensation guidance and expects to achieve
the following financial objectives in 2016:
- Combined net product sales from both HETLIOZ® and
Fanapt® of between $143 and $153
million.
- HETLIOZ® net product sales of between $73 and $78 million and 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.
- Non-GAAP Operating expenses excludes intangible asset
amortization expense of $10.9 million
and stock-based compensation of between $8
and $10 million. Prior guidance for stock-based compensation
was between $9 and $11 million.
- Year end 2016 Cash is expected to be between $123 and $143 million.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, July 27, 2016, at 4:30 PM ET. During the call, Vanda's
management will discuss the second quarter 2016 financial results
and other corporate activities. Investors can call
1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use
passcode 42972056. A replay of the call will be available on
Wednesday, July 27, 2016, beginning
at 7:00 PM ET and will be accessible
until Wednesday, August 3, 2016, at
11:59 PM ET. The replay call-in
number is 1-888-843-7419 for domestic callers and 1-630-652-3042
for international callers. The passcode number is
42972056.
The conference call will be broadcast simultaneously on Vanda's
website, www.vandapharma.com. Investors should click on the
Investor Relations tab and are advised to go to the website at
least 15 minutes early to register, download, and install any
necessary software or presentations. The call will also be
archived on Vanda's website for a period of 30 days.
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 Selling, general and administrative expenses" and
"Non-GAAP Research and development expenses" exclude stock-based
compensation. Vanda's "Non-GAAP Net income (loss)," "Non-GAAP Net
income (loss) per share" and "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 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.
These Non-GAAP financial measures, 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 these Non-GAAP financial measures is not
intended to be considered in isolation or as a substitute for
guidance prepared in accordance with GAAP. The principal limitation
of these Non-GAAP financial measures is that they exclude
significant elements that are required by GAAP to be recorded in
Vanda's financial statements. In addition, they are subject to
inherent limitations as they reflect the exercise of judgments by
management in determining these Non-GAAP financial measures.
In order to compensate for these limitations, Vanda presents
its Non-GAAP financial guidance in connection with its GAAP
guidance. Investors are encouraged to review the reconciliation of
our Non-GAAP financial measures to their most directly comparable
GAAP financial measure.
About Vanda Pharmaceuticals Inc.
Vanda is a specialty pharmaceutical company focused on the
development and commercialization of novel therapies to address
high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited
to, the 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, 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, which is 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 quarterly report on Form 10-Q for the quarter
ended June 30, 2016, to be filed with the SEC in the
third 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.
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
($ in thousands,
except per share amounts)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ® product sales,
net
|
|
$
|
17,460
|
|
$
|
10,017
|
|
$
|
33,661
|
|
$
|
17,477
|
Fanapt® product sales,
net
|
|
|
18,569
|
|
|
17,565
|
|
|
35,630
|
|
|
32,255
|
Total
revenues
|
|
|
36,029
|
|
|
27,582
|
|
|
69,291
|
|
|
49,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
6,494
|
|
|
5,766
|
|
|
12,450
|
|
|
10,781
|
Research and development
|
|
|
6,700
|
|
|
5,946
|
|
|
14,248
|
|
|
10,424
|
Selling, general and
administrative
|
|
|
24,682
|
|
|
18,386
|
|
|
53,972
|
|
|
37,192
|
Intangible asset
amortization
|
|
|
2,942
|
|
|
2,942
|
|
|
5,885
|
|
|
7,086
|
Total
operating expenses
|
|
|
40,818
|
|
|
33,040
|
|
|
86,555
|
|
|
65,483
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(4,789)
|
|
|
(5,458)
|
|
|
(17,264)
|
|
|
(15,751)
|
Other income
|
|
|
171
|
|
|
72
|
|
|
288
|
|
|
144
|
Net loss
|
|
$
|
(4,618)
|
|
$
|
(5,386)
|
|
$
|
(16,976)
|
|
$
|
(15,607)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.11)
|
|
$
|
(0.13)
|
|
$
|
(0.39)
|
|
$
|
(0.37)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding,
|
|
|
43,202,751
|
|
|
41,991,578
|
|
|
43,153,598
|
|
|
41,868,944
|
basic and
diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in
thousands)
|
|
|
|
|
June 30
2016
|
|
December 31
2015
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
23,194
|
|
$
|
50,843
|
|
|
|
Marketable
securities
|
|
|
|
|
112,795
|
|
|
92,337
|
|
|
|
Accounts receivable,
net
|
|
|
|
14,030
|
|
|
16,331
|
|
|
|
Inventory
|
|
|
|
|
|
927
|
|
|
1,294
|
|
|
|
Prepaid expenses and
other current assets
|
|
|
9,430
|
|
|
5,742
|
|
|
|
|
Total current
assets
|
|
|
|
|
160,376
|
|
|
166,547
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
4,246
|
|
|
4,570
|
|
|
Intangible assets,
net
|
|
|
|
|
32,867
|
|
|
38,752
|
|
|
Non-current inventory
and other
|
|
|
|
4,549
|
|
|
3,181
|
|
|
|
|
Total
assets
|
|
|
|
$
|
202,038
|
|
$
|
213,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
17,933
|
|
$
|
15,767
|
|
|
|
Accrued government
and other rebates
|
|
|
33,828
|
|
|
35,550
|
|
|
|
|
Total current
liabilities
|
|
|
|
51,761
|
|
|
51,317
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
25,000
|
|
|
25,000
|
|
|
|
Other non-current
liabilities
|
|
|
|
3,663
|
|
|
3,706
|
|
|
|
|
Total
liabilities
|
|
|
|
|
80,424
|
|
|
80,023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
43
|
|
|
43
|
|
|
|
Additional paid-in
capital
|
|
|
|
|
466,272
|
|
|
460,794
|
|
|
|
Accumulated other
comprehensive income
|
|
|
124
|
|
|
39
|
|
|
|
Accumulated
deficit
|
|
|
|
|
(344,825)
|
|
|
(327,849)
|
|
|
|
|
Total stockholders'
equity
|
|
|
|
121,614
|
|
|
133,027
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
202,038
|
|
$
|
213,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
|
June
30,
|
(in thousands,
except for share and per share amounts)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,618)
|
|
$
|
(5,386)
|
|
$
|
(16,976)
|
|
$
|
(15,607)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
2,074
|
|
|
2,068
|
|
|
4,340
|
|
|
4,013
|
Intangible asset
amortization
|
|
|
2,942
|
|
|
2,942
|
|
|
5,885
|
|
|
7,086
|
Non-GAAP Net income
(loss)
|
|
$
|
398
|
|
$
|
(376)
|
|
$
|
(6,751)
|
|
$
|
(4,508)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.01
|
|
$
|
(0.01)
|
|
$
|
(0.16)
|
|
$
|
(0.11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
43,202,751
|
|
|
41,991,578
|
|
#
|
43,153,598
|
|
|
41,868,944
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
$
|
40,818
|
|
$
|
33,040
|
|
$
|
86,555
|
|
$
|
65,483
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
(6,494)
|
|
|
(5,766)
|
|
|
(12,450)
|
|
|
(10,781)
|
Stock-based compensation
|
|
|
(2,074)
|
|
|
(2,068)
|
|
|
(4,340)
|
|
|
(4,013)
|
Intangible asset
amortization
|
|
|
(2,942)
|
|
|
(2,942)
|
|
|
(5,885)
|
|
|
(7,086)
|
Non-GAAP Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
excluding Cost of goods
sold
|
|
$
|
29,308
|
|
$
|
22,264
|
|
$
|
63,880
|
|
$
|
43,603
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
6,700
|
|
$
|
5,946
|
|
$
|
14,248
|
|
$
|
10,424
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
(489)
|
|
|
(603)
|
|
|
(1,013)
|
|
|
(1,227)
|
Non-GAAP Research and
development
|
|
$
|
6,211
|
|
$
|
5,343
|
|
$
|
13,235
|
|
$
|
9,197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
$
|
24,682
|
|
$
|
18,386
|
|
$
|
53,972
|
|
$
|
37,192
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
(1,585)
|
|
|
(1,465)
|
|
|
(3,327)
|
|
|
(2,786)
|
Non-GAAP Selling,
general and administrative
|
|
$
|
23,097
|
|
$
|
16,921
|
|
$
|
50,645
|
|
$
|
34,406
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPANY CONTACT:
Jim Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.