WASHINGTON, Feb. 15, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced
financial and operational results for the fourth quarter and full
year ended December 31, 2016.
"2016 was an exceptional year for Vanda as we continued to
demonstrate strong growth in our commercial business and secured
long-term exclusivity for Fanapt," said Mihael H. Polymeropoulos, M.D., Vanda's
President and CEO. "In addition, our emerging pipeline with
important 2017 milestones underscores Vanda's commitment to
bringing important new treatment options to patients and the
creation of shareholder value."
Key Highlights:
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $19.3 million in the fourth quarter of 2016, a 3%
increase compared to $18.7 million in
the third quarter of 2016 and a 27% increase compared to
$15.1 million in the fourth quarter
of 2015.
- HETLIOZ® net product sales were $71.7 million for the full year 2016, a 62%
increase compared to $44.3 million
for the full year 2015.
Fanapt® (iloperidone)
- Fanapt® net product sales were $18.9 million for the fourth quarter of 2016, a
4% decrease compared to $19.8 million
in the third quarter of 2016 and a 13% increase compared to
$16.7 million in the fourth quarter
of 2015.
- Fanapt® net product sales were $74.3 million for the full year 2016, a 13%
increase compared to $65.6 million
for the full year 2015.
- An expansion of the Fanapt® U.S. field sales team is
expected to be completed during the first quarter of 2017.
Cash, cash equivalents and marketable securities (Cash) were
$141.3 million as of December 31, 2016, representing a decrease to
Cash of $1.8 million during 2016.
Research and Development Progress and Objectives
HETLIOZ®
- Enrollment of patients for a Jet Lag Disorder clinical study is
ongoing. Results are expected in the second half of 2017.
- Enrollment in the Smith-Magenis Syndrome (SMS) clinical study
is ongoing with results expected in 2018.
- A pharmacokinetic study of the HETLIOZ® pediatric
formulation is enrolling with results expected in 2018.
Fanapt®
- The Marketing Authorization Application (MAA) for oral
Fanaptum® tablets is under evaluation by the European
Medicines Agency for the treatment of schizophrenia in adults. A
decision on the Fanaptum® MAA is expected during the
second half of 2017.
- An assessment of new Fanapt® clinical opportunities
is ongoing.
Tradipitant
- Enrollment in a tradipitant clinical study for the treatment of
chronic pruritus in patients with atopic dermatitis is approaching
completion. Results are expected in mid 2017.
- A tradipitant clinical study for the treatment of gastroparesis
began enrolling patients in the fourth quarter of 2016. Results are
expected in the fourth quarter of 2017.
Trichostatin A
- Vanda expects to submit an investigational new drug application
to the FDA in mid 2017 for trichostatin A, which will seek
clearance to begin a clinical study of hematologic
malignancies.
Non-GAAP Financial Results
For the fourth quarter of 2016, Non-GAAP net income was
$3.6 million, compared to a Non-GAAP
net loss of $10.0 million for the
fourth quarter of 2015. Vanda Non-GAAP net income was
$1.5 million for the full year 2016,
compared to a Non-GAAP net loss of $18.9
million for the full year 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 entitled "Non-GAAP Financial Information" and
"Reconciliation of GAAP to Non-GAAP Financial Information."
2017 Financial Guidance
Vanda expects to achieve the following financial objectives in
2017:
Financial
Objectives
|
2017
Guidance
|
Combined net product
sales from
both HETLIOZ® and Fanapt®
|
$165 to $175
million
|
HETLIOZ®
net product sales
|
$88 to $93
million
|
Fanapt®
net product sales
|
$77 to $82
million
|
Non-GAAP Operating
expenses,
excluding Cost of goods sold(1)
|
$162 to $172
million
|
Intangible asset
amortization
|
$1.7
million
|
Stock-based
compensation
|
$9 to $12
million
|
Year-end 2017
Cash
|
$121 to $141
million
|
|
(1) Non-GAAP
Operating expenses, excludes cost of goods sold, intangible asset
amortization and stock-based compensation.
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 15, 2017, at 4:30 PM ET. During the call, Vanda's
management will discuss the fourth quarter and full year 2016
financial results and other corporate activities. Investors
can call 1-888-771-4371 (domestic) or 1-847-585-4405
(international) and use passcode 44159815. A replay of the
call will be available on Wednesday,
February 15, 2017, beginning at 7:00
PM ET and will be accessible until Wednesday, February 22, 2017, 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 44159815.
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 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.
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 global biopharmaceutical company focused on the
development and commercialization of innovative 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 "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, 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.
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
|
December
31
|
|
December
31
|
|
December
31
|
|
December
31
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®
product sales, net
|
|
|
$
|
19,295
|
|
$
|
15,143
|
|
$
|
71,671
|
|
$
|
44,302
|
Fanapt®
product sales, net
|
|
|
|
18,949
|
|
|
16,706
|
|
|
74,346
|
|
|
65,623
|
Total
revenues
|
|
|
|
38,244
|
|
|
31,849
|
|
|
146,017
|
|
|
109,925
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
5,272
|
|
|
6,171
|
|
|
24,712
|
|
|
23,462
|
Research and
development
|
|
|
|
7,614
|
|
|
8,747
|
|
|
29,156
|
|
|
29,145
|
Selling, general and
administrative
|
|
|
|
23,907
|
|
|
28,881
|
|
|
99,787
|
|
|
84,531
|
Intangible asset
amortization
|
|
|
|
2,105
|
|
|
2,943
|
|
|
10,933
|
|
|
12,972
|
Total operating
expenses
|
|
|
|
38,898
|
|
|
46,742
|
|
|
164,588
|
|
|
150,110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(654)
|
|
|
(14,893)
|
|
|
(18,571)
|
|
|
(40,185)
|
Other
income
|
|
|
|
154
|
|
|
95
|
|
|
665
|
|
|
320
|
Loss before income
taxes
|
|
|
|
(500)
|
|
|
(14,798)
|
|
|
(17,906)
|
|
|
(39,865)
|
Provision for income
taxes
|
|
|
|
104
|
|
|
-
|
|
|
104
|
|
|
-
|
Net loss
|
|
|
$
|
(604)
|
|
$
|
(14,798)
|
|
$
|
(18,010)
|
|
$
|
(39,865)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
$
|
(0.01)
|
|
$
|
(0.35)
|
|
$
|
(0.41)
|
|
$
|
(0.94)
|
Diluted
|
|
|
$
|
(0.01)
|
|
$
|
(0.35)
|
|
$
|
(0.41)
|
|
$
|
(0.94)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
43,968,730
|
|
|
42,815,291
|
|
|
43,449,441
|
|
|
42,250,254
|
Diluted
|
|
|
|
43,968,730
|
|
|
42,815,291
|
|
|
43,449,441
|
|
|
42,250,254
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
December 31
2016
|
|
December 31
2015
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
40,426
|
|
$
|
50,843
|
Marketable
securities
|
|
|
|
100,914
|
|
|
92,337
|
Accounts receivable,
net
|
|
|
|
20,268
|
|
|
16,331
|
Inventory
|
|
|
|
779
|
|
|
1,294
|
Prepaid expenses and
other current assets
|
|
|
|
11,788
|
|
|
5,742
|
Total current
assets
|
|
|
|
174,175
|
|
|
166,547
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
5,015
|
|
|
4,570
|
Intangible assets,
net
|
|
|
|
27,819
|
|
|
38,752
|
Non-current inventory
and other
|
|
|
|
3,365
|
|
|
3,181
|
Total
assets
|
|
|
$
|
210,374
|
|
$
|
213,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
|
$
|
16,196
|
|
$
|
15,767
|
Accrued government and
other rebates
|
|
|
|
34,124
|
|
|
35,550
|
Total current
liabilities
|
|
|
|
50,320
|
|
|
51,317
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
|
|
25,000
|
|
|
25,000
|
Other non-current
liabilities
|
|
|
|
3,724
|
|
|
3,706
|
Total
liabilities
|
|
|
|
79,044
|
|
|
80,023
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
44
|
|
|
43
|
Additional paid-in
capital
|
|
|
|
477,087
|
|
|
460,794
|
Accumulated other
comprehensive income
|
|
|
|
58
|
|
|
39
|
Accumulated
deficit
|
|
|
|
(345,859)
|
|
|
(327,849)
|
Total stockholders'
equity
|
|
|
|
131,330
|
|
|
133,027
|
Total liabilities and
stockholders' equity
|
|
|
$
|
210,374
|
|
$
|
213,050
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
|
|
December
31
|
|
December
31
|
|
December
31
|
|
December
31
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Net loss
|
|
$
|
(604)
|
|
$
|
(14,798)
|
|
$
|
(18,010)
|
|
$
|
(39,865)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
2,103
|
|
|
1,887
|
|
|
8,543
|
|
|
7,961
|
Intangible asset
amortization
|
|
|
2,105
|
|
|
2,943
|
|
|
10,933
|
|
|
12,972
|
Non-GAAP Net income
(loss)
|
|
$
|
3,604
|
|
$
|
(9,968)
|
|
$
|
1,466
|
|
$
|
(18,932)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.08
|
|
$
|
(0.23)
|
|
$
|
0.03
|
|
$
|
(0.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
43,968,730
|
|
|
42,815,291
|
|
|
43,449,441
|
|
|
42,250,254
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
$
|
38,898
|
|
$
|
46,742
|
|
$
|
164,588
|
|
$
|
150,110
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
(5,272)
|
|
|
(6,171)
|
|
|
(24,712)
|
|
|
(23,462)
|
Stock-based
compensation
|
|
|
(2,103)
|
|
|
(1,887)
|
|
|
(8,543)
|
|
|
(7,961)
|
Intangible asset
amortization
|
|
|
(2,105)
|
|
|
(2,943)
|
|
|
(10,933)
|
|
|
(12,972)
|
Non-GAAP Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
excluding Cost of
goods sold
|
|
$
|
29,418
|
|
$
|
35,741
|
|
$
|
120,400
|
|
$
|
105,715
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,614
|
|
$
|
8,747
|
|
$
|
29,156
|
|
$
|
29,145
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(535)
|
|
|
(526)
|
|
|
(2,087)
|
|
|
(2,269)
|
Non-GAAP Research and
development
|
|
$
|
7,079
|
|
$
|
8,221
|
|
$
|
27,069
|
|
$
|
26,876
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
$
|
23,907
|
|
$
|
28,881
|
|
$
|
99,787
|
|
$
|
84,531
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(1,568)
|
|
|
(1,361)
|
|
|
(6,456)
|
|
|
(5,692)
|
Non-GAAP Selling,
general and administrative
|
|
$
|
22,339
|
|
$
|
27,520
|
|
$
|
93,331
|
|
$
|
78,839
|
COMPANY CONTACT:
Jim Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-fourth-quarter-2016-and-full-year-2016-financial-results-300408203.html
SOURCE Vanda Pharmaceuticals Inc.