WASHINGTON, Feb. 14, 2018
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:
VNDA) today announced financial and operational results for the
fourth quarter and full year ended December
31, 2017.
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $44.3 million
in the fourth quarter of 2017, a 7% increase compared to
$41.3 million in the third quarter of
2017 and a 16% increase compared to $38.2
million in the fourth quarter of 2016.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales were $25.0 million in the fourth quarter of 2017, a
12% increase compared to $22.3
million in the third quarter of 2017 and a 30% increase
compared to $19.3 million in the
fourth quarter of 2016.
Fanapt® (iloperidone)
- Fanapt® net product sales were $19.3 million in the fourth quarter of 2017, a 1%
increase compared to $19.1 million in
the third quarter of 2017 and a 2% increase compared to
$18.9 million in the fourth quarter
of 2016.
- Fanapt® prescriptions, as reported by IQVIA, were
28,159 in the fourth quarter of 2017, a 1% increase compared to the
third quarter of 2017, which represents the first quarter to
demonstrate sequential growth since the second quarter of
2014.
Research and Development
Tradipitant
- A tradipitant for atopic dermatitis Phase III clinical study is
expected to begin in the first half of 2018.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected by the end of 2018.
HETLIOZ®
- HETLIOZ® studies for the treatment of jet lag
disorder (2102 and 3107) have each completed enrollment. Results
from the jet lag disorder clinical program are expected in the
first quarter of 2018.
- Enrollment in a pharmacokinetic study of the
HETLIOZ® pediatric liquid formulation was completed in
the fourth quarter of 2017.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing. Results are expected by the end of 2018.
VTR-297 (histone deactetylase (HDAC) inhibitor)
- A VTR-297 Phase I study (1101) in patients with hematologic
malignancies is expected to start in the second half of 2018.
Cash, cash equivalents and marketable securities (Cash) were
$143.4 million as of December 31, 2017, representing an increase to
Cash of $2.1 million during 2017.
Non-GAAP Financial Results
Non-GAAP net income was $1.4
million for the fourth quarter of 2017, or $0.03 per share, compared to a Non-GAAP net
income of $3.6 million, or
$0.08 per share, for the fourth
quarter of 2016. Vanda Non-GAAP net loss was $3.4 million for the full year 2017, compared to
a Non-GAAP net income of $1.5 million
for the full year 2016.
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" for more
detailed information regarding Non-GAAP financial information.
2018 Financial Guidance
Vanda expects to achieve the following financial objectives in
2018:
Full Year
2018
Financial
Objectives
|
Full Year
2018 Guidance
|
Combined net product
sales from both HETLIOZ® and
Fanapt®
|
$180 to $200
million
|
HETLIOZ®
net product sales
|
$108 to $118
million
|
Fanapt®
net product sales
|
$72 to $82
million
|
Non-GAAP Operating
expenses, excluding Cost of goods sold(1)
|
$163 to $173
million
|
Intangible asset
amortization
|
$1.7
million
|
Stock-based
compensation
|
$11 to $15
million
|
Year-end 2018
Cash(2)
|
$115 to $125
million
|
(1) Non-GAAP
Operating expenses, excludes Cost of goods sold, intangible asset
amortization and stock-based compensation.
|
(2) Year-end 2018
Cash includes the expected payment of a $25 million milestone
obligation based on cumulative HETLIOZ® net product
sales.
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 14, 2018, at 4:30 PM ET. During the call, Vanda's
management will discuss the fourth quarter and full year 2017
financial results and other corporate activities. Investors can
call 1-888-771-4371 (domestic) or 1-847-585-4405 (international)
and use passcode 46291578. A replay of the call will be available
on Wednesday, February 14, 2018,
beginning at 7:00 PM ET and will be
accessible until Wednesday, February 21,
2018, 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
46291578.
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 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.
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 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, Vanda's assumptions regarding its
ability to continue to grow its business in the U.S. through the
HETLIOZ® to Psychiatrists Initiative, among other means,
Vanda's ability to complete the clinical development and obtain
regulatory approval of tradipitant for the treatment of atopic
dermatitis, 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,
2016 and quarterly report on Form 10-Q for the fiscal
quarter ended September 30, 2017,
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, 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.
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
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®
product sales, net
|
|
|
$
|
25,010
|
|
$
|
19,295
|
|
$
|
89,978
|
|
$
|
71,671
|
|
Fanapt®
product sales, net
|
|
|
|
19,266
|
|
|
18,949
|
|
|
75,105
|
|
|
74,346
|
|
|
Total
revenues
|
|
|
|
|
44,276
|
|
|
38,244
|
|
|
165,083
|
|
|
146,017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
4,791
|
|
|
5,272
|
|
|
17,848
|
|
|
24,712
|
|
Research and
development
|
|
|
|
10,154
|
|
|
7,614
|
|
|
38,547
|
|
|
29,156
|
|
Selling, general and
administrative
|
|
31,049
|
|
|
23,907
|
|
|
123,841
|
|
|
99,787
|
|
Intangible asset
amortization
|
|
|
|
432
|
|
|
2,105
|
|
|
1,750
|
|
|
10,933
|
|
|
Total operating
expenses
|
|
|
|
46,426
|
|
|
38,898
|
|
|
181,986
|
|
|
164,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
(2,150)
|
|
|
(654)
|
|
|
(16,903)
|
|
|
(18,571)
|
|
Other
income
|
|
|
|
|
399
|
|
|
154
|
|
|
1,472
|
|
|
665
|
Loss before income
taxes
|
|
|
|
|
(1,751)
|
|
|
(500)
|
|
|
(15,431)
|
|
|
(17,906)
|
|
Provision for income
taxes
|
|
|
|
87
|
|
|
104
|
|
|
136
|
|
|
104
|
Net loss
|
|
|
|
$
|
(1,838)
|
|
$
|
(604)
|
|
$
|
(15,567)
|
|
$
|
(18,010)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.04)
|
|
$
|
(0.01)
|
|
$
|
(0.35)
|
|
$
|
(0.41)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic and diluted
|
|
44,930,832
|
|
|
43,968,730
|
|
|
44,735,146
|
|
|
43,449,441
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31
2017
|
|
December 31
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
33,627
|
|
$
|
40,426
|
|
|
Marketable
securities
|
|
109,786
|
|
|
100,914
|
|
|
Accounts receivable,
net
|
|
17,601
|
|
|
20,268
|
|
|
Inventory
|
|
840
|
|
|
779
|
|
|
Prepaid expenses and
other current assets
|
|
8,003
|
|
|
11,788
|
|
|
|
Total current
assets
|
|
169,857
|
|
|
174,175
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
5,306
|
|
|
5,015
|
|
Intangible assets,
net
|
|
26,069
|
|
|
27,819
|
|
Non-current inventory
and other
|
|
4,193
|
|
|
3,365
|
|
|
|
Total
assets
|
$
|
205,425
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
20,335
|
|
$
|
16,196
|
|
|
Accrued government
and other rebates
|
|
23,028
|
|
|
34,124
|
|
|
Milestone obligations
under license agreements
|
|
27,000
|
|
|
-
|
|
|
|
Total current
liabilities
|
|
70,363
|
|
|
50,320
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligations
under license agreements
|
|
-
|
|
|
25,000
|
|
|
Other non-current
liabilities
|
|
3,675
|
|
|
3,724
|
|
|
|
Total
liabilities
|
|
74,038
|
|
|
79,044
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Common
stock
|
|
45
|
|
|
44
|
|
|
Additional paid-in
capital
|
|
492,802
|
|
|
477,087
|
|
|
Accumulated other
comprehensive income (loss)
|
|
(34)
|
|
|
58
|
|
|
Accumulated
deficit
|
|
|
(361,426)
|
|
|
(345,859)
|
|
|
|
Total stockholders'
equity
|
|
131,387
|
|
|
131,330
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
205,425
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Net loss
|
$
|
(1,838)
|
|
$
|
(604)
|
|
$
|
(15,567)
|
|
$
|
(18,010)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
2,782
|
|
|
2,103
|
|
|
10,465
|
|
|
8,543
|
|
Intangible asset
amortization
|
|
432
|
|
|
2,105
|
|
|
1,750
|
|
|
10,933
|
Non-GAAP Net income
(loss)
|
$
|
1,376
|
|
$
|
3,604
|
|
$
|
(3,352)
|
|
$
|
1,466
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
$
|
0.03
|
|
$
|
0.08
|
|
$
|
(0.07)
|
|
$
|
0.03
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
44,930,832
|
|
|
43,968,730
|
|
|
44,735,146
|
|
|
43,449,441
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
$
|
46,426
|
|
$
|
38,898
|
|
$
|
181,986
|
|
$
|
164,588
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
(4,791)
|
|
|
(5,272)
|
|
|
(17,848)
|
|
|
(24,712)
|
|
Stock-based
compensation
|
|
(2,782)
|
|
|
(2,103)
|
|
|
(10,465)
|
|
|
(8,543)
|
|
Intangible asset
amortization
|
|
(432)
|
|
|
(2,105)
|
|
|
(1,750)
|
|
|
(10,933)
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
$
|
38,421
|
|
$
|
29,418
|
|
$
|
151,923
|
|
$
|
120,400
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
10,154
|
|
$
|
7,614
|
|
$
|
38,547
|
|
$
|
29,156
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(194)
|
|
|
(535)
|
|
|
(1,152)
|
|
|
(2,087)
|
Non-GAAP Research and
development
|
$
|
9,960
|
|
$
|
7,079
|
|
$
|
37,395
|
|
$
|
27,069
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
|
31,049
|
|
$
|
23,907
|
|
$
|
123,841
|
|
$
|
99,787
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(2,588)
|
|
|
(1,568)
|
|
|
(9,313)
|
|
|
(6,456)
|
Non-GAAP Selling,
general and administrative
|
$
|
28,461
|
|
$
|
22,339
|
|
$
|
114,528
|
|
$
|
93,331
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPANY CONTACT:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-fourth-quarter-2017-and-full-year-2017-financial-results-300598894.html
SOURCE Vanda Pharmaceuticals Inc.