WASHINGTON, Aug. 2, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced
financial and operational results for the second quarter ended
June 30, 2017.
"During the second quarter of 2017, we advanced our company
growth strategy and delivered strong operational and financial
results," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO.
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $42.1 million
during the second quarter of 2017, a 12% increase compared to
$37.4 million in the first quarter of
2017 and a 17% increase compared to $36.0
million in the second quarter of 2016.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $22.5 million in the second quarter of 2017, a
12% increase compared to $20.2
million in the first quarter of 2017 and a 29% increase
compared to $17.5 million in the
second quarter of 2016.
- In July 2017, the Fanapt US field
force began promoting HETLIOZ® to psychiatrists for
their sighted Non-24 patients.
- Price negotiations for HETLIOZ® in Germany are expected to conclude by year-end
2017.
Fanapt® (iloperidone)
- Fanapt® net product sales grew to $19.5 million in the second quarter of 2017, a
13% increase compared to $17.2
million in the first quarter of 2017 and a 5% increase
compared to $18.6 million in the
second quarter of 2016.
- Fanapt® prescriptions, as reported by IMS, were
28,228 in the second quarter of 2017, a 1% decline compared to the
first quarter of 2017.
Research and Development
HETLIOZ®
- Enrollment of patients in the Jet Lag Disorder clinical program
is ongoing. Results are expected in the second half of 2017.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing. Results are expected in 2018.
- A pharmacokinetic study of the HETLIOZ® pediatric
formulation is enrolling. The study is expected to be fully
enrolled by the end of 2017.
Fanapt®
- During July 2017, the European
Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) adopted a negative opinion recommending against the
marketing authorization of Fanaptum® (oral iloperiodone
tablets) for the treatment of schizophrenia in adults. Vanda has
requested a re-examination by the CHMP.
Tradipitant
- Enrollment in a tradipitant clinical study for the treatment of
chronic pruritus in patients with atopic dermatitis is complete.
Results are expected in the third quarter of 2017.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected in the first half of 2018.
Cash, cash equivalents and marketable securities (Cash) were
$137.1 million as of June 30, 2017, representing a decrease to Cash of
$0.6 million during the second
quarter of 2017.
Non-GAAP Financial Results
For the second quarter of 2017, Non-GAAP net income was
$1.6 million, or $0.03 per share, compared to a Non-GAAP net
income of $0.4 million, or
$0.01 per share, for the second
quarter of 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."
2017 Financial Guidance
Vanda reiterates its prior 2017 financial guidance and 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(2)
|
|
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.
|
|
(2) Results are
expected to be at the lower end of the guidance
range.
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, August 2, 2017, at 4:30 PM ET. During the call, Vanda's
management will discuss the second quarter 2017 financial results
and other corporate activities. Investors can call 1-888-771-4371
(domestic) or 1-847-585-4405 (international) and use passcode
45253483. A replay of the call will be available on Wednesday, August 2, 2017, beginning at
7:00 PM ET and will be accessible
until Wednesday, August 9, 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 45253483.
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 request to the European Medicines
Agency's Committee for Medicinal Products for Human Use to review
the negative opinion recommending against the marketing
authorization for oral Fanaptum® 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 March 31, 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 quarterly
report on Form 10-Q for the fiscal quarter ended June 30, 2017, to be filed with the SEC in the
third 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
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
22,507
|
|
$
|
17,460
|
|
$
|
42,689
|
|
$
|
33,661
|
|
Fanapt®product sales, net
|
|
|
|
19,549
|
|
|
18,569
|
|
|
36,782
|
|
|
35,630
|
|
|
Total
revenues
|
|
|
|
|
42,056
|
|
|
36,029
|
|
|
79,471
|
|
|
69,291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
4,529
|
|
|
6,494
|
|
|
8,532
|
|
|
12,450
|
|
Research and
development
|
|
|
|
7,648
|
|
|
6,700
|
|
|
18,215
|
|
|
14,248
|
|
Selling, general and
administrative
|
|
|
|
31,371
|
|
|
24,682
|
|
|
61,668
|
|
|
53,972
|
|
Intangible asset
amortization
|
|
|
|
432
|
|
|
2,942
|
|
|
886
|
|
|
5,885
|
|
|
Total operating
expenses
|
|
|
|
43,980
|
|
|
40,818
|
|
|
89,301
|
|
|
86,555
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
(1,924)
|
|
|
(4,789)
|
|
|
(9,830)
|
|
|
(17,264)
|
|
Other
income
|
|
|
|
|
397
|
|
|
171
|
|
|
677
|
|
|
288
|
|
Loss before income
taxes
|
|
|
|
|
(1,527)
|
|
|
(4,618)
|
|
|
(9,153)
|
|
|
(16,976)
|
|
Provision for income
taxes
|
|
|
|
7
|
|
|
-
|
|
|
26
|
|
|
-
|
|
Net loss
|
|
|
|
$
|
(1,534)
|
|
$
|
(4,618)
|
|
$
|
(9,179)
|
|
$
|
(16,976)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
|
$
|
(0.03)
|
|
$
|
(0.11)
|
|
$
|
(0.21)
|
|
$
|
(0.39)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding,basic and diluted
|
44,718,597
|
|
|
43,202,751
|
|
|
44,559,368
|
|
|
43,153,598
|
|
VANDA
PHARMACEUTICALS INC.
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(in
thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30
2017
|
|
December 31
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
14,232
|
|
$
|
40,426
|
|
|
Marketable
securities
|
|
|
|
|
122,886
|
|
|
100,914
|
|
|
Accounts receivable,
net
|
|
|
|
21,024
|
|
|
20,268
|
|
|
Inventory
|
|
|
|
|
|
742
|
|
|
779
|
|
|
Prepaid expenses and
other current assets
|
|
|
15,725
|
|
|
11,788
|
|
|
|
Total current
assets
|
|
|
|
|
174,609
|
|
|
174,175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
5,709
|
|
|
5,015
|
|
Intangible assets,
net
|
|
|
|
|
26,933
|
|
|
27,819
|
|
Non-current inventory
and other
|
|
|
|
3,420
|
|
|
3,365
|
|
|
|
Total
assets
|
|
|
|
$
|
210,671
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
19,126
|
|
$
|
16,196
|
|
|
Accrued government
and other rebates
|
|
|
31,310
|
|
|
34,124
|
|
|
Milestone obligation
under license agreement
|
|
|
|
|
25,000
|
|
|
-
|
|
|
|
Total current
liabilities
|
|
|
|
75,436
|
|
|
50,320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
|
|
-
|
|
|
25,000
|
|
|
Other non-current
liabilities
|
|
|
|
3,817
|
|
|
3,724
|
|
|
|
Total
liabilities
|
|
|
|
|
79,253
|
|
|
79,044
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
45
|
|
|
44
|
|
|
Additional paid-in
capital
|
|
|
|
|
486,400
|
|
|
477,087
|
|
|
Accumulated other
comprehensive income
|
|
|
11
|
|
|
58
|
|
|
Accumulated
deficit
|
|
|
|
|
(355,038)
|
|
|
(345,859)
|
|
|
|
Total stockholders'
equity
|
|
|
|
131,418
|
|
|
131,330
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
210,671
|
|
$
|
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
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
Net loss
|
|
|
|
|
|
$
|
(1,534)
|
|
$
|
(4,618)
|
|
$
|
(9,179)
|
|
$
|
(16,976)
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
2,656
|
|
|
2,074
|
|
|
4,912
|
|
|
4,340
|
|
Intangible asset
amortization
|
|
|
|
432
|
|
|
2,942
|
|
|
886
|
|
|
5,885
|
|
Non-GAAP Net income
(loss)
|
|
|
$
|
1,554
|
|
$
|
398
|
|
$
|
(3,381)
|
|
$
|
(6,751)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.03
|
|
$
|
0.01
|
|
$
|
(0.08)
|
|
$
|
(0.16)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
44,718,597
|
|
|
43,202,751
|
|
|
44,559,368
|
|
|
43,153,598
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
$
|
43,980
|
|
$
|
40,818
|
|
$
|
89,301
|
|
$
|
86,555
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(4,529)
|
|
|
(6,494)
|
|
|
(8,532)
|
|
|
(12,450)
|
|
Stock-based
compensation
|
|
|
|
(2,656)
|
|
|
(2,074)
|
|
|
(4,912)
|
|
|
(4,340)
|
|
Intangible asset
amortization
|
|
|
|
(432)
|
|
|
(2,942)
|
|
|
(886)
|
|
|
(5,885)
|
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
$
|
36,363
|
|
$
|
29,308
|
|
$
|
74,971
|
|
$
|
63,880
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
$
|
7,648
|
|
$
|
6,700
|
|
$
|
18,215
|
|
$
|
14,248
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(285)
|
|
|
(489)
|
|
|
(694)
|
|
|
(1,013)
|
|
Non-GAAP Research and
development
|
|
|
$
|
7,363
|
|
$
|
6,211
|
|
$
|
17,521
|
|
$
|
13,235
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
$
|
31,371
|
|
$
|
24,682
|
|
$
|
61,668
|
|
$
|
53,972
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(2,371)
|
|
|
(1,585)
|
|
|
(4,218)
|
|
|
(3,327)
|
|
Non-GAAP Selling,
general and administrative
|
|
$
|
29,000
|
|
$
|
23,097
|
|
$
|
57,450
|
|
$
|
50,645
|
COMPANY CONTACT:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
View original
content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2017-financial-results-300498617.html
SOURCE Vanda Pharmaceuticals Inc.